How to Take MICRONOR (Progestin-Only Pills):

1. READ THESE DIRECTIONS
   • before you start taking your pills, and
   • any time you are not sure what to do.
2. LOOK AT YOUR PILL PACK
3. 28-PILL PACK: 28 active pills (with a hormone) taken daily for 28 days.
4. ALSO CHECK: the pill pack for instructions on 1) where to start and 2) direction to take pills (see package insert for illustration).
5. You may wish to use a second method of birth control (e.g., latex or polyurethane condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a backup in case pills are forgotten while you are getting used to taking them.
6. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
7. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST THREE MONTHS ON THE PILL. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic. The most common side effect of progestin-only pills is a change in menstrual bleeding. Your period may be either late or early and you may have some spotting.
8. MISSING PILLS ALSO CAN CAUSE SOME SPOTTING OR LIGHT BLEEDING, even if you make up the missed pills. You also could feel a little sick to your stomach on the days you take two pills to make up for missed pills.
9. IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT. THE GREATEST RISKS FOR PREGNANCY ARE:
   • when you start a pack late, or
   • if you are more than 3 hours late or you miss one or more progestin-only pills.
10. ALWAYS BE SURE YOU HAVE READY:
    • ANOTHER KIND OF BIRTH CONTROL (such as latex or polyurethane condoms and spermicidal foam or gel) to use as a backup in case you miss pills, and
    • AN EXTRA, FULL PACK OF PILLS.
11. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, your pills may not work as well. Use a backup method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
12. IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.
13. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.
14. IF YOUR QUESTIONS ARE NOT ANSWERED HERE, CALL YOUR DOCTOR OR CLINIC.

When to Start the First Pack of Pills:

BE SURE TO READ THESE INSTRUCTIONS:

• before you start taking your pills, and
• any time you are not sure what to do.

YOUR MICRONOR TABLETS ARE IN A 28-DAY PILL PACKAGE. With this type of birth control pill, you take 28 pills which contain only one hormone, a progestin.

STARTING PROGESTIN-ONLY PILLS

1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. With MICRONOR Tablets, it is best to start your first package of progestin-only pills on the first day of your menstrual period (Day 1)†. Then you simply continue taking one tablet every single day until your package is empty. Without missing a day, start taking MICRONOR Tablets from your new package.
2. If you have had a miscarriage or an abortion, you can start progestin-only pills the next day.
3. Take one pill at the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS. Your period should occur during the last seven days of using that pill pack. MICRONOR Tablets are taken every day, even when you are having some menstrual bleeding.

INSTRUCTIONS FOR USING YOUR DISCREET PACKAGE. FOLLOW THESE INSTRUCTIONS CAREFULLY:

1. For Day 1 start: Label the DISCREET Package by selecting the day label that starts with Day 1 of your menstrual period (the first day of menstruation is Day 1). For example, if your first day of menstruation is Tuesday, attach the day label that begins with TUEin the space provided.
2. OR
3. For Sunday start: No day label is required. The DISCREET Package is printed for a Sunday start. (The first Sunday after your period begins, or, if your period starts on Sunday, start that same day.)
4. Place the day label in the space where you see the words "Place day label here". Having the DISCREET Package labelled with the days of the week will help remind you to take your pill every day.
5. To begin taking your pills, start with the pill inside the red circle (where you see the word START). This pill should correspond to the day of the week that you are taking your first pill. To remove the pill, push through the back of the DISCREET Package.
6. On the following day, take the next pill in the same row, always proceeding from left to right (→). Each row will always begin on the same day of the week.

If you are Breast-Feeding:

1. If you are fully breast-feeding (not giving your baby any food or formula), you may start taking your pills 6 weeks after delivery.

• If you are partially breast-feeding (giving your baby some food or formula), you should start taking your pills 3 weeks after delivery.

If you are Switching Pills:

If you are switching from the combined pills to progestin-only pills, and you were on a 21-Day regimen, take the first progestin-only pill the day after you finish the last active combined pill. If you have been on a 28-Day regimen, do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to progestin-only pills, but this is normal and to be expected.

1. If you are switching from progestin-only pills to the combined pills, take the first active combined pill on the first day of your period, even if your progestin-only pill pack is not finished.
2. If you are breast-feeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breast-feeding or at least until 6 months after delivery.

What to do During the Month:

1. TAKE A PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Progestin-only pills must be taken at the same time every day since its action is time dependent. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
   • Try to associate taking your pill with some regular activity such as eating a meal or going to bed.
   • Do not skip pills even if you have bleeding between monthly periods or feel sick to your stomach (nausea).
   • Do not skip pills even if you do not have sex very often.
2. WHEN YOU FINISH A PACK OF 28 PILLS

• Start the next pack ON THE NEXT DAY. Take one pill every day. Do not wait any days between packs.

Overdose:

Symptoms of overdose may include nausea, vomiting or vaginal bleeding. Available information from cases of accidental ingestion of oral contraceptives by children indicates no serious effects.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

IF YOU ARE MORE THAN 3 HOURS LATE OR MISS TAKING YOUR PROGESTIN-ONLY PILLS

1. Take a missed pill as soon as you remember you missed it.
2. Then go back to taking progestin-only pills at your regular time.
3. But be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.

If you are not sure what to do about the pills you have missed, keep taking progestin-only pills and use a backup method until you can talk to your doctor or clinic.

Always be sure you have on hand:

• a backup method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) in case you miss pills, and
• an extra, full pack of pills.

IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, TALK TO YOUR DOCTOR OR CLINIC about ways to make pill-taking easier or about using another method of birth control.

Some users of birth control pills have side effects. The most common side effect of progestin-only pills is a change in menstrual bleeding. Your periods may be either early or late. You may have some spotting between periods or you may not have a period. Taking pills late or missing pills can result in some spotting or bleeding.

Less common side effects of progestin-only pills include headaches, tender breasts, nausea, vomiting, tiredness, weight gain, dizziness, acne, extra hair on your face or body, loss of hair, rash, abdominal pain, yellowing of the skin or eyes (jaundice), and tubal pregnancy.

Serious Warnings and Precautions

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in hormonal contraceptive users older than 35 years of age. Women should not smoke.

Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS.

For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH the birth control pills.

There are also conditions that your doctor will want to watch closely or that might cause your doctor to recommend a method of contraception other than birth control pills.

BEFORE you use MICRONOR, talk to your doctor or pharmacist if the following apply to you:

• breast disease (e.g., breast lumps) or a family history of breast cancer
• diabetes
• cigarette smoking
• migraine headaches
• depression
• fibroid tumours of the uterus
• pregnant or breast-feeding
• plans for forthcoming surgery.

You should also inform your doctor about a family history of blood clots, heart attacks or strokes.

If you see a different doctor, inform him or her that you are using MICRONOR.

Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.

Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of MICRONOR four weeks before surgery and not using MICRONOR for a time period after surgery or during bed rest.

MICRONOR should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.

Use MICRONOR only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant. If you and your doctor decide that, for you, the benefits of MICRONOR outweigh the risks, you should be aware of the following risks:

The Risks of Using MICRONOR

1. Ectopic Pregnancy: An ectopic pregnancy is a pregnancy outside the womb. Because progestin-only pills protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking progestin-only pills, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.
2. Ovarian Cysts: These cysts are small sacs of fluid in the ovary. They are more common among progestin-only pill users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.
3. WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your doctor or clinic immediately.
4. Breast Cancer: Some studies in women who use combined oral contraceptives that contain both estrogen and progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There are data to determine that the use of progestin-only pills may also increase this risk.
5. In progestin-only pill (POP) users, the older the age at stopping, the more breast cancers are diagnosed.
6. The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include obesity, never having children, and having your first full-term pregnancy at a late age.
7. Some women who use birth control pills may be at increased risk of developing breast cancer before menopause which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start using birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small; however, a yearly breast examination by a doctor is recommended for all women.
8. ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.
9. Cervical Cancer: Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of progestin-only pills increases the risk of developing cancer of the cervix.
10. Liver Tumours: In rare cases, combined oral contraceptives can cause benign liver tumours. These benign liver tumours can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with combined oral contraceptives and liver cancers in studies in which a few women who developed these very rare cancers were found to have used combined oral contraceptives for long periods of time. There is insufficient data to determine whether progestin-only pills increase the risk of liver tumours.
11. Diabetic Women: Diabetic women taking progestin-only pills generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.
12. Use During Pregnancy: Birth control pills should never be taken if you think you are pregnant. They will not prevent the pregnancy from continuing. There is no evidence, however, that the progestin-only pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.
13. Use After Pregnancy, Miscarriage or An Abortion: Your doctor will advise you of the appropriate time to start the use ofMICRONOR after childbirth, miscarriage, or therapeutic abortion.
14. Pregnancy After Stopping MICRONOR: You will have a menstrual period when you stop taking MICRONOR. You should delay pregnancy until another menstrual period occurs within four to six weeks. Contact your doctor for recommendations on alternative methods of contraception during this time.
15. Use While Breast-feeding: In most women, progestin-only contraceptives, such as MICRONOR, do not affect the quantity and quality of breast milk or length of lactation. However, isolated post-marketing cases of decreased milk production have been reported. Studies with various orally administered progestin-only contraceptives have shown that small amounts of progestins pass into the breast milk of nursing mothers resulting in detectable steroid levels in infant plasma.
16. No adverse effects have been found on the health, growth or development of the infant.

Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. You may also need to use a nonhormonal method of contraception during any cycle in which you take drugs that can make oral contraceptives less effective.

Drugs that may interact with MICRONOR include:

• drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, carbamazepine, rufinamide);
• drugs used for the treatment of tuberculosis (e.g., rifampin, rifabutin);
• drugs used for the HIV/AIDS (e.g., nelfinavir, ritonavir-boosted protease inhibitors, darunavir, (fos)amprenavir, lopinavir, nevirapine);
• (fos)aprepitant (drug used for nausea);
• bosentan (drug used for pulmonary hypertension);
• antifungals (griseofulvin);
• the herbal remedy St. John's wort (primarily used for the treatment of depressive moods); and
• sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate).

The pill may also interfere with the working of other drugs.

Please inform your doctor and pharmacist if you are taking or have recently taken any other drugs or herbal products, even those without a prescription. Also tell any other doctor or dentist who prescribes another drug (or the dispensing pharmacist) that you use MICRONOR. They can tell you if you need to use an additional method of contraception and if so, for how long.

This is not a complete list of possible drug interactions with MICRONOR. Talk to your doctor for more information about drug interactions.

The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

Dosage must be adjusted to the individual needs of each patients. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40 to 100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose. Because of the potential for gastric irritation (see WARNINGS), Micro-K (potassium chloride extended-release) ® Extencaps® should be taken with meals and with a full glass of water or other liquid.

Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of cool water or juice to ensure complete swallowing of the microcapsules. The food used should not be hot and should be soft enough to be swallowed without chewing. Any microcapsule/food mixture should be used immediately and not stored for future use.

• Mezavant XL tablets are taken once a day, at the same time each day. The tablets should be taken with food.
• The tablets should be swallowed whole with a glass of water. They must not be broken, crushed or chewed, as this would damage the special coating of the tablets that allows them to work in the intestine.
• The number of tablets to take will vary from person to person. It is important to follow the instructions given by your doctor. These will also be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• If you forget to take a dose don't worry, just take your next daily dose as usual. Do not take a double dose to make up for a missed dose.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. The more serious side effects listed here occur rarely.

• Diarrhoea.
• Nausea and vomiting.
• Abdominal pain or bloating.
• Excess gas in the stomach and intestines (flatulence).
• Headache.
• Dizziness.
• Inflammation around the heart. Tell your doctor if you experience chest pains or palpitations.
• Decrease in the normal numbers of blood cells in the blood - see the warning section above for symptoms to look out for.
• Allergic skin rashes.
• Worsening of colitis symptoms.
• Pain in the muscles or joints.
• Hair loss.
• Inflammation of the pancreas (pancreatitis).
• Inflammation of the liver (hepatitis).
• Kidney problems, such as inflammation of the kidneys or kidney failure.
• Lung problems, such as shortness of breath, cough or breathing difficulties.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

• Your kidney and liver function should be checked before you start treatment with this medicine. Your kidney function should then be monitored every three months for the first year of treatment and at least once a year thereafter, or as your doctor feels necessary.
• This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you should consult your doctor immediately if you experience any of the following symptoms while using this medicine: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want to take a blood test to check your blood cells.
• There are several different brands and forms of mesalazine available in the UK (see end of factsheet). The way that the mesalazine is released from these different products varies and allows the mesalazine to be released in specific areas of the intestine. You will be prescribed the brand that allows the mesalazine to be released in the part of your intestine that needs it most. For this reason, it is important that you always use the same brand of mesalazine. You should make sure you know which brand you normally have and check that you have been given the correct one each time your medicine is dispensed. (Your pharmacist will usually ask you, or call your doctor if this is not written on your prescription).

Use with caution in

• Elderly people.
• Decreased kidney function.
• Decreased liver function.
• Asthma.
• People who are allergic to a related medicine called sulfasalazine.
• People with any narrowing or blockage of the stomach or the gut.

Not to be used in

• People who are allergic to salicylates (eg aspirin).
• People with blood disorders.
• Severely decreased kidney function.
• Severely decreased liver function.
• Mezavant XL tablets are not recommended for children under 18 years of age. There are other forms of mesalazine available for treating children - see end of page.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

There may be an increased risk of side effects on the blood cells if mesalazine is used in combination with azathioprine or mercaptopurine.

There may be an increased risk of side effects on the kidneys if mesalazine is used in combination with other medicines that can affect kidney function, for example non-steroidal anti-inflammatory painkillers (NSAIDs) such as diclofenac.

Use Mexitil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Mexitil with food or antacids.
• Take Mexitil regularly to receive the most benefit from it. Taking Mexitil at the same time each day will help you remember to take it.
• Continue to use Mexitil even if you feel well. Do not miss any doses.
• If you miss a dose of Mexitil, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mexitil.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; clumsiness; constipation; diarrhea; dizziness or lightheadedness; headache; heartburn; incoordination; nausea; nervousness; stomach discomfort; tremor; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision problems; chest pain; fainting; fever; irregular, fast, or slow heartbeat; severe dizziness or lightheadedness; severe stomach pain; sore throat; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

• Mexitil may cause dizziness, lightheadedness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Mexitil. Using Mexitil alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not suddenly stop taking Mexitil without checking with your doctor.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mexitil.
• LAB TESTS, including liver and heart function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Mexitil with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Mexitil, discuss with your doctor the benefits and risks of using Mexitil during pregnancy. Mexitil is excreted in breast milk. Do not breast-feed while taking Mexitil.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: caffeine, theophylline, drugs that may affect the acid level of urine (such as acetazolamide, sodium bicarbonate, large doses of vitamin C).

Other medications can affect the removal of mexiletine from your body, which may affect how mexiletine works. Examples include cimetidine, fluvoxamine, propafenone, rifampin, anti-seizure drugs (such as phenytoin, phenobarbital), among others.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Read the Medication Guide provided by your pharmacist before you start taking meloxicam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Drink a full glass of water (8 ounces/240 milliliters) with it unless your doctor tells you otherwise. Do not lie down for at least 10 minutes after taking this drug.

If you are taking the liquid form of this medication, shake the bottle gently before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. The dosage is based on your medical condition and response to treatment. The lowest effective dosage should always be used, and only for the prescribed length of time. Do not take more of this medication than prescribed because higher doses increase the chance of stomach ulcers/bleeding.

The capsule form of meloxicam delivers different amounts of medication than the tablet and solution forms. Do not switch between the capsule and other forms of meloxicam without your doctor's permission and directions.

It may take up to two weeks before you get the full benefit of this drug. Use this medication regularly to get the most benefit from it. Remember to use it at the same time each day.

Stomach upset, nausea, dizziness, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, persistent/severe headache, mental/mood changes, sudden/unexplained weight gain, swelling of the hands/feet, signs of kidney problems (such as change in the amount of urine), unexplained stiff neck, unusual tiredness.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Before taking meloxicam, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirinor other NSAIDs), liver disease, stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as history of heart attack), high blood pressure, stroke, blood disorders (such as anemia, bleeding/clotting problems), growths in the nose (nasal polyps).

Kidney problems can sometimes occur with the use of NSAID medications, including meloxicam. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

This medication may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medication, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially stomach bleeding and kidney problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE inhibitors(such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), cidofovir, lithium, methotrexate (high-dose treatment), "water pills" (diuretics such as furosemide).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

If you are using the liquid form of meloxicam, tell your doctor if you are also using sodium polystyrene sulfonate.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to meloxicam and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with food or milk if it upsets your stomach.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using MESTINON. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the canister of moisture-absorbing preservative that comes with this medicine.

Seek emergency medical attention or call the Poison Help.

Overdose symptoms may include nausea, vomiting, diarrhea, stomach cramps, sweating, blurred vision, drooling, and weak or shallow breathing.

Worsening muscle weakness, or no change in your myasthenia gravis symptoms, may also be signs of overdose.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using MESTINON and call your doctor at once if you have any of these serious side effects:

• extreme muscle weakness;
• loss of movement in any part of your body;
• weak or shallow breathing;
• slurred speech, vision problems; or
• worsening or no improvement in your symptoms of myasthenia gravis.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea;
• muscle cramps, twitching;
• sweating, increased salivation;
• cough with mucus;
• rash; or
• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You should not use MESTINON if you have a bladder or bowel obstruction.

You should not use MESTINON if you are allergic to it, or if you have a bladder or bowel obstruction.

To make sure you can safely take MESTINON, tell your doctor if you have any of these other conditions:

• asthma; or
• kidney disease.

FDA pregnancy category C. It is not known whether MESTINON will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether MESTINON passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

MESTINON is not approved for use by anyone younger than 18 years old.

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of MESTINON.

Other drugs may interact with MESTINON, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

MEGACE comes as a tablet, liquid, or concentrated liquid (MEGACE ES) to take by mouth.

The tablets and liquid are typically taken several times a day.

MEGACE ES is usually taken once a day.

Try to take this drug around the same time each day for optimal benefits.

Follow the instructions on your prescription label carefully. Don't take more or less MEGACE than your doctor recommends.

Shake the liquid forms of the medicine well before using. Measure the liquid doses with a special measuring spoon or medicine cup. Ask your pharmacist if you don't have this item.

MEGACE ES and MEGACE (liquid or tablet) contain different concentrations of megestrol. Don't switch from one form to another without first talking to your doctor.

MEGACE Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of MEGACE

If you miss a dose of MEGACE, take it as soon as you remember.

But skip the missed dose if it's almost time for your next scheduled dose.

Don't take extra medicine to make up for a missed dose.

Common Side Effects of MEGACE

Tell your doctor if any of the following side effects become severe or don't go away:

• Unexpected vaginal bleeding

• Difficulty falling asleep or staying asleep

• Mild skin rash

• Gas

• Mild nausea

• Weight gain

Serious Side Effects of MEGACE

Call your doctor immediately if you experience any of the following serious side effects:

• Severe nausea

• Vomiting

• Dizziness

• Severe weakness

• Blurred vision

• Frequent urination

• Extreme thirst or hunger

• Thinning skin

• Easy bruising

• Increased acne or facial hair

• Difficulty breathing

• Leg pain

• Sharp, crushing chest pain or chest heaviness

• Sudden cough or coughing up blood

• Wheezing

• Weakness or numbness of an arm or leg

• Pain, warmth, swelling, or redness in one or both legs

• Slow or difficult speech

• Decreased sexual desire

• Impotence

MEGACE shouldn't be given to prevent weight loss or improve appetite in people who don't have AIDS or those who haven't yet developed the disease.

Before taking MEGACE, tell your doctor if you have or have ever had:

• An adrenal gland disorder
• Diabetes
• Stroke
• Blood clot
• Liver disease
• Kidney disease
• Allergies to medications

MEGACE may cause changes in a woman's normal menstrual period. Talk to your doctor if this is a concern.

Tell your doctor you're taking this drug before having any type of surgery, including a dental procedure.

Your dose of MEGACE may need to be changed if you have surgery, become ill, have an infection, or are under a lot of stress. Don't change your dose without first talking to your physician.

MEGACE can pass into body fluids such as urine, feces, vomit, semen, and vaginal fluid. Wear rubber gloves when cleaning up these fluids or changing a diaper. Wash your hands before and after.

Pregnancy and MEGACE

MEGACE can harm an unborn baby or cause birth defects. Don't take this medicine if you're pregnant.

Also, pregnant women shouldn't handle the body fluids of someone who takes MEGACE.

Be sure to use effective birth control methods to prevent pregnancy while taking MEGACE. Talk to your doctor about birth control options.

It's not known whether the medicine passes into breast milk or could harm a breastfeeding baby. Don't breastfeed while taking MEGACE without talking to your doctor first.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Antibiotics
• Crixivan (indinavir)
• Tikosyn (dofetilide)

The usual starting dose of MANERIX for adults is 150 mg twice daily. If necessary, your doctor may gradually increase your dose after the first week to a maximum of 300 mg twice daily. The recommended dose of MANERIX for adults ranges from 150 mg to 300 mg, taken twice daily after meals.

MANERIX should be swallowed whole with a glass of water. Do not split, crush, chew, or dissolve the tablets.

This medication may take a few days to several weeks to achieve the best effect. Unlike other MAO inhibitors, no special dietary restrictions are necessary when taking MANERIX. It is very important, however, to always take this medication immediately after you have eaten.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. Do not stop taking this medication without talking to your doctor first, even if you start to feel better. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• constipation
• diarrhea
• dizziness
• dryness of mouth
• headache
• nausea
• trouble sleeping

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• agitation
• blurred vision or other changes in vision
• fast, racing, or irregular  heartbeat
• feeling confused, disoriented, or lost
• slow heartbeat
• slurred speech
• stiff neck, severe throbbing headache
• symptoms of low sodium levels in the blood (e.g., achy, stiff or uncoordinated muscles, confusion, tiredness, weakness)
• thoughts of self-harm or hurting others

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a hypertensive reaction (e.g., severe headache with confusion and blurred vision, nausea, vomiting, severe anxiety, difficulty breathing, severe chest pain, seizures)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of serotonin syndrome (too much serotonin in the body; e.g., fast or racing heartbeat, loss of coordination, agitation, decreased reflexes, rapid changes in blood pressure, fever, heavy sweating, confusion)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Do not take this medication if you:

• are allergic to MANERIX or any ingredients of the medication
• are in an acute state of confusion
• are are taking any of the following medications:
  • bupropion
  • dextromethorphan
  • meperidine
  • other MAO inhibitors (e.g., tranylcypromine)
  • selegiline
  • SNRI antidepressants (e.g., desvenlafaxine)
  • SSRI antidepressants (e.g., fluoxetine, sertraline)
  • thioridazine
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline)
  • “triptan” migraine medications (e.g., sumatriptan)

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diet restrictions: Treatment with MANERIX does not require special diet restrictions as with other MAO inhibitors such as phenelzine. As a safety measure, immediately report the sudden occurrence of any of the following:

• extremely fast or slow heart rate
• headache
• neck stiffness
• other unusual symptoms not previously experienced
• palpitations

Drowsiness/reduced alertness: This medication may cause drowsiness or dizziness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Kidney disease: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. For people with severe liver dysfunction, the daily dose of MANERIX should be reduced to one-third or one-half of the standard dose.

Other medications: Treatment with tricyclic antidepressants may be started after MANERIX has been stopped for at least 2 days. Do not start treatment with MANERIX until antidepressants have been stopped for 2 weeks in most cases (wait 5 weeks after taking fluoxetine).

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Thyroid disease: With certain types of thyroid disease, this medication can cause a severe increase in blood pressure. If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: The safety of using MANERIX during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking MANERIX, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

There may be an interaction between MANERIX and any of the following:

• alcohol
• acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
• aclidinium
• alpha/beta agonists (e.g., epinephrine, norepinephrine)
• alpha agonists (e.g., clonidine, methyldopa)
• amphetamines (e.g., dextroamphetamine)
• anesthetics (e.g., halothane)
• angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
• anti-emetic medications (e.g., granisetron, ondansetron)
• antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotic medications (e.g., haloperidol, quetiapine, risperidone)
• appetite suppressants (e.g., sibutramine, mazindol)
• atomoxetine
• atropine
• azelastine
• “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• belladonna
• benztropine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• beta-2 agonists (e.g., salbutamol, formoterol, terbutaline)
• bezafibrate
• bromocriptine
• buprenorphine
• bupropion
• buspirone
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• carbamazepine
• clopidogrel
• cyclobenzaprine
• decongestants (e.g., phenylephrine, oxymetazoline, pseudoephedrine, tetrahydrazoline, xylometazoline)
• dabrafenib
• delaviridine
• dextromethorphan
• diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
• diazepam
• diethylpropion
• disopyramide
• domperidone
• entacapone
• ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• flavoxate
• gemfibrozil
• glaucoma medications (e.g., apraclonidine, brimonidine)
• isoniazid
• glucagon
• glycopyrrolate
• ipratropium
• isoniazid
• ketotifen
• levodopa
• lithium
• linezolid
• maprotiline
• meperidine
• methylphenidate
• metoclopramide
• mirtazapine
• modafinil
• other monoamine oxidase inhibitors (MAOIs; e.g., MANERIX, phenelzine, rasagiline, selegiline, tranylcypromine)
• narcotic medications (e.g., fentanyl, morphine, codeine, oxycodone)
• octreotide
• omeprazole
• orphenadrine
• oxybutynin
• phenobarbital
• phenytoin
• pizotifen
• potassium chloride
• reserpine
• St. John's wort
• scopolomine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sympathomimetic medications (e.g., epinephrine, norepinephrine)
• tapentadol
• tetrabenazine
• tetrahydrozoline
• thioridazine
• tiotropium
• ticlopidine
• tolterodine
• tramadol
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)
• "triptan" migraine medications (e.g., rizatriptan, sumatriptan)
• tryptophan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Use MALARONE regularly to best prevent malaria. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

Take MALARONE at the same time each day with food or a milky drink.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria:

• Start taking the medicine 1 or 2 days before entering an area where malaria is common. Continue taking the medicine every day during your stay and for at least 7 days after you leave the area.
• If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

If you are taking this medicine to treat malaria:

• Take the medicine every day for 3 days in a row.
• Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

In addition to taking MALARONE, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include stomach discomfort, vomiting, mouth sores, hair loss, easy bruising or bleeding, and peeling of the skin on your hands or feet.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe or uncontrolled vomiting or diarrhea;
• fever, mouth sores;
• problems with speech, balance, or walking;
• severe skin rash;
• nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); o
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Less serious side effects may include:

• mild stomach pain or upset stomach;
• mild diarrhea;
• headache;
• mild itching;
• weakness; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You should not use this medication if you are allergic to MALARONE. You should not use this medication to prevent malaria if you have severe kidney disease.

Before using this medication, tell your doctor if you have liver or kidney disease, severe complications from infection with malaria, or uncontrolled vomiting or diarrhea.

Take MALARONE at the same time each day with food or a milky drink.

If you vomit within 1 hour after taking this medication, take another dose. If your vomiting continues, call your doctor.

If you are taking this medicine to prevent malaria, start taking it 1 or 2 days before entering an area where malaria is common. Take the medication every day during your stay and for at least 7 days after you leave. If you stop taking the medicine early for any reason, contact a healthcare professional about another form of malaria prevention.

If you are taking this medicine to treat malaria, take the medication every day for 3 days in a row.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

In addition to taking MALARONE, use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Contact your doctor as soon as possible if you have been exposed to malaria, or if you have a fever or other symptoms of illness during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing malaria. For best results, keep using the medication as directed. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

You should not use this medication if you are allergic to MALARONE. You should not use this medication to prevent malaria if you have severe kidney disease.

To make sure you can safely take MALARONE, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease;
• severe complications from malaria; or
• uncontrolled vomiting or diarrhea.

FDA pregnancy category C. It is not known whether MALARONE will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.

MALARONE can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

MALARONE should not be used to treat malaria in a child who weighs less than 11 pounds, and should not be used to prevent malaria in a child who weighs less than 24 pounds.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all other medicines you use, especially:

• a blood thinner such as warfarin (Coumadin);
• rifabutin (Mycobutin);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane);
• tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or
• metoclopramide (Reglan).

This list is not complete and other drugs may interact with MALARONE. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.