You should not take XYLOCAINE if you have any of the following:

• Heart conditions like Adams-Stokes syndrome or heart blocks without a pacemaker
• Congestive heart failure (CHF) or heart shock

Talk to your doctor before taking XYLOCAINE if you are taking drugs called beta-blockers, including Inderal (propranolol), Bystolic (nebivolol), Lopressor (metoprolol tartrate), and Toprol XL (metoprolol succinate).

To date, whether XYLOCAINE can help prevent a heart attack remains much-debated. If you have any concerns about this issue, talk to your doctor.

XYLOCAINE Warnings

In 2014, the Food and Drug Administration (FDA) issued a black-box warning for XYLOCAINE because of its danger in small children.

The FDA warns that XYLOCAINE should not be used to relieve tooth pain in teething babies, because XYLOCAINE is easily absorbed into the bloodstream and may cause death.

Pregnancy and XYLOCAINE

XYLOCAINE is an FDA Pregnancy Category B drug, which means it is generally safe to use during pregnancy because there is low risk of harm for your developing baby.

Regardless, you should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

You should also alert your physician if you are breastfeeding or plan to breastfeed before using XYLOCAINE.

Common Side Effects of XYLOCAINE

• High blood pressure
• Swelling or swelling or redness of the skin at the site of injection if receiving XYLOCAINE via injection into the veins
• Constipation, nausea, and/or vomiting
• Confusion, dizziness, headache, funny feeling or tingling in the toes, fingers, or hands

Serious Side Effects

• Changes in heart rhythm
• Methemoglobinemia, a very rare-yet-serious blood disorder caused by the blood not being able to carry as much oxygen as it normally would
• A condition called malignant hyperthermia where body temperature can rise as high as 113 degrees Fahrenheit with fever, sweating, racing, heartbeat, muscle pain
• Seizures
• Anaphylaxis, a sudden, severe, and life-threatening allergic reaction where your tongue and throat swell, your throat may close, you break out in hives, your blood drops to a dangerously low level, and you have trouble breathing

Rare Side Effects

XYLOCAINE may cause some unpredictable side effects including baldness and dizziness.

It is always important to share with your doctor and pharmacist all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking.

You should not take XYLOCAINE if you are taking the following drugs:

• Exparel (bupivacaine liposome)
• Tikosyn (dofetilide)
• Cerdelga (eliglustat)
• Juxtapid (Lomitapide)

Talk to your doctor first about taking XYLOCAINE if you are taking any of the following:

• Inlyta (axitinib)
• Bosulif (bosutinib)
• Luvox (fluvoxamine)
• Lexiva (fosamprenavir)
• Kalydeco (Ivacaftor)
• Mefloquine
• Dilantin (phenytoin)
• Orap (pimozide)
• Pomalyst (pomalidomide)

XYLOCAINE and Alcohol

Since there is a possibility that XYLOCAINE may enter the bloodstream when using the patch or the cream forms, people wearing the patch, and those undergoing surgeries and other procedures for which they receive XYLOCAINE, should avoid drinking.

XYLOCAINE and Grapefruit Juice

XYLOCAINE may interact with grapefruit juice, so for best results, avoid drinking grapefruit juice while taking XYLOCAINE.

Apply XYLOCAINE patches directly to the affected area and leave it on for 12 hours. Then remove the patch and wait 12 hours before applying a new patch.

XYLOCAINE is also available over-the-counter in creams for pain relief or in combination with other medications via prescription.

XYLOCAINE solution for injection should only be administered by appropriate medical professionals.

XYLOCAINE Overdose

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

Missed Dose of XYLOCAINE

If you miss a dose of XYLOCAINE, try to take it as soon as you remember.

However, if it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Don't double up to make up for a missed dose.

Usual dose:

How to Take YAZ PLUS:

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, it has 28 pills.
3. The YAZ PLUS pill pack has 24 hormone-containing pink “active” pills to be taken for 24 days, followed by 4 hormone-free light-orange pills to be taken for four days. It is important to take the light-orange pills because they contain folate.
4. ALSO CHECK the pill pack for: 1) where to start, and 2) direction to take pills in (follow the arrows).
5. You should 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 back-up 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. IF YOU EXPERIENCE VOMITING OR DIARRHEA, OR IF YOU TAKE CERTAIN MEDICINES, such as antibiotics, your pills may not work as well. Use a back-up method, such as latex or polyurethane condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
8. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year.
9. Take the pills only on the advice of your doctor and carefully follow all directions given to you. You must take the pills exactly as prescribed. Otherwise, you may become pregnant.
10. Your doctor will advise you of the appropriate time to start the use of birth control pills after childbirth, miscarriage, or therapeutic abortion.
11. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.
12. 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.

Decide with your doctor or clinic what is the best day for you to start taking your first pack of pills. Pick a time of day which will be easy to remember.

1. THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. Your doctor may advise you to start taking the pills on Day 1 or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
2. Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS. Your period should occur during the last four days of using that pill pack.

What to Do During the Month:

1. TAKE A PILL AT APPROXIMATELY THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.
   • 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
3. Start the next pack on the day after your last hormone-free light-orange pill. Take one pill every day. It is important to take the light-orange pills because they contain folate. 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 Center immediately, even if there are no symptoms.

Missed dose:

MISSING PILLS 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.

IF YOU MISS PILLS AT ANY TIME, YOU COULD GET PREGNANT. THE GREATEST RISKS FOR PREGNANCY ARE:

• when you start a pack late, or

• when you miss pills at the beginning or at the very end of the pack.

What to Do if You Miss Pills:

The following chart outlines the actions you should take if you miss one or more of your birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack.

The following side effects have been observed in studies of women taking YAZ PLUS which may or may not be drug related:

Most side effects when using the birth control pill are not serious. The most common side effects are nausea, vomiting, bleeding or spotting between menstrual periods, breast pain, acne, itching, migraine, dizziness, emotional lability (sudden changes in emotional state without a reason), dysmenorrhea (painful menstrual cramps), headache, vaginal yeast infection, depression, back pain, abdominal pain, nervousness, rash.

Other side effects can occur such as gastrointestinal symptoms (abdominal cramps and bloating), darkening of the skin (particularly on the face), change in appetite, change in libido (sex drive), hair loss, change in weight (increase or decrease), swelling, breast changes (tenderness, enlargement, discharge), temporary infertility after discontinuation of treatment.

If you experience new onset of high blood pressure or worsening of high blood pressure, contact your doctor or pharmacist.

The following additional symptoms have been reported in women taking hormonal contraceptives in general:

• difficulty wearing contact lenses
• vaginal irritation or infections
• urinary tract infections or inflammation
• upper respiratory tract infections (colds, bronchitis, runny or stuffy nose, sore throat, etc)
• severe headaches
• depression, insomnia, nervousness
• amenorrhea (lack of a period or breakthrough bleeding)
• back pain
• abdominal pain
• flu-like symptoms
• allergy, fatigue, fever
• diarrhea, flatulence
• rash

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.

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, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including YAZ PLUS, should not be used by women who are over 35 years of age and smoke. 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 birth control pills.

YAZ PLUS is a birth control pill containing estrogen and progestin and a vitamin (levomefolate calcium). The progestin in YAZ PLUS is known as drospirenone and it may increase the levels of potassium in your blood. Therefore, you should not take YAZ PLUS if you have kidney, liver, or adrenal disease (a disease that may alter the body's fluid and mineral balance) because this could cause serious heart and health problems. Other drugs may also increase potassium (see Before you use YAZ PLUS, talk to your doctor or pharmacist if you:). During the first month that you take YAZ PLUS, you should have a blood test to check your potassium level.

It has been reported that drospirenone, the progestin in YAZ PLUS, may carry a higher risk of blood clots than some other progestins (including levonorgestrel). You should talk to your doctor about the available options.

BEFORE you use YAZ PLUS, talk to your doctor or pharmacist if you:

• smoke
• are overweight
• have a history of breast disease (e.g., breast lumps) or a family history of breast cancer
• have high blood pressure
• have high cholesterol
• have diabetes
• have heart or kidney disease
• have a history of seizures/epilepsy
• have a history of depression
• have a history of liver disease or jaundice
• wear contact lenses
• have uterine fibroids (benign tumors of the uterus)
• may be pregnant or are breastfeeding
• have systemic lupus erythematosus
• have inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• have haemolytic uremic syndrome
• have sickle cell disease
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• if you suffer from vitamin B12 deficiency (for example due to a reduced B12 diet such as a strict vegetarian diet, due to a history of gastrointestinal surgery or certain types of gastritis) tell your doctor that you use YAZ PLUS because folates may hide vitamin B12 deficiency
• have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages
• you are currently on daily, long-term treatment for a chronic condition with any of the medications listed below:
  • Non steroidal anti-inflammatory drugs (NSAIDs) when taken long-term and for treatment of arthritis or other problems (e.g., ibuprofen, naproxen, or others)
  • Potassium-sparing diuretics (spironolactone and others)
  • Potassium supplements
  • ACE inhibitors and Angiotensin-II receptor antagonists for the treatment of high blood pressure (e.g., captopril, enalapril, lisinopril, losartan, valsartan, irbesartan, or others)
  • Heparin

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

Inform your doctor if you are taking daily folate supplements.

YAZ PLUS contains the equivalent of 0.4 mg of folic acid.

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

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 YAZ PLUS four weeks before surgery and not using YAZ PLUS for a time period after surgery or during bed rest.

YAZ PLUS 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 YAZ PLUS 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 YAZ PLUS outweigh the risks, you should be aware of the following:

The Risks of Using YAZ PLUS:

1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes, or brain)
2. Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing blood clots is especially high during the first year a woman ever uses a hormonal contraceptive or restarts the same or a different hormonal contraceptive. Clots can occur in many parts of the body.
3. Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:
   • sharp pain in the chest which may increase with deep breathing; coughing blood; sudden shortness of breath or rapid breathing; sense of anxiety; severe light headedness or dizziness; rapid or irregular heartbeat. These symptoms could indicate a possible blood clot in the lung.
   • pain and/or swelling in the calf or along a vein in the leg; pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg; red or discoloured skin on the leg. These symptoms could indicate a possible blood clot in the leg.
   • crushing chest pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeats. These symptoms could indicate a possible heart attack.
   • sudden severe or worsening headache or vomiting; sudden trouble walking, dizziness, loss of balance or coordination; loss of consciousness or fainting with or without seizure; sudden confusion, disturbances of vision, speech or understanding; sudden weakness or numbness of the face, arm or leg. These symptoms could indicate a possible stroke.
   • sudden partial or complete loss of vision. This symptom could indicate a blood clot in the eye.
   • other signs of a blood clot can include sudden pain, swelling and slight blue discoloration of an extremity; acute abdomen.
4. Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.
5. The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.
6. Cancer of the breast, cervix, or liver may be life threatening or may result in death.
7. Breast cancer
8. 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.
9. Some women who use hormonal contraceptives 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 health care professional is recommended for all women.
10. ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.
11. Cervical cancer
12. Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.
13. Liver tumors
14. The short and long-term use of birth control pills have also been linked with the growth of liver tumors. Such tumors are extremely rare.
15. Contact your doctor immediately if you experience severe pain or a lump in the abdomen.
16. Gallbladder disease
17. Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.
18. Use in pregnancy
19. Birth control pills should not be taken by pregnant women. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy. Also, check with your doctor about appropriate folate supplementation if you stop taking YAZ PLUS, are pregnant, or plan on becoming pregnant.
20. Use after pregnancy, miscarriage or an abortion
21. Your doctor will advise you of the appropriate time to start the use of YAZ PLUS after childbirth, miscarriage, or therapeutic abortion.
22. Pregnancy after stopping YAZ PLUS
23. You will have a menstrual period when you stop using YAZ PLUS. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.
24. Use while breastfeeding
25. If you are breastfeeding, consult your doctor before starting the birth control pill. The hormones in birth control pills are known to appear in breast milk. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception and only consider starting the birth control pill once you have weaned your child completely.

Certain drugs may interact with birth-control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Please inform your doctor or 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 (or the dispensing pharmacist) who prescribes another drug that you use YAZ PLUS. They can tell you if you need to use an additional method of contraception and if so, for how long.

Drugs that may interact with YAZ PLUS include:

• drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate, phenobarbital, valproic acid); tuberculosis (e.g., rifampin, rifabutin), HIV infections (e.g., ritonavir, nevirapine), and Hepatitis C Virus infections (e.g., boceprevir, telaprevir)
• antibiotics (e.g., penicillins, tetracyclines, clarithromycin, erythromycin) for infectious diseases
• cyclosporine
• antifungals (e.g., griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
• cholesterol-lowering drugs (e.g., clofibrate)
• drugs used for the treatment of certain heart diseases or high blood pressure (e.g., diltiazem, verapamil)
• antidiabetic drugs and insulin (for diabetes)
• prednisone
• sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
• pain medication (meperidine)
• antidepressants (e.g., clomipramine)
• tizanidine (drug used for multiple sclerosis [MS])
• theophylline (drug used for asthma)
• some nutritional supplements (e.g., Vit. B12, folic acid)
• antacids (use 2 hours before or after taking YAZ PLUS)
• drugs that may decrease folate levels (e.g., methotrexate, trimethoprim, sulfasalazine, triamterene, cholestyramine, and antiepileptic drugs listed above)

YAZ PLUS may also interfere with the working of other drugs.

Herbal or food products that may interact with YAZ PLUS include:

• the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods)
• grapefruit juice

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

Your doctor may have suggested this medication for conditions other than the ones listed in this drug information. As well, some forms of this medication may not be used for all of the conditions discussed here. 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.

This medication should not be taken by anyone who:

• is allergic to drospirenone, ethinyl estradiol, or to any of the ingredients of the medication
• is or may be pregnant
• has active liver disease
• has any eye damage resulting from vascular (blood vessel) disease of the eye, such as partial or complete loss of vision or defect in visual fields
• has conditions that increase the risk of high potassium (such as diseases of the kidney, liver, or adrenal glands)
• has had a heart attack
• has had jaundice (yellowing of skin) with pregnancy or with prior pill use
• has, has had, or may have an endometrial cancer (cancer of the uterus lining) or another type of tumour that needs estrogen to grow
• has, has had, or may have breast cancer
• has heart valve disease with complications
• has or has had benign or malignant liver tumours
• has or has had cerebrovascular disorders (e.g., stroke) or a condition that may be the first sign of a stroke (such as a transient ischemic attack or small reversible stroke)
• has or has had coronary artery disease (e.g., angina)
• has or has had migraines with aura
• has or has had pancreatitis associated with extremely high triglyceride levels
• has or has had thrombophlebitis or thromboembolic (blood clotting) disorders
• has reduced kidney function
• has reduced liver function
• has problems with the adrenal gland
• has severe or multiple risk factors for blood clots:
  • diabetes with blood vessel involvement
  • heavy smoking (more than 15 cigarettes per day) and over age 35
  • inherited or acquired blood clotting disorders
  • major surgery associated with an increased risk of blood clots after surgery
  • prolonged bed rest
  • severe high blood pressure
  • severe high cholesterol
• has undiagnosed abnormal vaginal bleeding

Before you begin taking 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 take this medication.

Blood clots: All hormonal contraceptives can increase the risk of developing blood clots. Some studies show that birth control pills containing drosperinone have a higher risk of blood clots compared to other birth control pills. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Inform your doctor if you are planning an upcoming surgery or if you will be immobilized or inactive for a prolonged period of time (i.e., through accident or illness), as there is an increased risk of blood clot formation when using combination hormone contraceptives. If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision or speech changes, sudden severe headache, weakness or numbness in an arm or leg, or are coughing blood, get immediate medical attention as these symptoms could indicate a possible blood clot.

Blood pressure: People with high blood pressure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to visit your doctor more frequently to have your blood pressure checked while using this medication. Occasionally, high blood pressure may develop with the use of hormone contraceptives. This may require stopping this medication.

Cigarette smoking and heart disease: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as a woman gets older. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use the birth control pill. All women are urged not to smoke while taking this medication.

Other factors that increase your risk of heart disease include diabetes, high blood pressure, high cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk. For women who have a low risk of heart disease and do not smoke, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease, regardless of age. These women may continue to use birth control pills up to the age of menopause.

Depression: Women with a history of depression or other emotional problems should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Women with a history of depression or other emotional problems may be more likely to have a recurrence while taking oral birth control medications.

Diabetes: Women with diabetes or those with a family history of diabetes should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have diabetes, it may be necessary to test your blood sugar more often to detect any worsening of blood sugar control after starting birth control pills.

Epilepsy: Women with a history of epileptic seizures should speak to their doctor about the possibility of this medication increasing the numbers of epileptic seizures she may experience.

Electrolytes: This medication contains progesterone drospirenone, which may increase potassium levels in women who are at high risk for this condition. Women with reduced kidney or liver function or inadequate production of adrenal hormones are at increased risk. Women who receive other medications that can increase their potassium should have their potassium levels checked by their doctor when they first start this medication. Some of these medications include potassium supplements, ACE inhibitors, angiotensin-II receptor antagonists (e.g., candesartan, losartan), some diuretics, heparin, aldosterone antagonists (e.g., spironolactone), and nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen).

Eye problems: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye, which may cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

Fibroid tumours: This medication may worsen fibroid tumours (noncancerous growths in the uterus), causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gallbladder problems: The use of hormonal contraceptives increases the risk of gallbladder problems. If you experience symptoms of gallbladder problems, such as severe stomach or back (between the shoulder blades) pain, nausea or vomiting, contact your doctor.

Kidney disease: People with kidney disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to have regular blood tests while taking this medication.

Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems. See your doctor as soon as possible if you develop signs of liver problems such as yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin.

Migraine and headache: Women with migraines should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed. You should report to your doctor if you notice the development of worsening migraine headeaches or new types of headaches that are recurrent, persistent, or severe.

Regular checkups: You should visit your doctor yearly for a physical examination and follow-up while you are taking this medication.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Risk of cancer: The use of hormone contraceptives may increase the risk of breast and cervical cancer in women before menopause (around age 50). If you have been using hormone contraceptives for a long time (more than 8 years), started using them at an early age, or have a family history of cancer (mother or sister), you may be at an increased risk of developing cancer. Talk to your doctor about whether any special monitoring is needed.

If you are taking birth control pills, you should learn how to do a breast self-exam. Notify your doctor anytime you detect a lump. In a few women, the use of birth control pills may speed up the growth of a breast cancer that has not yet been diagnosed. A yearly clinical breast examination is also recommended because, if breast cancer should develop, medications that contain estrogen may cause the cancer to grow quickly.

Sexually transmitted infections (STIs): Birth control pills do not protect against HIV/AIDS and other sexually transmitted infections (STIs; formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with this medication to protect against these infections.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: The hormones in this medication pass into breast milk. These hormones may reduce the quantity and quality of the breast milk. Breast-feeding women should use another form of birth control until they are no longer breast-feeding. Talk to your doctor about your options.

Children: The safety and effectiveness of using this medication have not been established for children under 16 years of age.

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.

• abdominal cramping or bloating
• acne (usually less common after 3 months of treatment, and may improve if acne already exists)
• back pain
• breast pain, tenderness, or swelling
• changes in weight
• diarrhea
• dizziness
• nausea and vomiting
• nervousness

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

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

• changes in your bleeding pattern during periods or between periods, such as:
  • breakthrough bleeding or spotting between periods
  • complete stopping of menstrual bleeding several months in a row
  • decreased bleeding during periods
  • occasional stopping of menstrual bleeding
  • prolonged bleeding during periods
• for women with a history of abnormalities in the breast
  • breast cancer
  • cysts in the breast
  • lumps in the breast
• increased blood pressure
• persistent sad mood or other emotional changes
• signs of a liver problem (e.g., yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin)
• swelling of ankles and feet
• swelling, pain, or tenderness in upper abdominal area
• vaginal yeast infection with vaginal itching or irritation, or thick, white, or curd-like discharge
• worsening headaches or migraines

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

• crushing chest pain or heavy feeling
• pain in the calf
• redness, tenderness, itching, burning, or peeling of skin
• seizures
• sharp chest pain, coughing up blood, sudden shortness of breath
• signs of an allergic reaction (e.g., difficulty breathing, hives, swelling of the face or throat)
• sudden loss of vision (partly or completely)
• sudden severe or worsening headache; vomiting; dizziness; fainting; vision or speech problems; weakness or numbness in the face, arm, or leg

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.

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

• acetaminophen
• acetylsalicylic acid (ASA)
• alcohol
• aminocaproic acid
• anastrozole
• angiotensin converting enzyme inhibitors (ACE inhibitors; e.g., ramipril, lisinopril, or enalapril)
• angiotensin-II receptor blockers (e.g., candesartan, losartan)
• antacids (when taken within 2 hours of the medication)
• antibiotics (e.g., ampicillin, chloramphenicol, cotrimoxazole, erythromycin, metronidazole, penicillin, neomycin, nitrofurantoin, rifampin, sulfonamides, tetracyclines)
• anticonvulsants (e.g., carbamazepine, ethosuximide, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate)
• antidiabetes medication (e.g., glyburide, gliclazide, glipizide)
• antihistamines (e.g., chlorpheniramine, diphenhydramine)
• antipyridine
• aprepitant
• barbiturates (e.g., phenobarbital)
• benzodiazepines (e.g., lorazepam, diazepam, chlordiazepoxide)
• beta-blockers (e.g., propranolol, metoprolol, atenolol)
• caffeine
• certain diuretics (e.g., amiloride, spironolactone, triamterene)
• chloral hydrate
• chlordiazepoxide
• cholestyramine
• clofibrate
• clonidine
• cyclosporine
• folic acid
• griseofulvin
• guanethidine
• heparin
• insulin
• isoproterenol
• ketoconazole
• meperidine
• meprobamate
• methyldopa
• mitotane
• modafinil
• nevirapine
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
• phenothiazines (e.g., chlorpromazine, perphenazine)
• phenylbutazone
• potassium supplements or potassium-containing salt substitutes
• prednisone
• ritonavir
• St. John's wort
• theophylline
• tricyclic antidepressants (e.g., amitriptyline, clomipramine)
• vitamin B12
• vitamin E
• warfarin

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.

21-day pack: Take 1 tablet daily for 21 days. Take no tablets for 7 days, and then begin the next pack.

28-day pack: Take 1 tablet daily for 21 days, then take 1 "reminder" tablet daily for 7 days, and then begin the next pack.

Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts or on Day 1 or Day 5 of your period. The pills should be taken approximately the same time every day, (e.g., with a meal or at bedtime).

It is a good idea to use a second method of birth control (e.g., latex condoms, spermicidal foam or gel) for the first 7 days of the first cycle of pill use to ensure prevention of pregnancy.

Many women experience spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking 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.

If you have vomiting or diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. If you start a new medication while taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or pharmacist.

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 that you take this medication exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases.

If you miss one pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.

If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills on the day you remember and 2 pills the next day. Then take one pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss the pills.

If you start your pills on Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you start your pills on a day other than a Sunday and you miss 2 pills in a row during the third week of your cycle or 3 or more pills at anytime during your cycle, safely dispose of the rest of the pill pack and start a new pack that same day. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you are taking the 28-day pack and miss any of the white pills in week 4, safely dispose of the pills you missed and keep taking one pill each day until the pack is empty. Begin a new pack as you would normally.

See the package insert for additional information on where to start and what to do if you forget to take a pill.

Store this medication at room temperature in its original packaging 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.

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

• ALUPENT may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of ALUPENT, 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 ALUPENT.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking metaproterenol:

More common:

• Fast, pounding, or irregular heartbeat or pulse

Less common:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet
• worsening of asthma

Rare

• Blurred vision
• chest pain
• chills
• cough
• diarrhea
• dizziness
• fainting
• fever
• general feeling of discomfort or illness
• headache
• increased sweating
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• pounding in the ears
• puffiness of the face and fingers
• runny nose
• shivering
• slow or fast heartbeat
• sore throat
• sweating
• swelling
• trouble sleeping
• unusual tiredness or weakness
• vomiting

If any of the following symptoms of overdose occur while taking metaproterenol, get emergency help immediately:

Symptoms of overdose:

• Arm, back, or jaw pain
• chest discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• general feeling of discomfort or illness
• shortness of breath
• sleeplessness
• unable to sleep

Minor Side Effects

Some of the side effects that can occur with metaproterenol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Abdominal or stomach pain

Rare

• Bad, unusual, or unpleasant (after) taste
• change in appetite
• drowsiness
• dry mouth or throat
• itching skin
• pain
• raised red swellings on the skin, lips, tongue, or in the throat
• tightening of the muscles
• weakness

Do NOT use ALUPENT if:

• you are allergic to any ingredient in ALUPENT
• you have had an unexpected reaction to another sympathomimetic (eg, albuterol, pseudoephedrine)
• you have a fast heartbeat
• you are taking another beta-adrenergic bronchodilator (eg, albuterol) or droxidopa

Contact your doctor or health care provider right away if any of these apply to you.

Before using ALUPENT:

Some medical conditions may interact with ALUPENT. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems (eg, irregular heartbeat, congestive heart failure) or high blood pressure
• if you have a history of seizures (eg, epilepsy), diabetes, an overactive thyroid, or have an adrenal gland tumor (eg, pheochromocytoma)

Some MEDICINES MAY INTERACT with ALUPENT. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol) because the effectiveness of ALUPENT may be decreased
• Beta-adrenergic bronchodilators (eg, albuterol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), monoamine oxidase (MAO) inhibitors (eg, phenelzine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because side effects may be increased by ALUPENT
• Droxidopa because the risk of side effects, such as irregular heartbeat or heart attack, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if ALUPENT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

This medicine isn't effective for all forms of traveler's diarrhea. Your healthcare provider will decide if ZAXINE is right for you.

Before taking ZAXINE, tell your doctor if you have:

• Diarrhea with fever
• Watery or bloody diarrhea
• Liver disease
• Allergies to any medications

This drug won't treat viral infections such as the common cold or flu.

Call your physician if your symptoms don't improve or worsen after 24 hours of taking ZAXINE.

Antibiotics such as ZAXINE may increase your risk of developing Clostridium difficile-associated diarrhea, a serious form of infectious colitis caused by C. diff bacteria.

Tell your doctor if your diarrhea continues after you stop using ZAXINE.

Take this medicine for the entire amount of time that your doctor prescribes it. Your symptoms might improve before your infection clears.

Don't give ZAXINE to a child who is younger than 12.

Pregnancy and ZAXINE

It's not known whether ZAXINE will harm an unborn baby.

Tell your doctor if you're pregnant or might become pregnant before using this medicine.

It's also uncertain if the drug passes into breast milk or could hurt a breastfeeding baby. You shouldn't breastfeed while taking ZAXINE.

Common Side Effects of ZAXINE

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

• Stomach pain or nausea
• Headache
• Dizziness
• Swelling of the hands, feet, or midsection
• Flatulence or gas
• Feeling like your bowel isn't completely empty
• Feeling like you need to empty your bowel urgently

Serious Side Effects of ZAXINE

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

• Diarrhea that's watery or bloody
• Fever
• Signs of an allergic reaction, which may include hives, difficulty breathing, or swelling of the face, lips, tongue, or throat

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

• Antifungal medicines such as Sporanox (itraconazole) or Nizoral (ketoconazole)
• Heart or blood pressure medicines such as Capoten (captopril), Cardizem (diltiazem), Cordarone (amiodarone), Coreg (carvedilol), Covera-HS (verapamil), Multaq (dronedarone), Plendil (felodipine), Quinidex (quinidine), or Ranexa (ranolazine)
• Kaletra (lopinavir and ritonavir)
• Sandimmune (cyclosporine)
• Other antibiotics such as Z-Pak (azithromycin), Biaxin (clarithromycin), or E-Mycin (erythromycin)

You can take Xifaxan with or without food.

Xifaxan Overdose

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

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Xifaxan

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

However, skip the missed dose if it's almost time for your next dose.

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

You should not take LANOXIN if you:

• Are allergic to LANOXIN or any of the ingredients in the medication
• Have an irregular heartbeat caused by ventricular fibrillation

Talk to your doctor before taking LANOXIN if you:

• Have any current or previous heart conditions, including heart attack, endocarditis (infections of the heart muscle or in the lining that surrounds the heart), heart failure, or very slow heartbeat
• Have low concentrations of oxygen in the body, a condition known as hypoxia
• Have low levels of potassium or calcium in the blood, which might reduce the effect of LANOXIN
• High levels of calcium or low levels of magnesium in the blood
• Have Beriberi heart disease
• Have thyroid disease

The concentration of LANOXIN in your blood can vary based on many factors and could become dangerous if not kept within a certain range.

Your doctor will probably have you come in for lab work from time to time to monitor your LANOXIN levels.

LANOXIN Use in the Elderly

LANOXIN is considered safe to use in the elderly as long as the dose is no greater than 0.125 milligram (mg) or 125 mcg per day.

As we age, our kidney function changes and normally slows, so our bodies can't get rid of certain substances, like LANOXIN, as quickly as they once could have.

LANOXIN overdose symptoms in elderly are sometimes hard to pinpoint without running laboratory tests. Elderly people taking higher doses of LANOXIN may become delirious or confused and feel weak or tired.

Pregnancy and LANOXIN

LANOXIN should only be taken by pregnant women when the risks outweigh the benefit.

Talk to your doctor if you are pregnant or might become pregnant before taking this medication.

LANOXIN has been found to pass into breast milk, so talk to your doctor if you are breastfeeding or plan to breastfeed.

Common Side Effects of LANOXIN

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

• Dizziness
• Changes in mood and mental alertness, including confusion, depression and lost interest in usual activities
• Anxiety
• Nausea, vomiting and diarrhea
• Headache
• Rash
• Growth or enlargement of breast tissue in men (gynecomastia)
• Weakness

Serious Side Effects of LANOXIN

You should call your doctor immediately if you experience any of the following serious side effects:

• Changes in heart rhythm, including irregular heartbeat
• Fast or racing heartbeat
• Heart stopping or flat-lining (asystole)
• Problems with electrical functioning of the heart known as heart block
• Visual problems, including blurry vision and yellow halos
• Low platelet count

LANOXIN interacts with many drugs. As always, share with your doctor and pharmacist all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking.

You should not take LANOXIN if you are taking any herbal supplements belonging to the squill family, such as white quill or Mediterranean squill.

Before taking LANOXIN, tell your doctor if you are taking any of the following medications:

• Drugs for irregular heartbeat like: Pacerone, Nexterone, or Cordarone (amiodarone), Betapace or Betapace AF (sotalol),Tikosyn (dofetilde), Multaq (dronedarone), procainamide, or flecainide
• Aspirin (both tablet and suppository forms)
• Beta blockers like Zebeta or Ziac (betaxolol),Toprol XL or Lopressor (metoprolol), Tenormin (atenolol), and Bystolic (nebivolol)
• Heartburn medications like Prilosec (omeprazole), Nexium (esomeprazole), Aciphex (rabeprazole), Protonix (pantoprazole), and Dexilant (deslansoprazole)
• Other heartburn medications like Pepcid (famotidine) and Tums (calcium carbonate)
• The herbal supplement Lily of the Valley
• Macrolide antibiotics like Ery-Tab (erythromycin) and Biaxin (clarithromycin)
• Neoral, Sandimmune, and Gengraf (cyclosporine)

LANOXIN and Alcohol

LANOXIN can cause sleepiness, confusion, and problems with balance; drinking while taking LANOXIN could worsen these side effects.

For best results, avoid drinking alcohol while taking LANOXIN.

LANOXIN and Grapefruit Juice

Grapefruit juice can lessen LANOXIN's ability to work.

You should avoid eating grapefruit or drinking grapefruit juice while taking LANOXIN.

Your doctor will draw blood to determine how much LANOXIN you should be taking each day.

This will also determine the maximum amount of LANOXIN you are to receive.

You should be consistent in taking LANOXIN the same time every day.

LANOXIN Overdose

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

In certain situations of severe overdose, medical professionals may give you an antidote to LANOXIN.

Missed Dose of LANOXIN

If you miss a dose of LANOXIN, try to take it as soon as you remember.

If it's less than 12 hours before your next scheduled dose, skip the missed dose and resume your regular dosing schedule.

Don't take two doses of the medication at the same time.