You should not use FOSRENOL if you are allergic to it, or if you have:

• a bowel obstruction or severe constipation.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, tell the doctor ahead of time that you are using FOSRENOL.

To make sure FOSRENOL is safe for you, tell your doctor if you have:

• a stomach ulcer;

• ulcerative colitis;

• Crohn's disease;

• diabetes;

• problems with your teeth;

• any type of bowel obstruction;

• a history of colon cancer or intestinal surgery; or

• if you take any medicines that can cause constipation.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

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

Call your doctor at once if you have:

• severe constipation; or
• severe stomach cramps.

Common side effects may include:

• upset stomach, stomach pain, nausea, vomiting;
• constipation;
• itching, rash; or
• tooth injury while chewing a FOSRENOL tablet.

FOSRENOL can make it harder for your body to absorb other medicines you take by mouth.

• If you also take thyroid medication, take it at least 2 hours before or 2 hours after you take FOSRENOL.

• If you take an antibiotic such as ciprofloxacin (Cipro) or levofloxacin (Levaquin), take the antibiotic at least 1 hour before or 4 hours after you take FOSRENOL.

• Avoid taking an antacid within 2 hours before or 2 hours after you take FOSRENOL.

Other drugs may interact with FOSRENOL, 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.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take FOSRENOL with food or immediately after eating.

The chewable tablet should be chewed completely before you swallow it. Do not swallow whole.

Sprinkle the oral powder into a small amount of applesauce or other soft food (oral powder will not dissolve in liquid). Swallow right away without chewing. Do not save the mixture for later use.

While using FOSRENOL, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line.

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.

The usual dose is 960 mg (4 tablets) twice a day. Take 4 tablets in the morning. Then take 4 tablets in the evening about 12 hours later. Take ZELBORAF consistently with or without food. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets.

Overdose:

If you take more ZELBORAF than you should or 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.

Like all medicines, ZELBORAF can cause side effects, although not everybody gets them.

Very common side effects of ZELBORAF include:

• rash, itching, dry skin

• skin problems, including warts

• a type of skin cancer (cutaneous squamous cell carcinoma). Tell your doctor right away if you have any skin changes including a new wart, a skin sore or reddish bump, or a sore that bleeds or does not heal

• abnormal liver function (which can be severe and may cause the skin/whites of the eye to turn yellow , urine to turn dark or brown, nausea or vomiting or not wanting to eat)

• being more sensitive to sunlight, sun burn

• hair loss

• pain in joint or muscle, musculoskeletal pain

• feeling tired

• nausea, vomiting

• diarrhea

• constipation

• fever

• headache

• loss of appetite

• changes in the way things taste

• back pain

• pain in the extremities

• decrease in urine output

• abnormal kidney blood test results (creatinine increased)

• excess fluid usually in the legs

• redness, skin peeling or blisters on hand and feet (Palmar plantar syndrome)

• cough

• weight loss

Common side effects:

• a type of skin cancer (basal cell carcinoma)

• new primary melanoma

• tender red nodules just under the skin, fever, tiredness

• irregular heartbeat (atrial fibrillation)

• high blood pressure

• dizziness

• dehydration

• tingling or burning feeling in hands and feet (neuropathy peripheral)

• eye problems such as inflammation of the eye

• inflammation of hair's root

Possible serious side effects:

• Liver injury. Tell your doctor right away if:

  • your skin or the whites of your eyes turn yellow

  • you feel tired

  • your urine turns dark or brown

  • you have nausea or vomiting

  • you do not want to eat

• Kidney injury. Tell your doctor right away if:

  • you experience decreased urine output

  • you have fluid retention causing swelling in your legs, ankles or feet

• Changes in your heartbeat (called QT prolongation), very fast or abnormal heartbeats. Seek medical attention right away if you have abnormal heartbeats, feel dizzy or faint or have seizures.

• Allergic reactions may occur. Tell your doctor right away if you get a rash, feel faint, have trouble breathing or have swelling of the face, lips or tongue.

• Severe skin reactions. Tell your doctor right away if you develop a serious rash accompanied by fever and swollen glands (DRESS) or redness, pain, swelling or blistering of lips, eyes or mouth, skin-peeling and flu-like symptoms (SJS/TEN).

• Eye problems. Tell your doctor right away if:

  • you have eye pain, swelling, or redness

  • you have blurred vision or other vision changes

• Radiation injury. Worsening of radiation treatment side effects has been reported in patients who are treated with radiation before, during, or after ZELBORAF treatment. This can occur on the area that was treated with radiation, such as the skin, esophagus, bladder, liver, rectum, brain and lungs. Tell your doctor right away if:

  • you develop skin rash, blistering, peeling or discoloration of the skin

  • you have shortness of breath, which may be accompanied by a cough, fever or chills (pneumonitis)

  • you have difficulty or pain when swallowing, chest pain, heartburn or acid reflux (esophagitis)

Call your health care provider right away, if you have any of the symptoms listed above.

Serious Warnings and Precautions

Serious side effects include:

• Liver injury.

• Changes in electrical activity of the heart known as QT/QTc prolongation.

• Severe skin reactions (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS], Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]).

• Second cancers.

• Radiation injury.

ZELBORAF should only be prescribed by a doctor who is experienced in the use of anti-cancer drugs.

ZELBORAF has not been studied in patients with severe liver impairment.

ZELBORAF has an effect on the electrical activity of the heart known as QT/QTc prolongation. This effect can be measured as a change in the electrocardiogram (ECG). Drugs with this effect on the ECG can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain interacting drugs. In general, females and people more than 65 years in age are at higher risk. It is important to follow the instructions of your doctor with regard to dosing or any special tests. You will need to have electrocardiograms (ECGs) and blood tests to measure your levels of potassium, calcium, and magnesium at regular intervals during treatment with ZELBORAF. If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.

ZELBORAF may cause changes in your skin, including a new melanoma and cutaneous squamous cell carcinoma. Use of ZELBORAFmay also cause a serious rash accompanied by fever and swollen glands (DRESS) or redness, pain, swelling or blistering of lips, eyes or mouth, skin peeling and flu-like symptoms (SJS/TEN). Talk to your doctor if there are any changes in your skin while taking ZELBORAF and up to six months after the last dose.

You may also become more sensitive to sunlight and get sunburns that can be severe while taking ZELBORAF. During treatment, avoid going out in the sun or if you go into the sun,

• wear clothing which protects your skin, including your head and face, arms and legs, including hands and feet

• use a lip balm and a broad spectrum sunscreen (minimum of SPF 30, re-applied every 2 to 3 hours).

ZELBORAF may also cause severe allergic reaction. Symptoms include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting.

Based on how ZELBORAF works, it may cause certain cancers, particularly those with a mutation in another gene, called the RAS gene, to spread or get worse.

A medicine called YERVOY (ipilimumab) is another treatment for melanoma. Using this medicine at the same time with ZELBORAF has shown to increase liver problems. The combination of these two drugs is not recommended.

BEFORE you use ZELBORAF talk to your doctor or pharmacist if:

• You had a prior unrelated cancer or you currently have another second cancer;

• You have any heart disorder, including an irregular heartbeat, an abnormal electrical signal called “prolongation of the QT interval” or a family history of QT prolongation or sudden cardiac death at <50 years;

  • you have high blood pressure;

  • you have a personal history of fainting spells;

  • you have electrolyte disturbances (e.g., low blood calcium, potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration);

  • you have an eating disorder or are following a strict diet;

  • you have diabetes, especially with associated nerve disorders;

• You have liver or kidney problems;

• You have eye problems;

• You have received radiation treatment or are planning to receive radiation treatment;

• You are pregnant or are planning to become pregnant. ZELBORAF may harm an unborn child. Female patients who can get pregnant must use an effective birth control method while taking ZELBORAF and for at least six months after the last dose. If you are pregnant, think you may be pregnant, or plan to get pregnant while taking ZELBORAF tell your doctor right away.

• You are breast-feeding or plan to breast-feed. It is not known if ZELBORAF passes into your breast milk. You and your doctor should decide if you will take ZELBORAF or breast-feed.

ZELBORAF is not recommended for children and adolescents. The effects of ZELBORAF in people younger than 18 years old are not known.

Before starting treatment, please tell your doctor if you are taking or have recently taken any other medicines (including prescription and non-prescription medicines, vitamins, and herbal supplements). This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of medicines.

In particular, please tell your doctor if you are taking:

• A specific medicine used to prevent blood clots called warfarin

• A specific medicine for cough called dextromethorphan

• A specific sedative used during surgery called midazolam

• Medicines that may affect your heartbeat such as:

  • medicines for heart rhythm problems (anti-arrhythmics) such as quinidine, amiodarone

  • medicines for depression such as amitriptyline, imipramine

  • medicines for psychoses such as ziprasidone and haloperidol

  • medicines for infections such as erythromycin, clarithromycin, moxifloxacin, or ketoconazole

  • medicines for nausea and vomiting such as ondansetron, domperidone

  • other cancer drugs such as sunitinib or nilotinib

  • opioid painkillers

  • asthma drugs such as formoterol or salmeterol

  • diuretics (water pills)

  • digoxin.

• Medicines for seizures such as phenytoin or carbamazepine

• HIV medicines such as atazanavir, saquinavir ritonavir or indinavir

• Other antibiotics such as rifampin or rifabutin

• A specific medicine for relaxing muscles called tizanidine.

• A specific medicine for breathing problems called theophylline.

• A specific medicine for pain, depression and anxiety called duloxetine.

ZELBORAF may increase your body’s sensitivity to radiation therapy.

You should also speak to your doctor before starting any new medication while you are on ZELBORAF.

Grapefruit, grapefruit juice, or products containing grapefruit extract should be avoided while receiving ZELBORAF.

Excessive use of caffeine should be avoided.

Like other medications, REMERON can cause some side effects. You may not experience any of them. For most patients, side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

• You may experience some side effects, such as increase in appetite, constipation, swollen ankles or feet, occasional dizziness or faintness (especially when you get up quickly from a lying or sitting position), nausea, headache, localized swelling, swelling throughout the body, speech disorder, increased creatine kinase blood levels, and difficulty in passing urine (urinary retention).
• In rare cases, other effects may include rash, abnormal sensation in the skin (e.g., burning, stinging, tickling or tingly), involuntary trembling of muscle tremor, dry mouth, tiredness.
• In very rare cases, other effects may include abnormal sensations in the mouth, sensations of numbness in the mouth and swelling in the mouth.

Some side effects are temporary. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

Decrease in White Blood Cells:

If you experience signs of infection such as sudden unexplainable high fever, chills, sore throat and mouth or nose sores, tell your doctor right away. In rare cases, REMERON can cause a decrease in white blood cells, which are needed to fight infection.

New or Worsened Emotional or Behavioural Problems:

A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

Discontinuation Symptoms:

Contact your doctor before stopping or reducing your dosage of REMERON. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating and other symptoms have been reported after stopping REMERON. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of REMERON to alleviate the symptoms.

Effects on Newborns:

Some newborns whose mothers took an SSRI or other newer antidepressants during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can.

During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.

REMERON is not for use in children under 18 years of age.

Changes in Feelings and Behaviour:

It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as REMERON. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like REMERON for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking REMERON on your own.

BEFORE you use REMERON, talk to your doctor or pharmacist:

• if you have ever had an allergic reaction to any medication;
• if you have QT/QTc prolongation or a family history of QT/QTc prolongation;
• if you have heart disease;
• about all your medical conditions, including a history of seizures, liver or kidney disease, heart problems, such as certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart’s rhythm, diabetes, low blood pressure, glaucoma (increased intra-ocular pressure), high cholesterol and/or high triglycerides (fats in the blood), difficulties in urinating as a result of an enlarged prostate, psychiatric diseases such as schizophrenia and bipolar disorder (alternating periods of elation/overactivity and depressed mood);
• about any medications (prescription or nonprescription) you are taking
• about any natural or herbal products you are taking (e.g., St. John's wort);
• if you are pregnant or thinking of becoming pregnant, or if you are breastfeeding;
• about your habits of alcohol consumption;
• if you have hereditary galactose intolerance or glucose-galactose malabsorption.

REMERON is not for use in children under 18 years of age.

Refrain from potentially hazardous tasks, such as driving a car or operating dangerous machines, until you are certain that this medication does not affect your mental alertness or physical coordination.

Contact your physician before stopping or reducing your dosage of REMERON. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of REMERON. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of REMERON to alleviate these symptoms.

Effects on Pregnancy and Newborns:

If you are already taking/using REMERON and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Possible complications at birth (from taking any newer antidepressant, including REMERON):

Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants, such as REMERON, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

If you are pregnant, or nursing, and taking an SSRI or other newer antidepressants, such as REMERON, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor.

Serious Drug Interactions

Do not use REMERON if you are taking or have recently taken:

• Monoamine oxidase inhibitors (e.g., phenelzine, tranylcypromine, moclobemide, selegiline, linezolid, methylene blue)
• Thioridazine
• Pimozide

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

• other antidepressants, such as SSRIs, venlafaxine and certain tricyclics
• other drugs that affect serotonin such as tryptophan, triptans, lithium, tramadol, methylene blue (used to treat high levels of methemoglobin in the blood), St. John’s wort
• ketoconazole (medicine for treating fungal infections)
• cimetidine (used to treat reflux and stomach ulcers)
• erythromycin [used to treat bacterial infections (antibiotic)]
• drugs used to treat Human Immunodeficiency Virus (HIV), such as a combination of fosamprenavir and ritonavir
• nefazodone (used to treat depression)
• certain drugs used to treat epilepsy, such as carbamazepine and phenytoin
• rifampicin (used to treat tuberculosis)
• warfarin (used to prevent blood clotting)
• benzodiazepines (e.g., midazolam, oxazepam and diazepam)—as REMERON may add to the sedative effects of these agents.
• medicines that may affect the heart’s rhythm such as certain antibiotics and some anti-psychotics.

Avoid alcoholic drinks while taking REMERON.

FORADIL AEROLIZER may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using FORADIL AEROLIZER inhalation.

Do not use FORADIL AEROLIZER inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

Asthma is often treated with a combination of different drugs. If you use FORADIL AEROLIZER inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. This device is not to be used with a spacer. Ask your doctor or pharmacist if you have any questions.

FORADIL AEROLIZER capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.

If you are using FORADIL AEROLIZER inhalation to prevent exercise-induced asthma, use the medicine 15 minutes before exercising, or as directed by your doctor. Allow at least 12 hours to pass before you use the medicine again.

Use FORADIL AEROLIZER inhalation regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

Store at room temperature, away from moisture, light, and heat. Keep each capsule in the blister pack until you are ready to use one. Be sure your hands are dry when handling a FORADIL AEROLIZER capsule.

Do not try to clean or take apart the Aerolizer device. Throw it away when your capsules run out. Always use the new device provided with the medication when you get your prescription refilled.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include chest pain, nervousness, dry mouth, nausea, sleep problems (insomnia), tremors, chest pain, fast or irregular heartbeats, feeling weak or light-headed, fainting, or seizure (convulsions).

Use the medication as soon as you remember, then wait 12 hours before using the medication again. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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 any of these serious side effects:

• chest pain, fast or pounding heartbeats, tremors, headache, or restless feeling;

• seizure (convulsions);

• wheezing, choking, or other breathing problems after using this medication;

• increased thirst or hunger, urinating more than usual; or

• worsening asthma symptoms.

Less serious side effects may include:

• dizziness, anxiety, headache;

• sleep problems (insomnia);

• back pain, muscle cramps;

• sore throat, dry mouth, cough, stuffy nose

• skin rash, itching; or

• changes in your voice.

Do not use FORADIL AEROLIZER inhalation to treat an asthma attack that has already begun.

FORADIL AEROLIZER may increase the risk of asthma-related death. Use only the prescribed dose of this medication, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using FORADIL AEROLIZER inhalation.

Asthma is often treated with a combination of different drugs. If you use FORADIL AEROLIZER inhalation to treat asthma, you must use it together with another asthma control medication. Use all of your medications as directed by your doctor. Talk with your doctor if your medications do not seem to work as well in treating or preventing attacks. Do not change your doses or medication schedule without advice from your doctor.

FORADIL AEROLIZER capsules are for use only in the Foradil Aerolizer device. Use only one capsule at a time. Do not take the capsules by mouth. Never place a capsule in the mouthpiece of the inhaler.

Seek medical attention if you think any of your asthma medications are not working as well as usual. An increased need for medication could be an early sign of a serious asthma attack.

You should not use this medication if you are allergic to FORADIL AEROLIZER. If you have asthma, FORADIL AEROLIZER inhalation should not be your only asthma medication. You must use it together with at least one other asthma control medication.

To make sure you can safely use FORADIL AEROLIZER, tell your doctor if you have any of these other conditions:

• a food or drug allergy;

• heart disease or high blood pressure;

• epilepsy or other seizure disorder;

• diabetes; or

• a thyroid disorder.

The capsule form of FORADIL AEROLIZER may contain lactose and milk protein. Talk to your doctor before using this form of FORADIL AEROLIZER if you have allergies or severe problems with lactose (milk sugar).

It is not known whether FORADIL AEROLIZER inhalation will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use FORADIL AEROLIZER inhalation without telling your doctor if you are breast-feeding a baby.

FORADIL AEROLIZER should not be given to a child younger than 5 years old.

Do not use a second form of FORADIL AEROLIZER (such as Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or FORADIL AEROLIZER (Brovana) unless your doctor has told you to.

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

• cisapride (Propulsid);

• droperidol (Inapsine);

• methadone (Methadose);

• pentamidine (NebuPent, Pentam);

• aminophylline (Phyllocontin, Truphylline) or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

• a diuretic (water pill);

• caffeine, diet pills, cold medicine, or a stimulant medication;

• an antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), or thioridazine (Mellaril);

• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), nortriptyline (Pamelor), and others; or

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

This list is not complete and other drugs may interact with FORADIL AEROLIZER inhalation. 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.

Usual dose:

Before You Start Taking Your Pills:

1. BE SURE TO READ THESE DIRECTIONS:
   • Before you start taking your pills
   • Anytime you are not sure what to do
2. LOOK AT YOUR PILL PACK: LOLO contains 24 “active” BLUE pills (with progestin and estrogen hormones) for weeks 1, 2, 3 and the first part of week 4, 2 WHITE estrogen only pills, and 2 “reminder” LILAC pills (without hormones) for the last part of week 4.
3. Also, CHECK the pill pack for: 1) where to start taking pills and 2) in what order to take the pills (follow the arrows in the diagram).
4. 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.
5. When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
6. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH WHILE TAKING THE FIRST 1 to 3 PACKS OF PILLS. If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. This type of bleeding is usually transient and without significance. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
7. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even if you take these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
8. TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
9. IF YOU HAVE VOMITING OR DIARRHEA (within 3 to 4 hours after you take your pill) or IF YOU TAKE CERTAIN MEDICINES, including some antibiotics, or the herbal supplement St. John’s wort, your pills may not work as well. Use a back-up method of birth control (such as latex or polyurethane condoms or spermicide) until you check with your healthcare provider.
10. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
11. THERE IS NO NEED TO STOP TAKING BIRTH CONTROL PILLS FOR A REST PERIOD.
12. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare provider.

When to Start The First Pack of Pills:

You have a choice of which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you to start. Pick a time of day that will be easy to remember. It is important to take it at about the same time every day.

1. Pick the day label strip that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.)
2. Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic. Having the dispenser labelled with the days of the week will help remind you to take your pill every day.
3. 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.
4. LOLO is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle (1st day of period). If you start any day other than the day your period begins, use another method of birth control as a back-up method if you have sex anytime for the next 7 days. Latex or polyurethane condoms or spermicide are good back-up methods of birth control.
5. Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS.

When You Switch From a Different Method of Hormonal Contraception:

• When you switch from another birth control pill, start LOLO on the first day you would have started your previous birth control pack.
• When you switch from a vaginal ring or skin patch, finish the 21 days of use, and wait 7 days after removal of the ring or patch before starting LOLO.
• When you switch from a progestin-only pill, you should start LOLO the next day.
• When you switch from an implant or injectable contraceptive, you should start LOLO on the day of implant removal or, if using an injectable contraceptive, the day on which the next injection would be due.
• If you switch from an IUD, discuss with your healthcare provider when to start LOLO.

What To Do During the Month:

1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or 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 YOUR LOLO Start the next pack on the day after your last lilac “reminder” pill. Do not wait any days between packs. It is not uncommon to miss your period. However, if you have been having regular periods and then do not have a period for 2 cycles or longer, it is possible that you may be pregnant. You should speak to your doctor.

Overdose:

Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, vomiting and withdrawal bleeding in women.

In case of overdosage, contact your healthcare provider, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

Birth control pills may not be as effective if you miss any blue or white pills, and particularly if you miss the first few or the last few blue pills in a pack. The following chart outlines the actions you should take if you miss one or more birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack. If you miss one or more active pills and do not have a period that month, you may be pregnant, so you should speak to your doctor.

If you forget either the 2 lilac “reminder” pills in Week 4, follow these steps:

• Throw away the pills you missed.
• Keep taking one pill each day until the pack is empty.
• You do not need to use a BACK-UP METHOD of birth control.

If you are not sure what to do about the pills you have missed:

• Use a BACK-UP METHOD of birth control anytime you have sex.
• KEEP TAKING ONE ACTIVE (blue or white, depending on the day) PILL EACH DAY until you can reach your healthcare provider.

Always be sure you have on hand:

• non-hormonal back-up method of birth control (e.g. 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.

Non-contraceptive Benefits of Combined Hormonal Contraceptives:

Several health advantages have been linked to the use of hormonal contraceptives.

• Reduction in the incidence of cancer of the uterus and ovaries.
• Reduction in the likelihood of developing benign (noncancerous) breast disease and ovarian cysts.
• Less menstrual blood loss and more regular cycles. The risk of developing iron-deficiency anemia is thus reduced.
• There may be a decrease in painful menstruation and premenstrual syndrome (PMS).
• Acne, excessive hair growth and male-hormone- related disorders also may be improved.
• Ectopic (tubal) pregnancy may occur less frequently.
• Acute pelvic inflammatory disease may occur less frequently.

Most women do not develop serious and unpleasant side effects from using birth control pills. The most common side effects seen when using LOLO are similar to those seen with other birth control pills and include:

• headache
• nausea
• metrorrhagia (irregular menstrual bleeding)
• breast tenderness
• dysmenorrhea (painful menstrual cramps)
• weight change
• acne
• mood swings

In addition, the following side effects have been observed in women taking combination hormonal contraceptives in general, including LOLO:

• Upper respiratory tract infection (bronchitis, runny or stuffy nose, sore throat, etc.)
• Urinary tract infection
• HPV (Human papilloma virus)
• Abnormal cervical (Pap) smear
• Fungal infection
• Abdominal pain
• Influenza
• Vomiting
• Vaginal infection
• Anxiety
• Depression

Serious Warnings and Precautions

Cigarette smoking increases the risk of serious cardiovascular side effects (heart and blood vessels problems) associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and the number of cigarettes smoked. For this reason, LOLO should not be used by women who are over 35 years of age and 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.

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

• smoke
• are overweight
• have a history of breast disease (e.g. breast lumps) or 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 fibroid tumours (benign tumours of the uterus)
• may be pregnant or are breast feeding
• 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 problems with the valves in your heart and/or have an irregular heart rhythm
• 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 should also inform your doctor about a family history of blood clots, heart attacks and strokes.

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

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

LOLO 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 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 LOLO 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 LOLO outweigh the risks, you should be aware of the following:

The Risks of Using LOLO:

The information contained in this section is principally from studies carried out in women who used combination oral contraceptives with higher doses of hormones than those in common use today. The effect of long-term use of combination hormonal contraceptives with lower doses of both estrogen and progestin administered orally remains to be determined.

1. Circulatory disorders (including blood clot in legs, lungs, heart, eyes or brain): 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 clots is highest during the first year a woman uses a hormonal contraceptive. Clots may occur in many areas of the body.
2. Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:
   • Sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.
   • Pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
   • Crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.
   • Sudden severe or worsening headache or vomiting, dizziness or fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.
   • Sudden partial or complete loss of vision. This symptom could indicate a possible blood clot in the eye.
   • Other signs of a blood clot can include sudden pain, swelling and slight blue discoloration of an extremity.
3. 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.
4. 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.
5. Breast cancer: 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.
6. If you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
7. 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 is recommended for all women.
8. ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS OF REGULAR SELF-EXAMINATION OF YOUR BREASTS.
9. Cervical cancer: 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. Chronic infection with the Human Papilloma Virus (HPV) is believed to be the most important risk factor for cervical cancer. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.
10. Liver tumours: The short and long-term use of birth control pills also has been linked with the growth of liver tumours or liver injury (e.g., hepatitis, abnormal hepatic function). Such injury or tumours are extremely rare.
11. Contact your doctor immediately if you experience severe pain or a lump in the abdomen.
12. Gallbladder disease: 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.
13. Use in pregnancy: Birth control pills should not be taken by pregnant women. They will not prevent the pregnancy from continuing. 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.
14. Use after pregnancy, miscarriage or an abortion: Your doctor will advise you of the appropriate time to start the use of LOLOafter childbirth, miscarriage or therapeutic abortion.
15. Pregnancy after stopping LOLO: You will have a menstrual period when you stop using LOLO. 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.
16. Use while breast feeding: If you are breast-feeding, consult your doctor before starting the birth control pill. 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. The use of oral contraceptives is generally not recommended until the nursing mother has completely weaned her child.

Certain drugs may interact with birth control pills and prevent them from working properly making them less effective in preventing pregnancy or causing unexpected bleeding (spotting or breakthrough bleeding). Please inform your doctor or pharmacist if you are taking or have recently taken any other medications or herbal products, even those without a prescription. Also tell any doctor or dentist (or the dispensing pharmacist) who prescribes another medicine that you use LOLO. 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 LOLO include:

• drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate)
• drugs used for the treatment of tuberculosis (e.g., rifampicin, rifabutin)
• drugs used for treatment of HIV infections (e.g., ritonavir)
• drugs used for Hepatitis C virus (HCV) (e.g., boceprevir, telaprevir)
• antibiotics (e.g., penicillins, tetracyclines, metronidazole) for infectious diseases
• antifungals (e.g. griseofulvin)
• cholesterol lowering agents (e.g. clofibrate)
• anti-coagulants (blood thinners)
• the herbal remedy St. John’s wort
• antihypertensive drugs (for high blood pressure)
• 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)
• other drugs such as phenylbutazone, antihistamines, analgesics, antimigraine preparations, Vitamin E and Vitamin B12
• cyclosporine
• antacids (use 2 hours before or after taking LOLO)
• bosentan

LOLO may also interfere with the working of other drugs. This is not a complete list of possible drug interactions with LOLO. Talk to your doctor for more information about drug interactions.