Serious Warnings and Precautions

• Blood: Although infrequently reported, serious adverse effects affecting blood cell counts have been observed during the use of TRILEPTAL. Other side effects include: low white blood cell count, bone marrow depression and hepatitis. Close clinical and frequent laboratory supervision with your doctor should be maintained throughout treatment with TRILEPTAL in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue TRILEPTAL, if there is significant evidence of a bone marrow depression.
• Skin: Serious and sometimes fatal skin reactions known as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported with TRILEPTAL. Other serious skin reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and maculopapular rash have also been reported. Although very rare, serious forms of DRESS and AGEP may also lead to death. Since some cases of these skin reactions have been genetically linked, your doctor may recommend a blood test to determine whether you belong to an at-risk population.
• Contact your doctor immediately if you are developing a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever. Your doctor will determine if it is indeed drug-related, and discontinue TRILEPTAL in this case.

Important points you must tell your doctor before taking TRILEPTAL:

• If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine or to any other drugs. If you have had an allergic reaction to carbamazepine you have a 25%-30% chance of being allergic to TRILEPTAL.
• If you have a kidney disease.
• If you have a serious liver disease.
• If you are taking diuretics (medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• If you have a heart disease with shortness of breath and swelling of the feet or legs due to fluid retention.
• If you know that your blood level of sodium is low.
• If you are pregnant, breast-feeding or planning to become pregnant
• If you are taking other medicines
• If you have a history, or family history, of bone disease.

You should also tell your doctor if any of these statements were applicable at any time in the past.

If you are a woman taking a hormonal contraceptive (such as “the pill”), TRILEPTAL may render this contraceptive ineffective. Therefore, you should use either a different method of contraception or an additional non-hormonal method of contraception while you are taking TRILEPTAL. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, check with your doctor or health professional.

Do not stop your treatment with TRILEPTAL without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.

Will TRILEPTAL affect your ability to drive or use machines?

It is important to discuss with your doctor if you can drive a vehicle or operate machines. TRILEPTAL may make you feel sleepy or dizzy, or may cause blurred vision, double vision, lack of muscle coordination or a depressed level of consciousness, especially at the beginning of treatment, and may affect your ability to operate machinery, including a vehicle.

Important information about some of the ingredients of TRILEPTAL oral suspension:

One mL of TRILEPTAL oral suspension contains 175 mg of sorbitol (an inactive ingredient). When taken according to the dosage recommendations, the maximum daily dose contains 7 g of sorbitol. Sorbitol may cause stomach upset and diarrhea. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

TRILEPTAL oral suspension contains ethanol (alcohol), less than 100 mg per dose.

TRILEPTAL oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).

What special precautions should pregnant or breast-feeding women take?

Tell your doctor if you are pregnant, breast-feeding, or planning to become pregnant. It is important to control epileptic seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic drugs during pregnancy. Your doctor will tell you the benefits and potential risks involved and help you to decide whether you should take TRILEPTAL.

Do not stop your treatment with TRILEPTAL during pregnancy without first checking with your doctor.

During pregnancy there can be a gradual decrease in the amount of the active ingredient in TRILEPTAL in your blood. As a precaution to check that the blood levels of the active ingredient are adequate for controlling your seizures, your doctor may recommend periodic blood testing throughout your pregnancy.

The active ingredient in TRILEPTAL passes into breast milk. This could cause side effects for breast-fed babies. Therefore, you should not use TRILEPTAL during breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while you are breast-feeding.

The most common side-effects may include:

• Fatigue, sleepiness, dizziness, unsteadiness
• Headache
• Nausea, vomiting, abdominal pain, diarrhea, constipation
• Double vision, uncontrolled eye movement, blurred vision
• Anxiety, nervousness, feeling of depression, mood swing, memory problems, difficulty concentrating, apathy (feeling indifferent/loss of interest), agitation, confusion
• Trembling, problems with muscle coordination, weakness
• Acne, hair loss

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures in patients on long term-treatment with TRILEPTAL.

Can you use TRILEPTAL if you are taking other medicines?

Before taking any medicine at the same time as TRILEPTAL talk to your doctor or pharmacist. This applies to both prescription and non-prescription (over-the-counter) medicines, and especially to:

• Hormonal contraceptives (such as the birth-control pill).
• Other antiepileptic drug (such as carbamazepine, phenobarbital or phenytoin).
• Calcium antagonists (such as felodipine) (type of medicine used to treat high blood pressure).
• Medicines which reduce the level of sodium in your blood, e.g. diuretics (used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
• Medicines which control your body's immune system (such as cyclosporine).

What foods and drinks should be avoided?

Alcohol may increase the sedative effects (making you more sleepy) of TRILEPTAL. Avoid alcohol as much as possible and ask your doctor for advice.

TRILEPTAL can be taken with or without food.

Usual dose:

Take your medicine exactly as your doctor or pharmacist tells you.

TRILEPTAL should be taken twice a day, every day, at about the same time of day, unless the doctor tells you otherwise. Taking TRILEPTAL at the same time each day will have the best effect on controlling epilepsy. It will also help you to remember when to take TRILEPTAL.

The usual starting dose of TRILEPTAL for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice daily or two 150 mg tablets twice daily or 5 mL of oral suspension twice daily. This dosage may be gradually increased if necessary until the best results are obtained. This is usually achieved at a dose between 600 and 2400 mg per day.

If TRILEPTAL is being taken with another antiepileptic, best results may be obtained with a dose between 600 and 1200 mg per day. Your doctor will decide the best dose of TRILEPTAL if you are taking another antiepileptic.

The starting dose in patients with kidney disease (with impaired renal function) is half the usual starting dose.

The dosage for children will be calculated by your doctor and depends on your child's weight. The starting dose is 8-10 mg/kg bodyweight per day given in two divided doses.

Your doctor will tell you how long your/your child's treatment with TRILEPTAL will last. The duration of treatment is based on your/your child's seizure type; and ongoing treatment for many years may be necessary to control the seizures. Do not change the dose or stop treatment without talking to your doctor.

About the Medicine Dispensing System:

There are three parts to the dispensing system:

1. A plastic adapter that you push into the neck of the bottle the first time you open the bottle. The adapter must always remain in the bottle.
2. A bottle containing 250 mL of the medicine, with a child resistant cap. Always replace the cap after use.
3. A 10 mL oral dosing syringe that fits into the plastic adapter to withdraw the prescribed dose of medicine from the bottle.

Taking the Medicine:

The medicine can be swallowed directly from the oral syringe, or mixed in a small glass of water.

1. Shake the bottle well. Prepare the dose right away.
2. Push and turn the child resistant cap to open the bottle. (Note: always replace the cap after use.)
3. Check the plunger is fully down inside the barrel of the oral syringe.
4. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.
5. Hold the oral syringe in place and carefully turn the bottle upside down.
6. Slowly pull the plunger fully down so that the syringe fills with medicine. Push the plunger back up completely to expel any large air bubbles that may be trapped inside the oral syringe.
7. Withdraw the prescribed dose: slowly pull the plunger down until the top edge of the black ring is exactly level with the marker on the oral syringe barrel that indicates the prescribed dose.
8. Carefully turn the bottle upright. Take out the oral syringe by gently twisting it out of the plastic adapter. The plastic adapter should stay in the bottle. Note: If the prescribed dose is more than 10 mL, you will need to reload the oral syringe to make up the full dose.
9. The dose of medicine can be swallowed directly from the oral syringe (the patient must be sitting upright and the plunger must be pushed slowly to allow the patient to swallow). Alternatively, the dose can be mixed in a small glass of water just prior to administration. Stir and drink the entire mixture right away.
10. Replace the child resistant cap after use.
11. Cleaning: After use, rinse the syringe with water and shake out as much residual liquid as possible and leave out to dry.

Overdose:

If you have taken many more tablets or much more oral suspension than your doctor prescribed, contact your doctor, the nearest hospital or regional Poison Control Center immediately, even though you may not feel sick. You may require medical attention.

Missed dose:

If you have only forgotten one dose, take it as soon as you remember. However, if it is time for your next dose, do not take the missed dose. Just go back to your regular dosing timetable. Do not double the dose at any time.

If you have forgotten to take several doses, contact your doctor.

You should not use this medicine if you have recently had any type of bleeding in your brain or the retina of your eye.

You should not use this medicine if you are allergic to TRENTAL, or if you are allergic to caffeine or theophylline (Elixophyllin, Theo-24, Theo-Dur, Slo-Bid, Theochron, Theolair, Uniphyl, and others).

You also should not use TRENTAL if you have recently had any type of bleeding in your brain or the retina of your eyes.

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

• coronary artery disease (hardened arteries);
• liver or kidney disease;
• heart disease;
• a history of bleeding in your brain or inside your eyes;
• history of heart attack or stroke;
• a stomach or intestinal ulcer;
• if you have recently had surgery;
• if you are also using theophylline; or
• if you use medicine to treat or prevent blod clots.

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

TRENTAL can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using TRENTAL.

Stop taking TRENTAL and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;
• pounding heartbeats or fluttering in your chest;
• red or pink urine;
• a light-headed feeling, like you might pass out; or
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

• dizziness, headache;
• nausea, vomiting;
• diarrhea, gas; or
• bloating, upset stomach.

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

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

If you also take a blood thinner such as warfarin (Coumadin, Jantoven), you may need more frequent "INR" or prothrombin time tests to measure your blood-clotting time.

Other drugs may interact with TRENTAL, 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. Do not take this medicine in larger or smaller amounts or for longer than recommended.

TRENTAL is usually taken 3 times each day, with meals. Follow your doctor's instructions.

While using TRENTAL, you may need frequent blood tests.

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

It may take up to 4 weeks before your symptoms improve. Keep using the medicine as directed and tell your doctor if your symptoms do not improve after 8 weeks of treatment.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include severe drowsiness, agitation, fever, flushing (warmth, redness, or tingly feeling), fainting, or seizure.

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.

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

• you have trouble emptying your bladder (slow urinary stream), because of the risk of urinary retention;
• you have delayed or slow emptying of your stomach because of the risk of gastric retention;
• you have ulcerative colitis (ulcers in the large intestine or colon), intestinal atony or myasthenia gravis (muscle weakness);
• you have an eye problem called “narrow-angle glaucoma” that is being treated;
• you have liver or kidney disease
• you have congestive heart failure, hypokalemia (low potassium), or other conditions which may increase the risk of TROSEC affecting your heart rate;
• you have heart disease;
• you are pregnant, planning on becoming pregnant or are breast feeding.

The safety and effectiveness of TROSEC has not been studied in children.

Although uncommon, TROSEC may cause blurred vision and/or drowsiness in some people. Until you know how TROSEC affects you, caution should be exercised when driving or operating heavy machinery.

Consumption of alcohol while taking TROSEC may make drowsiness worse.

Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as TROSEC are used in a hot environment.

Common side effects:

In clinical studies, the most common side effects with TROSEC were dry mouth, constipation and abdominal pain.

Other side effects:

The following less common events may also occur with the use of TROSEC: dyspepsia (upset stomach), nausea, dizziness, flatulence, chest pain, dry eyes, blurred vision, increased heart rate, palpitation, urinary retention, and heat prostration.

Due to decreased sweating, heat prostration (overheating of the body) can occur when drugs such as TROSEC are used in a hot environment. Be sure to consume adequate amounts of liquid if you are in a hot environment for a prolonged period of time.

Tell your doctor or pharmacist if you have any side effects that bother you or don't go away.

The following events have rarely been reported during TROSEC use: Anaphylactic, Stevens-Johnson and toxic epidermal necrolysis reactions (rare, life-threatening, allergic reactions), angioedema (serious allergic reaction which can cause swelling of the face or throat), tachycardia (rapid heartbeat), syncope (fainting), myalgia (muscle pain), arthralgia (joint pain), rhabdomyolysis (destruction of muscle tissue), hallucinations, confusion, agitation, and hypertensive crisis (sudden, marked increase in blood pressure). If you think you are experiencing any of these rare effects, stop taking TROSEC immediately and go to the emergency room.

Drugs that may interact with TROSEC include: anticholinergic agents (such as amantadine, tricyclic antidepressants, quinidine, antihistamines, and disopyramide), beta agonists (such as salbutamol or formoterol), prokinetic agents (such as metoclopramide) and drugs that are eliminated by active renal secretion (such as digoxin, procainamide, pancuronium, morphine, vancomycin, metformin and tenofovir).

Tell your doctor or pharmacist about every medication you are taking including those you are taking without a prescription as well as any natural health products (herbal or vitamins).

Interactions with herbal medicines have not been studied.

Taking TROSEC with food reduces the amount of medication that will get into your body.

Overdose:

Overdosage with TROSEC may result in severe anticholinergic effects such as rapid and irregular heartbeat, flushed face, fever, ringing in the ears, and muscle spasms.

If you think you have taken an overdose of TROSEC, go to your nearest emergency room immediately. If possible, bring the package with you.

Missed dose:

If you miss a dose, take your next dose at the usual time (on an empty stomach at least 1 hour before your next meal). Do not double the next dose to make up for the missed dose.

Serious Warnings and Precautions—Pregnancy

TWYNSTA should not be used during pregnancy. If you discover that you are pregnant while taking TWYNSTA, stop the medication and contact your doctor, nurse, or pharmacist as soon as possible.

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

• Have experienced an allergic reaction to any drug used to lower blood pressure.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Swelling of your legs.
• Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with TWYNSTA is not recommended.
• Are taking an angiotensin-converting-enzyme inhibitor (ACEI).
• Have angina, narrowing of a heart valve or blood vessel, heart or blood vessel disease.
• Have diabetes mellitus, liver or kidney disease.
• Are on dialysis or have a kidney transplant.
• Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
• Are on a low-salt diet.
• Are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
• Are less than 18 years old.

In case of surgery or anaesthesia, you should tell your doctor that you are taking TWYNSTA.

Driving and using machines:

Before you perform tasks which may require special attention, wait until you know how you respond to TWYNSTA. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

Side effects may include:

• dizziness, vertigo (feeling of spinning)
• drowsiness, insomnia, fatigue
• urge to urinate during the night
• rash, eczema, redness of skin, skin eruptions, itching, hives (urticaria), scaling of the skin (exfoliative dermatitis), increased sweating, drug rash, hair loss, skin discolouration, photosensitivity reaction
• diarrhea, vomiting, constipation, nausea, upset stomach, abdominal pain, flatulence, change of bowel habit
• taste abnormalities, enlarged gums
• dry mouth
• headache, migraine, anxiety, mood changes, ringing in the ears
• sleepiness, sleeplessness, tiredness
• back or leg pain, muscle cramps, joint pain, muscle spasms
• visual disturbance
• upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), flu-like illness, cough, sneezing, runny nose, shortness of breath
• inability to obtain an erection
• enlarging of male breasts
• weight increased, weight decreased.

If any of these affects you severely, tell your doctor, nurse or pharmacist.

TWYNSTA can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with TWYNSTA:

• Agents increasing serum potassium, such as a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill”);
• Blood pressure lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. Rasilez), or angiotensin-converting-enzyme inhibitors (ACEIs);
• Clarithromycin, an antibiotic used to treat infections;
• Lithium used to treat mood bipolar disease;
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ASA (Aspirin), ibuprofen, naproxen, and celecoxib;
• Corticosteroids taken by mouth or injection;
• Digoxin to treat heart conditions;
• Warfarin used to prevent blood clots (blood thinner);
• Anticonvulsant agents. Examples include carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• Rifampicin, an antibiotic used to treat infections;
• Medicines used to treat HIV/AIDS. An example is ritonavir;
• Medicines used to treat fungal infections. Examples include ketoconazole, itraconazole;
• Atorvastatin and Simvastatin used to lower cholesterol;
• Sildenafil (Viagra);
• St. John's wort;
• Immunosuppressants, such as ciclosporin and tacrolimus.

Lower than normal blood pressure may occur when TWYNSTA is given with the following:

• alcohol;
• antidepressants;
• barbiturates (sleeping pills);
• narcotics (strong pain medications);
• nitroglycerin or other nitrates;

Take TWYNSTA exactly as prescribed. It is recommended to swallow your dose whole with water at about the same time everyday, preferably in the morning.

Take TWYNSTA with or without food, but it should be taken the same way each day.

Remove your TWYNSTA tablet from the blister just prior to intake.

Usual adult dose:

The usual dose of TWYNSTA is one tablet once a day.

If your liver is not working properly, the usual dose should not exceed 40/5 or 40/10 mg once daily.

Overdose:

If you think you have taken too much TWYNSTA contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately, even if there are no symptoms.

Missed dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

Before using this medicine, tell your doctor if you have, or have ever had:

• Diabetes
• A skin infection
• Rosacea, perioral dermatitis, or other skin problems
• Glaucoma or cataracts (eye conditions)
• An immune disorder
• Circulation problems
• Cushing's syndrome (an adrenal gland disorder)
• A recent vaccination
• Measles
• Tuberculosis (TB)
• Chickenpox or shingles
• Intracranial hypertension (increased pressure in the head)
• Allergies to medicines

If you have a skin infection, ULTRAVATE may make it harder for your skin to heal.

ULTRAVATE may affect your blood sugar levels if you have diabetes. Be sure to monitor your condition carefully.

Talk to your doctor before receiving any vaccinations while using this medicine.

ULTRAVATE shouldn't be used for longer than two weeks at a time.

Tell your doctor if your symptoms worsen or don't improve after two weeks.

Using too much ULTRAVATE — or using it for a long period of time — may increase your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

• Blurred vision
• Muscle weakness
• Dizziness or fainting
• Fast or irregular heartbeat
• Irritability, depression, or anxiety
• Unusual tiredness or weakness
• Increased thirst or urination
• Unusual weight gain
• Facial swelling
• New or worsening high blood pressure
• Loss of appetite or weight loss

Steroids may affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 12 without consulting with a doctor.

Tell your healthcare provider you're using ULTRAVATE before having any type of medical or dental procedure.

Pregnancy and ULTRAVATE

It's not known whether ULTRAVATE could harm an unborn baby if used during pregnancy.

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

It's also unknown whether ULTRAVATE passes into breast milk. Talk to your doctor before breastfeeding a baby while using this drug.

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

• Burning
• Stinging
• Redness
• Itching

Serious Side Effects of ULTRAVATE

Tell your doctor immediately if you experience any of the symptoms listed in the ULTRAVATE Warnings section above, or the following serious side effects:

• Severe burning, itching, or redness
• Skin thinning or discoloration
• Severe skin rash
• Swelling
• Nausea or vomiting
• Excessive hair growth
• Acne
• Inflamed hair follicles
• Irregular menstrual periods (in women)
• Changes in sexual function
• Signs of a skin infection, which may include redness, swelling, or oozing of the skin
• Symptoms of anaphylaxis, which may include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue

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

• Other topical medicines
• Vitamins
• Any drug that affects your immune system
• Other medicines that contain corticosteroids

ULTRAVATE comes as a cream, ointment, or lotion to apply to your skin.

It's typically used once or twice a day.

Follow the instructions on the package label carefully. Don't apply more or less ULTRAVATE than is recommended.

Wash your hands before and after using this medicine, unless your hands are being treated.

Apply a thin layer of ULTRAVATE to the affected area, and rub it in gently.

Don't apply this medicine to a large area of the skin.

Ask your doctor before using cosmetics or other skin products on areas of your body that are being treated with ULTRAVATE.

Don't wrap or bandage treated areas of your skin unless your doctor tells you to do so. Follow your healthcare provider's instructions carefully if you need to apply a wrap or bandage.

If you're applying ULTRAVATE to a baby's diaper area, avoid dressing your child in plastic pants or tight-fitting diapers.

Don't apply this medicine to your face, underarms, or groin area unless your doctor tells you otherwise.

Also, avoid areas of the skin that are sunburned, dry, chapped, or irritated.

Try not to get this medicine in your eyes. If you do, flush them immediately with water.

ULTRAVATE Overdose

If you suspect an overdose of ULTRAVATE or accidentally swallow this medicine, contact a poison control center or emergency room immediately.

Missed Dose of ULTRAVATE

If you miss a dose of ULTRAVATE, apply it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular application schedule.

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

Common Side Effects of VISKEN

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

• Mild dizziness or lightheadedness
• Trouble sleeping
• Unusual dreams
• Tiredness
• Nausea
• Heartburn
• Weakness
• Mild muscle or joint pain
• Nervousness or anxiety

Serious Side Effects of VISKEN

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

• Chest pain
• Fast, slow, or irregular heartbeat
• Cold fingers or toes
• Severe dizziness or lightheadedness
• Fainting
• Mental or mood changes
• Fever, chills, or sore throat
• Numbness, tingling, or burning
• Short-term memory problems
• Unexplained weight gain
• Swelling of the arms or legs
• Shortness of breath
• Unusual bleeding or bruising
• Pain in the upper right part of the stomach
• Yellowing of the skin or eyes
• Dark-colored urine
• Clay-colored stools
• Depression
• Signs of a severe allergic reaction, which may include hives, rash, severe itching, difficulty breathing, tightness in the chest, or swelling of the mouth, face, lips, or tongue

Other medicines and VISKEN may interfere with each other. These medicines include:

• medicines used to treat high blood pressure, chest pain (angina pectoris), disturbances of heart rhythm,
• digoxin and digitalis glycosides, a heart medicine,
• medicines containing adrenaline or similar substances, such as nose and eye drops, cough medicines, or remedies for the common cold (substances that raise blood pressure),
• insulin or antidiabetic medicines taken by mouth,
• medicines used to relieve pain or inflammation (especially non-steroidal anti-inflammatory drugs),
• ergot alkaloids, a class of medicines used in the prevention and treatment of migraine headaches,
• monoamine oxidase inhibitors (antidepressant drugs),
• medicine used to relieve heartburns and gastrointestinal ulcer (called as cimetidine),
• medicines used to treat anxiety and/or panic disorder, schizophrenia or psychosis.

Follow your doctor's instructions carefully. Do not exceed the recommended dose.

How much VISKEN to take:

The dose of this medicine will be different for different patients. Also, the number of doses you take each day and the time allowed between doses depend on the medical problem for which you are taking VISKEN.

Treatment is usually started with the lowest dose. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

In general the average daily dosage for the tablets is in the following ranges:

Usual adult dose:

• High blood pressure
• 5 to 15 mg once daily in the morning.
• Doses of 20 mg should be taken in 2 divided doses in the morning and the evening.
• Angina pectoris (chest pain) and Increased heart rate (tachycardia)
• 10 to 30 mg daily in 3 or 4 divided doses.
• Hyperkinetic heart syndrome
• 10 to 20 mg daily

Take VISKEN at the same time each day. Swallow the table(s) with a little liquid with food. Do not stop taking this drug without your doctor's advice.

This drug is not recommended for children under 18 years of age.

Patients at the age of 65 or over may experience more side effects than young patients. Close monitoring by your doctor may be required.

If you have questions about how long to take VISKEN, talk to your doctor or your pharmacist.

Overdose:

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.

If you accidentally take a lot more VISKEN tablets than your doctor has prescribed, contact or go to the nearest hospital emergency department or your doctor immediately, or make sure that someone else can contact them for you.

Signs and symptoms caused by taking more of VISKEN can be: abnormally low heartbeat, low blood pressure, low blood sugar; insufficient action of the heart to pump blood which may lead to loss of consciousness; irregular heart beat; heart failure; difficulty breathing with wheezing or coughing; shortness of breath; vomiting; convulsions (seizures); heart attack.

Missed dose:

If you forget to take a dose of VISKEN, take the missed dose as you notice it. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosage schedule. Do not double doses.