You should not use this medication if you are allergic to OPTIVAR.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use this medication while wearing contact lenses. OPTIVAR ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using OPTIVAR before putting your contact lenses in.

Stop using OPTIVAR ophthalmic and call your doctor if you have severe eye pain, trouble breathing, or severe burning, stinging, itching, or redness in your eyes.

You should not use this medication if you are allergic to OPTIVAR.

Do not wear contact lenses while your eyes are red or irritated. OPTIVAR ophthalmic should not be used to treat minor contact lens irritation.

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

Do not give this medication to a child younger than 3 years old.

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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• severe burning, stinging, itching, or eye redness after using this medication;
• eye pain;
• trouble breathing; or
• fever, chills, sore throat, flu symptoms.

Less serious side effects may include:

• mild burning or stinging
• mild itching, irritation or discomfort;
• runny nose;
• blurred vision (temporary);
• headache; or
• a bitter taste in your mouth.

Do not use other eye medications during treatment with OPTIVAR unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on OPTIVAR used in the eyes. But many drugs can interact with each other. 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.

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

Do not use this medication while wearing contact lenses. OPTIVAR ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
• Use only the number of drops your doctor has prescribed.
• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
• Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

The 0.2 milliliter (0.2 mL) container of OPTIVAR is for one use only. Throw away after one use, even if there is still some medicine left in it. Each 0.2 mL container must be used within one month after you open the foil pouch.

Store at room temperature away from heat and moisture. Keep each single-use 0.2 mL container in the foil pouch until you are ready to use it.

Seek emergency medical attention or call the Poison Help line.

Use the missed dose as soon as you remember. 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.

Although the vast majority of ZOMIG and ZOMIG RAPIMELT users have not experienced any significant problems, you should be aware that the following side effects may occur.

Commonly reported side effects of ZOMIG and ZOMIG RAPIMELT are:

• feeling sick

• vomiting

• dizziness

• tiredness

• weakness

ZOMIG may commonly cause drowsiness. Do not drive or operate machinery until you are sure that you are not drowsy.

Other common side effects include:

• muscle aches and pains

• difficulty swallowing

• dry mouth

• headache

• stomach pain

Uncommon side effects include:

• increase in the production of urine or in the frequency of urination

Tell your doctor of these symptoms at your next visit.

Migraineurs may be at risk of certain cerebrovascular events such as cerebral bleeding and stroke. In very rare cases, as with other drugs of this type, such diseases have been reported in association with the use of zolmitriptan.

In very rare cases, as with other drugs of this type (5HT₁ agonists), the following side effects have been reported:

• spasm of the blood vessels of the heart

• spasm of the blood vessels of the Gastro-Intestinal tract and spleen with possible infarctions

For any unexpected effects while taking ZOMIG/ZOMIG RAPIMELT, contact your doctor or pharmacist.

Tell your doctor or pharmacist about any other drugs you take, including:

• other 5-HT₁ agonist migraine drugs (sumatriptan succinate, naratriptan hydrochloride, rizatriptan benzoate, almotriptan malate) or migraine drugs that contain ergotamine, dihydroergotamine, methysergide.

• drugs for depression such as selective serotonin reuptake inhibitors (SSRI's), for example, fluoxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, paroxetine hydrochloride, etc., or serotonin norepinephrine reuptake inhibitors (SNRIs), for example, venlafaxine hydrochloride, or monoamine oxidase inhibitors (MAOIs), for example, phenelzine sulfate, tranylcypromine sulfate or moclobemide.

• drugs used to treat upset stomach or stomach ulcers (cimetidine).

• antibiotics from the quinolone family (for example ciprofloxacin).

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those that can be bought without a prescription.

TIVICAY will not stop you from passing HIV to others through sexual contact or blood contamination. You should use appropriate precautions, such as using condoms when you have oral or penetrative sex, and not reusing or sharing needles.

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

• have liver problems, including hepatitis B or C
• are pregnant or planning to become pregnant; do not take TIVICAY without speaking with your doctor. Your doctor will consider the benefit to you and the risk to your baby when taking TIVICAY while pregnant. If you take TIVICAY while you are pregnant, talk to your doctor about enrolling in the Antiretroviral Pregnancy Registry.
• are breastfeeding or plan to breastfeed. Where possible, women who are HIV positive should not breast feed, because HIV infection can pass into breast milk and harm your baby.
• It is not known if TIVICAY can pass into breast milk and harm your baby. Talk to your doctor immediately, if you are breastfeeding, or thinking about breastfeeding. Do not breastfeed while taking TIVICAY.
• have any other medical condition
• are taking any other medications

The most common side effects of TIVICAY include:

• diarrhea
• headache
• trouble sleeping (insomnia)
• feeling sick (nausea)
• lack of energy (fatigue)

Other side effects include, rash, itching (pruritus), being sick (vomiting), stomach pain (abdominal pain), stomach (abdominal) discomfort, intestinal gas (flatulence), dizziness, abnormal dreams, depression (feelings of deep sadness and unworthiness), and suicidal thoughts and behaviours (mainly in patients who have had depression or mental health problems before). If you have such feelings, talk to your doctor.

Side effects that may show up in blood tests include an increase in bilirubin (a substance produced by the liver), and/or an increase in the level of enzymes produced in the muscles (creatine phosphokinase, creatinine).

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor immediately.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat on the upper back and neck (“buffalo hump”), breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Tell your healthcare provider about all prescription and non-prescription medications you are taking; including any vitamins, herbal supplements, and dietary supplements. Some drugs may interact with TIVICAY and can affect how TIVICAY works, or make it more likely that you will have side effects. These include:

• metformin, to treat diabetes
• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it.
• calcium and iron supplements. Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take food with your medicine, you can take a calcium or iron supplement at the same time asTIVICAY.
• etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
• rifampin, to treat tuberculosis (TB) and other bacterial infections
• phenytoin and phenobarbital, to treat epilepsy
• oxcarbazepine and carbamazepine, to treat epilepsy and bipolar disorder
• St. John’s wort, (Hypericum perforatum), a herbal remedy to treat depression

Always take TIVICAY exactly as your doctor has told you to. Check with your doctor or pharmacist if you're not sure. Do not change your dose or stop taking TIVICAY without talking with your doctor.

Usual dose:

For adults and adolescents 12-18 years weighing at least 40 kg, the usual dose of TIVICAY is one 50 mg tablet, once a day.

For adults with HIV infection that is resistant to other HIV medicines similar to TIVICAY, the usual dose of TIVICAY is one 50 mg tablet, twice a day.

Your doctor will decide on the correct dose of TIVICAY for you.

Swallow the tablet with some liquid. TIVICAY can be taken with or without food.

Antacid medicines:

Antacids, to treat indigestion and heartburn, can stop TIVICAY from being absorbed into your body and make it less effective.

Do not take an antacid during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as TIVICAY. Talk to your doctor for further advice on taking acid-lowering medicines with TIVICAY.

Calcium or iron supplements:

Calcium or iron supplements can stop TIVICAY from being absorbed into your body and make it less effective.

Do not take a calcium or iron supplement during the 6 hours before you take TIVICAY, or for at least 2 hours after you take it. If you take food with TIVICAY, then you can take calcium and iron supplements at the same time as TIVICAY.

Be sure to keep a supply of your anti-HIV medicines:

• When your TIVICAY supply starts to run low, get more from your physician or pharmacy.
• Do not wait until your medicine runs out to get more.

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 take too many tablets of TIVICAY, contact your doctor or pharmacist for advice. If possible, show them the TIVICAY pack.

Missed dose:

If you miss a dose, take it as soon as you remember, but if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. DO NOT take a double dose of your medicine to make up for a missed dose.

Older adults with dementia who take THORAZINE are at an increased risk for developing life-threatening conditions such as heart failure, a fast/irregular heartbeat, and pneumonia. The drug is not approved for use in older adults with dementia.

It may take several weeks before you feel the full benefits of THORAZINE. You shouldn't stop taking this drug without first talking to your doctor.

You should stop taking THORAZINE immediately if you experience twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be signs of dangerous side effects.

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

• Emphysema, asthma, or a lung or bronchial tube infection
• Glaucoma (an eye condition that causes increased pressure)
• Breast cancer
• Seizures
• An abnormal electroencephalogram (EEG)
• An enlarged prostate or urinary problems
• Any condition that affects the production of blood cells by your bone marrow
• Heart, liver, or kidney disease
• Pheochromocytoma (a tumor on the gland near the kidneys)

You should also alert your physician if you plan to work with organophosphorus insecticides, which are chemicals used to kill insects. Also, tell your doctor if you had to stop taking a drug for mental illness in the past because of severe side effects.

This medicine may cause dizziness, fast heartbeat, fainting, or lightheadedness, especially when you get up quickly from a lying position. You can avoid this problem by getting out of bed slowly.

Tell your doctor you are taking THORAZINE before having any type of surgery, including dental procedures. You should also tell your healthcare provider that you are taking this medicine before having an X-ray of the spine.

THORAZINE may make it harder for your body to cool down after it gets very hot, so use caution in extreme heat or during vigorous exercise and drink plenty of fluids when the weather is hot.

Pregnancy and THORAZINE

THORAZINE has not been assigned a formal pregnancy category by the Food and Drug Administration (FDA). It's sometimes used during pregnancy for treating nausea and vomiting, but studies have been conflicting, with some showing it may cause harm to an unborn baby.

THORAZINE may cause problems in newborns following delivery if it's taken during the last months of pregnancy. You should tell your doctor if you are pregnant or plan to become pregnant while taking THORAZINE.

This medicine can pass into breast milk and may harm a breastfeeding baby. You shouldn't use THORAZINE without first talking to your doctor if you are breastfeeding.

Common Side Effects of THORAZINE

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

• Shuffling walk
• Restlessness, agitation, or confusion
• Drowsiness
• Blank facial expression
• Nervousness
• Difficulty falling asleep or staying asleep
• Weight gain
• Constipation or stomach pain
• Nausea
• Increased appetite
• Breast milk production or breast enlargement
• Missed menstrual periods
• Decreased sexual ability (trouble having an orgasm)
• Uncontrollable or unusual movements of any body part
• Dry mouth
• Stuffy nose
• Changes in skin color
• Difficulty urinating
• Widening or narrowing of the pupils in the eye

Serious Side Effects of THORAZINE

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

• Confusion
• Muscle stiffness
• Fast or irregular heartbeat
• Yellowing of the eyes or skin
• Sweating
• Fever or flu-like symptoms
• Sore throat, chills, or other signs of infection
• Neck cramps
• Unusual bruising or bleeding
• Tightness in the throat
• Tongue that sticks out of the mouth
• Difficulty swallowing or breathing
• Uncontrollable mouth or jaw movements
• Fine, worm-like tongue movements
• Seizures
• Blisters, rash, hives, or itching
• Swelling of the eyes, face, mouth, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• Vision loss (especially at night)
• Seeing things in a brown tint

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

• Anticoagulants (blood thinners) such as warfarin (Coumadin)
• Antidepressants
• Antihistamines
• Atropine (in Motofen, in Lomotil, in Lonox)
• Barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal)
• Chemotherapy
• Diuretics (water pills)
• Epinephrine (EpiPen)
• Guanethidine (not available in the U.S.)
• Ipratropium (Atrovent)
• Lithium (Eskalith, Lithobid)
• Drugs for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems
• Medicines for seizures such as phenytoin (Dilantin)
• Narcotic drugs for pain
• Propranolol (Inderal)
• Sedatives
• Sleeping pills
• Tranquilizers

THORAZINE and Alcohol

Alcohol can worsen certain side effects associated with THORAZINE. You should talk to your doctor before consuming alcohol while taking this medicine.

THORAZINE and Other Interactions

THORAZINE may make you drowsy and may impair your reactions. You should not drive or operate machinery until you know how this drug affects you.

The medicine can also make your skin more sensitive to sunlight. You should avoid unnecessary or prolonged sun exposure while taking THORAZINE.

THORAZINE comes as a tablet and is typically taken two to four times daily. Your dose will depend on your condition, age, and response to the medicine.

For controlling nausea and vomiting, THORAZINE is typically taken every four to six hours. To relieve nervousness before surgery, it's typically taken two to three hours before the procedure. To relieve hiccups, THORAZINE is usually taken three to four times a day, for up to three days or until the hiccups stop.

Your doctor may start you on a low dose of THORAZINE and gradually increase it to lower your risk of side effects.

THORAZINE Overdose

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

Missed Dose of THORAZINE

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

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule. Don't double up on doses to make up for a missed one.

You should not take UROXATRAL if you have moderate to severe liver disease.

There are many other drugs that can interact with UROXATRAL. Tell your doctor about all medications you use.

You should not take UROXATRAL if you are allergic to it, or if you have:

• moderate to severe liver disease.

Some medicines can interact with UROXATRAL and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• imatinib;
• isoniazid;
• nefazodone;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
• heart medication--nicardipine, quinidine;
• antiviral medicine to treat hepatitis C or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir; or
• medicines similar to UROXATRAL--doxazosin, prazosin, silodosin, tamsulosin, or terazosin.

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

• low blood pressure, or a history of low blood pressure caused by taking medications;
• kidney disease;
• a personal or family history of long QT syndrome;
• heart disease, angina (chest pain), high blood pressure;
• coronary artery disease (hardened arteries);
• a history of prostate cancer; or
• a condition for which you take a nitrate medication (such as nitroglycerin).

UROXATRAL can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medicine.

Although UROXATRAL is not for use in women, this medicine is not expected to harm an unborn baby or a nursing baby. If you are a woman and you take UROXATRAL, tell your doctor if you are pregnant or breast-feeding.

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

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:

• a light-headed feeling, like you might pass out;
• new or worsening chest pain;
• upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

• dizziness;
• headache;
• feeling tired; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Many drugs can interact with UROXATRAL, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with UROXATRAL. Give a list of all your medicines to any healthcare provider who treats you.

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.

UROXATRAL is usually taken once daily just after a meal. Do not take UROXATRAL on an empty stomach. Take the medicine at the same time each day.

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

UROXATRAL lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it. You may feel very dizzy when you first wake up. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

While using UROXATRAL, your blood pressure and prostate will need to be checked often.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, or heavy sweating. Call your doctor if you have a prolonged illness that causes diarrhea or vomiting.

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

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.

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 may have depression or thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

You should not use XENAZINE if you have severe or untreated depression, suicidal thoughts, liver disease, or if you have taken reserpine in the past 20 days.

Do not use XENAZINE if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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

• severe or untreated depression;
• suicidal thoughts;
• liver disease; or
• if you have taken reserpine in the past 20 days.

Do not use XENAZINE if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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

• depression, an emotional disorder, or mental illness;
• a history of suicidal thoughts or actions;
• past or present breast cancer;
• heart disease or heart rhythm disorder;
• a personal or family history of long QT syndrome; or
• if you recently had a heart attack.

Taking XENAZINE may increase your risk of depression or thoughts about suicide. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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 XENAZINE passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• tremors, shaking, restless movement, problems with balance;
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• trouble swallowing;
• fast or pounding heartbeats;
• a light-headed feeling, like you might pass out; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats.

Common side effects may include:

• drowsiness, tiredness;
• depressed mood;
• nausea; or
• feeling anxious, agitated, or restless.

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

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Other drugs may interact with XENAZINE, 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.

You may take XENAZINE with or without food.

Call your doctor if your symptoms do not improve, or if they get worse.

You should not stop using XENAZINE suddenly or your symptoms may return. Talk to your doctor before you stop taking this medicine.

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.

If you miss your doses for more than 5 days in a row, ask your doctor before you start taking XENAZINE again.