Topiramate

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●     Topiramate tablets may cause eye problems . Serious eye problems include:

• ●               any sudden decrease in vision with or without eye pain and redness

• ●               a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma).

• ●               These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms.

• ●      Topiramate tablets may cause decreased sweating and increased body temperature (fever).People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.

• ●      Like other antiepileptic drugs, topiramate tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

• ● Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• ●     thoughts about suicide or dying

• ●     attempts to commit suicide

• ●     new or worse depression

• ●     new or worse anxiety

• ●     feeling agitated or restless

• ●     panic attacks

• ●     trouble sleeping (insomnia)

• ●     new or worse irritability

• ●     acting aggressive, being angry, or violent

• ●     acting on dangerous impulses

• ●     an extreme increase in activity and talking (mania)

• ●     other unusual changes in behavior or mood

• ●     Stopping topiramate tablets suddenly can cause serious problems.

• ●     Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

• ●     Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

• ●     Keep all follow-up visits with your healthcare provider as scheduled.

• ●     Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

• ●     to treat certain types of seizures (partial onset seizures and primary generalized tonic-clonic seizures) in people 10 years and older

• ●     with other medicines to treat certain types of seizures (partial onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older

• ●     have or have had depression, mood problems or suicidal thoughts or behavior

• ●     have kidney problems, kidney stones, or are getting kidney dialysis

• ●     have a history of metabolic acidosis (too much acid in the blood)

• ●     have liver problems

• ●     have osteoporosis, soft bones, or decreased bone density

• ●     have lung or breathing problems

• ●     have eye problems, especially glaucoma

• ●     have diarrhea

• ●     have a growth problem

• ●     are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet

• ●     are having surgery

• ●     are pregnant or plan to become pregnant. It is not known if topiramate tablets will harm your unborn baby. If you become pregnant while taking topiramate tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

• ●     are breastfeeding. It is not known if topiramate passes into breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take topiramate tablets.

• ●     Valproic acid

• ●     any medicines that impair or decrease your thinking, concentration, or muscle coordination.

• ●     birth control pills. Topiramate tablets may make your birth control pills less effective. Tell your healthcare provider if your menstrual bleeding changes while you are taking birth control pills and topiramate tablets.

• ●     Take topiramate tablets exactly as prescribed.

• ●     Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.

• ●     Topiramate tablets should be swallowed whole. Do not chew the tablets. They may leave a bitter taste.

• ●     Do not store any medicine and food mixture for later use.

• ●     Topiramate tablets can be taken before, during, or after a meal. Drink plenty of fluids during the day. This may help prevent kidney stones while taking topiramate tablets.

• ●     If you take too many topiramate tablets, call your healthcare provider or poison control center right away or go to the nearest emergency room.

• ●     If you miss a single dose of topiramate tablets, take it as soon as you can. However, if you are within 6 hours of taking your next scheduled dose, wait until then to take your usual dose of topiramate tablets, and skip the missed dose. Do not double your dose. If you have missed more than one dose, you should call your healthcare professional for advice.

• ●     Do not stop taking topiramate tablets without talking to your healthcare provider. Stopping topiramate tablets suddenly may cause serious problems. If you have epilepsy and you stop taking topiramate tablets suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking topiramate tablets slowly.

• ●     Your healthcare provider may do blood tests while you take topiramate tablets.

• ●     Do not drink alcohol while taking topiramate tablets. Topiramate tablets and alcohol can affect each other causing side effects such as sleepiness and dizziness.

• ●     Do not drive a car or operate heavy machinery until you know how topiramate tablets affect you. Topiramate tablets can slow your thinking and motor skills.

• ●      Metabolic Acidosis.Metabolic acidosis can cause:

• ●               tiredness

• ●               loss of appetite

• ●               irregular heartbeat

• ●               impaired consciousness

• ●      High blood ammonia levels.High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when topiramate tablets are taken with a medicine called valproic acid.

• ●      Kidney stones.Drink plenty of fluids when taking topiramate tablets to decrease your chances of getting kidney stones.

• ●      Effects on Thinking and Alertness.Topiramate tablets may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. Topiramate tablets may cause depression or mood problems, tiredness, and sleepiness.

• ●      Dizziness or Loss of Muscle Coordination.

• ●Call your healthcare provider right away if you have any of the symptoms above.

• ●     tingling of the arms and legs (paresthesia)

• ●     not feeling hungry

• ●     nausea

• ●     a change in the way foods taste

• ●     diarrhea

• ●     weight loss

• ●     nervousness

• ●     upper respiratory tract infection

• ●     Store topiramate tablets at 20to 25(68to 77to 30(59to 86

• ●     Keep topiramate tablets in a tightly closed container

• ●     Keep topiramate tablets dry and away from moisture

• ●     Keep topiramate tablets and all medicines out of the reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION