Topiramate

Brand(s)

Manufacturer

• Cilag AG / GenPharma International Pvt. Ltd. / Intas Pharmaceuticals Ltd.

Disease(s)

• Seizures / Migraine / Headache

Topiramate tablet

What is this medicine?

TOPIRAMATE is effective in helping to control seizures (convulsions) in adults or children with various forms of epilepsy. Topiramate may also be prescribed for other conditions, such as prevention of migraine headaches.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• cirrhosis of the liver or other liver disease
• depression
• diarrhea
• glaucoma
• kidney stones
• kidney disease
• lung disease
• metabolic acidosis
• on a ketogenic diet
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to topiramate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take topiramate tablets and capsules by mouth. Swallow the tablets whole with a drink of water; do not crush or chew. The capsules can be swallowed whole or opened carefully and the contents sprinkled on about on a small amount of soft food, such as applesauce, pudding, ice cream, oatmeal, or yogurt. This mixture must be swallowed immediately; do not chew or store the sprinkles on the food for later use. Be sure to take the entire dose. You may take topiramate with meals. Take your doses at regular intervals. Do not take your medicine more often than directed.

Topiramate should be taken on a daily basis as prescribed by your health care professional for the prevention of migraine headaches. Topiramate should not be used to 'abort' or stop a migraine once it has started.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. Topiramate has been used in children for the treatment of various seizure disorders.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• acetazolamide
• birth control pills or other hormones for birth control, including implants or injections
• bosentan
• carbamazepine
• dichlorphenamide
• digoxin
• ethanol
• hydrochlorothiazide
• medications for pain, sleep, or muscle relaxation
• methazolamide
• phenobarbital or primidone
• phenytoin
• pioglitazone
• probenecid
• sevelamer
• valproic acid

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking this medicine?

Visit your prescriber or health care professional for a regular check on your progress. Do not stop taking this medicine suddenly. This increases the risk of seizures if you are using this medicine to control epilepsy. Wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medications, and prescriber or health care professional.

You should drink plenty of fluids while taking this medicine. If you have had kidney stones in the past, this will help to reduce your chances of forming kidney stones.

If you have stomach pain, with nausea or vomiting and yellowing of your eyes or skin, call your health care provider immediately.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce dizziness, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

If you take birth control pills, this medicine may reduce their effectiveness at preventing pregnancy. Notify your prescriber or health care professional if you notice changes in your monthly cycles or bleeding patterns. You may want to discuss birth control options with your health care provider.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

If you notice blurred vision, eye pain, or other eye problems, seek medical attention at once for an eye exam.

If you are going to have surgery, tell your prescriber or health care professional that you are taking this medicine.

What side effects may I notice from this medicine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• agitation, restlessness, irritability, or other changes in mood
• decreased sweating and/or rise in body temperature
• difficulty breathing
• difficulty speaking
• difficulty walking or controlling muscle movements
• eye pain, redness or swelling
• hearing impairment
• kidney stones (severe pain in the side or back, or on urination)
• nose bleeds
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• skin rash, itching
• stomach pain with nausea or vomiting
• swelling of the face, lips or tongue
• tingling, pain or numbness in the hands or feet
• unusual weakness or tiredness
• vision problems, like blurred vision
• vomiting
• worsening of mood, thoughts or actions of suicide or dying
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• back pain, joint aches and pains
• breast pain
• diarrhea, or constipation
• difficulty sleeping
• dizziness, drowsiness
• dry mouth
• headache
• heartburn or stomach acid reflux
• hot flashes
• loss of appetite
• menstrual disorder
• muscle aches or pains
• nausea
• swelling of the gums
• stomach upset, indigestion
• stuffy, runny nose
• sweating
• tiredness or weakness
• taste altered
• tremor

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) in a tightly closed container. Protect from moisture. Throw away any unused medicine after the expiration date.