Topamax (Topiramate) 60 Tablets

USAGE INSTRUCTIONS

TOPAMAX 50 mg film tablet

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug

What is TOPAMAX and what is it used for?

TOPAMAX 50 mg Film The tablet is in the form of light yellow colored tablets coated with a thin film on the other side of the kap TOP film mark on the other side and marked, 50 ”. Each box contains 60 tablets.

TOPAMAX contains topiramate as an active ingredient in the antiepileptic group (used against epilepsy).

Topamax is used to treat the following conditions:

- Sara (epilepsy) in the treatment of diseases

✓ alone: Adults and 6 years in the big boys in the seizure, ✓ along with other epilepsy drugs: adults and two older children inseizure

the  - the prevention of adults in migraine attacks

by your Topamax doctor this cases may be prescribed alone or in addition to other drugs.

TOPAMAX prevents epileptic seizures and migraine attacks by affecting nerves and chemicals in the brain.

TOPAMAX may have been prescribed by your doctor for any other reason. If you have any questions about why this medicine is prescribed to you, ask your doctor about this.

2. Things to consider before using

TOPAMAX DO NOT use TOPAMAX in the following cases.

If;

- If you have any allergiesactive substance of the drug or to any of the excipients in its composition

(hypersensitivity) to the(see the list of excipients at the beginning of this instruction). - Do not use this medicine in pregnant women who are pregnant or do not use effective contraception (see section on pregnancy and breastfeeding for more information). Talk to your doctor about the best method of contraception you should use when using TOPAMAX.

If you are not sure whether these conditions apply to you, contact your doctor or pharmacist.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

- The active substance (topiramate) contained in TOPAMAX passes into breast milk. Breastfeeding, diarrhea, somnolence, irritability and less weight gain were observed in infants. In this case, your doctor will talk to you about stopping breastfeeding or TOPAMAX treatment. Your doctor will take into account the importance of the drug to the mother and the risk to the baby.

-breastfeeding your baby and using TOPAMAX,an unusual condition in your baby

If you aretell your doctor immediately if you see.

use of tools and

Topamaxmachines,tools and fatigue affect your ability to use machines, dizziness, can lead to dizziness. It can also affect your vision, causing visual impairment and / or blurred vision. Do not use tools and machines without talking to your doctor.

Use with other drugs In

addition to TOPAMAX, consult your doctor before taking any medication.

Please inform your doctor or pharmacist if you are presently using any kind of prescription or over-the-counter medication or have recently used it. With Topamax, certain drugs may interact with each other. In some cases, it may be necessary to adjust the doses of other drugs or at the TOPAMAX dose. Please inform your doctor or pharmacist if you are using the following medicines:

- Medicines such as phenytoin, carbamazepine, valproic acid,

phenobarbital, primidone or lamotrigine used for the treatment of sore - Digoxin (a drug used to treat heart diseases) John's Wort), such as herbal medicine can be used to treat depression, - birth control pills (topamax can reduce the effect thereof), - lithium, risperidone (bipolar drugs for the diseases, and schizophrenia, such as mental illness) - hydrochlorothiazide (due to fluid accumulation in body tissue swelling orhigh blood pressure

in case ofused a drug)

- metformin, pioglitazone, glibenclamide (glyburide, diabetes,used to

drugstreat)- Propranolol (drug mainly used for high blood pressure) - diltiazem (in case of high blood pressure or for use for preventing heart angina garding the use of

adrug) - any drug that slows your reaction time (including sleeping pills or painkillers can create state of stupor in the first, temperament lows drugs, tranquilizers, can be found muscle relaxants or antihistamines) - amitriptyline, dihydroergotamine, haloperidol, sumatriptan, pizotifen, venlafaxine , flunarizine - TOPAMAX inhibits the enzyme CYP2C19 and is interfered with by other substances that are metabolized by this enzyme (e.g. diazepam, imipramine, moclobemide, proguanil, omeprazole). - It isto be used with drugs and alcohol that depress the Central Nervous System

recommended not.

The effects of these drugs may change when you use TOPAMAX, or these medications may alter the effect of TOPAMAX. Your doctor will tell you what to do if you use any of these drugs.

If you are taking other medications, especially in your thoughts, concentration, or other causes of muscle co-ordination (such as central nervous system suppressive drugs; muscle relaxants and tranquilizers), tell your doctor or pharmacist if you are taking birth control pills. TOPAMAX may reduce the effect of your birth control pill. Talk to your doctor about the most effective method of contraception you should use when using TOPAMAX.

Tell your doctor if you are taking birth control pills with TOPAMAX and there is a change in your menstruation.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or have recently used it.

TOPAMAXimportant information on some of the ingredients of

61.70 mg lactose monohydrate containsTOPAMAX. If you have been told by your doctor that you are not sure of some sugars, contact your doctor before taking this medicinal product.

3. How to use TOPAMAX?

• General instructions for proper use and frequency of dosing / administration:

Follow these instructions unless your doctor gives you separate advice.

- Do not forget to take your medication in time.

- Your doctor will tell you how long your treatment will take with TOPAMAX.treatment

Do not cut theearly because you cannot get the desired result. - Your doctor will probably start you with a low dose andthe right dose for

slowly increase until you findyou.

The recommended doses are usually indicated in this instruction. However, if your doctor has told you to use TOPAMAX higher or lower than stated here, please use as your doctor says.

Dosage in adults:

- Sara disease - Treatment starts at doses as low as 25 - 50 mg per day. Thethen

most appropriate dose isreached. - Migraine - This dose is used for one week starting with a single dose of 25 mg taken at night. Then, with a dose increase of 25 mg once a week or more, the most appropriate dose is reached.

• Method and method of application: You can take

TOPAMAX before or after meals. Tablets should always be taken with plenty of water. When taking TOPAMAX should drink plenty of fluids throughout the day to prevent the formation of kidney stones. Swallow the tablets as a whole, do not chew

• Different age groups:: For

Use in childrenchildren of

epilepsy aged two and above, treatment is started at a dose of 25 mg or less per day based on the child's body weight. Then, with a dose increase of 25 mg once a week or more, the most appropriate dose is reached to the child.

Use in the elderly:

No dose adjustment is required for use in the elderly unless there is an underlying kidney disease.

• Special Use Cases:

Renal failure

Care should be taken when administering medication in patients with kidney disease or kidney failure, especially kidney stones.

Hepatic impairmentwith

Caution should be exercised when administering medication in patientsmoderate or severe hepatic impairment.

If you have an impression that TOPAMAX is too strong or weak, talk to your doctor or pharmacist.

If you used TOPAMAX more than you should use:

If you have used TOPAMAX more than you should, see your doctor immediately. You may experience drowsiness, fatigue, carelessness, lack of coordination, dizziness due to low blood pressure, disturbances in speech or concentration, double or blurred vision, a depression in your temper or agitation, abdominal pain, seizures.

Overdose may develop if you are taking TOPAMAX with other drugs.

Talk to a doctor or pharmacist if you have used more than you should use TOPAMAX.

If you forget to use TOPAMAX:As soon as

-you remember that you forgot to take your medicine, take the dose you forgot to take and

then continue to take it during the hours you normally use. - When you remember that you forgot to take your medication, skip this dose if it is too close to the time you need to take the next dose, and then continue to take it during the hours you normally use. - If you have forgotten to take two or more doses, contact your doctor.

Do not take double doses to compensate for forgotten doses.

The effects that may occur when treatment with TOPAMAX is terminated:

You should continue to treat TOPAMAX until your doctor tells you to interrupt. Your doctor will tell you how long your treatment will take with TOPAMAX. Do not cut the treatment early because you cannot get the desired result and the symptoms of your disease may return. The discontinuation of the treatment should be done by gradually reducing the dose used.

4. What are the possible side effects?

As with all medications, side effects may occur in people who are sensitive to substances found in the content of TOPAMAX.

Side effects are classified as follows:

Very common: It can be seen in at least 1 of 10 patients.

Common: Less than one in 10 patients, but more than one in 100 patients.

Uncommon: Less than one in 100 patients, but more than one in 1,000 patients.

Rare: Less than one in 1,000 patients, but more than one in 10,000 patients

.

Very rare: less than one in 10,000 patients.

Unknown: Unpredictable from available data.

If you have any of the following, stop using TOPAMAX and IMMEDIATELY tell your doctor or contact your nearest hospital emergency department:

- Hypersensitivity to TOPAMAX is infrequent. Hypersensitivity can be recognized by symptoms such as skin rashes, itching, hives, breathing or breathing, and / or swelling.

These are all very serious side effects.

If you have one of these, you have serious allergies to TOPAMAX. You may need urgent medical attention or hospitalization.

If you notice any of the following, tell your doctor immediately or contact the emergency department of the hospital nearest you:

Very common (may affect more than 1 in 10 people): - Depression in depression;which may

common (affect less than 1 in 10 people): - Seizures - state of fear and anxiety, extreme restlessness, changes in mood (temperament),

confusion, loss of harmony of time and place - Concentration disorder, slowing down of thinking ability, memory loss, memory-related

problems (new onset, sudden changes or deterioration) - Kidney stone, frequent urination or pain when urinating

Uncommon (may affect less than 1 in 100 people): - Increased acidity in the blood (including shortness of breath, breathing problems, loss of appetite, nausea, vomiting, excessive fatigue, heartbeat may cause symptoms such as acceleration or irregularity) - Decrease in sweating or no sweating (especially in youngexposed to high temperatures

children) - Self-harm or self-harmarea

sparse(less than 1 in 1000 people) may affect I): - Glaucoma (accumulation of fluid in the eyes and increased intraocular pressure, pain in the eyes and

visual impairment) - Difficulty in thinking, remembering information and problem solving, feeling less alert or aware, feeling very sleepy with low energy - these symptoms brain function (hyperammonemic encephalopathy) may cause changes in the high level of ammonia (hyperammonemia)

. Emergency medical intervention may be required.

If you notice any of the following, tell your doctor:

Very common (may affect more than 1 in 10 people): - A feeling of fullness in the nose, runny nose, sore throat - Tingling, pain or numbness in various parts of the body - Sleepiness, tiredness - Dizziness - Nausea, diarrhea - Weight loss

Common (may affect less than 1 in 10 people): - Anemia - Allergic reactions (such as rashes, redness, itching, swelling of the skin, hives, etc.) - Loss of appetite, decreased appetite - Aggression, excessive excitement and mobility, Anger, abnormal behavior - Difficulties in falling asleep or sleep - Speech problems, Speechlessness - Failure to maintain order in movements or clumsiness, Imbalance in walking - Decrease in the ability to perform daily routine - Decreased or lost sense of taste, or absence of this sensation - Request shivering or shaking; uncontrollable and rapid mobility in eyes - Visual disturbances (double vision, blurred vision, decreased vision,focusing somewhere

difficulty in) - Rotation sensation (vertigo), tinnitus, ear pain - Shortness of breath - Cough - Nose bleeding - Fever, good self feeling, weakness - vomiting, constipation, abdominal pain or restlessness, indigestion, stomach or intestinal

infection - Dry mouth - Hair loss - Itching - Pain or swelling in the joints, spasms or twitches in the muscles, pain or weakness in the muscles,

chest pain - Weight gain

Uncommon (may affect less than 1 in 100 people): - Reduction of blood flakes (blood cells that stop bleeding), reduction in white blood cells that provide protection against infections, decrease in potassium levels in blood - Increase in liver enzymes, increase in blood cells called eosinophils - Neck, armpit or groin glands - Appetite plus I - rise in temperament (excessive cheerfulness and mobility) - not reality, things that are not, see or feel, severe mental illness (psychosis) - Affective loss, to show emotion strength, unusual suspiciousness, panic attacks

- reading, talking, or problems with writing - Restlessness, excessive mobility - Decline in thinking ability, decline in alertness or alertness - Decrease or deceleration in body movements, abnormal or repetitive muscle

movements - Unconsciousness - Distortion in touch sense - Distortion or loss of sense of smell - Unusual sensation or sensations before a migraine or epileptic seizure - Dryness of the eyes, sensitization of the eyes to light, twitching in the eyelid, tearing - Loss or loss of hearing, hearing loss in one ear - Slow or irregular heartbeat, heart in the chest Feeling the shots - Drop in blood pressure, stand up when blood pressure drops (when some patients who take TOPAMAX suddenly suddenly stand up when they stand up or suddenly sit down, they may feel fainting or dizziness or faint) - Redness and swelling of the face and neck, hot flashes burning behind the bone, swelling or tension in the abdomen - Gum bleeding, increased saliva, saliva from the mouth, breath smell - Excess fluid drinking, feeling thirsty - Color discoloration - Muscular stiffness, side pain - Blood in urine, urinary incontinence (lack of urine control) , urgency to urinate, flank or

kidney pain - difficulty in curing or difficulty in hardening, sexual dysfunction - flu-like symptoms - cold in the hands and toes - feeling of drunkenness - learning difficulties

Sparse (may affect less than 1 in 1000 people): - A lot of temperament excessive rise (extreme joy and mobility) - Loss of consciousness - one eye vision loss, temporary blindness, night blindness - Amblyopia - Eye in and around swelling - when exposed to cold numbness in the hands or toes, tingling, and

discoloration(white, blue and then red) - Inflammation of the liver, liver failure - Stevens-Johnson syndrome (skin rash, a life-threatening disease that gives symptoms such as blisters on the skin and wounds in the mucous regions, such as the mouth, nose, eye, and hypersensitivity) - Abnormal skin smell - discomfort in the arms and legs - Kidney disorders

Unknown (unpredictable from current data):

- Maculopathy is a disease of the small area of ​​the eye called the macula, where the vision of the retina is the sharpest. If you notice a decrease or a change in your vision, you should contact your doctor. - Toxic epidermal necrolysis: a disease associated with Stevens-Johnson syndrome, but more severe than that. Common skin blisters and skin peels are characteristic (see Infrequent side effects).

Children: Side effects in children are generally similar to those seen in adults, but the following side effects may be more common in children than in adults.

- Concentration problems - Increased acid level in blood - Exposure to serious harm to himself - Fatigue - Decreased or increased appetite - Aggression, abnormal behavior - Difficulty in falling asleep or sleep - Feeling unwell - Decrease in potassium in the blood - Impairment and / or not feeling - Tickling - Decreased or irregular heartbeats

Other side effects in children:

Common (10 people may affect less than 1)

- Rotation sensation (vertigo) - Vomiting - Fever

Uncommon (may affect less than 1 in 100 people)

- Kanda increase in eosinophils - a kind of blood cell - hyperactivity - feeling of heat - learning disorder

These are mild side effects of TOPAMAX.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

Report side effectsside effects that are

If you experience anyincluded in the instructions for use or not, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

5. Storage ofKeep TOPAMAX in a place

TOPAMAXwhere children cannot see, reach and pack.

Store TOPAMAX at room temperature below 25 ° C in its original packaging to protect it from moisture.

Use in accordance with the expiration date.

Do not use TOPAMAX after the expiration date in its packaging.

If you notice any defects in the product and / or its packaging, do not use TOPAMAX.

Do not throw away any expired or unused medicines!