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1. Topiramate Cipla 25 Mg Film-Coated Tablets
2. Topiramate Cipla 25 Mg Film-Coated Tablets

Package leaflet: Information for the user TOPIRAMATE CIPLA 25 mg film-coated tablets TOPIRAMATE CIPLA 50 mg film-coated tablets TOPIRAMATE CIPLA 100 mg film-coated tablets TOPIRAMATE CIPLA 200 mg film-coated tablets topiramate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.    .

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others; it may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1.    What Topiramate Cipla is and what it is used for

Topiramate is the active substance of Topiramate Cipla. Topiramate Cipla belong to a group of medicines called “antiepileptic medicines”. They can be used:

•    alone to treat seizures in adults and children over age 6

•    with other medicines to treat seizures in adults and children over age 2

•    to prevent migraine headaches in adults

2.    What you need to know before you take Topiramate Cipla

Do not take Topiramate Cipla:

•    if you are allergic (hypersensitive) to topiramate or any of the other ingredients

of this medicine (listed in section 6).

•    for migraine prevention if you are pregnant or you are able to become pregnant but

are not using effective contraception (see section Pregnancy and breast-feeding for further information).

If you are not sure if the above apply to you, talk to your doctor or pharmacist before using Topiramate Cipla

Warnings and precautions

Talk to your doctor or pharmacist before taking Topiramate Cipla if you:

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

•    have a history of blood and body fluid abnormality (metabolic acidosis)

•    have liver problems

•    have eye problems, especially glaucoma

•    have a growth problem

•    are on a high fat diet (ketogenic diet)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Topiramate Cipla.

It is important that you do not stop taking this medicine without first consulting your doctor. You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate Cipla.

You may lose weight while taking Topiramate Cipla so your weight should be checked regularly. If you are losing too much weight, or a child using this medicine is not gaining enough weight, you should consult your doctor.

A small number of people being treated with anti-epileptic medicines such as Topiramate Cipla have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Topiramate Cipla

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Topiramate Cipla and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate Cipla will have to be adjusted.

Especially tell you doctor if you are taking:

•    other medicines that impair or decrease your thinking, concentration or muscle co-ordination (e.g. central nervous system depressant medicines such as muscle relaxants and sedatives)

•    birth control pills. Topiramate Cipla may make your birth control pills less effective

Tell your doctor if your menstrual bleeding changes while you are taking birth control pills and Topiramate Cipla.

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Keep a list of all the medicines you take. Show this list to your doctor and pharmacist before you start a new medicine.

Other medicines you should discuss with your doctor include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine St. John's wort (Hypericum perforatum)

(a herbal preparation used to treat depression).

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Topiramate Cipla.

Topiramate Cipla with food and drink

This medicine can be taken with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Cipla. You should avoid drinking alcohol while taking Topiramate Cipla.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can take this medicine. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if this medicine are used during pregnancy. Make sure you are very clear about the risks and benefits of this medicine for epilepsy during pregnancy.

You should not take Topiramate Cipla for migraine prevention if you are pregnant or you are able to become pregnant and you are not using effective contraception.

Mothers who breast-feed while taking this medicine must tell their doctor as soon as possible if the baby experiences anything unusual.

Driving and using machines

Dizziness, tiredness and vision problems may occur during treatment with Topiramate Cipla. Do not drive or use any tools or machines without talking to your doctor first.

Topiramate Cipla contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Topiramate Cipla

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

•    Your doctor will usually start you on a low dose of topiramate and slowly increase your dose until the best dose is found for you.

•    Topiramate Cipla are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

•    Topiramate Cipla can be taken before, during, or after a meal. Drink plenty of fluids during the day to prevent kidney stones while taking this medicine.

If you take more Topiramate Cipla than you should

If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. Signs and symptoms of over dosage may include convulsions, drowsiness, speech disturbances, double vision, impaired thinking, abnormal coordination, dulling of consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression.

Overdose can happen if you are taking other medicines together with Topiramate Cipla.

If you forget to take Topiramate Cipla

If you miss a dose do not worry, take it as soon as you remember, then keep taking the medicine as your doctor has told you. If it is almost time for the next dose, do not take the missed dose. Take your next dose at the usual time and then carry on as prescribed. If you miss two or more doses, contact your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop taking Topiramate Cipla

Do not stop taking this medicine unless told to do so by your doctor. If you stop too suddenly your seizures or migraines might come back. If your doctor decides to stop this medication, your dose may be decreased gradually over a few days.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor, or seek medical attention immediately if you have the following side effects:

Very common (may affect more than 1 in 10 people)

•    depression (new or worse)

Common (may affect up to 1 in 10 people)

•    seizures (fits)

•    anxiety, irritability, changes in mood, confusion, disorientation

•    problems with concentration, slowness of thinking, loss of memory, problems with memory (new onset, sudden change or increased severity)

•    kidney stone, frequent or painful urination

Uncommon (may affect up to 1 in 100 people)

•    inflammation of the pancreas causing pain in the upper abdomen. This could become severe and cause nausea and vomiting, fever and rapid heart rate. This could require hospitalization and may be life threatening.

•    having thoughts of serious self-harm, trying to cause serious self-harm    Page 2

Rare (may affect up to 1 in 1,000 people)

•    glaucoma-blockage of fluid in eye causing increased pressure in the eye, pain, or decreased vision.

•    severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, and erythema multiforma, a condition of raised red spots that can blister.

Not known (frequency cannot be estimated from the available data)

•    maculopathy is a disease of the macula, the small spot in the retina where vision is keenest. You should call your doctor if you notice a change or decrease in your vision.

Other side effects include the following, if they get serious, please tell your doctor or pharmacist:

Very common (may affect more than 1 in 10 people):

•    weight loss

•    tingling in the arms and legs

•    drowsiness or sleepiness; tiredness; dizziness

•    diarrhoea; nausea (feeling sick)

•    stuffy, runny nose and sore throat Common (may affect up to 1 in 10 people):

•    weight gain; decrease or loss of appetite

•    anaemia (low blood count)

•    changes in thinking and alertness, including confusion, problems with concentration, memory or slowness in thinking; slurred speech

•    clumsiness, or problems with walking; involuntary shaking in the arms, hands or legs

•    reduced sense of touch or sensation

•    involuntary movement of the eyes; visual disturbances, blurred vision, double vision

•    distorted sense of taste

•    ringing sound in the ears; ear pain

•    shortness of breath

•    nose bleeds

•    vomiting (being sick); constipation; stomach pain; indigestion

•    dry mouth; tingling or numbness of the mouth

•    kidney stones; frequent urination; painful urination

•    hair loss

•    skin rash or itchy skin

•    joint pain; muscle spasms, muscle twitching or muscle weakness

•    chest pain

•    fever

•    loss of strength

•    general feeling of feeling unwell

•    cough

•    nasal congestion (blocked nose)

Uncommon (may affect up to 1 in 100 people):

•    crystals in the urine

•    abnormal blood counts, including reduced white blood cell count or platelet count, or increased eosinophils

•    irregular heartbeat or slowness of the heart beat

•    swollen glands in the neck, armpit or groin

•    increase in seizures

•    problems with verbal communication

•    drooling

•    restlessness or increase in mental and physical activity

•    fainting

•    slow or diminished movements

•    disturbed or poor quality sleep

•    impaired or distorted sense of smell

•    problems with handwriting

•    feeling of movement under the skin

•    eye problems including dry eyes, light sensitivity, involuntary twitching, tearing and decreased vision

•    decreased or loss of hearing

•    hoarseness of the voice

•    gas; heartburn

•    loss of sensitivity to touch in the mouth; bleeding gums; painful or burning sensations in the mouth; breath odour

•    fullness or bloating

•    leakage of urine and/or stools; urgent desire to urinate; pain in the kidney area and/or bladder caused by kidney stones

•    decrease or loss of sweating

•    skin discolouration; localized swelling in the skin

•    swelling of the face; swelling of the joints

•    musculoskeletal stiffness

•    increased acid levels in the blood; low potassium levels in the blood

•    increased appetite; increased thirst and drinking abnormally large amounts of fluid

•    low blood pressure or decrease in blood pressure that occurs when you stand up

• hot flushing; flu like illness; cold extremities (e.g. hands and face)    _{Page 3}

•    problems with learning

•    disturbances in sexual function (erectile dysfunction, loss of libido)

•    hallucinations

•    decreased verbal communication Rare (may affect up to 1 in 1,000 people):

•    excessive skin sensitivity

•    loss of consciousness

•    impaired sense of smell

•    renal tubular acidosis

•    odour

•    swelling in the tissues around the eye

•    Raynaud's syndrome. A disorder affecting the blood vessels in the fingers, toes, ears and causing pain and cold sensitivity

•    tissue calcification (calcinosis)

Not known (frequency cannot be estimated from the available data):

•    swelling of the conjunctiva of the eye.

•    Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see serious rare side effects).

Children and adolescents

The side effects in children are generally similar to those seen in adults. However, some side effects are either seen more frequently in children and/or can be more severe in children than in adults. Side effects which may be more severe include decreased or loss of sweating and increase of the acid level in the blood. Side effects which may occur more frequently in children include upper respiratory tract illnesses.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Topiramate Cipla

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton after 'EXP'. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Topiramate Cipla contain:

The active ingredient is topiramate. Each Topiramate Cipla film-coated tablets contains 25, 50, 100, or 200 mg of topiramate.

Tablet core:

The ingredients are lactose monohydrate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.

Film-coating:

Topiramate 25 mg Tablets are coated with OPADRY® White YS-1-7079, the ingredients of which are titanium dioxide, hypromellose, polysorbate 80 and indigo carmine aluminium lake (E132).

Topiramate 50 & 100 mg Tablets are coated with OPADRY® Beige YS-1-17174-A, the ingredients of which are titanium dioxide, hypromellose, polysorbate 80, iron oxide yellow (E172) and iron oxide red (E172).

Topiramate 200 mg Tablets are coated with OPADRY® Pink YS-1-14779-A, the ingredients of which are titanium dioxide, hypromellose, polysorbate 80 and iron oxide red (E172).

What Topiramate Cipla look like and the contents of the pack:

Topiramate Cipla 25 mg: white coloured, circular, biconvex film-coated tablets.

Topiramate Cipla 50 mg: light-orange coloured, circular, biconvex film-coated tablets. Topiramate Cipla 100 mg: orange coloured, circular, biconvex film-coated tablets. Topiramate Cipla 200 mg: pink coloured, biconvex, caplet-shaped film-coated tablets.

Topiramate Cipla are available in containers of 60, 100 & 200 film-coated tablets and blister packs of 28, 56, 60 & 84 film-coated tablets. Not all pack sizes will be marketed. Marketing Authorisation Holder:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW,

United Kingdom.

Manufacturer:

Cipla (EU) Limited, 20 Balderton Street, London, W1K 6TL,United Kingdom Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium This leaflet was last revised in 10/2015.

Cipla