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

PATIENT INFORMATION LEAFLET TOPIRAMATE CIPLA 25 mg, 50 mg, 100 mg and 200 mg FILM-COATED TABLETS

(topiramate)

The name of this medicine is Topiramate Cipla 25 mg, 50 mg, 100 mg or 200 mg Film-Coated Tablets, which will be referred to as Topiramate Tablets throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

1.    WHAT TOPIRAMATE TABLETS ARE AND WHAT THEY ARE USED FOR

Topiramate Tablets 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.    BEFORE YOU TAKE TOPIRAMATE TABLETS

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.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before you start a new medicine.

Taking your medicine with food and drink

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

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding. Your doctor will decide if Topiramate Tablets are suitable for you. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate Tablets are used during pregnancy. Make sure you are very clear about the risks and benefits of Topiramate Tablets for epilepsy during pregnancy.

You should not take Topiramate Tablets 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 Topiramate Tablets 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 Tablets. Do not drive or use any tools or machines without talking to your doctor first.

Important information about some of the ingredients of Topiramate Tablets

This product 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 TABLETS

Always take Topiramate Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.

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

•    reduced number of red blood cells

•    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

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

•    loss of consciousness

•    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)

•    problems with learning    Page 3

•    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

•    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).

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 TABLETS

Keep out of the sight and reach of children.

Do not take this medicine after the expiry date (Exp.) stated. 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Topiramate Tablets contain:

The active ingredient is 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 Tablets look like and the contents of the pack:

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

Topiramate 50 mg: light-orange coloured, circular, biconvex film-coated tablets.

Topiramate 100 mg: orange coloured, circular, biconvex film-coated tablets.

Topiramate 200 mg: pink coloured, biconvex, caplet-shaped film-coated tablets.

Topiramate Tablets 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, 4th Floor, 1 Kingdom Street, London, W2 6BY,

United Kingdom

This leaflet was last revised in August 2014.

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