Package leaflet: Information for the patient TOPIRAMATE FANNIN 25 mg, 50 mg, 100 mg and 200 mg FILM-COATED TABLETS

(topiramate)

The name of this medicine is Topiramate Fannin 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 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. 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.

What is in this leaflet

1.    What Topiramate Tablets are and what they are used for

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

3.    How to take Topiramate Tablets

4.    Possible side effects

5.    How to store Topiramate Tablets

6.    Contents of the pack and other information

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.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATE TABLETS

Do not take Topiramate Tablets:

•    if you are allergic (hypersensitive) to topiramate, or any of the other ingredients in Topiramate Tablets (these are listed in section 6, Contents of the pack and other information)

•    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 Tablets.

Warnings and precautions

Before you take Topiramate Tablets you should tell your doctor 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 Tablets.

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 Tablets.

Decreased sweating and a rise in body temperature may occur while taking Topiramate Tablets especially in young children exposed to high ambient temperature.

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

Impairment of cognitive function may occur during treatment with Topiramate Tablets. If this occurs you should contact your doctor.

You may lose weight while taking Topiramate Tablets 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.

Other medicines and Topiramate Tablets

Please tell your doctor if you are taking or have recently taken any of the following medicines, including medicines obtained without a prescription, vitamins and herbal medicines. Topiramate Tablets and certain other medicines can affect each other.

Sometimes the dose of some of your other medicines or Topiramate Tablets 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 Tablets 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 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 or valproic acid.

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 anti-epilepsy 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.

•    Take Topiramate Tablets exactly as prescribed. 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 Tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

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

If you take more Topiramate Tablets 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. You may feel sleepy, tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits. Overdose can happen if you are taking other medicines together with Topiramate Tablets.

If you forget to take Topiramate Tablets

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 Tablets

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.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Topiramate Tablets can cause side effects, although not everybody gets them.

Very common side effects (affects more than 1 user in 10):

•    weight loss

•    tingling in the arms and legs

•    drowsiness or sleepiness; tiredness; dizziness

•    diarrhoea; nausea (feeling sick)

•    stuffy, runny nose and sore throat

•    depression

Common side effects (affects 1 to 10 users in 100):

•    changes in mood or behaviour, including anger, nervousness, sadness

•    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

•    allergic reaction

Uncommon side effects (affects 1 to 10 users in 1,000):

•    crystals in the urine

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

•    increase in liver enzymes

•    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

•    inflammation of the pancreas

•    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

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

•    hallucinations

•    decreased verbal communication

Rare side effects (affects 1 to 10 users in 10,000):

•    excessive skin sensitivity

•    impaired sense of smell

•    glaucoma which is a blockage of fluid in the eye causing increased pressure in the eye, pain and decreased vision

•    renal tubular acidosis

•    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 erythma multiforma, a condition of raised red spots that can blister

•    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)

•    swelling and inflammation of the liver (hepatitis); liver failure Side effects of unknown frequency:

•    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.

•    swelling of the conjunctiva of the eye.

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

•    Cough

Reporting of side effects

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

5.    HOW TO STORE TOPIRAMATE TABLETS

Keep out of the reach and sight of children.

Do not take this medicine after the expiry date which is stated on the 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.

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.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Topiramate Tablets contain:

The active substance is topiramate.

Each film-coated tablet contains 25 mg, 50 mg, 100 mg 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, 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-1-171174-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-1-14779A, 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, 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:

Fannin (UK) Limited, 42-46 booth Drive, Park Farm South, Wellingborough, NN8 6GT

Manufacturer responsible for batch release:

Neolab Limited, 57 High Street, Odiham, Hants, RG29 1LF

This leaflet was last approved in February 2014.