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Topiramate Aptil 100mg Film-Coated Tablets

Informations for option: Topiramate Aptil 100mg Film-Coated Tablets, show other option

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramate Aptil 25, 50, 100 and 200 mg Film-coated Tablets

Topiramate

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 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 this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Topiramate Film-coated Tablets are and what they are used for

2.    Before you take Topiramate Film-coated Tablets

3.    How to take Topiramate Film-coated Tablets

4.    Possible side effects

5.    How to store Topiramate    Film-coated    Tablets

6.    Further information

1. WHAT TOPIRAMATE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Topiramate belongs to a group of medicines called “antiepileptic medicines.” It is 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 FILM-COATED TABLETS Do not take Topiramate Film-coated Tablets

-    if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate Film-coated Tablets (listed in section 6).

-    for migraine prevention if you are pregnant or you are able to become pregnant but you are not using effective contraception (see section ‘pregnancy and breastfeeding’ for further information).

If you are not sure if the above applies to you, talk to your doctor or pharmacist before using Topiramate Film-coated Tablets.

Take special care with Topiramate Film-coated Tablets

Check with your doctor or pharmacist before taking Topiramate Film-coated Tablets 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 apply to you, talk to your doctor or pharmacist before using Topiramate Film-coated Tablets.

It is important that you do not stop taking your medicine without first consulting your doctor.

You should also to talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramate Film-coated Tablets.

You may lose weight if you use Topiramate Film-coated Tablets so your weight should be checked regularly when using this medicine. 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 Film-coated Tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal medicines. Topiramate Film-coated Tablets and certain other medicines can affect each other. Sometimes the dose of some of your other medicines or Topiramate Film-coated Tablets will have to be adjusted.

Especially, tell your doctor or pharmacist if you are taking:

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

-    birth control pills. Topiramate Film-coated 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 Film-coated 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 or pharmacist 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 using Topiramate Film-coated Tablets.

Taking Topiramate Film-coated Tablets with food and drink

You can take Topiramate Film-coated Tablets with or without food. Drink plenty of fluids during the day to prevent kidney stones while taking Topiramate Film-coated Tablets. You should avoid drinking alcohol when taking Topiramate Film-coated Tablets.

Pregnancy and breast-feeding

Talk to your doctor before using Topiramate Film-coated Tablets if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will decide if you can take Topiramate Film-coated Tablets. As with other antiepilepsy medicines, there is a risk of harm to the unborn child if Topiramate Film-coated Tablets are used during pregnancy. Make sure you are very clear about the risks and the benefits of using Topiramate Film-coated Tablets for epilepsy during pregnancy.

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

Mothers who breastfeed while taking Topiramate Film-coated Tablets must tell the doctor as soon as possible if the baby experiences anything unusual.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dizziness, tiredness, and vision problems may occur during treatment with Topiramate Film-coated 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 Film-coated Tablets

Topiramate 50 mg, 100 mg and 200 mg Film-coated Tablets contain lecithin (soya oil). If you are allergic to peanuts or soya, do not use this medicinal product.

3. HOW TO TAKE TOPIRAMATE FILM-COATED TABLETS

Always take Topiramate Film-coated Tablets exactly as your doctor has told you. You

should check with your doctor or pharmacist if you are not sure.

-    Take Topiramate Film-coated Tablets exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate Film-coated Tablets and slowly increase your dose until the best dose is found for you.

-    Topiramate Film-coated Tablets are to be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.

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

If you take more Topiramate Film-coated Tablets than you should

-    See a doctor right away. Take the medicine pack with you.

-    Signs and symptoms of over dosage may include convulsions (fits), drowsiness (sleepy or tired), speech disturbances, double vision, impaired thinking, abnormal coordination (abnormal body movements or problems standing and walking), dulling of consciousness, low blood pressure, abdominal pain, agitation, dizziness, depression and abnormal heart beats.

Overdose can happen if you are taking other medicines together with Topiramate Film-

coated Tablets.

-    If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor.

-    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Topiramate Film-coated Tablets

Do not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. 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 Film-coated Tablets can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common    (affects 1 to    10    users in 100)

uncommon    (affects 1 to    10    users in 1,000)

rare    (affects 1 to    10    users in 10,000)

very rare    (affects less    than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Very common side effects include:

-    Weight loss

-    Tingling in the arms    and legs

-    Drowsiness or sleepiness

-    Dizziness

-    Diarrhoea

-    Nausea

-    Stuffy, runny nose and sore throat

-    Tiredness

-    Depression

Common side effects include:

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

-    Distorted sense of taste

-    Visual disturbance, blurred vision, double vision

-    Ringing sound in the ears

-    Ear pain

-    Shortness of breath

-    Nose bleeds

-    Vomiting

-    Constipation

-    Stomach pain

-    Indigestion

-    Dry mouth

-    Tingling or numbness of the mouth

-    Kidney stones

-    Frequent urination

-    Painful urination

-    Hair loss

-    Skin rash and/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 include:

-    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 increased 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

-    Fullness or bloating

-    Painful or burning sensations in the mouth

-    Breath odour

-    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 include:

-    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 multiforme, 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).

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 uncommon side effects).

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

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original packaging (blisters, bottles) in order to protect from moisture. Keep the bottle tightly closed in order to protect from moisture.

Do not use Topiramate Film-coated Tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Topiramate tablets supplied in bottles must be used within 60 days of opening. There is a space provided on the bottle for you to write the date that you opened them.

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 substance is topiramate.

Each tablet contains either 25mg, 50mg, 100mg or 200mg of the active substance.

The other ingredients are mannitol, starch (pregelatinised), cellulose (microcrystalline), croscarmellose sodium, silica (colloidal anhydrous), magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogols (macrogol 3350), talc.

The following ingredients are also in the

•    50mg and 100mg tablets - lecithin (Soya) (E322) and iron oxide yellow (E172).

•    200mg tablets - lecithin (Soya) (E322) and iron oxide red (E172).

What Topiramate tablets looks like and contents of the pack

Topiramate 25mg Film-coated Tablets are round, biconvex, white tablets Topiramate 50mg Film-coated Tablets are round, biconvex, light yellow tablets Topiramate 100mg Film-coated Tablets are round, biconvex, yellow tablets Topiramate 200mg Film-coated Tablets are oval, biconvex, salmon-coloured tablets Topiramate Film-coated Tablets are available in packs of 60 tablets.

Marketing Authorisation Holder

Aptil Pharma Limited

9th Floor, CP House

97-107 Uxbridge Road, Ealing

London

W5 5TL

Manufacturer

Actavis hf

Reykjavikurvegur 78 IS-220

Hafnarfjordur

Iceland

This leaflet was last updated in 01/2014.