Package leaflet: Information for the patient

50 mg film-coated tablets 100 mg film-coated tablets 200 mg film-coated tablets

Sultiame

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 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.

What is in this leaflet 1. What is and w hat it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information

1. What is and what it is used for

contains the active substance sultiame and belongs to a group of medicines called anti-epileptics.

The medicine is used for the alternative treatment for Rolandic epilepsy w hen the treatment w ith other anti-epileptics has not produced the desired effect. Note: The treatment w ith should only be performed by child neurologists (neuropaediatricians) w ith experience in the treatment of epilepsy.

2. What you need to know before you take

Do not take - if you are allergic to Sultiame, sulphonamides or any of the other ingredients of this medicine (listed in section 6); - if you suffer from hyperthyroidism; - if you suffer from arterial hypertension; - in the case of congenital or acquired disorders of the endogenous production of haemoglobin (acute porphyria).

Warnings and precautions Talk to your doctor before taking . - if you suffer from impaired renal function; - if you suffer from psychiatric disorders; - if you are pregnant or breast-feeding.

Consult your doctor immediately if symptoms like fever, sore throat, allergic skin reactions w ith lymph node sw elling and/or flu-like symptoms occur during the treatment w ith

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NAME>, and have a blood count taken. In the event of certain changes in the blood count, reduced number of w hite blood cells or blood platelets (leucocytopenia or thrombocytopenia) associated w ith symptoms such as fever or sore throat, your doctor may order that is discontinued. Immediately stop taking in the case of severe allergic reactions.

It is recommended to take a blood count and determine the liver enzyme and kidney values before starting the treatment w ith , and subsequently check them w eekly during the first month of treatment and then monthly. After six months of treatment betw een tw o and four checks annually should be sufficient.

A small number of patients treated w ith anti-epileptics such as Sultiame have developed thoughts about self-harm or suicidal thoughts. If at any time during the treatment you have such thoughts, tell your doctor immediately.

Effect on laboratory tests Sultiame may interfere w ith the estimation of barbiturates in laboratory tests on blood.

Other medicines and Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. and the follow ing medicines may interfere w ith each other w hen taken/used at the same time.

Combination of and medicines for the treatment of epilepsy: - Phenytoin: The phenytoin level in plasma can rise significantly. This combination requires close monitoring. Your doctor w ill therefore check your phenytoin level in blood frequently, in particular w hen you suffer from impaired renal function. - Lamotrigine: In individual cases the lamotrigine level in blood may rise. At the beginning of such concomitant treatment your lamotrigine level in blood should be checked more frequently. - Primidone: Side effects of can be potentiated. In particular, unstable gait, dizziness and drow siness may occur. - Carbamazepine: There is evidence that the Sultiame level in blood is decreased w hen carbamazepine is taken concomitantly.

The concomitant administration of carbonic anhydrase inhibitors (e.g. topiramate for the treatment of epilepsy and migraine, or acetazolamide for the treatment of increased intraocular pressure) can increase the risk for side effects due to carbonic anhydrase inhibition.

Taking with alcohol Do not drink alcohol w hile taking as alcohol can change or potentiate the effect of unpredictably. Also, w hen taken w ith alcohol, can cause very unpleasant reactions w ith vasodilatation, pulsating headache, shortness of breath, nausea, vomiting, rapid heartbeat, drop in blood pressure, blurred vision, confusion, shock reactions, cardiac irregularities, loss of consciousness and seizures. The degree and duration of these symptoms can vary to a great extent.

Pregnancy, and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy should not be taken w hen you are pregnant (section 2). If during the treatment w ith you intend to become pregnant or think that you are pregnant, tell your doctor immediately to allow him to decide w hether to continue or discontinue

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the treatment.

Lactation It is not know n w hether sultiame is excreted into human breast milk. should therefore not be taken w hen breastfeeding.

Fertility There are no clinical data available on the effects of sultiame on human fertility.

Driving and using machines This medicine can change your reactivity to an extent that you are no longer able to participate safely in road traffic or operate machines, in particular at the beginning of treatment. This is even more so w hen drinking alcohol.

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

3. How to take

Alw ays take this medicine exactly as your doctor has told you. You should check w ith your doctor or pharmacist if you are not sure.

The usual daily maintenance dose is 5-10 mg per kilogram body w eight. The treatment should be started at low initial doses and increased gradually to optimum amounts w ithin one w eek. If possible, the daily dose should be divided in three single doses taken over the day.

Sw itching from another medicine to or from another combination treatment should be gradual.

How to take is for oral use. Sw allow the film-coated tablets w ith plenty of w ater (e.g. a glass of w ater). Do not take the film-coated tablets w hen lying dow n.

100 mg film-coated tablets 100 mg film-coated tablets can be divided into tw o equal doses.

200 mg film-coated tablets 200 mg film-coated tablets can be divided into four equal doses.

How long to take Anti-epileptic therapies are principally long-term therapies. A child neurologist (neuropediatrician) w ith experience in the treatment of epilepsy should decide about duration and discontinuation of the treatment on an individual basis. should not be stopped suddenly.

If you take more than you should Side effects may be potentiated. In the event of an overdose a doctor/emergency doctor should be consulted as soon as possible and, if possible, the medicine together w ith this package leaflet presented.

Symptoms of intoxication are: - Abnormal coordination (ataxia) - Clouding of consciousness

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- Laboratory value changes (Metabolic acidosis and crystals in urine)

If you forget to take Do not take a double dose to make up for a forgotten dose. Take your next dose w hen you are meant to. Tell your doctor that you forgot to take a dose.

If you stop taking If you w ish to discontinue the treatment w ith , talk to your doctor first. Do not stop taking the medicine w ithout checking w ith your doctor. This may jeopardise the success of the treatment and cause the recurrence of epileptic fits. The duration of treatment and the dose vary from one patient to another and are determined by the attending doctor on an individual basis.

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

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people) - Stomach disorders

Common side effects (may affect up to 1 in 10 people): - Difficulty breathing up to shortness of breath (dose dependent) - Chest tightness, rapid heartbeat - Tingling arms, legs or face - Dizziness, headache - Double vision - Hiccup, loss of w eight or loss of appetite

Uncommon side effects (may affect up to 1 in 100 people): - Hallucination, anxiety, lack of drive - Muscular w eakness, joint pain - More frequent seizures, grand mal state

Not know n (frequency cannot be estimated from the available data): - Delayed oversensitivity reactions affecting several organ systems including fever, skin rash, vasculitis, sw ollen lymph nodes, joint pain, changes in the number of w hite blood cells, enlarged liver or spleen and severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) - Acute renal failure - Significant deterioration of visual acuity, inflammation of several nerves - Reactions damaging the liver and/or elevated liver test values - Behavioural anomaly such as aggressiveness, irritability, mood sw ings - Drow siness - Deterioration in cognitive function

In one patient Sultiame caused increasingly w eak limbs, increased salivation, slurred speech, increasing drow siness up to coma. These symptoms abated w ithin a few hours of Sultiame being discontinued.

Sulthiamine belongs to a group of active substances (carbonic anhydrase inhibitors) w here renal stone formation and changes in the blood composition (metabolic acidosis, haemodilution, changes in the serum electrolyte values) cannot be excluded.

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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date w hich is stated on the carton and the blister after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via w astewater . Ask your pharmacist how to throw aw ay medicines you no longer use. These measures w ill help protect the environment.

6. Contents of the pack and other information

What contains The active substance is: Sultiame.

50 mg film-coated tablets Each film-coated tablets contains 50 mg Sultiame.

100 mg film-coated tablets Each film-coated tablets contains 100 mg Sultiame.

200 mg film-coated tablets Each film-coated tablets contains 200 mg Sultiame.

The other ingredients are: Tablet core Lactose monohydrate, starch, maize, gelatine, silica, colloidal anhydrous, magnesium stearate (Ph. Eur.)

Coating Hypromellose, titanium dioxide (E 171), Macrogol 4000, talc

What looks like and contents of the pack 50 mg film-coated tablets White, round, biconvex film-coated tablets w ith a diameter of approximately 6.0 mm.

100 mg film-coated tablets White, round, biconvex film-coated tablets scored on one side w ith a diameter of approximately 8.0 mm. The film-coated tablets can be divided into tw o equal doses.

200 mg film-coated tablets White, round, biconvex film-coated tablets cross-scored on one side w ith a diameter of approximately 11.0 mm. The film-coated tablets can be divided into four equal doses.

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The film-coated tablets are available in OPA/AI/PVC//Al blisters.

Pack sizes is available in packs of 50 and 200 film-coated tablets.

Marketing Authorisation Holder and Manufacturer [to be completed nationally]

This leaflet was last revised in {month YYYY}.

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