PACKAGE LEAFLET: INFORMATION for the USER Topiramat Orion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramat Orion 25 mg, 50 mg, 100 mg and 200 mg film-coated tablets Topiramate

Read all of this leaflet carefully before you start using 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 Topiramat Orion is and what it is used for 2. Before you take Topiramat Orion 3. How to take Topiramat Orion 4. Possible side effects 5. How to store Topiramat Orion 6. Further information

1. WHAT TOPIRAMAT ORION IS AND WHAT IT IS USED FOR

The active substance in Topiramat Orion is topiramate which belongs to a group of medicines called anticonvulsants or antiepileptic drugs.

Topiramate is used to treat various types of epilepsy (partial seizures and/or generalized tonic-clonic seizures and/or seizures in Lennox-Gastaut syndrome) in adults and children aged 2 years and older. Topiramate can be taken either on its own or in combination with other medicines used to treat epilepsy.

Topiramat is also used to prevent frequently recurring migraine headaches in adults when earlier treatment with other medicinal products was not effective. This medicine does not provide relief for individual migraine attacks.

2. BEFORE YOU TAKE TOPIRAMAT ORION

Do not take Topiramat Orion

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramat Orion • for the prevention of migraine headaches if you are pregnant or of child bearing age and you are not using an effective method of contraception.

Take special care with Topiramat Orion

Consult your doctor before taking this medicine if • you suffer from kidney or liver disease • you suffer from a severe respiratory organ disorder • you suffer from severe or chronic diarrhea • you have epileptic seizures that last over 30 minutes (status epilepticus) • you recently have had a surgery • your diet is high in fat and proteins • you or any member of your family has ever suffered from kidney stones • you have an increase in the level of calcium in the urine • you have or have had any mood disorders, depression or thoughts of harming yourself.

Kidney stones and how to prevent them Topiramate may increase the risk of kidney stone formation in pre-disposed patients. You should drink plenty of water and avoid fatty and low carbonate diets to prevent kidney stones. See also section ”Taking other medicines”. Body temperature increase Topiramate may inhibit or reduce sweating, mostly in children. See also section 4 ”How to prevent and treat body temperature increase”.

Controlling weight Topiramate may cause lack of appetite and reduce weight. You should be weighed regularly while taking topiramate. When you experience significant and continuing weight loss, please tell your doctor.

Children and adolescents Epilepsy: Topiramate is not recommended to children under 2 years of age. Migraine: Topiramate should not be used to treat migraine in children and adolescents under 18 years of age.

See also section 4 “When to immediately contact a doctor”.

Notice! The tablet container contains desiccant pouch. Do not swallow.

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.

Topiramate may alter the effectiveness and safety of other medicines and other medicines may alter the effectiveness of topiramate when they are taken together.

It is especially important to tell your doctor if you are taking any of the following: • other medicines for epilepsy (phenytoin, carbamazepine, sultiame or zonisamide). Topiramate may increase the effects of phenytoin. Carbamazepine and phenytoin may reduce the effects of topiramate. • a medicine for heart disease (digoxin), because the effect may be decreased due to topiramate • a medicine for high blood pressure and chest pain caused by angina (diltiazem) • a medicine for high blood pressure (propranolol) • a diuretic (hydrochlorothiazide). Your doctor may need to reduce the topiramate dose. • hormonal contraceptives because their effectiveness may be reduced while you are on topiramate • medicines for diabetes (metformin, glibenclamide or pioglitazone) • a medicine for bipolar affective disorder (lithium) • a medicine for depression (amitriptyline) • a medicine for mental illness (haloperidol) • a medicine for glaucoma (acetazolamide), a diuretic (triamterene) or high doses of Vitamin C. These medicines can increase the risk of suffering kidney stones. Your doctor may need to change your dose of topiramate or the dose of the other medicine.

Taking Topiramat Orion with food and drink

Topiramat Orion can be taken with or without a meal with a sufficient quantity of liquid.

Alcohol You should avoid drinking alcohol when taking this medicine. Alcohol may increase the effects of topiramate on your central nervous system.

Pregnancy and breast-feeding

2 Tell your doctor if you are pregnant or if you intend to become pregnant. Use of topiramate during pregnancy may damage the developing foetus. However, untreated epilepsy and serious seizures caused by suddenly stopping your medication might cause more damage. Your doctor will discuss with you if you should continue to take topiramate.

Do not use Topiramat Orion film-coated tablets to prevent migraine attacks if you are pregnant or if you are a woman of child bearing age and you are not using effective contraception.

Do not breast-feed your child during topiramate therapy because topiramate is excreted in human breast milk. You should contact your doctor for advice on what is appropriate for you.

Driving and using machines

Before driving or using machines you should talk to your doctor. While taking topiramate your reactions may be slowed down. Side effects like drowsiness or dizziness can affect your ability to drive or to operate machines.

Important information about some of the ingredients of Topiramat Orion

Topiramat Orion film-coated tablets contain 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 TOPIRAMAT ORION

Always take Topiramat Orion exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will start with a low dose and slowly increase the dose until you are on the lowest amount needed to control your epilepsy or migraine headaches. Always check that you have enough tablets and do not run out.

Dosage in epilepsy:

Adults and adolescents aged 12 years and older If you take only topiramate to treat your epilepsy The starting dose is 25 mg for 7 days to be taken in the evening. Your doctor may then increase your daily dose. The maintenance dose is usually 50 mg in the morning and 50 mg in the evening. The maximum recommended daily dose is 400 mg.

If you are taking topiramate and other antiepileptic drugs to treat your epilepsy The starting dose is 25–50 mg for 7 days to be taken in the evening. Your doctor may then increase your daily dose. The maintenance dose is usually 100–200 mg in the morning and 100–200 mg in the evening. The maximum recommended daily dose is 800 mg.

Children aged between 2 years and 12 years If you take only topiramate to treat your epilepsy The starting dose is determined by the doctor on the basis of the body weight of the child, that is 0.5–1 mg/kg given for 7 days in the evening. Your doctor may then increase the daily dose. The usual maintenance dose is 1.5–3 mg/kg in the morning and 1.5–3 mg/kg in the evening.

If you are taking topiramate and other antiepileptic drugs to treat your epilepsy The starting dose is determined by the doctor on the basis of the body weight of the child and it is given for 7 days in the evening. Usually it is 25 mg or lower. Your doctor may then increase the daily dose. The usual maintenance dose is 2.5–4.5 mg/kg in the morning and 2.5–4.5 mg/kg in the evening.

Children less than 2 years

3 The use of Topiramat Orion in children less than 2 years is not recommended.

Dosage in preventing migraine headaches:

Adults The starting dose is 25 mg for 7 days to be taken in the evening. Your doctor may then increase your daily dose. The usual maintenance dose is 50 mg in the morning and 50 mg in the evening.

Children and adolescents under 18 years of age Topiramat Orion should not be used for the prevention of migraine in children or adolescents.

Patients with kidney problems: If you suffer from kidney disease your doctor will prescribe half the usual starting dose and increase the dose slower.

Patients on kidney dialysis: You must tell your doctor if you are undergoing kidney dialysis treatment as you may need an additional dose (half the usual dose) on your dialysis days.

Patients with liver problems: If you suffer from liver disease your doctor may need to prescribe a lower topiramate dose.

Method of administration:

Try to take the tablets at the same time every day. Part of your total daily dose should be taken in the morning and the remainder in the evening. Swallow the tablets whole with plenty of water. Do not chew or break the tablets.

If you take more Topiramat Orion than you should

Contact your doctor or nearest hospital immediately. Take the container and any remaining tablets with you. Signs and symptoms of overdose include: drowsiness, speech disturbances, blurred vision, double vision, inability to concentrate, tiredness and a lack of energy, lack of responsiveness, low blood pressure, abdominal pain, headache, agitation, dizziness, abnormal coordination, depression and seizures.

If you forget to take Topiramat Orion

If you miss a dose take it as soon as you remember unless it is nearly time for your next dose. In which case, do not take the missed dose simply carry on as normal. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Topiramat Orion

Do not stop taking this medicine without talking to your doctor first. Your doctor will gradually reduce your dose to reduce your risk for suffering an epileptic fit or migraine attack.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Topiramat Orion can cause side effects, although not everybody gets them.

When to immediately contact a doctor: • if you have low back pain or pain in the genital region or if you notice blood in your urine. These symptoms may be a sign of kidney stones.

4 • if you are suffering from acute short-sightness (myopia), a blurred vision and/or pain in the eyes. The symptoms may be caused by increased pressure in the eye (glaucoma) caused by topiramate. • if you notice any mood changes, feel depressed or have thoughts of harming yourself or taking your life. • if you have fever or feel unwell or have skin rashes, blisters on the skin and sore mouth/eyes.

The frequencies of the side effects are defined as: Very common (affects more than 1 patient in 10) Common (affects 1 to 10 patients in 100) Uncommon (affects 1 to 10 patients in 1,000) Rare (affects 1 to 10 patients in 10,000).

Very common headaches, feeling sick, dizziness, exhaustion, tiredness, nervousness, weight loss and loss of appetite, changes in thinking including difficulty in concentrating, slow thinking and slow moving, confusion and forgetfulness, drowsiness, sleepiness and speech disorders, depression, anxiety, uncoordinated movements, tingling and vision disorders including blurred vision and double vision.

Common pain in bones, allergic reactions, trouble sleeping, changes in the blood (including blood acidity, a decrease in red and white blood cells, a decrease in platelets), nosebleeds, bruising of the skin, feelings of apathy or euphoria, mood swings, weakness, agitation, reduced sex drive, changes in taste, kidney stones (that may cause blood in the urine or pain in the lower back or genital area), incontinence, constipation, abdominal pain, hair loss, tremors and co-ordination problems including problems walking normally, psychosis or psychotic symptoms and aggressive behaviour, cognitive problems including changes in thinking or awareness, involuntary eye movements and menstrual disturbances.

Uncommon hallucinations, personality disorders, thoughts or attempts of committing suicide, difficulty breathing, diarrhoea, being sick, suffering from a dry mouth, folliculitis (infection of hair roots), itchiness, lack of movements or spontaneous movements, loss of responsiveness.

Rare neutropenia (a decrease in the number of neutrophilic white blood cells in the blood), difficulty seeing including eye pain and short-sightedness (glaucoma and acute myopia), increase in liver enzymes, changes in liver function which may rarely result in hepatitis or liver failure.

The following side effects have also been reported: Fever, feeling abnormal, hyperammonaemia (elevated level of ammonia in blood) and rash.

How to prevent and treat body temperature increase Topiramate may sometimes inhibit or reduce sweating, mostly in children. Body temperature may then increase more than usually during exercise or in particularly warm conditions. To prevent symptoms (headaches and nausea) caused by body temperature increase, you should drink plenty of fluids before and during exercise or during staying in particularly warm conditions. If symptoms occur you should relax in a cool place and drink plenty of water.

In addition to the above mentioned side effects, the following side effects have been observed in children aged 2 years or above: excessive movements of muscles, abnormal behaviour, hypersalivation.

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

5. HOW TO STORE TOPIRAMAT ORION

Keep out of the reach and sight of children.

5 Do not use Topiramat Orion after the expiry date which is stated on the carton or bottle. The expiry date refers to the last day of that month.

Do not store above 30°C.

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 Topiramat Orion contains

- The active substance is topiramate. Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg of topiramate. - The other ingredients in the tablet core are: microcrystalline cellulose, lactose monohydrate, pregelatinised maize starch, sodium starch glycolate (type A), magnesium stearate. - The other ingredients in the film-coating are hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80; in addition iron oxide yellow (E172) in 50 mg and 100 mg tablets and iron oxide red (E172) in 200 mg tablets.

What Topiramat Orion looks like and contents of the pack

Circular, biconvex film-coated tablets debossed with ‘E’ on one side.

Topiramat Orion 25 mg: white tablets debossed with ‘22’ on the other side.

Topiramat Orion 50 mg: light yellow tablets debossed with ‘33’ on the other side.

Topiramat Orion 100 mg: dark yellow tablets with beveled edges and debossed with ‘23’ on the other side.

Topiramat Orion 200 mg: pink tablets with beveled edges and debossed with ‘24’ on the other side.

Pack sizes: 60 and 100 film-coated tablets in HDPE bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

To be completed nationally.

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg potahované tablety Denmark: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmovertrukne tabletter Estonia: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg õhukese polümeerikattega tabletid Finland: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg tabletti, kalvopäällysteinen; Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmdragerad tablett Germany: TopiCare 25 mg, 50 mg, 100 mg, 200 mg Filmtabletten Hungary: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmtabletta Latvia: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg apvalkotās tabletes Lithuania: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg plėvele dengtos tabletės Norway: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg tablett, filmdrasjert Poland: Oritop 25 mg, 50 mg, 100 mg, 200 mg, tabletki powlekane Slovak Republic: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmom obalené tablety Sweden: Topiramat Orion 25 mg, 50 mg, 100 mg, 200 mg filmdragerad tablett

This leaflet was last approved in July 2008.

LABELLING

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING

CARTON AND PLASTIC BOTTLE

1. NAME OF THE MEDICINAL PRODUCT

Topiramat Orion 25 mg film-coated tablets

Topiramat Orion 50 mg film-coated tablets

Topiramat Orion 100 mg film-coated tablets

Topiramat Orion 200 mg film-coated tablets topiramate

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Topiramat Orion 25 mg film-coated tablets: Each film-coated tablet contains 25 mg topiramate.

Topiramat Orion 50 mg film-coated tablets: Each film-coated tablet contains 50 mg topiramate.

Topiramat Orion 100 mg film-coated tablets: Each film-coated tablet contains 100 mg topiramate.

Topiramat Orion 200 mg film-coated tablets: Each film-coated tablet contains 200 mg topiramate.

3. LIST OF EXCIPIENTS

Contains lactose. See leaflet for further information.

4. PHARMACEUTICAL FORM AND CONTENTS

Film-coated tablet

60 film-coated tablets 100 film-coated tablets

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Oral use. Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY -

8. EXPIRY DATE

EXP:

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE -

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

To be completed nationally.

12. MARKETING AUTHORISATION NUMBER(S)

To be completed nationally

13. BATCH NUMBER

Lot:

14. GENERAL CLASSIFICATION FOR SUPPLY

To be completed nationally

15. INSTRUCTIONS ON USE -

16. INFORMATION IN BRAILLE

Topiramat Orion 25 mg Topiramat Orion 50 mg Topiramat Orion 100 mg Topiramat Orion 200 mg