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

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

•    The full name of this medicine is Topiramate Actavis 25mg, 50mg, 100mg and 200mg Film-coated Tablets but within the leaflet it will be referred to as Topiramate tablets.

In this leaflet:

T| What Topiramate tablets are and what they are used for

2| Before you take How to take

J Possible side effects

5| How to store

6| Further information

3 What Topiramate 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.

3 Before you take

Do not take Topiramate tablets and tell your doctor

•    if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate tablets (see section 6).

•    for migraine prevention do not take if you are pregnant or you are able to become pregnant but you are not using effective contraception (see 'Pregnancy and breastfeeding' for further information).

Check with your doctor or pharmacist before taking Topiramate tablets if you

•    have kidney problems, especially kidney stones, or are having 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.

Other warnings

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

•    You should also talk to your doctor before taking any other medicine containing topiramate that is given to you as an alternative to Topiramate tablets.

•    You may experience significant and continuing weight loss while taking Topiramate tablets. Therefore your weight should be checked regularly when using this medicine. If you are losing too much weight or if 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 tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor at once.

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 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 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 as Topiramate may make these pills less effective. If your menstrual bleeding changes, you have breakthrough bleeding or spotting, tell your doctor.

•    other antiepileptic medicines

•    risperidone, lithium, amitriptyline, venlafaxine (for depression)

•    hydrochlorothiazide, propranolol, diltiazem (for angina and high blood pressure)

•    metformin, pioglitazone, glyburide (anti diabetic medicines)

•    flunarazine.

Taking Topiramate tablets with food and drink

You can take Topiramate tablets with or without food.

To prevent kidney stones whilst being treated with Topiramate tablets, drink plenty of fluids during the day.

You should avoid drinking alcohol when taking Topiramate tablets.

Pregnancy and breast-feeding

Talk to your doctor before using Topiramate tablets if you are pregnant, trying to become pregnant or are breast-feeding. Your doctor will decide if you can take Topiramate tablets. 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 the benefits of using Topiramate tablets for epilepsy during pregnancy.

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

Mothers who breastfeed while taking Topiramate 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 whilst taking Topiramate tablets. Do not drive or use any tools or machines without talking to your doctor first.

Important information about one of the ingredients of Topiramate tablets

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

3 How to take

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

Your doctor will usually start you on a low dose and slowly increase your dose until the best dose is found.

Swallow whole. Do not chew. Take with or without food. To prevent kidney stones while taking Topiramate tablets, drink plenty of fluids during the day.

If you take Topiramate tablets only for epilepsy

•    Adults - starting dose of 25mg at night. The dose will be slowly increased to a maintenance dose, usually 100-200mg a day in 2 divided doses. Maximum dose of 500mg a day in 2 divided doses.

•    Children over 6 years of age - starting dose of 0.5-1mg per kg of body weight at night increasing slowly to a maintenance dose, usually 100mg a day.

If you take Topiramate tablets with another epilepsy medicine

•    Adults - starting dose of 25-50mg at night. The dose will be slowly increased to a maintenance dose, usually 200-400mg a day in 2 divided doses.

•    Children over 2 years of age - starting dose of 1-3mg per kg of body weight at night increasing slowly to a maintenance dose, usually 5-9mg per kg of body weight a day in 2 divided doses.

Prevention of migraines

•    Adults - starting dose of 25mg at night. The dose will be slowly increased to a maintenance dose of 100mg a day in 2 divided doses.

•    Children - Not recommended for use in children.

If you take more Topiramate tablets than you should

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

Signs and symptoms of overdose may include; feeling sleepy or tired, abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, abnormal heart beats or fits, double vision, changes in thinking and alertness, loss of consciousness, speech problems, changes in mood or behaviour (including anger or depression), stomach pain.

Overdose can happen if you are taking other medicines together with Topiramate tablets.

If you forget to take Topiramate 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 tablets

Do not stop taking this medicine even if you feel better unless your doctor tells you to as 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 tablets can cause side effects, although not everybody gets them.

Contact your doctor at once if you have the following side effects:

•    signs of an allergic reaction such as difficulty breathing, swelling of the face, lips, trunk and limbs, hives, skin rash and redness or severe skin reactions such as flushing, blisters and ulcers.

•    severe skin reactions, 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.

•    Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome.

•    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.

•    problems with the eyes including signs of raised pressure in the eye (glaucoma) such as blurred or decreased vision, eye pain and redness of the eyes.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

•    weight loss, diarrhoea, feeling sick

•    tingling in the arms and legs

•    drowsiness or sleepiness, tiredness, dizziness

•    stuffy, runny nose and sore throat

•    depression

Common (affects 1 to 10 users in 100):

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

•    changes in thinking and alertness including confusion, problems with concentration, memory or slowness in thinking

•    weight gain, decrease or loss of appetite

•    being sick, constipation, stomach pain, indigestion

•    dry mouth, altered sense of taste, tingling or numbness of the mouth

•    kidney stones causing sudden pain in the abdomen, frequent or painful urination

•    reduced number of red blood cells. You may notice excessive tiredness, paleness of the skin.

•    slurred speech, clumsiness or problems with walking, involuntary shaking in the arms, hands or legs

•    reduced sense of touch or sensation

•    ringing sound in the ears, ear pain

•    shortness of breath, nose bleeds

•    skin rash and/or itchy skin, hair loss

•    joint pain, muscle spasms, muscle twitching or muscle weakness, loss of strength

•    chest pain

•    fever, general feeling of being unwell

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

•    wind, heartburn, fullness or bloating, increased appetite

•    increased thirst and drinking abnormally large amounts of fluid

•    crystals in the urine, leakage of urine and/or stools, urgent desire to urinate

•    changes in the numbers and types of blood cells. You may notice increased bruising, nosebleeds, sore throats, infections, breathlessness on exertion.

•    increased acid levels in the blood, low potassium levels in the blood (causing muscle twitching or weaknesses, abnormal heart beat)

•    irregular heartbeat or slowness of the heart beat

•    swollen glands in the neck armpit or groin

•    increase in seizures

•    problems with or decreased verbal communication, problems with learning or handwriting

•    drooling, decreased or loss of sweating

•    restlessness or increased mental and physical activity, hallucinations, loss of consciousness, fainting, disturbed or poor quality sleep

•    reduced or altered sense of smell

•    feeling of movement under the skin, skin discolouration, pins and needles

•    decreased or loss of hearing, hoarseness of the voice

•    inflammation of the pancreas, causing severe abdominal pain

•    loss of sensitivity to touch in the mouth, painful or burning sensations in the mouth, breath odour, bleeding gums

•    swelling of the joints, stiffness, slow or reduced movements

•    low blood pressure or drop in blood pressure that occurs when you stand up

•    hot flushing, flu like illness, cold extremities (e.g. hands and feet)

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

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

•    excessive skin sensitivity, odour

•    renal tubular acidosis

•    raynaud's syndrome. A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity

•    abdominal build up of calcium salts in the tissues

•    increase in liver enzymes seen in tests

•    yellowing of the skin or eyes, or tiredness, pain in the abdomen, joints or muscles (hepatitis, hepatic failure)

Unknown (cannot be estimated from the available data):

•    cough

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.

T| How to store

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Topiramate tablets which are 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 (the ingredient that makes the tablet work) 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 look like and contents of the

pack

25mg tablets are round, biconvex, white tablets.

50mg tablets are round, biconvex, light yellow tablets.

100mg tablets are round, biconvex, yellow tablets.

200mg tablets are oval, biconvex, salmon-coloured tablets.

Pack size of 60 tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Manufacturer

Actavis hf

Reykjavikurvegur 78 IS-220 Hafnarfjordur Iceland

This leaflet was last revised in February 2015

If you would like a leaflet with larger text, please contact 01271 311257.

Actavis

Actavis, Barnstaple, EX32 8NS, UK

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

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

•    The full name of this medicine is Topiramate Actavis 25mg, 50mg, 100mg and 200mg Film-coated Tablets but within the leaflet it will be referred to as Topiramate tablets.

In this leaflet:

J What Topiramate tablets are and what they are used for Before you take How to take Possible side effects

Tj How to store

« Further information

J What Topiramate 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.

Before you take

Do not take Topiramate tablets and tell your doctor

•    if you are allergic (hypersensitive) to topiramate or any of the other ingredients of Topiramate tablets (see section 6).

•    for migraine prevention do not take if you are pregnant or you are able to become pregnant but you are not using effective contraception (see 'Pregnancy and breastfeeding' for further information).

Check with your doctor or pharmacist before taking Topiramate tablets if you

•    have kidney problems, especially kidney stones, or are having 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.

Other warnings

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

•    You should also talk to your doctor before taking any other medicine containing topiramate that is given to you as an alternative to Topiramate tablets.

•    You may experience significant and continuing weight loss while taking Topiramate tablets. Therefore your weight should be checked regularly when using this medicine. If you are losing too much weight or if 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 tablets have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor at once.

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 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 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 as Topiramate may make these pills less effective. If your menstrual bleeding changes, you have breakthrough bleeding or spotting, tell your doctor.

•    other antiepileptic medicines

•    risperidone, lithium, amitriptyline, venlafaxine (for depression)

•    hydrochlorothiazide, propranolol, diltiazem (for angina and high blood pressure)

•    metformin, pioglitazone, glyburide (anti diabetic medicines)

•    flunarazine.

Taking Topiramate tablets with food and drink

You can take Topiramate tablets with or without food.

To prevent kidney stones whilst being treated with Topiramate tablets, drink plenty of fluids during the day.

You should avoid drinking alcohol when taking Topiramate tablets.

Pregnancy and breast-feeding

Talk to your doctor before using Topiramate tablets if you are pregnant, trying to become pregnant or are breast-feeding. Your doctor will decide if you can take Topiramate tablets.

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 the benefits of using Topiramate tablets for epilepsy during pregnancy.

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

Mothers who breastfeed while taking Topiramate 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 whilst taking Topiramate tablets. Do not drive or use any tools or machines without talking to your doctor first.

Important information about one of the ingredients of Topiramate tablets

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

^ How to take

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

Your doctor will usually start you on a low dose and slowly increase your dose until the best dose is found.

Swallow whole. Do not chew. Take with or without food. To prevent kidney stones while taking Topiramate tablets, drink plenty of fluids during the day.

If you take Topiramate tablets only for epilepsy

•    Adults - starting dose of 25mg at night. The dose will be slowly increased to a maintenance dose, usually 100-200mg a day in 2 divided doses. Maximum dose of 500mg a day in 2 divided doses.

•    Children over 6 years of age - starting dose of 0.5-1mg per kg of body weight at night increasing slowly to a maintenance dose, usually 100mg a day.

If you take Topiramate tablets with another epilepsy medicine

•    Adults - starting dose of 25-50mg at night. The dose will be slowly increased to a maintenance dose, usually 200-400mg a day in 2 divided doses.

•    Children over 2 years of age - starting dose of 1-3mg per kg of body weight at night increasing slowly to a maintenance dose, usually 5-9mg per kg of body weight a day in 2 divided doses.

Prevention of migraines

•    Adults - starting dose of 25mg at night. The dose will be slowly increased to a maintenance dose of 100mg a day in 2 divided doses.

•    Children - Not recommended for use in children.

If you take more Topiramate tablets than you should

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

Signs and symptoms of overdose may include; feeling sleepy or tired, abnormal body movements, problems standing and walking, feeling dizzy due to low blood pressure, abnormal heart beats or fits, double vision, changes in thinking and alertness, loss of consciousness, speech problems, changes in mood or behaviour (including anger or depression), stomach pain.

Overdose can happen if you are taking other medicines together with Topiramate tablets.

If you forget to take Topiramate 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 tablets Do not stop taking this medicine even if you feel better unless your doctor tells you to as 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.

Possible side effects

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

Contact your doctor at once if you have the following side effects:

•    signs of an allergic reaction such as difficulty breathing, swelling of the face, lips, trunk and limbs, hives, skin rash and redness or severe skin reactions such as flushing, blisters and ulcers.

•    severe skin reactions, 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.

•    Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome.

•    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.

•    problems with the eyes including signs of raised pressure in the eye (glaucoma) such as blurred or decreased vision, eye pain and redness of the eyes.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

•    weight loss, diarrhoea, feeling sick

•    tingling in the arms and legs

•    drowsiness or sleepiness, tiredness, dizziness

•    stuffy, runny nose and sore throat

•    depression

Common (affects 1 to 10 users in 100):

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

•    changes in thinking and alertness including confusion, problems with concentration, memory or slowness in thinking

•    weight gain, decrease or loss of appetite

•    being sick, constipation, stomach pain, indigestion

•    dry mouth, altered sense of taste, tingling or numbness of the mouth

•    kidney stones causing sudden pain in the abdomen, frequent or painful urination

•    reduced number of red blood cells. You may notice excessive tiredness, paleness of the skin.

•    slurred speech, clumsiness or problems with walking, involuntary shaking in the arms, hands or legs

•    reduced sense of touch or sensation

•    ringing sound in the ears, ear pain

•    shortness of breath, nose bleeds

•    skin rash and/or itchy skin, hair loss

•    joint pain, muscle spasms, muscle twitching or muscle weakness, loss of strength

•    chest pain

•    fever, general feeling of being unwell

•    feeling of movement under the skin, skin discolouration, pins and needles

•    decreased or loss of hearing, hoarseness of the voice

•    inflammation of the pancreas, causing severe abdominal pain

•    loss of sensitivity to touch in the mouth, painful or burning sensations in the mouth, breath odour, bleeding gums

•    swelling of the joints, stiffness, slow or reduced movements

•    low blood pressure or drop in blood pressure that occurs when you stand up

•    hot flushing, flu like illness, cold extremities (e.g. hands and feet)

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

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

•    excessive skin sensitivity, odour

•    renal tubular acidosis

•    raynaud's syndrome. A disorder affecting the blood vessels, in the fingers, toes, ears and causing pain and cold sensitivity

•    abdominal build up of calcium salts in the tissues

•    increase in liver enzymes seen in tests

•    yellowing of the skin or eyes, or tiredness, pain in the abdomen, joints or muscles (hepatitis, hepatic failure)

Unknown (cannot be estimated from the available data):

•    cough

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.

How to store

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Topiramate tablets which are 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.

« Further information

What Topiramate tablets contain

The active substance (the ingredient that makes the tablet work) 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 look like and contents of the pack

25mg tablets are round, biconvex, white tablets. 50mg tablets are round, biconvex, light yellow tablets.

100mg tablets are round, biconvex, yellow tablets.

200mg tablets are oval, biconvex, salmon-coloured tablets.

Pack size of 60 tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland

Manufacturer

Balkanpharma - Dupnitsa AD 3 Samokovsko Schosse Str.

Dupnitsa 2600 Bulgaria