Xitop: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramato Tecnimede 25 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Topiramato Tecnimede is and what it is used for
What you need to know before taking Topiramato Tecnimede
How to take Topiramato Tecnimede
Possible side effects
How to store Topiramato Tecnimede
Contents of the pack and other information

1. WHAT TOPIRAMATO TECNIMEDE IS AND WHAT IT IS USED FOR:

Topiramato Tecnimede belongs to a group of medicines called "antiepileptic drugs". It is used:

alone for the treatment of epileptic seizures in adults and children over 6 years of age.
in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age.
for the prevention of migraine in adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TOPIRAMATE TECNIMEDE

Do not take Topiramate Tecnimede

if you are allergic (hypersensitive) to topiramate or to any of the other ingredients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or of childbearing age but are not using an effective contraceptive method (see section “Pregnancy and breastfeeding” for more information).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Topiramate Tecnimede.
Consult your doctor or pharmacist before taking Topiramate Tecnimede if:

you have kidney problems, especially kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid abnormalities (metabolic acidosis)
you have liver problems
you have eye problems, particularly glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before starting treatment with Topiramate Tecnimede.
It is important that you do not stop taking this medicine without first consulting your doctor.
You should also speak with your doctor before taking any other topiramate-containing medicine prescribed as an alternative to Topiramate Tecnimede.
While taking Topiramate Tecnimede, you may lose weight; therefore, your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking the medicine does not gain sufficient weight, consult your doctor.
A small number of patients treated with antiepileptic medicines such as Topiramate Tecnimede have experienced suicidal thoughts or self-harming thoughts. If at any time you experience such thoughts, contact your doctor immediately.

Other medicines and Topiramate Tecnimede

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, and herbal supplements. Topiramate Tecnimede and certain other medicines may affect each other. Sometimes, the dose of either Topiramate Tecnimede or other medicines you are taking may need to be adjusted.
In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
oral contraceptives. Topiramate Tecnimede may reduce the effectiveness of oral contraceptives.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topiramate Tecnimede.
Keep a list of all medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine.
Other medicines to discuss with your doctor or pharmacist include other antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.
If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Topiramate Tecnimede with food and drinks
You may take Topiramate Tecnimede during or between meals. Drink plenty of fluids throughout the day when taking Topiramate Tecnimede to help prevent kidney stone formation. Avoid drinking alcohol during treatment with Topiramate Tecnimede.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will decide whether you can take this medicine. As with other antiepileptic medicines, there is a risk of congenital malformations in the fetus if Topiramate Tecnimede is taken during pregnancy. Make sure you are fully informed about the risks and benefits of using Topiramate Tecnimede for epilepsy treatment during pregnancy.
You must not take Topiramate Tecnimede for migraine prevention if you are pregnant or of childbearing age and not using an effective contraceptive method.
Breastfeeding mothers taking Topiramate Tecnimede should inform their doctor as soon as possible if the baby shows any unusual symptoms.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Dizziness, fatigue, and vision problems may occur during treatment with Topiramate Tecnimede. Do not drive or operate tools or machinery without first discussing this with your doctor.

Topiramate Tecnimede contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE TOPIRAMATE TECNIMEDE

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.

Take Topiramate Tecnimede exactly as directed. Your doctor will usually start you on a low dose of Topiramate Tecnimede, gradually increasing it until the optimal dose for you is reached.
Topiramate Tecnimede tablets must be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
Topiramate Tecnimede can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to reduce the risk of kidney stone formation while taking Topiramate Tecnimede.

If you take more Topiramate Tecnimede than you should

Contact a doctor immediately. Take the medicine package with you.
Signs and symptoms of overdose may include seizures, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, reduced level of consciousness, low blood pressure, abdominal pain, agitation, dizziness, and depression.

If you are taking other medicines together with Topiramate Tecnimede, overdose may occur.
If you forget to take Topiramate Tecnimede

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. 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 Tecnimede
Do not stop taking this medicine unless your doctor tells you to. Your symptoms may return. If your doctor decides to discontinue this medicine, your dose may be gradually reduced over several days.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the possible adverse reactions listed below is defined using the following convention:

very common (affects more than 1 in 10 people)
common (affects from 1 to 10 in 100 people)
uncommon (affects from 1 to 10 in 1,000 people)
rare (affects from 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (cannot be estimated from the available data)

Very common adverse reactions include:

Weight loss
Tingling in arms and legs
Numbness or drowsiness
Dizziness
Diarrhea
Nausea
Stuffy, runny nose, and sore throat
Fatigue
Depression

Common adverse reactions include:

Changes in mood or behavior, including anger, nervousness, sadness
Weight gain
Decreased or loss of appetite
Reduction in red blood cell count
Changes in thinking and alertness, including confusion, problems with concentration, memory, or slowed thinking
Slurred speech
Clumsiness, or difficulty walking
Involuntary tremor of arms, hands, or legs
Reduced sense of touch or sensation
Involuntary eye movements
Altered taste
Vision disturbances, blurred vision, double vision
Ringing in the ears
Ear pain
Shortness of breath
Nosebleeds
Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent need to urinate
Pain when urinating
Hair loss
Skin rash and/or itching
Joint pain
Muscle spasms, muscle contractions, or muscle weakness
Chest pain
Fever
Loss of strength
General feeling of malaise
Allergic reaction

Uncommon adverse reactions include:

Crystals in urine
Abnormal blood count, including reduced white blood cell or platelet count, or increased eosinophils
Irregular heartbeat or slowed heart rate
Swelling of glands in the neck, armpits, or groin
Increased frequency of epileptic seizures
Problems with verbal communication
Loss of saliva
Inability to stay still or increased mental and physical activity
Loss of consciousness
Fainting
Slowed or reduced movements
Poor or disturbed sleep quality
Distorted or impaired sense of smell
Problems with writing
Sensation of movement under the skin
Eye problems, including dry eyes, light sensitivity, involuntary contractions, tearing, and decreased vision
Decreased or loss of hearing
Hoarseness
Inflammation of the pancreas
Gas
Heartburn
Loss of sensitivity to touch in the mouth
Bleeding gums
Feeling of fullness or bloating
Sensation of pain or burning in the mouth
Bad breath
Loss of urine and/or feces
Urgent need to urinate
Pain in the kidney and/or bladder area due to kidney stones
Decreased or absent sweating
Discoloration of the skin
Localized skin swelling
Facial swelling
Joint swelling
Musculoskeletal stiffness
Increased levels of acids in the blood
Low potassium levels in the blood
Increased appetite
Increased thirst and excessive intake of fluids
Low blood pressure or drop in blood pressure upon standing
Hot flushes
Flu-like malaise
Cold extremities (e.g., hands and face)
Learning difficulties
Sexual dysfunction (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication

Rare adverse reactions include:

Excessive skin sensitivity
Impaired sense of smell
Glaucoma, which involves fluid retention in the eye leading to increased intraocular pressure, pain, and decreased vision
Renal tubular acidosis
Severe skin reaction, including Stevens-Johnson syndrome, a potentially life-threatening skin condition in which the outer layer of skin separates from the underlying layers, and erythema multiforme, a condition characterized by the appearance of red spots that may turn into blisters
Unusual odor
Swelling of tissues around the eye
Raynaud's syndrome: a disorder affecting blood vessels in fingers, thumbs, and ears, causing pain and cold sensations
Tissue calcifications (calcinosis)

Adverse reactions with unknown frequency

Maculopathy, a disease of the macula—the small part of the retina where vision is sharpest. If you notice any change or decrease in vision, contact your doctor.
Swelling of the eye conjunctiva
Toxic epidermal necrolysis, a more severe form of Stevens-Johnson syndrome (see uncommon adverse reactions).

If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

5. HOW TO STORE TOPIRAMATE TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

The active substance is topiramate. Each film-coated tablet contains 25 mg of topiramate.
The other components are (tablet core): monohydrate lactose, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate; and (tablet coating): basic butylated methacrylic copolymer, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171).

Description of the appearance of Topiramato Tecnimede and pack contents

Topiramato Tecnimede is available as film-coated tablets.
Topiramato Tecnimede "25 mg film-coated tablets" consists of white, round, convex tablets.
Topiramato Tecnimede is available in packs of 10 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A
Rua da Tapada Grande nº 2,
Abrunheira
2710-089 Sintra, Portugal

Manufacturers responsible for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Rafarm S.A.
Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki, 19002, Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Topiramato Tecnimede 25, 50, 100, 200 mg Film-coated tablets
Greece: JADIX 25, 50, 100, 200 mg film-coated tablets
Portugal: Topiramato Clindonim
United Kingdom: Topiramate 25, 50, 100, 200 mg Film-coated tablets

This leaflet was last updated in 06/2013

PATIENT INFORMATION LEAFLET

Topiramato Tecnimede 50 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Topiramato Tecnimede is and what it is used for
What you need to know before taking Topiramato Tecnimede
How to take Topiramato Tecnimede
Possible side effects
How to store Topiramato Tecnimede
Contents of the pack and other information

1. WHAT TOPAMATE TECNIMEDE IS AND WHAT IT IS USED FOR:

Topiramato Tecnimede belongs to a group of medicines called "antiepileptic drugs". It is used:

as monotherapy for the treatment of epileptic seizures in adults and children over 6 years of age.
in combination with other medications for the treatment of epileptic seizures in adults and children over 2 years of age.
for the prevention of migraine in adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TOPIRAMATE TECNIMEDE

Do not take Topiramate Tecnimede

if you are allergic (hypersensitive) to topiramate or to any of the other ingredients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or of childbearing age but are not using an adequate contraceptive method (see section "Pregnancy and breastfeeding" for more information).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Topiramate Tecnimede.

Consult your doctor or pharmacist before taking Topiramate Tecnimede if:

you have kidney problems, especially kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid abnormalities (metabolic acidosis)
you have liver problems
you have eye problems, especially glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before starting treatment with Topiramate Tecnimede.

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

You should also speak with your doctor before taking any other topiramate-containing medicine that may be prescribed as an alternative to Topiramate Tecnimede.

Use of Topiramate Tecnimede may lead to weight loss. Therefore, while taking this medicine, your weight should be monitored regularly. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of patients treated with antiepileptic medicines such as Topiramate Tecnimede have experienced suicidal thoughts or thoughts of self-harm. If at any time you experience such thoughts, contact your doctor immediately.

Other medicines and Topiramate Tecnimede

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, vitamins, or herbal supplements. Topiramate Tecnimede and certain other medicines may interact with each other. Sometimes, the dose of one or more of the medicines you are taking, including Topiramate Tecnimede, may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives).
oral contraceptives. Topiramate Tecnimede may reduce the effectiveness of oral contraceptives.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topiramate Tecnimede.

Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine.

Other medicines to discuss with your doctor or pharmacist include other antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, and flunarizine.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Topiramate Tecnimede with food and drink

You may take Topiramate Tecnimede with or without food. Drink plenty of fluids throughout the day when taking Topiramate Tecnimede to help prevent kidney stone formation. Avoid drinking alcohol during treatment with Topiramate Tecnimede.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Your doctor will decide whether you can take this medicine. As with other antiepileptic medicines, taking Topiramate Tecnimede during pregnancy may increase the risk of congenital malformations in the unborn child. Make sure you are fully informed about the risks and benefits of using Topiramate Tecnimede for epilepsy treatment during pregnancy.

You must not take Topiramate Tecnimede for migraine prevention if you are pregnant or of childbearing age and not using an effective contraceptive method.

Breastfeeding mothers taking Topiramate Tecnimede should inform their doctor as soon as possible if the baby shows any unusual symptoms.

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 Tecnimede. Do not drive or operate machinery without first discussing this with your doctor.

Topiramate Tecnimede contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE TOPIRAMATE TECNIMEDE

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.

Take Topiramate Tecnimede exactly as prescribed. Your doctor will usually start you on a low dose of Topiramate Tecnimede and then gradually increase it until the best dose for you is reached.
The Topiramate Tecnimede tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topiramate Tecnimede may be taken before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent kidney stone formation while taking Topiramate Tecnimede.

If you take more Topiramate Tecnimede than you should

Contact a doctor immediately. Take the medicine package with you.
Signs and symptoms of overdose may include seizures, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, reduced consciousness, low blood pressure, abdominal pain, agitation, dizziness, and depression.

If you are taking other medicines together with Topiramate Tecnimede, an
overdose may occur.
If you forget to take Topiramate Tecnimede

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. 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 missed dose.

If you stop taking Topiramate Tecnimede
Do not stop taking this medicine unless your doctor tells you to. Your
symptoms may return. If your doctor decides to discontinue this medicine, your
dose may be gradually reduced over several days.
If you have any questions about using this medicine, consult your doctor, pharmacist, or
nurse.

4. POSSIBLE ADVERSE REACTIONS

very common (affects more than 1 in 10 people)
common (affects from 1 to 10 in 100 people)
uncommon (affects from 1 to 10 in 1,000 people)
rare (affects from 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (cannot be estimated from available data)

Very common adverse reactions include:

Weight loss
Tingling in arms and legs
Numbness or drowsiness
Dizziness
Diarrhea
Nausea
Stuffy or runny nose, and sore throat
Fatigue
Depression

Common adverse reactions include:

Changes in mood or behavior, including anger, nervousness, sadness
Weight gain
Decreased or loss of appetite
Reduction in red blood cell count
Changes in thought and alertness, including confusion, problems with concentration, memory, or slowed thinking
Slurred speech
Clumsiness, or difficulty walking
Involuntary tremor of arms, hands, or legs
Reduced sense of touch or sensation
Involuntary eye movements
Altered taste
Vision disturbances, blurred vision, double vision
Ringing in the ears
Ear pain
Shortness of breath
Nosebleeds
Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent need to urinate
Pain when urinating
Hair loss
Skin rash and/or skin itching
Joint pain
Muscle spasms, muscle contractions, or muscle weakness
Chest pain
Fever
Loss of strength
General feeling of malaise
Allergic reaction

Uncommon adverse reactions include:

Crystals in urine
Abnormal blood count, including reduced white blood cell or platelet count, or increased eosinophils
Irregular heartbeat or slowed heart rate
Swelling of glands in the neck, armpits, or groin
Increased frequency of epileptic seizures
Problems with verbal communication
Loss of saliva
Inability to remain still or increased mental and physical activity
Loss of consciousness
Fainting
Slowed or reduced movements
Poor or disturbed sleep quality
Distorted or impaired sense of smell
Problems with writing
Sensation of movement under the skin
Eye problems, including dry eyes, light sensitivity, involuntary contractions, tearing, and decreased vision
Decreased or loss of hearing
Hoarseness
Inflammation of the pancreas
Gas
Heartburn
Loss of sensitivity to touch in the mouth
Bleeding gums
Feeling of fullness or bloating
Sensation of pain or burning in the mouth
Bad breath
Involuntary loss of urine and/or feces
Urgent need to urinate
Pain in the kidney and/or bladder area due to kidney stones
Decreased or absent sweating
Skin discoloration
Localized skin swelling
Facial swelling
Joint swelling
Musculoskeletal stiffness
Increased levels of acids in the blood
Low potassium levels in the blood
Increased appetite
Increased thirst and excessive intake of fluids
Low blood pressure or drop in blood pressure upon standing
Hot flushes
Flu-like malaise
Cold extremities (e.g., hands and face)
Learning difficulties
Sexual dysfunction (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication

Rare adverse reactions include:

Excessive skin sensitivity
Impaired sense of smell
Glaucoma, which involves fluid retention in the eye leading to increased intraocular pressure, pain, and vision loss
Renal tubular acidosis
Severe skin reaction, including Stevens-Johnson syndrome, a potentially life-threatening skin condition in which the upper layer of skin separates from the lower layer, and erythema multiforme, a condition characterized by red spots that may develop into blisters
Odor
Swelling of tissues around the eye
Raynaud's syndrome. A disorder affecting blood vessels in fingers, thumbs, and ears, causing pain and cold sensation
Tissue calcifications (calcinosis)

Adverse reactions with frequency not known

Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. If you notice any change or decrease in vision, contact your doctor.
Swelling of the eye conjunctiva
Toxic epidermal necrolysis, representing a more severe form of Stevens-Johnson syndrome (see uncommon adverse reactions).

If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

5. HOW TO STORE TOPIRAMATE TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

The active substance is topiramate. Each film-coated tablet contains 50 mg of topiramate.
The other components are (tablet core): monohydrate lactose, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate; and (tablet coating): basic butylated methacrylic copolymer, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171), and yellow iron oxide (E172).

Description of the appearance of Topiramato Tecnimede and packaging contents
Topiramato Tecnimede is available as film-coated tablets.
Topiramato Tecnimede “50 mg film-coated tablets” consists of yellow, round, convex tablets.
Topiramato Tecnimede is available in packs of 10 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A
Rua da Tapada Grande nº 2,
Abrunheira
2710-089 Sintra, Portugal
Responsible manufacturers for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
Rafarm S.A.
Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki, 19002, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Topiramato Tecnimede 25, 50, 100, 200 mg Film-coated tablets
Greece: JADIX 25, 50, 100, 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Portugal: Topiramato Clindonim
United Kingdom: Topiramate 25, 50, 100, 200 mg Film-coated tablets

This leaflet was last updated on 06/2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramato Tecnimede 100 mg film-coated tablets
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Topiramato Tecnimede is and what it is used for
What you need to know before taking Topiramato Tecnimede
How to take Topiramato Tecnimede
Possible side effects
How to store Topiramato Tecnimede
Contents of the pack and other information

1. WHAT TOPIRAMATE TECNIMEDE IS AND WHAT IT IS USED FOR:

Topiramate Tecnimede belongs to a group of medicines called "antiepileptic drugs". It is used:

as monotherapy for the treatment of epileptic seizures in adults and children over 6 years of age.
in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age.
for the prevention of migraine in adults.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TOPIRAMATE TECNIMEDE

Do not take Topiramato Tecnimede

if you are allergic (hypersensitive) to topiramate or to any of the other ingredients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or of childbearing age but are not using an adequate contraceptive method (see section "Pregnancy and breastfeeding" for more information).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramato Tecnimede.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Topiramato Tecnimede.

Consult your doctor or pharmacist before taking Topiramato Tecnimede if:

you have kidney problems, particularly kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid abnormalities (metabolic acidosis)
you have liver problems
you have eye problems, particularly glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before starting treatment with Topiramato Tecnimede.

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

You should also speak with your doctor before taking any other topiramate-containing medicine prescribed as an alternative to Topiramato Tecnimede.

While taking Topiramato Tecnimede, you may lose weight. Therefore, your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of patients treated with antiepileptic medicines such as Topiramato Tecnimede have experienced suicidal thoughts or self-harming thoughts. If at any time you experience such thoughts, contact your doctor immediately.

Other medicines and Topiramato Tecnimede

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, and herbal supplements. Topiramato Tecnimede and other medicines may affect each other. Sometimes, the dose of either Topiramato Tecnimede or your other medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives)
oral contraceptives. Topiramato Tecnimede may reduce the effectiveness of oral contraceptives.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topiramato Tecnimede.

Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine.

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before using Topiramato Tecnimede.

Topiramato Tecnimede with food and drink

You may take Topiramato Tecnimede during or between meals. Drink plenty of fluids throughout the day when taking Topiramato Tecnimede to help prevent the formation of kidney stones. Avoid drinking alcohol during treatment with Topiramato Tecnimede.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

Your doctor will decide whether you can take this medicine. As with other antiepileptic medicines, if Topiramato Tecnimede is taken during pregnancy, there is a risk of congenital malformations in the unborn child. Make sure you are fully informed about the risks and benefits of using Topiramato Tecnimede for epilepsy treatment during pregnancy.

You must not take Topiramato Tecnimede for migraine prevention if you are pregnant or of childbearing age and not using an effective contraceptive method.

Breastfeeding mothers taking Topiramato Tecnimede should inform their doctor as soon as possible if the infant shows any unusual symptoms.

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

Driving and using machines

During treatment with Topiramato Tecnimede, dizziness, fatigue, and vision problems may occur. Do not drive or operate tools or machinery without first discussing this with your doctor.

Topiramato Tecnimede contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE TOPIRAMATE TECNIMEDE

Take this medicine exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.

Take Topiramate Tecnimede exactly as directed. Your doctor will usually start you on a low dose of Topiramate Tecnimede, gradually increasing it until the optimal dose for you is reached.
Topiramate Tecnimede tablets must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topiramate Tecnimede can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent the formation of kidney stones while taking Topiramate Tecnimede.

If you take more Topiramate Tecnimede than you should

Contact a doctor immediately. Take the medicine package with you.
Signs and symptoms of overdose may include seizures, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, reduced level of consciousness, low blood pressure, abdominal pain, restlessness, dizziness, and depression.

If you are taking other medicines together with Topiramate Tecnimede, an
overdose may occur.
If you forget to take Topiramate Tecnimede

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. 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 missed dose.

If you stop taking Topiramate Tecnimede
Do not stop taking this medicine unless your doctor tells you to. Your
symptoms may return. If your doctor decides to discontinue this medicine, your
dose may be gradually reduced over several days.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the possible side effects listed below is defined using the following convention:

very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (cannot be estimated from the available data)

Very common side effects include:

Weight loss
Tingling in the arms and legs
Numbness or drowsiness
Dizziness
Diarrhea
Nausea
Stuffy, runny nose, and sore throat
Fatigue
Depression

Common side effects include:

Changes in mood or behaviour, including anger, nervousness, sadness
Weight gain
Decreased or loss of appetite
Reduction in red blood cell count
Changes in thinking and alertness, including confusion, problems with concentration, memory or slowed thinking
Slurred speech
Clumsiness, or problems walking
Involuntary tremor of the arms, hands or legs
Reduced sense of touch or sensation
Involuntary eye movements
Altered taste
Vision disturbances, blurred vision, double vision
Ringing in the ears
Ear pain
Shortness of breath
Nosebleeds
Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent need to urinate
Pain when urinating
Hair loss
Skin rash and/or skin itching
Joint pain
Muscle spasms, muscle contractions or muscle weakness
Chest pain
Fever
Loss of strength
General feeling of being unwell
Allergic reaction

Uncommon side effects include:

Crystals in the urine
Abnormal blood count, including reduced white blood cell or platelet count, or increased eosinophils
Irregular heartbeat or slowed heartbeat
Swelling of the glands in the neck, armpits or groin
Increased frequency of epileptic seizures
Problems with verbal communication
Reduced saliva production
Inability to stay still or increased mental and physical activity
Loss of consciousness
Fainting
Slowed or reduced movements
Poor or disturbed quality of sleep
Distorted or impaired sense of smell
Problems with writing
Sensation of movement under the skin
Eye problems, including dry eyes, light sensitivity, involuntary contractions, tearing, and decreased vision
Decreased or loss of hearing
Hoarseness
Inflammation of the pancreas
Gas
Heartburn
Loss of touch sensitivity in the mouth
Bleeding gums
Feeling of fullness or bloating
Sensation of pain or burning in the mouth
Bad breath
Loss of urine and/or faeces
Urgent need to urinate
Pain in the kidney and/or bladder area due to kidney stones
Reduced or absent sweating
Skin discoloration
Localised skin swelling
Facial swelling
Joint swelling
Musculoskeletal rigidity
Increased levels of acids in the blood
Low levels of potassium in the blood
Increased appetite
Increased thirst and excessive intake of fluids
Low blood pressure or drop in blood pressure when standing up
Hot flushes
Influenza-like malaise
Coldness in the extremities (e.g., hands and face)
Learning difficulties
Sexual function disorders (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication

Rare side effects include:

Excessive skin sensitivity
Impaired sense of smell
Glaucoma, which consists of fluid retention in the eye leading to increased intraocular pressure, pain, and vision loss
Renal tubular acidosis
Severe skin reaction, including Stevens-Johnson syndrome, a potentially life-threatening skin condition in which the top layer of skin separates from the lower layers, and erythema multiforme, a condition characterised by the appearance of red spots that may develop into blisters
Odour
Swelling of tissues around the eye
Raynaud's syndrome. A disorder affecting blood vessels in the fingers, thumbs, and ears, causing pain and cold sensations
Tissue calcifications (calcinoses)

Side effects with frequency not known

Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. If you notice any change or decrease in vision, contact your doctor.
Swelling of the eye conjunctiva
Toxic epidermal necrolysis, which is a more severe form of Stevens-Johnson syndrome (see uncommon side effects).

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.

5. HOW TO STORE TOPIRAMATE TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Topiramato Tecnimede contains

The active substance is topiramate. Each film-coated tablet contains 100 mg of topiramate.
The other components are (tablet core): monohydrate lactose, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate; and (tablet coating): basic butylated methacrylic copolymer, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Topiramato Tecnimede and contents of the pack

Topiramato Tecnimede is available as film-coated tablets.
Topiramato Tecnimede "100 mg film-coated tablets" consists of yellow, round, convex tablets.
Topiramato Tecnimede is available in packs of 10 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A
Rua da Tapada Grande nº 2,
Abrunheira
2710-089 Sintra, Portugal

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Topiramato Tecnimede 25, 50, 100, 200 mg Film-coated tablets
Greece: JADIX 25, 50, 100, 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Portugal: Topiramato Clindonim
United Kingdom: Topiramate 25, 50, 100, 200 mg Film-coated tablets

This leaflet was last updated on 06/2013

PACKAGE LEAFLET: INFORMATION FOR THE USER

Topiramato Tecnimede 200 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

What Topiramato Tecnimede is and what it is used for
What you need to know before taking Topiramato Tecnimede
How to take Topiramato Tecnimede
Possible side effects
How to store Topiramato Tecnimede
Contents of the pack and other information

1. WHAT TOPIRAMATE TECNIMIDE IS AND WHAT IT IS USED FOR:

Topiramate Tecnimede belongs to a group of medicines called "antiepileptic drugs". It is used:

as monotherapy for the treatment of epileptic seizures in adults and children over 6 years of age.
in combination with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age.
for the prevention of migraine in adults.

2. WHAT YOU SHOULD KNOW BEFORE TAKING TOPIRAMATE TECNIMEDE

Do not take Topiramate Tecnimede

if you are allergic (hypersensitive) to topiramate or to any of the other ingredients of this medicine (listed in section 6).
for migraine prevention if you are pregnant or of childbearing age but not using an adequate contraceptive method (see section "Pregnancy and breastfeeding" for more information).

If you are unsure whether any of the conditions listed above may apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Topiramate Tecnimede.

Consult your doctor or pharmacist before taking Topiramate Tecnimede if:

you have kidney problems, especially kidney stones, or if you are undergoing renal dialysis
you have a history of blood or body fluid abnormalities (metabolic acidosis)
you have liver problems
you have eye problems, especially glaucoma
you have growth problems
your diet is high in fat (ketogenic diet)

If you are unsure whether any of the conditions listed above may affect you, speak with your doctor or pharmacist before starting treatment with Topiramate Tecnimede.

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

You should also speak with your doctor before taking any other topiramate-containing medicine prescribed as an alternative to Topiramate Tecnimede.

While taking Topiramate Tecnimede, you may lose weight. Therefore, your weight should be monitored regularly during treatment. If you lose too much weight, or if a child taking this medicine does not gain sufficient weight, consult your doctor.

A small number of patients treated with antiepileptic medicines such as Topiramate Tecnimede have experienced suicidal thoughts or self-harming thoughts. If at any time you experience such thoughts, contact your doctor immediately.

Other medicines and Topiramate Tecnimede

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, vitamins, or herbal supplements. Topiramate Tecnimede and certain other medicines may affect each other. Sometimes, the dose of either Topiramate Tecnimede or your other medicines may need to be adjusted.

In particular, inform your doctor or pharmacist if you are taking:

other medicines that impair thinking, concentration, or muscle coordination (e.g., central nervous system depressants such as muscle relaxants and sedatives)
oral contraceptives. Topiramate Tecnimede may reduce the effectiveness of oral contraceptives.

Inform your doctor if you notice any changes in your menstrual bleeding while taking oral contraceptives and Topiramate Tecnimede.

Keep a list of all medicines you are taking. Show this list to your doctor or pharmacist before starting any new medicine.

Other medicines you should discuss with your doctor or pharmacist include other antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.

If you are unsure whether any of the conditions listed above apply to you, speak with your doctor or pharmacist before using Topiramate Tecnimede.

Topiramate Tecnimede with food and drinks

You may take Topiramate Tecnimede during or between meals. Drink plenty of fluids throughout the day while taking Topiramate Tecnimede to help prevent kidney stone formation. Avoid drinking alcohol during treatment with Topiramate Tecnimede.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.

You must not take Topiramate Tecnimede for migraine prevention if you are pregnant or of childbearing age and not using an effective contraceptive method.

Breastfeeding mothers taking Topiramate Tecnimede should inform their doctor as soon as possible if the baby shows any unusual symptoms.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Dizziness, fatigue, and vision problems may occur during treatment with Topiramate Tecnimede. Do not drive or operate tools or machinery without first discussing this with your doctor.

Topiramate Tecnimede contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE TOPIRAMATE TECNIMEDE

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Take Topiramate Tecnimede exactly as directed. Your doctor will usually start you on a low dose of Topiramate Tecnimede and then gradually increase it until the best dose for you is reached.
The tablets of Topiramate Tecnimede must be swallowed whole. Avoid chewing the tablets, as they may leave a bitter taste.
Topiramate Tecnimede can be taken before, during, or after a meal. Drink plenty of fluids throughout the day to help prevent the formation of kidney stones while taking Topiramate Tecnimede.

If you take more Topiramate Tecnimede than you should

Contact a doctor immediately. Take the medicine pack with you.
Signs and symptoms of overdose may include seizures, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, blunted consciousness, low blood pressure, abdominal pain, agitation, dizziness, and depression.

If you are taking other medicines together with Topiramate Tecnimede, an overdose may occur.

If you forget to take Topiramate Tecnimede

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. 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 missed dose.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not all people experience them.
The frequency of the possible adverse reactions listed below is defined using the following convention:

very common (affects more than 1 in 10 people)
common (affects 1 to 10 in 100 people)
uncommon (affects 1 to 10 in 1,000 people)
rare (affects 1 to 10 in 10,000 people)
very rare (affects fewer than 1 in 10,000 people)
not known (cannot be estimated from available data)

Very common adverse reactions include:

Weight loss
Tingling in arms and legs
Numbness or drowsiness
Dizziness
Diarrhea
Nausea
Stuffy or runny nose, and sore throat
Fatigue
Depression

Common adverse reactions include:

Changes in mood or behavior, including anger, nervousness, sadness
Weight gain
Decreased or loss of appetite
Reduction in red blood cell count
Changes in thinking and alertness, including confusion, problems with concentration, memory, or slowed thinking
Slurred speech
Clumsiness, or difficulty walking
Reduced sense of touch or sensation
Involuntary eye movements
Altered taste
Vision disturbances, blurred vision, double vision
Ringing in the ears
Ear pain
Shortness of breath
Nosebleeds
Vomiting
Constipation
Stomach pain
Indigestion
Dry mouth
Tingling or numbness of the mouth
Kidney stones
Frequent need to urinate
Pain when urinating
Hair loss
Skin rash and/or itching
Joint pain
Muscle spasms, muscle contractions, or muscle weakness
Chest pain
Fever
Loss of strength
General feeling of malaise
Allergic reaction

Uncommon adverse reactions include:

Crystals in the urine
Abnormal blood count, including reduced white blood cell count or platelets, or increased eosinophils
Irregular heartbeat or slowed heart rate
Swelling of the glands in the neck, armpits, or groin
Increased frequency of epileptic seizures
Problems with verbal communication
Loss of saliva
Inability to stay still or increased mental and physical activity
Loss of consciousness
Fainting
Slowed or reduced movements
Poor or disturbed sleep quality
Distorted or impaired sense of smell
Problems with writing
Sensation of movement under the skin
Eye problems, including dry eyes, light sensitivity, involuntary contractions, tearing, and decreased vision
Decreased or loss of hearing
Hoarseness
Inflammation of the pancreas
Gas
Heartburn
Loss of touch sensitivity in the mouth
Bleeding gums
Feeling of fullness or bloating
Sensation of pain or burning in the mouth
Bad breath
Loss of urine and/or feces
Urgent need to urinate
Pain in the kidney and/or bladder area due to kidney stones
Decreased or absent sweating
Skin discoloration
Localized skin swelling
Facial swelling
Joint swelling
Musculoskeletal rigidity
Increased levels of acids in the blood
Low levels of potassium in the blood
Increased appetite
Increased thirst and excessive intake of fluids
Low blood pressure or drop in blood pressure upon standing
Hot flushes
Influenza-like malaise
Cold extremities (e.g., hands and face)
Learning difficulties
Sexual dysfunction (erectile dysfunction, loss of libido)
Hallucinations
Decreased verbal communication

Rare adverse reactions include:

Excessive skin sensitivity
Impaired sense of smell
Glaucoma, which consists of fluid retention in the eye leading to increased intraocular pressure, pain, and decreased vision
Renal tubular acidosis
Severe skin reaction, including Stevens-Johnson syndrome, a potentially life-threatening skin condition in which the top layer of skin separates from the lower layer, and erythema multiforme, a condition characterized by red spots that may develop into blisters
Odor
Swelling of tissues around the eye
Raynaud's syndrome. A disorder affecting blood vessels in fingers, thumbs, and ears, causing pain and cold sensation
Tissue calcifications (calcinosis)

Adverse reactions with frequency not known

Maculopathy, a disease of the macula, the small part of the retina where vision is sharpest. If you notice any change or decrease in vision, contact your doctor.
Swelling of the eye conjunctiva
Toxic epidermal necrolysis, a more severe form of Stevens-Johnson syndrome (see uncommon adverse reactions).

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse.

5. HOW TO STORE TOPIRAMATE TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

The active substance is topiramate. Each film-coated tablet contains 200 mg of topiramate.
The other components are (tablet core): monohydrate lactose, pregelatinized maize starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate; and (tablet coating): basic butyl methacrylate copolymer, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Topiramato Tecnimede and pack contents

Topiramato Tecnimede is available as film-coated tablets.
Topiramato Tecnimede "200 mg film-coated tablets" consists of yellow, round, convex tablets.
Topiramato Tecnimede is available in packs of 10 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A
Rua da Tapada Grande nº 2,
Abrunheira
2710-089 Sintra, Portugal

This medicinal product is authorised in the European Economic Area countries with the following names:
Italy: Topiramato Tecnimede 25, 50, 100, 200 mg Film-coated tablets
Greece: JADIX 25, 50, 100, 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
Portugal: Topiramato Clindonim
United Kingdom: Topiramate 25, 50, 100, 200 mg Film-coated tablets

This leaflet was last updated on 06/2013