XITOP 25 mg Фильм-Coated Таблетки

Содержание инструкции

1. WHAT TOPIRAMATO TECNIMEDE IS AND WHAT IT IS USED FOR:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE
3. HOW TO TAKE TOPIRAMATO TECNIMEDE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TOPIRAMATO TECNIMEDE
6. PACKAGE CONTENTS AND OTHER INFORMATION
7. WHAT IS TOPIRAMATO TECNIMEDE AND WHAT IT IS USED FOR:
8. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE
9. HOW TO TAKE TOPIRAMATO TECNIMEDE
10. POSSIBLE SIDE EFFECTS
11. HOW TO STORE TOPIRAMATO TECNIMEDE
12. PACKAGE CONTENTS AND OTHER INFORMATION
13. WHAT TOPIRAMATO TECNIMEDE IS AND WHAT IT IS USED FOR:
14. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE
15. HOW TO TAKE TOPIRAMATO TECNIMEDE
16. POSSIBLE SIDE EFFECTS
17. HOW TO STORE TOPIRAMATO TECNIMEDE
18. PACKAGE CONTENTS AND OTHER INFORMATION
19. WHAT TOPIRAMATO TECNIMEDE IS AND WHAT IT IS USED FOR:
20. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE
21. HOW TO TAKE TOPIRAMATO TECNIMEDE
22. POSSIBLE SIDE EFFECTS
23. HOW TO STORE TOPIRAMATO TECNIMEDE
24. PACKAGE CONTENTS AND OTHER INFORMATION

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

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

Contents of this leaflet:

• 1. What Topiramato Tecnimede is and what it is used for
• 2. What you need to know before you take Topiramato Tecnimede
• 3. How to take Topiramato Tecnimede
• 4. Possible side effects
• 5. How to store Topiramato Tecnimede
• 6. 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.
• with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age.
• to prevent migraine in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE

Do not take Topiramato Tecnimede

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (listed in section 6). -
• for the prevention of migraine if you are pregnant or of childbearing potential but not using adequate contraception (see section “pregnancy and breastfeeding” for more information). -

If you are not sure whether the conditions mentioned above apply to you, talk to 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 kidney dialysis
• you have a history of blood and fluid imbalances in the body (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 not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before starting treatment with Topiramato Tecnimede.
It is important that you do not stop taking the medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramato Tecnimede.
With the use of Topiramato Tecnimede you may lose weight, so while taking this medicine, your weight should be checked regularly. If you lose too much weight or if a child taking the medicine does not gain enough weight, consult your doctor.
A small number of people treated with antiepileptics such as Topiramato Tecnimede have experienced self-harmful or suicidal thoughts. If, at any time, you have these types of thoughts, contact your doctor immediately.

• Other medicines and Topiramato Tecnimede

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription, vitamins and herbal products. Topiramato Tecnimede and some other medicines can affect each other. Sometimes the dose of some of the medicines you are taking or of Topiramato Tecnimede may need to be adjusted.
In particular, tell your doctor or pharmacist if you are taking:

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

Tell your doctor if you notice a change in your menstrual bleeding while taking the birth control pill and Topiramato Tecnimede.
Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting to take a 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 not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Tecnimede.

Topiramato Tecnimede with food and drink
You can take Topiramato Tecnimede during or away from meals. Drink plenty of fluids during the day when taking Topiramato Tecnimede to prevent the formation of kidney stones. During treatment with Topiramato Tecnimede you should avoid drinking alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Your doctor will decide whether you can take this medicine. As also indicated for other antiepileptic drugs, if Topiramato Tecnimede is taken during pregnancy, there is a risk of congenital malformations in the fetus. Make sure you are well informed about the risks and benefits of taking Topiramato Tecnimede for the treatment of epilepsy during pregnancy.
You should not take Topiramato Tecnimede for the prevention of migraine if you are pregnant or of childbearing potential and not using effective contraception.
Mothers who are breastfeeding while taking Topiramato Tecnimede should inform their doctor as soon as possible if the baby shows anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Dizziness, fatigue and vision problems may occur during treatment with Topiramato Tecnimede. Do not drive or use tools or machinery until you have spoken to your doctor.

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

3. HOW TO TAKE TOPIRAMATO TECNIMEDE

Take this medicine following exactly the instructions of your doctor. If you have any
doubts, consult your doctor or pharmacist.

• Take Topiramato Tecnimede exactly as prescribed. Your doctor will usually give you a low dose of Topiramato Tecnimede, then gradually increase it until they find the best dose for you.
• Topiramato Tecnimede tablets must be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramato Tecnimede can be taken before, during or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking Topiramato Tecnimede.

If you take more Topiramato Tecnimede than you should

• Consult a doctor immediately. Bring the medicine packaging with you.
• Signs and symptoms of overdose may include convulsions, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, impaired consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression.

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

If you forget to take Topiramato Tecnimede

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Topiramato Tecnimede
Do not stop taking this medicine unless your doctor tells you to. Your
symptoms may return. If your doctor decides to stop this medicine, your
dose may be gradually reduced over a few days.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 less than 1 in 10,000 people)
• not known (frequency cannot be estimated from available data)

Very common side effects include:

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

Common side effects include:

• Changes in mood or behavior, including anger, nervousness, sadness
• Weight gain
• Decreased or loss of appetite
• Reduced number of red blood cells
• 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 disorders, 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 discomfort
• Allergic reaction

Uncommon side effects include:

• Crystals in the urine
• Abnormal blood count, including reduced white blood cells or platelets, or increased eosinophils
• Irregular or slowed heartbeat
• Swelling of the glands in the neck, armpits or groin
• Increased seizures
• Problems with verbal communication
• Loss of saliva
• Inability to stand still or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or decreased 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, sensitivity to light, 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 stool
• Urgent need to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decreased or absence of sweating
• Skin discoloration
• Localized swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increasedlevels 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 decreased blood pressure when standing up
• Hot flashes
• Flu-like illness
• Cold extremities (e.g., hands and face)
• Learning problems
• Sexual dysfunction (erectile dysfunction, loss of libido)
• Hallucinations -
• Decreased verbal communication -

Rare side effects include:

• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma, which is a retention of fluid in the eye that determinesincreased eye pressure, pain and decreased vision
• 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 the appearance of red spots that can turn into blisters
• Odor
• Swelling in the tissues around the eye
• Raynaud's syndrome. A disorder that affects blood vessels in the fingers, thumbs, ears, and causes pain and a feeling of cold
• Calcifications in the tissues (calcinosis)

Side effects with unknown frequency

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

If you experience any side effects, including those not listed in this
leaflet, please tell your doctor, pharmacist or nurse.

5. HOW TO STORE TOPIRAMATO TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

• The active ingredient is topiramate. Each film-coated tablet contains 25 mg of topiramate.
• The other ingredients are (tablet core): lactose monohydrate, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate, and (tablet coating): butylated methacrylate copolymer

basic, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide
(E171).

Description of the appearance of Topiramato Tecnimede and package contents
Topiramato Tecnimede is available in film-coated tablets.
Topiramato Tecnimede “25 mg film-coated tablets” consists of
white, round and 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 Member States of the European Economic Area 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 on06/2013

Topiramato Tecnimede 50 mg film-coated tablets
Generic medicine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Topiramato Tecnimede is and what it is used for
• 2. What you need to know before you take Topiramato Tecnimede
• 3. How to take Topiramato Tecnimede
• 4. Possible side effects
• 5. How to store Topiramato Tecnimede
• 6. Contents of the pack and other information

1. WHAT IS TOPIRAMATO TECNIMEDE 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.
• with other medicines for the treatment of epileptic seizures in adults and children over 2 years of age.
• to prevent migraine in adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE

Do not take Topiramato Tecnimede

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (listed in section 6). -
• for the prevention of migraine if you are pregnant or of childbearing potential but are not using adequate contraception (see section “Pregnancy and breastfeeding” for more information). -

If you are not sure whether the conditions mentioned above apply to you, talk to 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, in particular kidney stones, or if you are undergoing kidney dialysis
• you have a history of blood and fluid imbalances in the body (metabolic acidosis)
• you have liver problems
• you have eye problems, in particular glaucoma
• you have growth problems
• your diet is high in fat (ketogenic diet)

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before starting treatment with Topiramato Tecnimede.
It is important that you do not stop taking the medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramato Tecnimede.
With the use of Topiramato Tecnimede you may lose weight, so while taking this medicine, your weight should be checked regularly. If you lose too much weight or if a child taking the medicine does not gain enough weight, consult your doctor.
A small number of people treated with antiepileptics such as Topiramato Tecnimede have experienced self-harmful or suicidal thoughts. If, at any time, you have these types of thoughts, contact your doctor immediately.

• Other medicines and Topiramato Tecnimede

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription, vitamins and herbal products. Topiramato Tecnimede and some other medicines can affect each other. Sometimes the dose of some of the medicines you are taking or of Topiramato Tecnimede will need to be adjusted.
In particular, tell your doctor or pharmacist if you are taking:

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

Tell your doctor if you notice a change in your menstrual bleeding while taking the contraceptive pill and Topiramato Tecnimede.
Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting to take a new medicine.
Other medicines to talk to your doctor or pharmacist about include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.
If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Tecnimede.

Topiramato Tecnimede with food and drink
You can take Topiramato Tecnimede during or away from meals. Drink plenty of fluids during the day while taking Topiramato Tecnimede to prevent the formation of kidney stones. During treatment with Topiramato Tecnimede you should avoid drinking alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The 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 fetus. Make sure you are well informed about the risks and benefits of taking Topiramato Tecnimede for the treatment of epilepsy during pregnancy.
You should not take Topiramato Tecnimede for the prevention of migraine if you are pregnant or of childbearing potential and are not using effective contraception.
Mothers who are breastfeeding while taking Topiramato Tecnimede should inform their doctor as soon as possible if the baby shows anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Dizziness, fatigue and vision problems may occur during treatment with Topiramato Tecnimede. Do not drive or use tools or machinery until you have spoken to your doctor.

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

3. HOW TO TAKE TOPIRAMATO TECNIMEDE

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.

• Take Topiramato Tecnimede exactly as prescribed. Your doctor will usually give you a low dose of Topiramato Tecnimede, then gradually increase it until the best dose for you is found.
• Topiramato Tecnimede tablets must be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramato Tecnimede can be taken before, during or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking Topiramato Tecnimede.

If you take more Topiramato Tecnimede than you should

• Consult a doctor immediately. Bring the medicine packaging with you.
• Signs and symptoms of overdose may include convulsions, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, impaired consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression.

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

If you forget to take Topiramato Tecnimede

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

If you stop taking Topiramato Tecnimede
Do not stop taking this medicine unless your doctor tells you to do so. Your
symptoms may return. If your doctor decides to stop this medicine, your
dose may be gradually reduced over a few days.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone 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 less than 1 in 10,000 people)
• not known (frequency cannot be estimated from available data)

Very common side effects include:

• Weight loss
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy nose, 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
• Reduced number of red blood cells
• 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 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 cells or platelets, or increased eosinophils
• Irregular heartbeat or slowed heartbeat
• Swelling of the glands in the neck, armpits, or groin
• Increased seizures
• Problems with verbal communication
• Loss of saliva
• Inability to stand still or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or decreased 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, sensitivity to light, 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 stool
• Urgent need to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decreased or absence of sweating
• Skin discoloration
• Localized swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increasedlevels of acids in the blood
• Low potassium levels in the blood
• Increased appetite
• Increased thirst and excessive intake of fluids
• Low blood pressure or decrease in blood pressure when standing up
• Hot flashes
• Flu-like illness
• Cold extremities (e.g., hands and face)
• Learning problems
• Sexual dysfunction (erectile dysfunction, loss of libido)
• Hallucinations -
• Decreased verbal communication -

Rare side effects include:

• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma, which consists of a retention of fluid in the eye which determinesan increased ocular pressure, pain and decreased vision
• 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 the appearance of red spots that can turn into blisters
• Odour
• Swelling in the tissues around the eye
• Raynaud's syndrome. A disorder that affects blood vessels in the fingers, thumbs, ears, and causes pain and cold sensation
• Calcifications in the tissues (calcinosis)

Side effects with unknown frequency

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

If you get any side effects, even if not listed in this
leaflet, tell your doctor, pharmacist or nurse.

5. HOW TO STORE TOPIRAMATO TECNIMEDE

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

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

• The active ingredient is topiramate. Each film-coated tablet contains 50 mg of topiramate.
• The other ingredients are (tablet core): lactose monohydrate, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate, and (tablet coating): butylated methacrylate copolymer

basic, sodium lauryl sulfate, magnesium stearate, stearic acid, talc, titanium dioxide
(E171) and yellow iron oxide (E172).

Description of the appearance of Topiramato Tecnimede and package contents
Topiramato Tecnimede is available in film-coated tablets.
Topiramato Tecnimede “50 mg film-coated tablets” consists of
yellow, round and 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 Member States of the European Economic Area 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 on06/2013

Topiramato Tecnimede 100 mg film-coated tablets
Generic medicine
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Topiramato Tecnimede is and what it is used for
• 2. What you need to know before you take Topiramato Tecnimede
• 3. How to take Topiramato Tecnimede
• 4. Possible side effects
• 5. How to store Topiramato Tecnimede
• 6. 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 for:

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE

Do not take Topiramato Tecnimede

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (listed in section 6). -
• for the prevention of migraine if you are pregnant or of childbearing potential but are not using adequate contraception (see section “pregnancy and breastfeeding” for more information). -

If you are not sure whether the conditions mentioned above apply to you, talk to 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, in particular, kidney stones, or if you are undergoing renal dialysis
• you have a history of blood and fluid imbalances in the body (metabolic acidosis)
• you have liver problems
• you have eye problems, in particular glaucoma
• you have growth problems
• your diet is high in fat (ketogenic diet)

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before starting treatment with Topiramato Tecnimede.
It is important that you do not stop taking the medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramato Tecnimede.
With the use of Topiramato Tecnimede you may lose weight, so while taking this medicine, your weight should be checked regularly. If you lose too much weight or if a child taking the medicine does not gain enough weight, consult your doctor.
A small number of people treated with antiepileptics such as Topiramato Tecnimede have experienced self-harmful or suicidal thoughts. If you have these types of thoughts at any time, contact your doctor immediately.

• Other medicines and Topiramato Tecnimede

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter medicines, vitamins and herbal products. Topiramato Tecnimede and some other medicines can affect each other. Sometimes the dose of some of the medicines you are taking or of Topiramato Tecnimede may need to be adjusted.
In particular, tell your doctor or pharmacist if you are taking:

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

Tell your doctor if you notice a change in your menstrual bleeding while taking the contraceptive pill and Topiramato Tecnimede.
Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting to take a new medicine.
Other medicines to talk to your doctor or pharmacist about include other antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.
If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Tecnimede.

Topiramato Tecnimede with food and drink
You can take Topiramato Tecnimede during or away from meals. Drink plenty of fluids during the day while taking Topiramato Tecnimede to prevent the formation of kidney stones. During treatment with Topiramato Tecnimede you should avoid drinking alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The doctor will decide whether you can take this medicine. As with other antiepileptic drugs, if Topiramato Tecnimede is taken during pregnancy there is a risk of congenital malformations in the fetus. Make sure you are well informed about the risks and benefits of taking Topiramato Tecnimede for the treatment of epilepsy during pregnancy.
You should not take Topiramato Tecnimede for the prevention of migraine if you are pregnant or of childbearing potential and are not using effective contraception.
Mothers who are breastfeeding when taking Topiramato Tecnimede should inform their doctor as soon as possible if the baby shows anything unusual.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Dizziness, fatigue and vision problems may occur during treatment with Topiramato Tecnimede. Do not drive or use tools or machinery until you have spoken to your doctor.

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

3. HOW TO TAKE TOPIRAMATO TECNIMEDE

Take this medicine following exactly the instructions of your doctor. If you have any
doubts, consult your doctor or pharmacist.

• Take Topiramato Tecnimede exactly as prescribed. Your doctor will usually give you a low dose of Topiramato Tecnimede, then gradually increase it until they find the best dose for you.
• Topiramato Tecnimede tablets must be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramato Tecnimede can be taken before, during or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking Topiramato Tecnimede.

If you take more Topiramato Tecnimede than you should

• Consult a doctor immediately. Bring the medicine packaging with you.
• Signs and symptoms of overdose may include convulsions, drowsiness, speech disorders, double vision, impaired thinking, abnormal coordination, impaired consciousness, low blood pressure, abdominal pain, agitation, dizziness and depression.

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

If you forget to take Topiramato Tecnimede

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Topiramato Tecnimede
Do not stop taking this medicine unless your doctor tells you to. Your
symptoms may return. If your doctor decides to stop this medicine, your
dose may be gradually reduced over a few days.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone 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 people in 100)
• uncommon (affects 1 to 10 people in 1,000)
• rare (affects 1 to 10 people in 10,000)
• very rare (affects less than 1 in 10,000 people)
• not known (frequency cannot be estimated from available data)

Very common side effects include:

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

Common side effects include:

• Changes in mood or behavior, including anger, nervousness, sadness
• Weight gain
• Decreased or loss of appetite
• Reduced number of red blood cells
• 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 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 cells or platelets, or increased eosinophils
• Irregular heartbeat or slowed heartbeat
• Swelling of the glands in the neck, armpits, or groin
• Increased seizures
• Problems with verbal communication
• Loss of saliva
• Inability to stand still or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or decreased movements
• Poor or disturbed sleep quality
• Distorted or impaired sense of smell
• Problems with writing
• Feeling of movement under the skin
• Eye problems, including dry eyes, sensitivity to light, involuntary contractions, tearing, and decreased vision
• Decreased or loss of hearing
• Hoarseness
• Inflammation of the pancreas
• Gas
• Heartburn
• Loss of sensation in the mouth
• Bleeding gums
• Feeling of fullness or bloating
• Feeling of pain or burning in the mouth
• Bad breath
• Loss of urine and/or stool
• Urgent need to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decreased or absence of sweating
• Skin discoloration
• Localized swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increasedlevels of acids in the blood
• Low potassium levels in the blood
• Increased appetite
• Increased thirst and consumption of excessively large amounts of fluids
• Low blood pressure or decreased blood pressure when standing up
• Hot flashes
• Flu-like illness
• Cold extremities (e.g., hands and face)
• Learning difficulties
• Sexual dysfunction (erectile dysfunction, loss of libido)
• Hallucinations -
• Decreased verbal communication -

Rare side effects include:

• Excessive skin sensitivity
• Impaired sense of smell
• Glaucoma, which consists of a retention of fluid in the eye which determinesan increased ocular pressure, pain and decreased vision
• 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 the appearance of red spots that can turn into blisters
• Odor
• Swelling in the tissues around the eye
• Raynaud's syndrome. A disorder that affects blood vessels in the fingers, thumbs, ears, and causes pain and a feeling of cold
• Calcifications in the tissues (calcinosis)

Side effects with unknown frequency

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

If you get any side effects, even if not listed in this
leaflet, tell your doctor, pharmacist or nurse.

5. HOW TO STORE TOPIRAMATO TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

• The active ingredient is topiramate. Each film-coated tablet contains 100 mg of topiramate.
• The other ingredients are (tablet core): lactose monohydrate, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate, and (tablet coating): butyl methacrylate copolymer basic, 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 in film-coated tablets.
Topiramato Tecnimede “100 mg film-coated tablets” consists of
yellow, round and 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 Member States of the European Economic Area 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 on06/2013

Topiramato Tecnimede 200 mg film-coated tablets
Generic medicine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, talk to your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Topiramato Tecnimede is and what it is used for
• 2. What you need to know before you take Topiramato Tecnimede
• 3. How to take Topiramato Tecnimede
• 4. Possible side effects
• 5. How to store Topiramato Tecnimede
• 6. 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 for:

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPIRAMATO TECNIMEDE

Do not take Topiramato Tecnimede

• if you are allergic (hypersensitive) to topiramate or any of the other ingredients of this medicine (listed in section 6). -
• for the prevention of migraine if you are pregnant or of childbearing potential but are not using adequate contraception (see section “Pregnancy and breastfeeding” for more information). -

If you are not sure whether the conditions mentioned above apply to you, talk to 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, in particular, kidney stones, or if you are undergoing renal dialysis
• you have a history of blood and fluid abnormalities in the body (metabolic acidosis)
• you have liver problems
• you have eye problems, in particular glaucoma
• you have growth problems
• your diet is high in fat (ketogenic diet)

If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before starting treatment with Topiramato Tecnimede.
It is important that you do not stop taking the medicine without first consulting your doctor.
You should also talk to your doctor before taking any medicine containing topiramate that is given to you as an alternative to Topiramato Tecnimede.
With the use of Topiramato Tecnimede you may lose weight, so while taking this medicine, your weight should be checked regularly. If you lose too much weight or if a child taking the medicine does not gain enough weight, consult your doctor.
A small number of people treated with antiepileptics such as Topiramato Tecnimede have experienced self-harmful or suicidal thoughts. If you have these types of thoughts at any time, contact your doctor immediately.

• Other medicines and Topiramato Tecnimede

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription, vitamins and herbal products. Topiramato Tecnimede and some other medicines can affect each other. Sometimes the dose of some of the medicines you are taking or of Topiramato Tecnimede may need to be adjusted.
In particular, tell your doctor or pharmacist if you are taking:

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

Tell your doctor if you notice a change in your menstrual bleeding while taking the contraceptive pill and Topiramato Tecnimede.
Keep a list of all the medicines you are taking. Show this list to your doctor or pharmacist before starting to take a new medicine.
Other medicines to discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, gliburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine.
If you are not sure whether any of the conditions mentioned above apply to you, talk to your doctor or pharmacist before using Topiramato Tecnimede.

Topiramato Tecnimede with food and drink
You can take Topiramato Tecnimede during or away from meals. Drink plenty of fluids during the day while taking Topiramato Tecnimede, to prevent the formation of kidney stones. During treatment with Topiramato Tecnimede you should avoid drinking alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The 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 fetus. Make sure you are well informed about the risks and benefits of taking Topiramato Tecnimede for the treatment of epilepsy during pregnancy.
You should not take Topiramato Tecnimede for the prevention of migraine if you are pregnant or of childbearing potential and are not using effective contraception.
Mothers who are breastfeeding when taking Topiramato Tecnimede should inform their doctor as soon as possible if the baby shows anything unusual.
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 Topiramato Tecnimede. Do not drive or use tools or machines until you have spoken to your doctor.

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

3. HOW TO TAKE TOPIRAMATO TECNIMEDE

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.

• Take Topiramato Tecnimede exactly as prescribed. Your doctor will usually give you a low dose of Topiramato Tecnimede, then gradually increase it until they find the best dose for you.
• Topiramato Tecnimede tablets must be swallowed whole. Avoid chewing the tablets as they may leave a bitter taste.
• Topiramato Tecnimede can be taken before, during or after a meal. Drink plenty of fluids during the day to avoid the formation of kidney stones while taking Topiramato Tecnimede.

If you take more Topiramato Tecnimede than you should

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

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

If you forget to take Topiramato Tecnimede

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue as usual. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Topiramato Tecnimede
Do not stop taking this medicine unless your doctor tells you to do so. Your
symptoms may return. If your doctor decides to stop this medicine, your
dose may be gradually decreased over a few days.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone 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 people in 100)
• uncommon (affects 1 to 10 people in 1,000)
• rare (affects 1 to 10 people in 10,000)
• very rare (affects less than 1 in 10,000 people)
• not known (the frequency cannot be estimated from the available data)

Very common side effects include:

• Weight loss
• Tingling in the arms and legs
• Drowsiness or sleepiness
• Dizziness
• Diarrhoea
• Nausea
• Stuffy nose, 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
• Reduced number of red blood cells
• 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 problems, 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 being unwell
• Allergic reaction

Uncommon side effects include:

• Crystals in the urine
• Abnormal blood count, including reduced number of white blood cells or platelets, or increased eosinophils
• Irregular or slowed heartbeat
• Swelling of the glands in the neck, armpits or groin
• Increased seizures
• Problems with verbal communication
• Loss of saliva
• Inability to stand still or increased mental and physical activity
• Loss of consciousness
• Fainting
• Slowed or decreased movements
• Poor or disturbed sleep quality
• Distorted or impaired sense of smell
• Problems with writing
• Feeling of movement under the skin
• Eye problems, including dry eyes, sensitivity to light, 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
• Feeling of pain or burning in the mouth
• Bad breath
• Loss of urine and/or stools
• Urgent need to urinate
• Pain in the kidney area and/or bladder caused by kidney stones
• Decreased or absence of sweating
• Skin discoloration
• Localized swelling in the skin
• Swelling of the face
• Swelling of the joints
• Musculoskeletal stiffness
• Increasedlevels of acids in the blood
• Low levels of potassium in the blood
• Increased appetite
• Increased thirst and consumption of excessively large amounts of fluids
• Low blood pressure or decrease in blood pressure when standing up
• Hot flashes
• Flu-like illness
• Cold extremities (e.g., hands and face)
• Learning problems
• Sexual dysfunction (erectile dysfunction, loss of libido)
• Hallucinations
• Decreased verbal communication

Rare side effects include:

• Excessive skin sensitivity
• Impairment of the sense of smell
• Glaucoma, which consists of a retention of fluid in the eye which determinesan increased ocular pressure, pain and decreased vision
• 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 the appearance of red spots that can turn into blisters
• Odour
• Swelling in the tissues around the eye
• Raynaud's syndrome. A disorder that affects blood vessels in the fingers, thumbs, ears, and causes pain and a feeling of cold
• Calcifications in the tissues (calcinosis)

Side effects with unknown frequency

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

If you get any side effects, even if not listed in this
leaflet, tell your doctor, pharmacist or nurse.

5. HOW TO STORE TOPIRAMATO TECNIMEDE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Topiramato Tecnimede contains

• The active ingredient is topiramate. Each film-coated tablet contains 200 mg of topiramate.
• The other ingredients are (tablet core): lactose monohydrate, pregelatinized corn starch, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate, and (tablet coating): basic butylated 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 package contents
Topiramato Tecnimede is available in film-coated tablets.
Topiramato Tecnimede “200 mg film-coated tablets” consists of
yellow, round and 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

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 Member States of the European Economic Area 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 on06/2013