Etoprod

Package leaflet: Information for the user

Etopro, 25 mg, film-coated tablets
Etopro, 50 mg, film-coated tablets
Etopro, 100 mg, film-coated tablets
Etopro, 200 mg, film-coated tablets
Topiramate

This medicinal product will be subject to additional monitoring. This will allow for rapid
identification of new safety information. Patients can also help by reporting any adverse reactions that occur after using the medicine. For information on how to report adverse reactions – see section 4.
Please read this leaflet carefully before taking this medicine, as it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Etopro is and what it is used for

Etopro belongs to a group of medicines called antiepileptic drugs. It is used:

• as monotherapy in 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 headaches in adults.

2. Important information before using Etopro

When not to use Etopro:

• if the patient is allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). Migraine prophylaxis
• Etopro must not be used during pregnancy.

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• If the patient is of childbearing potential, Etopro must not be taken without the use of a highly effective method of contraception during treatment. See below in the section "Pregnancy, breastfeeding and fertility – important advice for women". Epilepsy treatment
• Etopro must not be used if the patient is pregnant, unless no other treatment method provides adequate seizure control;
• if the patient is of childbearing potential, Etopro must not be used without the use of a highly effective method of contraception during treatment. The only exception is when Etopro is the only medicine providing adequate seizure control and the patient plans to become pregnant. Talk to your doctor to ensure that you have received information about the risks of using Etopro during pregnancy and the risk of seizures during pregnancy. See below in the section "Pregnancy, breastfeeding and fertility – important advice for women".

You must read the patient leaflet provided by your doctor or scan the QR code
(see section 6 "Contents of the pack and other information").
A patient card is included in the Etopro packaging, reminding of the risks associated with pregnancy.
If the patient is unsure whether any of the symptoms described above apply, they should consult a doctor or pharmacist before using Etopro.
Warnings and precautions
Before starting treatment with Etopro, discuss with your doctor or pharmacist if any of the following apply:

• kidney disorders, especially kidney stones or dialysis;
• abnormalities in blood and body fluids (metabolic acidosis). If symptoms such as deep breathing, rapid breathing (Kussmaul respiration), shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, tachycardia or arrhythmia occur, a blood bicarbonate level test is recommended;
• liver disorders;
• eye disorders, especially glaucoma;
• growth disorders;
• if a high-fat diet (ketogenic diet) is used;
• if the patient is a woman of childbearing potential. Etopro taken during pregnancy may harm the unborn child. During treatment and for at least 4 weeks after the last dose of Etopro, a highly effective method of contraception must be used. Further information can be found in the section "Pregnancy and breastfeeding";
• if the patient is pregnant. Etopro taken during pregnancy may harm the unborn child. If in doubt whether any of the above warnings apply, consult your doctor before using Etopro. If the patient has epilepsy, it is important not to discontinue treatment without consulting a doctor. The patient should consult their doctor before taking any medicine containing topiramate prescribed as a substitute for Etopro. During treatment with Etopro, the patient may lose weight; therefore, body weight should be monitored regularly during treatment. If the patient loses too much weight or if a child taking this medicine does not gain sufficient weight, consult the treating doctor.

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A small number of people taking antiepileptic medicines, such as Etopro,
have experienced thoughts of self-harm or suicide.
If such thoughts ever occur, contact your doctor immediately.
Etopro may rarely cause increased blood ammonia levels (detected in blood tests), which may lead to
changes in brain function, especially when the patient is also taking a medicine containing valproic acid or sodium valproate. Since this may be an acute condition, inform your doctor immediately if the following adverse effects occur
(see also section 4 "Possible side effects"):

• difficulties with thinking, memory or problem-solving,
• reduced alertness or consciousness,
• feeling very sleepy with lack of energy.

The risk of these symptoms may increase with higher doses of Etopro.
Cases of decreased sweating after topiramate use have been reported. Reduced sweating and hyperthermia (elevated body temperature) may occur, especially in young children exposed to high environmental temperatures.
Adults treated with Etopro may experience cognitive impairment symptoms and may require dose reduction or discontinuation of treatment. Cognitive impairment symptoms in children still require further research.
Etopro and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. Etopro may interact with other medicines. Therefore, the dose of the patient's current medicines may sometimes need to be adjusted, or the dose of Etopro may need to be changed accordingly.
Tell your doctor or pharmacist especially if the patient is taking:

• other medicines that have harmful effects or reduce thinking, concentration or muscle coordination (e.g. central nervous system depressants such as muscle relaxants and sedatives);
• hormonal contraceptives. Etopro may reduce the effectiveness of hormonal contraceptives. An additional barrier method of contraception, such as a condom or diaphragm/cervical cap, should be used. Talk to your doctor about the best contraceptive method to use during Etopro treatment. Inform your doctor if menstrual bleeding changes while using hormonal contraceptives and Etopro. Irregular bleeding may occur. In such a case, continue using hormonal contraceptives and inform your doctor. Keep a list of all medicines taken. Show this list to your doctor and pharmacist when starting a new treatment. The use of other medicines such as antiepileptic drugs, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarizine, St John's wort (Hypericum perforatum) (a herbal product used in depression treatment), warfarin (an anticoagulant), should be discussed with your doctor or pharmacist.

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If the patient is unsure whether the above text applies to them, they should consult a doctor or pharmacist before using Etopro.
Etopro with food, drink and alcohol
Etopro can be taken with or without food. Drink plenty of fluids throughout the day to prevent kidney stone formation during Etopro treatment. Alcohol consumption should be avoided during Etopro treatment.
Pregnancy and breastfeeding
Important advice for women of childbearing potential
Etopro may harm the unborn child. Women of childbearing age should discuss other possible treatment options with their doctor. At least once a year, visit a doctor to review treatment and discuss risks.
Migraine prophylaxis:

• In the case of migraine, Etopro must not be used during pregnancy.
• In the case of migraine, Etopro must not be used if the patient is of childbearing potential unless using a highly effective method of contraception.
• A pregnancy test must be performed before starting Etopro treatment in women of childbearing potential.

Epilepsy treatment

• In the case of epilepsy, Etopro must not be used if the patient is pregnant, unless no other treatment method provides adequate seizure control.
• In the case of epilepsy, Etopro must not be used if the patient is of childbearing potential unless using a highly effective method of contraception. The only exception is when Etopro is the only medicine providing adequate seizure control and the patient plans to become pregnant. Talk to your doctor to ensure that the patient has received information about the risks of using Etopro during pregnancy and the risk of seizures during pregnancy, which may endanger the patient or the unborn child.
• A pregnancy test must be performed before starting Etopro treatment in women of childbearing potential.

Risk of using topiramate during pregnancy (regardless of the disease for which topiramate is used):
There is a risk of harmful effects on the unborn child if Etopro is used during pregnancy.

• Using Etopro during pregnancy increases the risk of congenital malformations in the child. In women taking topiramate, congenital malformations occur in approximately 4–9 children per 100. For comparison, this rate is 1–3 per 100 children born to women who do not have epilepsy and do not use antiepileptic medicines. In particular, cleft lip (cleft upper lip) and cleft palate (cleft palate) have been observed. In male newborns, a developmental disorder of the penis (hypospadias) may also occur.

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These malformations may develop early in pregnancy, even before the patient knows she is pregnant.

• When Etopro is used during pregnancy, the risk of autism spectrum disorders, intellectual disability or attention deficit hyperactivity disorder (ADHD) in the child may be 2 to 3 times higher than in children born to women with epilepsy who do not take antiepileptic medicines.
• When Etopro is used during pregnancy, the child may be smaller and have a lower than expected birth weight. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected at birth, compared to 5% of newborns in women without epilepsy who did not take antiepileptic medicines.
• If in doubt, ask your doctor about pregnancy risks.
• Other medicines used to treat this disease, which carry a lower risk of congenital malformations, may be available.

Need for contraception in women of childbearing potential:

• Women of childbearing potential should discuss alternative treatment options with their doctor instead of Etopro. If the decision is made to start treatment with Etopro, a highly effective method of contraception must be used during treatment and for at least 4 weeks after the last dose of Etopro.
• Use one highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods, such as an oral contraceptive combined with a mechanical method (such as a condom or diaphragm/cervical cap). Talk to your doctor to find out which contraceptive method is most suitable for the patient.
• If the patient uses hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, an additional barrier method of contraception (such as a condom or diaphragm/cervical cap) should be used.
• If irregular menstrual bleeding occurs, inform your doctor.

Use of Etopro in girls:
Parents or guardians of a girl treated with Etopro must contact the doctor immediately when the child has her first menstrual period. The doctor will inform them about the risks to the unborn child due to exposure to topiramate during pregnancy and the need for a highly effective method of contraception.
If the patient wishes to become pregnant while using Etopro:

• Make an appointment with your doctor.
• Do not discontinue contraception until this issue has been discussed with your doctor.
• If the patient uses Etopro due to epilepsy, do not discontinue treatment without consulting a doctor, as the condition may worsen.

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• The doctor will reassess treatment and alternative treatment options. The doctor will inform the patient about the risks of using Etopro during pregnancy. The doctor may also refer the patient to another specialist. If the patient becomes pregnant or suspects she may be pregnant while using Etopro:
• Make an urgent appointment with your doctor.
• In the case of using Etopro for migraine prophylaxis, stop taking the medicine immediately and contact your doctor, who will assess whether alternative treatment is necessary.
• If the patient uses Etopro due to epilepsy, do not discontinue treatment without consulting a doctor, as this may worsen the disease. Worsening epilepsy may endanger the patient or the unborn child.
• The doctor will reassess treatment and alternative treatment options. The doctor will inform the patient about the risks of using Etopro during pregnancy. The doctor may also refer the patient to another specialist.
• If Etopro is used during pregnancy, the patient will remain under close monitoring to assess the development of the unborn child. You must read the patient instruction provided by your doctor. The patient guide can also be obtained by scanning the QR code; see section 6. "Contents of the pack and other information". A patient card is included in the Etopro packaging, reminding of the risks associated with using topiramate during pregnancy.

Breastfeeding
The active substance of Etopro (topiramate) passes into human milk. Adverse effects such as diarrhoea, drowsiness, irritability and poor weight gain have been observed in infants breastfed by mothers taking this medicine. Therefore, the doctor will discuss with the patient whether to discontinue breastfeeding or discontinue Etopro treatment, taking into account the importance of the medicine for the mother and the risk to the child.
Mothers taking Etopro during lactation must inform their doctor immediately if they notice any change in their child's behaviour.
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans pregnancy, she should talk to her doctor or pharmacist before using this medicine.
Driving and operating machinery
Dizziness, fatigue and vision problems may occur during Etopro treatment. Before consulting a doctor, do not drive, operate any mechanical equipment or use tools.
Etopro 25 mg, 50 mg and 200 mg contain lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.
Etopro 100 mg only contains the azo dye Orange Yellow FCF (E 110), which may cause allergic reactions.
Etopro contains sodium.
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The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Etopro

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Girls and women of childbearing age:
Treatment with Etopro should be initiated and supervised by a doctor experienced in the treatment of
epilepsy or migraine. A medical check-up to review the treatment should be carried out at least once a year.
The doctor usually starts treatment with a low dose of Etopro and gradually increases it until the
optimal dose for the individual patient is established.
Etopro tablets should be swallowed whole. Chewing the tablets is not recommended, as they may
leave a bitter taste.
Etopro may be taken before, during, or after meals. While taking Etopro, it is important to drink
plenty of fluids to help prevent the formation of kidney stones.
Taking more Etopro than prescribed
Contact your doctor immediately. Take the medicine packaging with you.
In case of topiramate overdose, the following symptoms may occur: drowsiness, feeling of fatigue
or reduced alertness; lack of motor coordination; speech or concentration disturbances; double or
blurred vision; dizziness due to low blood pressure; feelings of depression or agitation; abdominal pain or
seizures.
Overdose may also occur when taking other medicines together with Etopro.
If you forget to take Etopro
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the
missed dose and continue with your regular dosing schedule. If you miss two or more doses, contact your doctor.
Do not take a double dose to make up for a missed dose.
Stopping Etopro
Do not stop treatment unless instructed by your doctor. After stopping therapy, symptoms of the
underlying disease may return. If your doctor decides to discontinue treatment, the dose of the medicine may be
gradually reduced over several days.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
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Seek immediate medical advice or contact your doctor if any of the following adverse reactions occur:
Very common (may affect more than 1 in 10 people)

• Depression (either new onset or worsening of existing depression).

Common (may affect up to 1 in 10 people)

• Seizures;
• Anxiety, irritability, mood changes, confusion, disorientation;
• Difficulty concentrating, slowed thinking, memory loss, memory problems (new onset, sudden change, or worsening of symptoms);
• Kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• Increased levels of acid in the blood (which may cause breathing difficulties including shortness of breath, shallow breathing, loss of appetite, nausea, vomiting, excessive tiredness, and rapid or irregular heartbeat);
• Reduced or absent sweating (especially in younger children exposed to high temperatures);
• Thoughts or attempts of severe self-harm;
• Loss of part of the visual field.

Rare (may affect up to 1 in 1000 people)

• Glaucoma – blockage of fluid in the eye chamber causing increased pressure inside the eyeball, eye pain, or impaired vision;
• Difficulty thinking, remembering information, or solving problems, reduced alertness or consciousness, feeling very sleepy and lacking energy – these symptoms may result from high levels of ammonia in the blood (hyperammonemia), which may lead to changes in brain function (hyperammonemic encephalopathy).
  Frequency not known (cannot be estimated from available data)
• Inflammation of the eye (uveitis) with the following symptoms: redness of the eye, pain, sensitivity to light, floaters, or blurred vision.

Other adverse reactions are listed below. If these symptoms worsen, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people)

• Stuffy nose, runny nose, or sore throat;
• Tingling, pain, and/or numbness in various parts of the body;
• Drowsiness, fatigue;
• Dizziness;
• Nausea, diarrhoea;
• Weight loss.

Common (may affect up to 1 in 10 people)

• Anaemia (reduced number of red blood cells);
• Allergic reactions (e.g. skin rash, redness, itching, facial swelling, hives);
• Loss of appetite, decreased appetite;
• Aggression, restlessness, anger, behavioural disturbances;
• Difficulty falling or staying asleep;
• Speech problems or speech disorders, slurred speech;
• Motor clumsiness or lack of coordination, feeling unbalanced while walking;
• Reduced ability to perform routine tasks;
• Decreased, lost, or absent sense of taste;
• Involuntary tremors or twitching; sudden, uncontrolled eye movements;
• Vision disturbances such as double vision, blurred vision, reduced field of vision, problems with visual acuity;
• Sensation of spinning (dizziness), ringing in the ears, ear pain;
• Shortness of breath (shallow breathing);
• Cough;
• Nosebleeds;
• Fever, malaise, weakness;
• Vomiting, constipation, abdominal pain or discomfort, indigestion, stomach or intestinal infection;
• Dry mouth;
• Hair loss;
• Itching;
• Joint pain or swelling, muscle cramps or twitching, muscle pain or weakness, chest pain;
• Weight gain.

Uncommon (may affect up to 1 in 100 people)

• Decreased platelet count (blood cells responsible for blood clotting), reduced number of white blood cells (which help protect the body from infection), low potassium levels in the blood;
• Increased liver enzyme activity, increased number of eosinophils (a type of white blood cell) in the blood;
• Swelling of lymph nodes in the neck, armpits, or groin;
• Increased appetite;
• Elevated mood, abnormally increased mood;
• Hallucinations (seeing, hearing, or feeling things that are not there), acute psychiatric disturbances (psychosis);
• Lack of emotional expression and/or inability to feel emotions, unusual suspiciousness, panic attacks;
• Reading difficulties, speech disorders, handwriting problems;
• Restlessness, hyperactivity;
• Slowed thinking, reduced alertness;
• Slowed or weakened body movements, involuntary abnormal or repetitive muscle contractions;
• Fainting, loss of consciousness;
• Unusual sensation to touch, altered sense of touch;
• Distorted, impaired, or absent sense of smell;
• Unusual sensation or aura preceding migraine or certain types of seizures;
• Dry eyes, sensitivity to light, eyelid twitching, watery eyes;
• Hearing loss, reduced hearing, hearing loss in one ear;
• Slow or irregular heartbeat, palpitations;
• Low blood pressure, reduced blood pressure upon standing (which may result in some patients taking Etopro experiencing faintness, dizziness, or loss of consciousness when standing up or sitting up suddenly);
• Hot flushes, feeling of warmth;
• Pancreatitis;
• Excessive gas, heartburn, feeling of fullness in the stomach or bloating;
• Bleeding gums, excessive saliva production, drooling, bad breath;
• Excessive fluid intake, increased thirst; 9/14
• Skin discoloration;
• Muscle stiffness, flank pain;
• Blood in urine, urinary incontinence, sudden urge to urinate, flank or kidney pain;
• Difficulty achieving or maintaining erection, sexual dysfunction;
• Flu-like symptoms;
• Cold sensation in fingers and toes;
• Feeling of alcohol intoxication;
• Learning difficulties.

Rare (may affect up to 1 in 1000 people)

• Vision loss in one eye, transient blindness, night blindness;
• Lazy eye;
• Swelling of the eye and tissues around the eye;
• Numbness, tingling, and skin colour changes (white, blue, then red) in fingers and toes upon exposure to cold;
• Hepatitis, liver failure;
• Stevens-Johnson syndrome, a potentially life-threatening condition involving mucosal damage in multiple sites (e.g. mouth, nose, eyes), skin rash, and blisters;
• Unpleasant skin odour;
• Discomfort in upper and lower limbs;
• Kidney disorders.

Frequency not known (frequency cannot be estimated from available data)

• Macular degeneration – a disease of the macula of the retina, the area responsible for sharpest vision. If you notice changes in vision or impaired vision, contact your doctor;
• Toxic epidermal necrolysis, a life-threatening condition which is a more severe form of Stevens-Johnson syndrome, characterized by widespread blisters and peeling (desquamation) of the outer layers of the skin (see rare adverse reactions).

Children
Adverse reactions in children are generally similar to those observed in adults; however, the following adverse reactions may occur more frequently in children than in adults:

• Difficulty concentrating;
• Increased levels of acid in the blood;
• Thoughts of severe self-harm;
• Fatigue;
• Decreased or increased appetite;
• Aggression, behavioural disturbances;
• Difficulty falling and staying asleep;
• Feeling unsteady while walking;
• Malaise;
• Low potassium levels in the blood;
• Lack of emotional expression and/or inability to feel emotions;
• Watery eyes;
• Slow or irregular heartbeat.

Other adverse reactions that may occur in children include:
Common (may affect up to 1 in 10 people)
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• Sensation of spinning (dizziness);
• Vomiting;
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Increased number of eosinophils (a type of white blood cell) in the blood;
• Hyperactivity;
• Feeling of warmth;
• Learning difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Etopro

Keep this medicine out of the sight and reach of children.
Blister 100 mg: do not store above 30°C.
Blister 25 mg, 50 mg, 200 mg: no special storage conditions required.
HDPE container: no special storage conditions required.
Do not use this medicine after the expiry date stated on the cardboard box, blister, or container after: EXP. The expiry date (EXP) refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Etopro contains

• The active substance is topiramate:
  Tablets 25 mg: Each tablet contains 25 mg of topiramate.
  Tablets 50 mg: Each tablet contains 50 mg of topiramate.
  Tablets 100 mg: Each tablet contains 100 mg of topiramate.
  Tablets 200 mg: Each tablet contains 200 mg of topiramate.
• Other ingredients are: 11/14

Tablet core:
Microcrystalline cellulose
Mannitol
Sodium starch glycolate (type A)
Pregelatinized corn starch
Crospovidone
Povidone
Magnesium stearate
Carnauba wax

Coating, 25 mg coated tablet:
Opadry II White OY-LS-28908
Hypromellose 15 cP
Hypromellose 3 cP
Hypromellose 50 cP
Lactose monohydrate
Titanium dioxide (E 171)
Macrogol 4000

Coating, 50 mg coated tablet:
Opadry II White OY-LS-28908
Hypromellose 15 cP
Hypromellose 3 cP
Hypromellose 50 cP
Lactose monohydrate
Titanium dioxide (E 171)
Macrogol 4000
Opadry Yellow 02H2229
Hypromellose 5 cP
Titanium dioxide (E 171)
Talc
Propylene glycol (E1520)
Quinoline yellow (E 104)

Coating, 100 mg coated tablet:
Opadry Orange 02H23314:
Hypromellose 5 cP
Titanium dioxide (E 171)
Talc
Propylene glycol (E1520)
Orange GFC lake (E 110)

Coating, 200 mg coated tablet:
Opadry II Pink 39F24041
Hypromellose 15 cP
Hypromellose 3 cP
Hypromellose 50 cP
Lactose monohydrate
Titanium dioxide (E 171)
Macrogol 4000
Iron oxide red (E 172)
Iron oxide yellow (E 172)
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What Etopro looks like and contents of the pack
Tablets 25 mg: White, round, biconvex coated tablets.
Tablets 50 mg: Yellow, round, biconvex coated tablets.
Tablets 100 mg: Orange, oblong, biconvex coated tablets.
Tablets 200 mg: Pink, oblong, biconvex coated tablets.

Pack sizes:
28 or 60 coated tablets in blisters made of PVC/PE/PVDC/Aluminium, packed in a cardboard box.
60 coated tablets in a HDPE container with a PP cap and a desiccant, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Pharmathen S.A.
6, Dervenakion str.
153 51 Pallini, Attikis
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5
69300 Rodopi
Greece
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Poland
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland

This medicinal product is authorised in the European Economic Area under the following names:
Denmark: Topiramat Pharmathen
Greece: Toramat 25 mg, 50 mg, 100 mg & 200 mg
Cyprus: Toramat
Estonia: Topiramate ELVIM
Hungary: Etopro 25 mg, 50 mg, 100 mg & 200 mg filmtabletta
Lithuania: Topiramate ELVIM 25 mg, 50 mg & 100 mg plėvele dengtos tabletės
Latvia: Topiramate ELVIM 25 mg, 50 mg & 100 mg apvalkotās tabletes
Poland: Etopro

Other sources of information
The most up-to-date approved information (Patient Information Leaflet) for this medicine is available by scanning the following QR code with a smartphone. The same information is also available at the following website (URL):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After accessing the website, enter the medicine name and then open "Materials for download".
QR code
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