Etopro

Leaflet accompanying the packaging: patient information

Etopro, 25 mg, coated tablets

Etopro, 50 mg, coated tablets

Etopro, 100 mg, coated tablets

Etopro, 200 mg, coated tablets

Topiramate

This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out more, see section 4.

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Etopro and what is it used for
• 2. Important information 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 is Etopro and what is it used for

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

• as the only medicine 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;
• to prevent migraine headaches in adults.

2. Important information before taking Etopro

When not to take 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 taken during pregnancy.

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• If the patient is of childbearing age, she should not take Etopro without using highly effective contraception during treatment. See below in the section "Pregnancy, breastfeeding and fertility - important advice for women". Epilepsy treatment
• Etopro must not be taken if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures;
• if the patient is of childbearing age, she should not take Etopro without using highly effective contraception during treatment. The only exception is when Etopro is the only medicine that provides sufficient control of seizures, and the patient plans to become pregnant. The patient should discuss this with her doctor to ensure she has been informed about the risk of taking Etopro during pregnancy and the risk of seizures during pregnancy, which may put the patient or the unborn child at risk.

It is essential to read the patient instruction provided by the doctor or scan the QR code (see section 6 "Contents of the pack and other information"). A patient card is attached to the Etopro packaging, which reminds about the risk associated with pregnancy. If the patient is unsure whether any of the above applies to her, she should consult her doctor or pharmacist before taking Etopro.

Warnings and precautions

Before starting treatment with Etopro, the patient should discuss the following with her doctor or pharmacist:

• kidney disease, especially kidney stones or dialysis;
• blood and body fluid disorders (metabolic acidosis). If symptoms such as deep breathing, rapid breathing (Kussmaul's breathing), shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, tachycardia or arrhythmia occur, it is recommended to perform a blood bicarbonate test;
• liver disease;
• eye diseases, especially glaucoma;
• growth disorders;
• if the patient is on a high-fat diet (ketogenic diet);
• if the patient is a woman of childbearing age. 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 should 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. In case of doubts whether any of the above warnings apply to the patient, she should consult her doctor before taking Etopro. If the patient has epilepsy, it is essential not to stop taking Etopro without consulting a doctor. The patient should consult her doctor before taking any medicine containing topiramate, which has been prescribed as a substitute for Etopro. During treatment with Etopro, the patient may lose weight, so it is essential to regularly monitor body weight during treatment with this medicine. If the patient loses too much weight or if a child taking this medicine does not gain enough weight, the patient should consult her doctor.

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In a small number of people taking antiepileptic medicines, such as Etopro, thoughts of self-harm or suicide have occurred.
If such thoughts ever occur to the patient, she should immediately contact her doctor.
Etopro may rarely cause an increase in blood ammonia levels (detected in blood tests), which can lead to changes in brain function, especially if the patient is also taking a medicine containing valproic acid or sodium valproate. Since this can be a severe condition, the patient should immediately tell her doctor if she experiences any of the following side effects (see also section 4 "Possible side effects"):

• difficulty thinking, remembering or solving problems,
• decreased alertness or awareness,
• feeling extremely drowsy with a lack of energy.

The risk of these symptoms may increase with higher doses of Etopro.
There have been reports of decreased sweating after taking topiramate. Decreased sweating and hyperthermia (elevated body temperature) may occur, especially in young children exposed to high environmental temperatures.
Adults treated with Etopro may exhibit symptoms of impaired cognitive function and may require a dose reduction or discontinuation of treatment. Symptoms of impaired cognitive function in children are still being studied.

Etopro and other medicines

The patient should tell her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take. Etopro may interact with other medicines. In some cases, the dose of the medicines taken by the patient may need to be adjusted or the dose of Etopro may need to be changed.

• The patient should especially tell her doctor or pharmacist if she is taking:
• other medicines that have a harmful effect or decrease thinking, concentration or muscle coordination (e.g., central nervous system depressants, such as muscle relaxants and sedatives);
• hormonal contraceptives. Etopro may decrease the effectiveness of hormonal contraceptives. The patient should use an additional barrier method of contraception, such as a condom or a diaphragm/cervical cap. The patient should discuss with her doctor the best method of contraception to use while taking Etopro. If the patient experiences changes in menstrual bleeding while taking hormonal contraceptives and Etopro, she should inform her doctor. Irregular bleeding may occur. In such cases, the patient should continue to use hormonal contraceptives and inform her doctor.

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If the patient is unsure whether the above text applies to her, she should consult her doctor or pharmacist before taking Etopro.

Etopro with food, drink, and alcohol

Etopro can be taken with or without food. The patient should drink plenty of fluids throughout the day to prevent the formation of kidney stones while taking Etopro. The patient should avoid consuming alcohol while taking Etopro.

Pregnancy and breastfeeding

Important advice for women of childbearing age
Etopro may harm the unborn child. Women of childbearing age should discuss with their doctor the possibility of using other treatment methods instead of Etopro. If the decision is made to start treatment with Etopro, the patient should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Etopro.
Migraine prophylaxis:

• Etopro must not be taken during pregnancy.
• Etopro must not be taken if the patient is of childbearing age, unless she uses highly effective contraception.
• Before starting treatment with Etopro, the patient should undergo a pregnancy test.

Epilepsy treatment

• Etopro must not be taken if the patient is pregnant, unless no other treatment method provides sufficient control of epileptic seizures.
• Etopro must not be taken if the patient is of childbearing age, unless she uses highly effective contraception. The only exception is when Etopro is the only medicine that provides sufficient control of seizures, and the patient plans to become pregnant. The patient should discuss this with her doctor to ensure she has been informed about the risk of taking Etopro during pregnancy and the risk of seizures during pregnancy, which may put the patient or the unborn child at risk.
• Before starting treatment with Etopro, the patient should undergo a pregnancy test.

Risk of taking topiramate during pregnancy (regardless of the disease being treated):
There is a risk of harm to the unborn child if Etopro is taken during pregnancy.

• Taking Etopro during pregnancy increases the risk of birth defects in the child. Birth defects occur in about 4-9 out of 100 children born to women taking topiramate. For comparison, this figure is 1-3 out of 100 children born to women who do not have epilepsy and do not take antiepileptic medicines. In particular, cleft lip (cleft lip) and cleft palate (cleft palate) have been observed. In newborn boys, a developmental defect of the penis (hypospadias) may also occur.

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These defects can develop early in pregnancy, even before the patient knows she is pregnant.

• The risk of the child developing autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) may be 2 to 3 times higher if Etopro is taken during pregnancy than in children born to women with epilepsy who do not take antiepileptic medicines.
• If Etopro is taken during pregnancy, the child may be smaller and have a lower birth weight than expected. In one study, 18% of children born to mothers taking topiramate during pregnancy were smaller and weighed less than expected, while in women without epilepsy who did not take antiepileptic medicines, this figure was 5%.
• In case of doubts, the patient should ask her doctor about the risks during pregnancy.
• Other medicines used to treat this disease may be available, which are associated with a lower risk of birth defects.

Necessity of using contraception in women of childbearing age:

• Women of childbearing age should discuss with their doctor the possibility of using other treatment methods instead of Etopro. If the decision is made to start treatment with Etopro, the patient should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Etopro.
• The patient should use one highly effective contraceptive method (such as an intrauterine device) or two complementary methods of contraception, such as a contraceptive pill in combination with a mechanical method of contraception (such as a condom or a diaphragm/cervical cap). The patient should discuss with her doctor which method of contraception is most suitable for her.
• If the patient is taking hormonal contraceptives, topiramate may decrease their effectiveness. Therefore, the patient should use an additional barrier method of contraception (such as a condom or a diaphragm/cervical cap).
• If the patient experiences irregular menstrual bleeding, she should inform her doctor.

Use of Etopro in girls:
The parents or guardians of a girl treated with Etopro should immediately contact the doctor when the girl experiences her first menstrual period. The doctor will inform them about the risk to the unborn child resulting from exposure to topiramate during pregnancy and the need to use highly effective contraception.
If the patient wants to become pregnant while taking Etopro:

• The patient should make an appointment with her doctor.
• The patient should not stop using contraception until she has discussed this with her doctor.
• If the patient is taking Etopro for epilepsy, she should not stop taking it without consulting her doctor, as the disease may worsen.

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• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risk of taking 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 taking Etopro:
• The patient should make an urgent appointment with her doctor.
• If the patient is taking Etopro for migraine prophylaxis, she should immediately stop taking the medicine and contact her doctor, who will assess whether alternative treatment is necessary.
• If the patient is taking Etopro for epilepsy, she should not stop taking it without consulting her doctor, as the disease may worsen. Worsening of epilepsy may put the patient or the unborn child at risk.
• The doctor will reassess the treatment and alternative treatment options. The doctor will inform the patient about the risk of taking Etopro during pregnancy. The doctor may also refer the patient to another specialist.
• If Etopro is taken during pregnancy, the patient will be closely monitored to check the development of the unborn child. The patient should read the patient instruction provided by the 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 attached to the Etopro packaging, which reminds about the risk associated with topiramate during pregnancy.

Breastfeeding
The active substance of Etopro, topiramate, passes into breast milk. In children breastfed by mothers taking this medicine, side effects such as diarrhea, drowsiness, irritability, and poor weight gain have occurred. Therefore, the doctor will discuss with the patient whether to stop breastfeeding or stop taking Etopro. The doctor will consider the importance of the medicine for the mother and the risk to the child.
Mothers who are breastfeeding while taking Etopro should immediately inform their doctor if they notice any changes in their child's behavior.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines

While taking Etopro, the patient may experience dizziness, fatigue, and vision problems.
The patient should not drive or operate any machinery or tools before consulting her doctor.

Etopro 25 mg, 50 mg, and 200 mg contain lactose.

If the patient has been diagnosed with intolerance to some sugars, she should contact her doctor before taking the medicine.
Etopro 100 mg onlycontains 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, which means it is essentially "sodium-free".

3. How to take Etopro

This medicine should always be taken as directed by the doctor. If the patient has any doubts, she should consult her doctor or pharmacist.
Girls and women of childbearing age:
Treatment with Etopro should be started and supervised by a doctor with experience in treating epilepsy or migraines. The patient should visit her doctor at least once a year to monitor her treatment.
The doctor will usually start treatment with a low dose of Etopro and gradually increase it until the optimal dose for the patient is determined.
Etopro tablets should be swallowed whole. It is not recommended to chew the tablets, as they may leave a bitter taste.
Etopro can be taken before, during, or after a meal. While taking Etopro, the patient should drink plenty of fluids to prevent the formation of kidney stones.

Taking a higher dose of Etopro than recommended

The patient should immediately contact her doctor. The patient should take the packaging of the medicine with her.
In case of an overdose of topiramate, the patient may experience symptoms such as drowsiness, fatigue, or decreased alertness; lack of coordination; speech or concentration disorders; double or blurred vision; dizziness due to low blood pressure; feeling of depression or excitement; abdominal pain or seizures.
Overdose may also occur when taking other medicines with Etopro.

Missing a dose of Etopro

If the patient misses a dose, she should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose and continue with her treatment. If the patient misses two or more doses, she should contact her doctor.
The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Etopro

The patient should not stop treatment unless her doctor advises her to do so. After stopping treatment, the symptoms of the underlying disease may return. If the doctor decides to stop treatment, the dose of Etopro may be gradually decreased over a few days.
If the patient has any further doubts about taking the medicine, she should consult her doctor or pharmacist.

4. Possible side effects

Like all medicines, Etopro can cause side effects, although not everybody gets them.
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The patient should immediately contact her doctor or seek medical attention if she experiences any of the following side effects:

Very common (may affect more than 1 in 10 people)

• depression (for the first time or worsening of existing depression).

Common (may affect up to 1 in 10 people)

• seizures;
• anxiety, irritability, mood changes, confusion, disorientation;
• concentration problems, slowed thinking, memory loss, memory problems (for the first time, sudden change or worsening of symptoms);
• kidney stones, frequent or painful urination.

Uncommon (may affect up to 1 in 100 people)

• increased blood acid levels (may cause breathing difficulties, including shallow breathing, rapid breathing, shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, and rapid or irregular heartbeat);
• decreased sweating (especially in younger children exposed to high temperatures);
• thoughts of serious 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 in the eyeball, pain, or decreased vision;
• difficulty thinking, remembering information, or solving problems, decreased alertness or awareness, feeling extremely drowsy with a lack of energy - these symptoms may be due to high blood ammonia levels (hyperammonemia), which can lead to changes in brain function (hyperammonemic encephalopathy).

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

• eye inflammation (uveitis) with symptoms such as eye redness, pain, sensitivity to light, or blurred vision.

Other side effects are listed below. If these symptoms worsen, the patient should inform her doctor or pharmacist.

Very common (may affect more than 1 in 10 people)

• nasal congestion, runny nose, or sore throat;
• tingling, pain, and/or numbness in different parts of the body;
• drowsiness, fatigue;
• dizziness;
• nausea, diarrhea;
• weight loss.

Common (may affect up to 1 in 10 people)

• anemia (decreased red blood cell count);
• allergic reactions (e.g., skin rash, redness, itching, swelling of the face, hives);
• loss of appetite, decreased appetite;
• aggression, excitement, anger, behavioral disorders;
• sleep disorders or sleep disturbances;
• speech or language disorders, slurred speech;
• clumsiness or lack of coordination, feeling unbalanced while walking;
• reduced ability to perform routine tasks;
• reduced, lost, or altered sense of taste;
• involuntary, abnormal, or repetitive muscle contractions; sudden, uncontrolled eye movements;
• vision disorders, such as double vision, blurred vision, decreased visual field, or vision problems;
• feeling of spinning (vertigo), ringing in the ears, ear pain;
• shortness of breath (shallow breathing);
• cough;
• nasal bleeding;
• fever, malaise, weakness;
• vomiting, constipation, abdominal pain or discomfort, indigestion, gastrointestinal infection;
• dry mouth;
• hair loss;
• itching;
• joint pain or swelling, muscle cramps or twitching, muscle pain or weakness;
• weight gain.

Uncommon (may affect up to 1 in 100 people)

• decreased platelet count (blood cells responsible for blood clotting), decreased white blood cell count, which helps protect the body against infection, decreased potassium levels in the blood;
• increased liver enzyme activity, increased eosinophil count (a type of white blood cell) in the blood;
• swollen lymph nodes in the neck, armpits, or groin;
• increased appetite;
• elevated mood, abnormally increased mood;
• hearing, seeing, or feeling things that are not there, severe mental disorders (psychosis);
• lack of emotional expression and/or lack of emotional feelings, unusual suspiciousness, panic attacks;
• reading problems, speech disorders, problems with handwriting;
• restlessness, hyperactivity;
• slowed thinking, decreased alertness;
• weak or slow body movements, involuntary, abnormal, or repetitive muscle contractions;
• fainting, loss of consciousness;
• abnormal or altered sense of touch;
• altered or lost sense of smell;
• unusual sensation or feeling preceding the onset of a migraine or a certain type of seizure;
• dry eye, sensitivity to light, eyelid twitching, tearing;
• hearing loss, hearing loss in one ear;
• slow or irregular heartbeat, feeling of heartbeat in the chest;
• low blood pressure, decreased blood pressure when standing up (which may cause a feeling of fainting, dizziness, or loss of consciousness in some patients taking Etopro when standing up or sitting down quickly);
• hot flashes, feeling of heat;
• pancreatitis;
• excessive gas, heartburn, feeling of fullness in the stomach or bloating;
• gum bleeding, excessive saliva production, drooling, bad breath;
• excessive fluid intake, increased thirst;
• skin discoloration;
• muscle stiffness, side pain;
• blood in the urine, urinary incontinence, sudden urge to urinate, side or kidney pain;
• difficulty achieving or maintaining an erection, sexual dysfunction;
• flu-like symptoms;
• feeling of cold hands and feet;
• feeling of intoxication;
• learning difficulties.

Rare (may affect up to 1 in 1000 people)

• loss of vision in one eye, transient blindness, night blindness;
• lazy eye;
• swelling of the eye and surrounding tissues;
• numbness, tingling, and color change (white, blue, and then red) of the fingers and toes after exposure to cold;
• liver inflammation, liver failure;
• Stevens-Johnson syndrome, a potentially life-threatening disease that can cause damage to the mucous membranes in many areas (e.g., mouth, nose, and eyes), skin rash, and blisters;
• unpleasant body odor;
• discomfort in the arms and legs;
• kidney disorders.

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

• macular degeneration - a disease of the macula, the yellow spot on the retina, the area of sharpest vision. If the patient notices any changes in her vision or decreased vision, she should contact her doctor;
• toxic epidermal necrolysis, a life-threatening disease that is a more severe form of Stevens-Johnson syndrome, characterized by widespread blisters and peeling of the outer layers of the skin (see rare side effects).

Children

Side effects in children are generally similar to those observed in adults, but the following side effects may occur more frequently in children than in adults:

• concentration problems;
• increased blood acid levels;
• thoughts of serious self-harm;
• fatigue;
• decreased or increased appetite;
• aggression, behavioral disorders;
• sleep disorders or sleep disturbances;
• feeling unbalanced while walking;
• malaise;
• decreased potassium levels in the blood;
• lack of emotional expression and/or lack of emotional feelings;
• tearfulness;
• slow or irregular heartbeat. Other side effects that may occur in children are as follows:

Common (may affect up to 1 in 10 people)

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• feeling of spinning (vertigo);
• vomiting;
• fever.

Uncommon (may affect up to 1 in 100 people)

• increased eosinophil count (a type of white blood cell) in the blood;
• hyperactivity;
• feeling of heat;
• learning difficulties.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, she should tell her doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Etopro

The medicine should be stored out of sight and reach of children.
Blister 100 mg: do not store above 30°C.
Blisters 25 mg, 50 mg, 200 mg: no special storage precautions.
HDPE container: no special storage precautions.
Do not use this medicine after the expiry date stated on the carton, blister, or container after: EXP. The expiry date (EXP) is the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask her pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Etopro contains

• The active substance of Etopro is topiramate: 25 mg tablets:One tablet contains 25 mg of topiramate. 50 mg tablets:One tablet contains 50 mg of topiramate. 100 mg tablets:One tablet contains 100 mg of topiramate. 200 mg tablets:One tablet contains 200 mg of topiramate.
• Other ingredients are:

Tablet core:
Microcrystalline cellulose
Mannitol
Sodium carboxymethylcellulose (type A)
Corn starch, pregelatinized
Crospovidone
Povidone
Magnesium stearate
Carnauba wax
Coating, 25 mg 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 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 tablet:
Opadry Orange 02H23314:
Hypromellose 5 cP
Titanium dioxide (E 171)
Talc
Propylene glycol (E1520)
Orange yellow FCF, lake (E 110)
Coating, 200 mg 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

25 mg tablets:White, round, biconvex, film-coated tablets.
50 mg tablets:Yellow, round, biconvex, film-coated tablets.
100 mg tablets:Orange, oval, biconvex, film-coated tablets.
200 mg tablets:Pink, oval, biconvex, film-coated tablets.
Pack size:
28 or 60 film-coated tablets in PVC/PE/PVDC/Aluminum blisters, in a cardboard box.
60 film-coated tablets in an HDPE container with a PP cap and a desiccant, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Topiramat Pharmathen
Greece:
Toramat 25 mg, 50 mg, 100 mg & 200 mg
Cyprus:
Toramat
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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
Date of last revision of the leaflet:February 2024

Other sources of information

The latest approved information (Patient Guide) for this medicine is available by scanning the QR code below with a smartphone. The same information is also available on the following website (URL):
https://rejestry.ezdrowie.gov.pl/rpl/search/public
After being redirected to the website, the patient should enter the name of the medicine and then open "Materiały do pobrania".
QR code
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