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 learn how to report side effects, see section 4.

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

• 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet

• 1. What Etopro is and what it is 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 Etopro is and what it is used for

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

• as the only medicine to treat seizures in adults and children over 6 years old;
• in combination with other medicines to treat seizures in adults and children over 2 years old;
• to prevent migraine headaches in adults.

2. Important information before taking Etopro

When not to take Etopro:

• if you are allergic to topiramate or any of the other ingredients of this medicine (listed in section 6). Migraine prevention
• Etopro must not be taken during pregnancy.

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• If you are of childbearing age, you 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 you are pregnant, unless no other treatment method provides sufficient control of seizures;
• if you are of childbearing age, you 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 you plan to become pregnant. You should discuss this with your doctor to ensure you have been informed about the risk of taking Etopro during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn baby at risk.

You must read the patient instruction provided by your doctor or scan the QR code (see section 6 "Package contents and other information"). A patient card is attached to the Etopro packaging, which reminds you of the risk associated with pregnancy. If you are not sure if any of the above warnings apply to you, you should consult your doctor or pharmacist before taking Etopro.

Warnings and precautions

Before starting treatment with Etopro, you should discuss with your doctor or pharmacist if you have:

• kidney disease, especially kidney stones or dialysis;
• blood and body fluid disorders (metabolic acidosis). If such symptoms occur, such as deep breathing, rapid breathing (Kussmaul's breathing), shortness of breath, loss of appetite, nausea, vomiting, excessive fatigue, tachycardia or arrhythmia, it is recommended to perform a blood bicarbonate test;
• liver disease;
• eye diseases, especially glaucoma;
• growth disorders;
• if you are on a high-fat diet (ketogenic diet);
• if you are a woman of childbearing age. Etopro taken during pregnancy may harm the unborn baby. During treatment and for at least 4 weeks after the last dose of Etopro, you should use highly effective contraception. Further information can be found in the section "Pregnancy and breastfeeding";
• if you are pregnant. Etopro taken during pregnancy may harm the unborn baby. If you have any doubts whether any of the above warnings apply to you, you should consult your doctor before taking Etopro. If you have epilepsy, it is important not to stop taking Etopro without consulting your doctor. You should consult your doctor before taking any medicine containing topiramate, which has been prescribed to you as a substitute for Etopro. During treatment with Etopro, you may lose weight, so you should regularly check your body weight during treatment with this medicine. If you lose too much weight or if your child taking this medicine does not gain enough weight, you should consult your doctor.

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A small number of people taking antiepileptic drugs, such as Etopro, have had thoughts of self-harm or suicide.
If you ever have these thoughts, you should contact your doctor immediately.
Etopro may rarely cause an increase in blood ammonia levels (detected in blood tests), which can lead to changes in brain function, especially if you are also taking a medicine containing valproic acid or sodium valproate. As this can be a serious condition, you should immediately tell your doctor if you experience 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 when taking 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 dose reduction or discontinuation of treatment. Symptoms of impaired cognitive function in children are still being studied.

Etopro and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. Etopro may interact with other medicines. Therefore, sometimes the dose of the medicines you are taking may need to be adjusted, or the dose of Etopro may need to be changed.
You should especially tell your doctor or pharmacist if you are taking:

• other medicines that have a negative effect 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. You should use an additional barrier method of contraception, such as a condom or diaphragm/cervical cap. You should discuss with your doctor the best method of contraception to use while taking Etopro. You should tell your doctor if your menstrual bleeding changes while taking hormonal contraceptives and Etopro. Irregular bleeding may occur. In such cases, you should continue taking hormonal contraceptives and inform your doctor. You should keep a list of all the medicines you are taking. When starting a new medicine, you should show this list to your doctor and pharmacist. 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 to treat depression), warfarin (an anticoagulant), should be discussed with your doctor or pharmacist.

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If you are not sure if the above text applies to you, you should consult your doctor or pharmacist before taking Etopro.

Etopro with food, drink, and alcohol

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

Pregnancy and breastfeeding

Important advice for women of childbearing age
Etopro may harm the unborn baby. 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, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Etopro.
Migraine prevention:

• Etopro must not be taken during pregnancy.
• Etopro must not be taken if you are of childbearing age, unless you are using highly effective contraception.
• Before starting treatment with Etopro, you should have a pregnancy test.

Epilepsy treatment

• Etopro must not be taken if you are pregnant, unless no other treatment method provides sufficient control of seizures.
• Etopro must not be taken if you are of childbearing age, unless you are using highly effective contraception. The only exception is when Etopro is the only medicine that provides sufficient control of seizures, and you plan to become pregnant. You should discuss this with your doctor to ensure you have been informed about the risk of taking Etopro during pregnancy and the risk of seizures during pregnancy, which may put you or your unborn baby at risk.
• Before starting treatment with Etopro, you should have a pregnancy test.

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

• Taking Etopro during pregnancy increases the risk of birth defects in the baby. In women taking topiramate, birth defects occur in about 4-9 out of 100 babies. For comparison, this figure is 1-3 out of 100 babies born to women who do not have epilepsy and are not taking antiepileptic drugs. 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.
• These defects can develop early in pregnancy, even before you know you are pregnant.

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(hypospadias). These defects can develop early in pregnancy, even before you know you are pregnant.

• The risk of the baby developing autism spectrum disorders, intellectual disability, or attention deficit hyperactivity disorder (ADHD) may be 2 to 3 times higher than in children born to women with epilepsy who are not taking antiepileptic drugs.
• Babies born to mothers taking Etopro during pregnancy may be smaller and have a lower birth weight than expected. In one study, 18% of children whose mothers took topiramate during pregnancy were smaller and weighed less than expected, while in women without epilepsy who did not take antiepileptic drugs, this figure was 5% of newborns.
• If you have any doubts, you should ask your doctor about the risks during pregnancy.
• There may be other medicines used to treat this disease that are associated with a lower risk of birth defects.

Necessity of 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, you should use highly effective contraception during treatment and for at least 4 weeks after the last dose of Etopro.
• You should use one highly effective contraceptive method (such as an intrauterine device) or two complementary contraceptive methods, such as a contraceptive pill, in combination with a mechanical contraceptive method (such as a condom or diaphragm/cervical cap). You should discuss with your doctor which contraceptive method will be most suitable for you.
• If you are taking hormonal contraceptives, topiramate may reduce their effectiveness. Therefore, you should use an additional barrier method of contraception (such as a condom or diaphragm/cervical cap).
• If you experience irregular menstrual bleeding, you should inform your doctor.

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

• You should make an appointment with your doctor.
• You should not stop using contraception until you have discussed this with your doctor.
• If you are taking Etopro for epilepsy, you should not stop taking it without consulting your doctor, as your condition may worsen.

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• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risks of taking Etopro during pregnancy. They may also refer you to another specialist. If you become pregnant or think you may be pregnant while taking Etopro:
• You should make an urgent appointment with your doctor.
• If you are taking Etopro for migraine prevention, you should stop taking it immediately and contact your doctor, who will assess whether alternative treatment is necessary.
• If you are taking Etopro for epilepsy, you should not stop taking it without consulting your doctor, as this may worsen your condition. Worsening of epilepsy may put you or your unborn baby at risk.
• Your doctor will reassess your treatment and alternative treatment options. Your doctor will inform you about the risks of taking Etopro during pregnancy. They may also refer you to another specialist.
• If Etopro is taken during pregnancy, you will be closely monitored to check the development of the unborn baby. 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 "Package contents and other information". A patient card is attached to the Etopro packaging, which reminds you of 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 been reported. Therefore, your doctor will discuss with you whether to stop breastfeeding or stop taking Etopro. Your doctor will consider the importance of the medicine for the mother and the risk for the baby.
Mothers taking Etopro during breastfeeding should immediately inform their doctor if they notice any changes in their child's behavior.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

While taking Etopro, you may experience dizziness, fatigue, and vision problems.
Before consulting your doctor, you should not drive, operate any machinery, or use tools.

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

If you have been diagnosed with intolerance to some sugars, you should contact your 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, i.e., the medicine is considered "sodium-free".

3. How to take Etopro

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Girls and women of childbearing age:
Treatment with Etopro should be started and supervised by a doctor experienced in the treatment of epilepsy or migraine. You should visit your doctor at least once a year to monitor your treatment.
Your doctor will usually start treatment with a low dose of Etopro and gradually increase it until the optimal dose for you is reached.
Etopro tablets should be swallowed whole. It is not recommended to chew the tablets, as they may have a bitter taste.
Etopro can be taken before, during, or after meals. While taking Etopro, you should drink plenty of fluids to prevent the formation of kidney stones.

Taking a higher dose of Etopro than recommended

You should immediately contact your doctor. You should take the packaging of the medicine with you.
In case of topiramate overdose, you may experience the following symptoms: drowsiness, feeling tired or less alert; lack of coordination; speech or concentration disorders; double or blurred vision; dizziness due to low blood pressure; feeling depressed or agitated; abdominal pain or seizures.
Overdose may also occur when taking other medicines with Etopro.

Missing a dose of Etopro

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and continue with your regular dosing schedule. If you miss two or more doses, you should contact your doctor.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Etopro

You should not stop treatment unless your doctor tells you to. After stopping treatment, the symptoms of the underlying disease may return. If your doctor decides to stop treatment, the dose of Etopro may be gradually decreased over a few days.
If you have any further questions about taking Etopro, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Etopro can cause side effects, although not everybody gets them.
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You should immediately contact your doctor or seek medical attention if you experience 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, 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 floaters in the eyes.

Other side effects are listed below. If these symptoms worsen, you should inform your 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 (reduced red blood cell count);
• allergic reactions (e.g., skin rash, redness, itching, swelling of the face, hives);
• loss of appetite, decreased appetite;
• aggression, agitation, anger, behavioral disorders;
• sleep disturbances or sleep problems;
• speech or language problems, unclear 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 problems, such as double vision, blurred vision, reduced visual field, or problems with visual acuity;
• 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)

• reduced platelet count (blood cells responsible for blood clotting), reduced white blood cell count, which helps protect the body against infection, decreased blood potassium levels;
• 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 feeling, unusual suspiciousness, panic attacks;
• reading problems, speech problems, handwriting problems;
• restlessness, hyperactivity;
• slowed thinking, decreased alertness;
• weak or slowed 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 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;
• 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 function disorders;
• 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 problems.

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

• macular degeneration - a disease of the macula, the yellow spot of the retina, the area of sharpest vision. If you notice any changes in your vision or blurred vision, you should contact your 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 disturbances;
• feeling unbalanced while walking;
• malaise;
• decreased blood potassium levels;
• lack of emotional expression and/or lack of emotional feeling;
• 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 warmth;
• learning difficulties.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help provide more information on the safety of this 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) refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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)
Cornstarch
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 yellow FCF, 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

25 mg tablets:White, round, biconvex, coated tablets.
50 mg tablets:Yellow, round, biconvex, coated tablets.
100 mg tablets:Orange, oval, biconvex, coated tablets.
200 mg tablets:Pink, oval, biconvex, coated tablets.
Package size:
28 or 60 coated tablets in PVC/PE/PVDC/Aluminum blisters, in a cardboard box.
60 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.
Przemysłowa 2
35-959 Rzeszów
Poland
Bausch Health Poland sp. z o.o.
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
Estonia:
Topiramat ELVIM
Hungary:
Etopro 25 mg, 50 mg, 100 mg & 200 mg film-coated tablets
Lithuania:
Topiramat ELVIM 25 mg, 50 mg & 100 mg coated tablets
Latvia:
Topiramat ELVIM 25 mg, 50 mg & 100 mg tablets

Other sources of information

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