Patient Information Leaflet

Bewim, 10 mg, film-coated tablets
Prasugrel
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Table of contents

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

1. What Bewim is and what it is used for

Bewim contains the active substance prasugrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells circulating in the blood. When a blood vessel is damaged, for example by a cut, platelets stick together to help form a blood clot. Platelets therefore play a key role in stopping bleeding.
However, the formation of a blood clot inside an artery narrowed by atherosclerosis is very dangerous, as it may block blood flow and lead to a heart attack (myocardial infarction), stroke, or death. The presence of a clot in arteries supplying blood to the heart may reduce blood flow and cause unstable angina (increased chest pain).
Bewim works by inhibiting platelet aggregation, thereby reducing the risk of blood clot formation.
Bewim has been prescribed by your doctor because you have had a myocardial infarction or unstable angina, and you have previously undergone a procedure to open blocked arteries in your heart. You may have undergone a procedure during which one or more stents were placed to keep open a blocked or narrowed artery supplying blood to the heart.
Bewim reduces the risk of another heart attack, stroke, or death due to such events. Your doctor will also recommend that you take acetylsalicylic acid (e.g. aspirin), which is also an antiplatelet medicine.

2. Important information before using Bewim

When not to use Bewim

If the patient has a known allergy (hypersensitivity) to prasugrel or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include rash, itching, facial swelling, lip swelling or shortness of breath. If any of these symptoms occur, you must immediately inform your doctor.
If the patient currently has a medical condition causing bleeding, e.g. gastrointestinal bleeding.
If the patient has ever had a stroke or transient ischaemic attack (TIA).
If the patient has severe liver disease.

Warnings and precautions
Before starting Bewim:
Starting treatment with Bewim should be discussed with a doctor. If any of the following situations apply to the patient, they must inform their doctor before taking Bewim:

If there is an increased risk of bleeding, such as:
- Age 75 years or older. The treating physician will recommend a daily dose of 5 mg (half a tablet), because the risk of bleeding is higher in patients aged 75 years and above;
- Recent severe trauma;
- Recent surgical procedure (including dental surgery);
- Recent or recurrent gastrointestinal bleeding (e.g. gastric ulcer or colon polyps);
- Body weight less than 60 kg. If the patient weighs less than 60 kg, the treating physician will recommend a daily dose of Bewim of 5 mg (half a tablet);
- Moderate kidney or liver disease;
- Use of certain medications (see below "Bewim with other medicines");
- Planned surgery within the next seven days (including dental procedures). Due to increased risk of bleeding, the doctor may advise temporarily stopping Bewim.
If the patient has previously experienced allergic reactions (hypersensitivity) to clopidogrel or other antiplatelet medicines, this must be reported to the doctor before starting Bewim. If allergic reactions occur after taking Bewim, such as rash, itching, facial swelling, lip swelling or difficulty breathing, the patient must immediately inform their doctor.

While taking Bewim:
The patient should immediately inform their doctor if they develop a medical condition called thrombotic thrombocytopenic purpura (TTP), which may present with symptoms such as fever and bruising under the skin appearing as small red spots, with or without symptoms of extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents
Bewim must not be used in children and adolescents under 18 years of age.

Bewim with other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, dietary supplements, or herbal medicines. In particular, inform the doctor if the patient is taking clopidogrel (an antiplatelet medicine), warfarin (an anticoagulant), or non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and fever (such as ibuprofen, naproxen, etoricoxib). Taking these medicines together with Bewim may increase the risk of bleeding.
Inform your doctor if the patient is taking morphine or other opioids (used to treat severe pain).
Only take medicines approved by your doctor while using Bewim.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
If the patient becomes pregnant or suspects she is pregnant while taking Bewim, she should immediately inform her doctor.
Bewim may be used only after discussing with a doctor the potential benefits and risks to the unborn child.
If the patient is breastfeeding, she should consult her doctor or pharmacist before taking any medicine.

Driving and operating machinery
It is unlikely that Bewim will affect the ability to drive or operate machinery.

Bewim contains lactose.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Bewim

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose of Bewim is 10 mg per day. Treatment should be initiated with a single dose of 60 mg.
If the patient weighs less than 60 kg or is over 75 years of age, the daily dose of Bewim is 5 mg (half a tablet). Your doctor will advise on the appropriate dose of acetylsalicylic acid (usually between 75 mg and 325 mg per day).
Bewim may be taken with or between meals. The dose should be taken at approximately the same time each day. Tablets may be divided into equal doses.
It is very important to inform your doctor, dentist, and pharmacist that you are taking Bewim.
Taking more Bewim than prescribed
Contact your doctor or go to hospital immediately due to increased risk of bleeding. Show the Bewim packaging to your doctor.
Missing a dose of Bewim
If a dose is missed, take it as soon as possible. If the patient forgets to take the dose for the entire day, take the next dose of Bewim the following day at the usual time. Do not take a double dose to make up for a missed dose.
When using packs of 28 tablets, the patient can check the calendar printed on the blister to determine the last day on which a Bewim tablet was taken.
Stopping Bewim treatment
Do not stop taking Bewim without consulting your doctor. Stopping treatment with Bewim too early may increase the risk of heart attack.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Immediately contact your doctor if any of the following occur:

sudden numbness or weakness of the arm, leg, or face, especially on one side of the body,
sudden confusion, difficulty speaking or understanding others,
sudden difficulty moving, loss of balance or coordination,
sudden dizziness or sudden severe headaches of unknown cause.
All of the above events may be symptoms of stroke. Stroke is an uncommon adverse reaction in patients treated with Bewim who have never previously had a stroke or transient ischaemic attack.

Also immediately contact your doctor if any of the following occur:

fever and bruising under the skin, which may appear as red pinpoint spots, with or without symptoms of extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "Important information before using Bewim"),
rash, itching, or swelling of the face, swelling of the lips or tongue, or difficulty breathing. These may be symptoms of a severe allergic reaction (see section 2 "Important information before using Bewim").

Promptly contact your doctor if any of the following occur:

blood in the urine,
rectal bleeding, blood in the stool, or black stools,
uncontrolled bleeding, e.g. from a cut wound.
All of the above symptoms may indicate bleeding, which is the most common adverse reaction during treatment with Bewim. Severe bleeding, although uncommon, may be life-threatening.

Common adverse reactions (may occur in 1 out of 10 people)

Gastrointestinal bleeding,
Bleeding at injection site,
Nosebleeds,
Rash,
Small red bruises on the skin (petechiae),
Blood in the urine,
Haematoma (subcutaneous bleeding at the injection site, or intramuscular bleeding causing swelling),
Low haemoglobin levels or low red blood cell count (anaemia),
Bruising.

Uncommon adverse reactions (may occur in 1 out of 100 people)

Allergic reaction (rash, itching, swelling of lips or tongue, or difficulty breathing),
Spontaneous bleeding into the eye, rectum, gums, or into the abdominal area around internal organs,
Bleeding after surgical procedures,
Coughing up blood-stained sputum,
Blood in the stool.

Rare adverse reactions (may occur in 1 out of 1,000 people)

Low platelet count,
Subcutaneous haematoma (subcutaneous bleeding causing swelling).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: 22 49 21 301, Fax: 22 49 21 309
E-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Bewim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bewim contains

The active substance is prasugrel.

Each coated tablet contains 10 mg prasugrel (in base form).

Other ingredients are: lactose, low-substituted hydroxypropylcellulose, sodium croscarmellose, glycerol dibehenate, sodium lauryl sulfate; Tablet coating - Opadry AMB II 88A220016 Yellow: polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylate (type 1), sodium lauryl sulfate, yellow iron oxide (E 172)

What Bewim looks like and contents of the pack
Yellow, round, biconvex coated tablets, marked „B23” on one side and a break line on the other.
The tablet diameter is approximately 10 mm.
The tablet can be divided into equal doses.
28, 30, 56, 60 and 90 coated tablets packed in blisters.
Blister OPA/Aluminium/PVC/Aluminium, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Manufacturer
Gedeon Richter România S.A.
99-105 Cuza Vodă Street 99-105
540306 Târgu-Mureş
Romania