CLOPIDOGREL 75 mg Tabletki Powlekane

Treść ulotki

1. Clopidogrel Viatris 75 mg film-coated tablets
   1. What is Clopidogrel Viatris and what it is used for
   2. What you need to know before taking Clopidogrel Viatris
   3. How to take Clopidogrel Viatris
   4. Possible side effects
   5. How to store Clopidogrel Viatris
   6. Package contents and other information

Clopidogrel Viatris 75 mg film-coated tablets

clopidogrel

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Clopidogrel Viatris and what it is used for

Clopidogrel Viatris contains clopidogrel and belongs to a group of medicines called
antiplatelet agents. Platelets are microscopic elements of the blood that
aggregate together during blood coagulation. By preventing this aggregation, antiplatelet agents
decrease the possibility of blood clot formation (a phenomenon
called thrombosis).
Clopidogrel Viatris is taken by adults to prevent the formation of blood clots (thrombi)
in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause events of
atherothrombotic origin (such as stroke, heart attack, or death).
Clopidogrel Viatris has been prescribed to you as an aid in preventing blood clot formation and
to reduce the risk of these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis), and
• you have previously had a heart attack, stroke, or a condition known as peripheral obliterating arterial disease, or
• you have previously suffered from a severe type of chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore blood flow. Your doctor may have also prescribed acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• you have had symptoms of stroke that disappear within a short period of time (also known as transient ischemic attack) or mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid starting from the first 24 hours,
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and the development of existing ones. You will have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Viatris and acetylsalicylic acid in the treatment of this condition. If you cannot take “oral anticoagulants” and do not have a higher risk of bleeding, your doctor may have prescribed Clopidogrel Viatris plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Viatris

Do not take Clopidogrel Viatris:

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have active bleeding, such as a stomach ulcer or bleeding in the brain;
• if you suffer from a severe liver disease.

If any of these apply to you, or if you are unsure, consult your doctor before
taking Clopidogrel Viatris.

Warnings and precautions
If any of the following situations apply to you, inform your doctor before taking Clopidogrel
Viatris:

• if you are at risk of bleeding such as:
• a medical condition that puts you at risk of internal bleeding (such as a gastric ulcer)
• a blood disorder that makes you prone to internal bleeding (bleeding inside any tissue, organ or joint of the body)
• a recent serious injury
• recent surgery (including dental surgery)
• planned surgery (including dental surgery) in the next seven days
• if you have had a blood clot in an artery in the brain (ischaemic stroke) that occurred in the last 7 days
• if you have kidney or liver disease
• if you have had an allergy or reaction to any medicine used to treat your condition
• if you have had a brain haemorrhage in the past that was not caused by an injury.

While you are taking Clopidogrel Viatris:

• You must inform your doctor if you need to have surgery (including dental surgery)
• You must immediately inform your doctor if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruises under the skin that appear as red dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”)
• If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works as it prevents blood clots from forming. For minor cuts and wounds, such as cuts from shaving, this usually does not cause problems. However, if you are concerned about the bleeding, contact your doctor immediately (see section 4 “Possible side effects”)
• Your doctor may prescribe blood tests

Children and adolescents
Do not give this medicine to children because it is not effective.

Other medicines and Clopidogrel Viatris
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Some medicines can affect the use of Clopidogrel Viatris or vice versa.
You must tell your doctor accurately if you are taking:

• medicines that can increase your risk of bleeding such as: oral anticoagulants, medicines used to reduce blood clotting or a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints, or heparin or any other injectable drug used to reduce blood clotting, or ticlopidine or other antiplatelet agents, or a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression, or rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other anti-retroviral medicines (used for the treatment of HIV infection), carbamazepine, a medicine used to treat some forms of epilepsy,
• moclobemide, medicine used to treat depression.
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer.
• opioids: while you are being treated with clopidogrel, you must inform your doctor before you are prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischaemic
attack or a mild ischaemic stroke, you may have been prescribed Clopidogrel Viatris
in combination with acetylsalicylic acid, a substance present in many medicines used to relieve
pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1,000 mg in 24
hours) should generally not cause problems, but prolonged use in other circumstances should be
discussed with your doctor.

Clopidogrel Viatris with food and drink
Clopidogrel Viatris can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be, tell your doctor or pharmacist before taking Clopidogrel Viatris.
If you become pregnant while taking Clopidogrel Viatris, consult your doctor immediately, as it is recommended not to take Clopidogrel Viatris during pregnancy.
Do not breastfeed while taking this medicine.
If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Clopidogrel Viatris will affect your ability to drive and use machines

Clopidogrel Viatris contains lactose:
If your doctor has told you that you have an intolerance to some sugars (e.g. lactose), consult your
doctor before taking this medicine.

Clopidogrel Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially
“sodium-free”.

3. How to take Clopidogrel Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose, including patients with a condition called “atrial fibrillation”
(irregular heartbeat), is one 75 mg tablet of Clopidogrel Viatris per day, to be
taken orally with or without food, at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300
mg or 600 mg of Clopidogrel Viatris (4 or 8 tablets of 75 mg) once at the beginning of treatment.
Subsequently, the recommended dose is one 75 mg tablet of Clopidogrel Viatris per day,
as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as
transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg
of Clopidogrel Viatris (4 tablets of 75 mg) once at the beginning of treatment. Following this, the recommended dose
is one 75 mg tablet of Clopidogrel Viatris per day, as described above, in
combination with acetylsalicylic acid for 3 weeks. Afterwards, your doctor will prescribe Clopidogrel
Viatris alone or acetylsalicylic acid alone.
Clopidogrel Viatris must be taken for as long as your doctor considers it necessary.

If you take more Clopidogrel Viatris than you should
Contact your doctor or the nearest emergency room due to the increased risk of bleeding.

If you forget to take Clopidogrel Viatris
If you forget to take a dose of Clopidogrel Viatris, but remember within 12 hours of your usual time,
take one tablet immediately and then take the next one at your usual time.
If more than 12 hours have passed, simply take your normal single dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Viatris:
Do not stop treatment unless your doctor has told you to. Before stopping it
contact your doctor or pharmacist.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of these occur, contact your doctor immediately:

• fever, signs of infection or severe weakness. These effects may be due to a rare decrease in some blood cells
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).
• swelling in the mouth or skin disorders such as rash, itching, blisters. These may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Viatris is bleeding.The
bleeding may manifest as bleeding in the stomach or intestine, the formation of
bruises, hematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In
rare cases, bleeding in the eye, intracranial, in the lungs or in the
joints has also been reported.

If you experience prolonged bleeding while taking Clopidogrel Viatris
If you cut or injure yourself, it may take longer than usual for
the bleeding to stop. This is due to the way the medicine works as it prevents the
formation of blood clots. For minor cuts and wounds, such as cutting yourself or shaving, this
usually does not cause problems. However, if you are concerned about the bleeding, contact your doctor
immediately (see section 2 “Warnings and precautions”).

Other side effects include:
Common side effects (may affect up to 1 in 10 people):
Diarrhea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or
intestine, rash, itching, dizziness, tingling and numbness.
Rare side effects (may affect up to 1 in 1,000 people):
Dizziness, breast enlargement in men.
Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain, fever, shortness of breath sometimes
associated with cough; widespread allergic reactions (for example, a feeling of warmth with
sudden general malaise up to fainting), swelling in the mouth, blisters, skin allergy,
mouth pain (stomatitis), decreased blood pressure, confusion,
hallucinations, joint pain; muscle pain; changes or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated based on available data):
hypersensitivity reactions with chest or abdominal pain, persistent symptoms of
hypoglycemia.
In addition, your doctor may have identified changes in blood or urine tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. This includes any possible side effects not listed in this
national reporting website at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Clopidogrel Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and on the
blister, after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clopidogrel Viatris contains
The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besilate).
The other ingredients are (see section 2 “Clopidogrel Viatris contains lactose”):

• Tablet core: hydroxypropylcellulose (E463), mannitol (E421), crospovidone (Type A), citric acid monohydrate, microcrystalline cellulose, macrogol 6000, stearic acid, sodium stearyl fumarate
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), titanium dioxide (E 171).

Description of the appearance of Clopidogrel Viatris and package contents
Clopidogrel Viatris film-coated tablets are pink, round and biconvex.
They are supplied in:

• blisters in PVC/PE/PVDC/aluminum in packs containing 7, 14, 28, 30, 30 x 1 (unit dose), 50, 50 x 1 (unit dose), 56, 84, 90 or 100 film-coated tablets

Not all pack sizes may be marketed

Marketing authorization holder and manufacturers:
Marketing authorization holder:
Viatris Limited
Damastown Industrial Park,
Mulhuddart,
Dublin 15,
DUBLIN
Ireland
Manufacturers:
Pharmathen S.A.,
6 Dervenakion
15351 Pallini Attiki
Greece
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece
For further information on this medicinal product, contact the local representative of the marketing authorization holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Česká republika
Viatris CZ s.r.o.
Tel: + 420 222 004 400

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: +49 800 0700 800

Nederland
Mylan BV
Tel: +31 (0)20 426 3300

Eesti*
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 210 0 100 002

Österreich
Viatris Austria GmbH
Tel: +43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. z.o.o.
Tel.: + 48 22 546 64 00

France
Viatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Viatris Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 23 63 180

Ísland
Icepharma hf.
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0)2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: +358 20 720 9555

Κύπρος
GPA Pharmaceuticals Ltd
Τηλ: +357 22863100

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
Detailed information is available on the website of the European Medicines Agency:
http://www.ema.europa.eu/