CLOPIDOGREL 75 mg Tabletki Powlekane

Treść ulotki

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

Clopidogrel ratiopharm 75 mg film-coated tablets

clopidogrel

Read this leaflet carefully before you start taking this medicine as 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, as 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 Clopidogrel ratiopharm is and what it is used for
• 2. What you need to know before you take Clopidogrel ratiopharm
• 3. How to take Clopidogrel ratiopharm
• 4. Possible side effects
• 5. How to store Clopidogrel ratiopharm
• 6. Contents of the pack and other information

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

Clopidogrel ratiopharm contains clopidogrel and belongs to a group of medicines called
antiplatelet agents. Platelets are microscopic elements of the blood that come
together during blood coagulation. By preventing this aggregation, antiplatelet agents
decrease the possibility of blood clot formation (a phenomenon
called thrombosis).
Clopidogrel ratiopharm 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
atherothrombotic events (such as stroke, heart attack, or death).
You have been prescribed Clopidogrel ratiopharm to help prevent 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 severe 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 coagulation).
• you have had symptoms of stroke that disappear within a short period of time (also known as a transient ischemic attack) or mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid starting within 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 have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel ratiopharm 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 ratiopharm plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel ratiopharm

Do not take Clopidogrel ratiopharm

• If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6)
• If you suffer from another disorder that is causing bleeding, such as a stomach ulcer or a haemorrhage in an area of the brain
• If you suffer from a severe liver disease.

If you believe that any of these cases apply to you, or if you have any doubts, consult your doctor before
using Clopidogrel ratiopharm.

Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel ratiopharm:

• if you have a risk of bleeding such as
• a medical condition that puts you at risk of internal bleeding (such as a stomach 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),
• surgery (including dental surgery) planned in the next 7 days.
• if you have had a blood clot in an artery in the brain (ischaemic stroke) that occurred in the last seven days.
• if you have liver or kidney disease.
• if you have had an allergy or reaction to any medicine used to treat your condition.
• if you have had a brain haemorrhage of non-traumatic origin in the past.

While you are taking Clopidogrel ratiopharm:

• You must inform your doctor if you need to undergo 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 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 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 ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can affect the use of Clopidogrel ratiopharm or vice versa.
You must tell your doctor accurately if you are taking:

• medicines that can increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting,

o a non-steroidal anti-inflammatory drug, usually used to treat pain and/or inflammation of muscles or joints,
o heparin or any other injectable drug used to reduce blood clotting,
o ticlopidine or other antiplatelet agents,
o a selective serotonin reuptake inhibitor (including but not limited to
fluoxetine or fluvoxamine), medicines usually used to treat depression,
o rifampicin (used to treat serious infections),

• omeprazole or esomeprazole, medicines used for stomach problems,
• fluconazole or voriconazole, medicines for treating 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, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: while you are in therapy 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
ratiopharm in association with acetylsalicylic acid, a substance used to relieve pain and to
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 ratiopharm with food and drink
Clopidogrel ratiopharm can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine. If you become pregnant while taking
Clopidogrel ratiopharm, consult your doctor immediately, as it is recommended not to take
clopidogrel during pregnancy.
Do not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, ask 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 ratiopharm will affect your ability to drive vehicles or use machines.

Clopidogrel ratiopharm contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

Clopidogrel ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
"sodium-free".

3. How to take Clopidogrel ratiopharm

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, even for patients diagnosed with “atrial fibrillation” (an irregular heartbeat), is
one 75 mg tablet of Clopidogrel ratiopharm per day, to be taken orally during or away from meals, and 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 ratiopharm (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) once at the
beginning of treatment. Subsequently, the recommended dose is one 75 mg tablet of Clopidogrel
ratiopharm per day as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as a
transient ischemic attack) or an ischemic stroke of mild severity, your doctor may prescribe 300 mg of
Clopidogrel ratiopharm (4 tablets of 75 mg) once at the beginning of treatment. Following this, the
recommended dose is one 75 mg tablet of Clopidogrel ratiopharm per day, as described above, in
combination with acetylsalicylic acid for 3 weeks. Afterwards, your doctor will prescribe Clopidogrel
ratiopharm alone or acetylsalicylic acid alone.
Clopidogrel ratiopharm must be taken for as long as it has been prescribed by your doctor.
Please note that instructions on how to remove the tablet from the blister are reported on the external
cardboard of the blister packs with a peelable film.

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

If you forget to take Clopidogrel ratiopharm
If you forget to take a dose of Clopidogrel ratiopharm and realize it within 12 hours of the usual time,
take the tablet immediately and then take the next tablet at the usual time.
If, however, more than 12 hours have passed, simply take the normal dose at the usual time. Do not
take a double dose to make up for a forgotten tablet.
For the 28x1 tablet pack, you can check the day you took the last tablet of Clopidogrel ratiopharm by
referring to the calendar printed on the blister.

If you stop taking Clopidogrel ratiopharm
Do not stop treatment unless your doctor has told you to.Before stopping it, contact your doctor or
pharmacist.
If you have any further questions on the use of 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.

Contact your doctor immediately if you experience:

• Fever, signs of infection or a severe feeling of weakness. These effects may be due to a decrease in certain 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 ratiopharm is bleeding. The
bleeding may appear as bleeding in the stomach or intestine, bruising,
hematoma (abnormal bleeding or bruising under the skin), nosebleeds, or 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 ratiopharm
If you cut yourself or get injured, 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):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine,
rash, itching, dizziness, sensations of tingling and numbness.
Rare side effects (may affect up to 1 in 1,000 people):
Dizziness, enlargement of the breasts in males.
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 on the skin; 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
hypoglycaemia.
In addition, your doctor may have identified changes in blood and urine tests.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Clopidogrel ratiopharm

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, the bottle or
the blister after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 ratiopharm contains

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are (see section 2 “Clopidogrel ratiopharm contains lactose” and “Clopidogrel ratiopharm contains sodium”):
• Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose (E463), crospovidone (Type A), hydrogenated vegetable oil and sodium lauryl sulfate.
• Tablet coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), macrogol 4000, red iron oxide (E172), yellow iron oxide (E172), aluminium lake containing indigo carmine (E132).

Description of the appearance of Clopidogrel ratiopharm and package contents

• The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets. The number “93” is embossed on one side of the tablet. The number “7314” is embossed on the other side of the tablet.
• Clopidogrel ratiopharm is available in perforated aluminium/aluminium blisters, single-dose or HDPE bottles with a polypropylene closure or a child-resistant polypropylene closure and silica gel desiccant. Pack sizes:
• Perforated aluminium/aluminium blisters with a tear-off strip, single-dose or without a tear-off strip, containing 14x1, 28x1, 30x1, 50x1, 84x1, 90x1 or 100x1 tablets
• Calendar pack with blisters without a tear-off strip containing 28x1 tablets
• Bottles containing 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Teva B.V.,
Swensweg 5,
2031GA Haarlem,
Netherlands

Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Luxembourg/Luxemburg
ratiopharm GmbH
Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos,
Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666