CLOPIDOGREL 75 mg Tabletki Powlekane

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1. Clopidogrel Krka d.d. 75 mg film-coated tablets
   1. What is Clopidogrel Krka d.d. and what it is used for
   2. What you need to know before taking Clopidogrel Krka d.d.
   3. How to take Clopidogrel Krka d.d.
   4. Possible side effects
   5. How to store Clopidogrel Krka d.d.
   6. CONTENT OF THE PACK AND OTHER INFORMATION

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

1. What is Clopidogrel Krka d.d. and what it is used for

Clopidogrel Krka d.d. 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 Krka d.d. 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).
Clopidogrel Krka d.d. has been prescribed to help prevent the formation of blood clots 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 clotting).
• 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 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 Krka d.d. 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 Krka d.d. plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Krka d.d.

Do not take Clopidogrel Krka d.d.

• If you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6).
• If you have ongoing bleeding, such as a gastric ulcer or a haemorrhage in an area of the brain.
• If you suffer from a severe liver disease.

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

Warnings and precautions
If any of the situations mentioned below apply to you, inform your doctor before taking
Clopidogrel Krka d.d.:

• if you have a 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
• a recent surgical intervention (including dental surgery)
• a surgical intervention (including dental surgery) planned 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 seven days
• if you have kidney or liver diseases
• if you have had an allergy or a 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 Krka d.d.:

• You must inform your doctor if you need to undergo a surgical intervention (including dental surgery)
• You must also 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 administer this medicine to children because it is not effective.

Other medicines and Clopidogrel Krka d.d.
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 Krka d.d. or vice versa.
You must inform 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 medicine, usually used to treat pain and/or inflammation of muscles or joints,
o heparin or any other injectable medicine 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 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 infections),
• carbamazepine, a medicine used to treat certain 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 undergoing therapy with clopidogrel, you must inform your doctor before any opioid (used to treat severe pain) is prescribed to you,
• 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 Krka d.d. in association 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 Krka d.d. with food and drinkClopidogrel Krka d.d. can be taken with or without food. Pregnancy and breastfeedingIt is preferable not to take this medicine during pregnancy. If you are pregnant or believe you may be, inform your doctor or pharmacist before taking Clopidogrel Krka d.d. If you become pregnant while taking Clopidogrel Krka d.d., consult your doctor immediately, as it is recommended not to take clopidogrel during pregnancy. You must not breastfeed while taking this medicine. If you are breastfeeding or intend to breastfeed, consult your doctor before taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machinesIt is unlikely that Clopidogrel Krka d.d. will affect your ability to drive vehicles and use machines.

3. How to take Clopidogrel Krka d.d.

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 Krka d.d. daily, 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 Krka d.d. (4 or 8 tablets of 75 mg) once at the beginning of
treatment. Subsequently, the recommended dose is one 75 mg tablet of Clopidogrel Krka
d.d. daily, 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 Krka d.d. (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Krka d.d. daily, as
described above, in combination with acetylsalicylic acid for 3 weeks. Following this, your doctor
will prescribe Clopidogrel Krka d.d. alone or acetylsalicylic acid alone.
Clopidogrel Krka d.d. must be taken for as long as your doctor considers it necessary.

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

If you stop taking Clopidogrel Krka d.d.
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 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 Krka d.d. is bleeding.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 a few cases, bleeding in the eye, intracranial, in the lungs and joints has also been reported. If you experience prolonged bleeding while taking Clopidogrel Krka d.d.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 create problems. However, if you are concerned about the bleeding, contact your doctor immediately (see section 2 "Warnings and precautions"). Other side effects includeCommon 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, 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 1000 people):
dizziness, increased breast volume 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; generalized allergic reactions (for example, a widespread feeling of heat 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
hypoglycemia.
In addition, your doctor may have identified changes in blood and urine tests.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Clopidogrel Krka d.d.

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 package and on the blister after
EXP. The expiry date refers to the last day of the month.
Keep the medicine in the original package to protect it from moisture and light.
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. CONTENT OF THE PACK AND OTHER INFORMATION

What Clopidogrel Krka d.d. contains

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
• The excipients in the tablet core are: microcrystalline cellulose, anhydrous colloidal silica, crospovidone (type A), macrogol 6000, hydrogenated castor oil and in the tablet coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E 172), talc and macrogol 3000. Description of the appearance of Clopidogrel Krka d.d. and content of the packThe film-coated tablets are pink, round and slightly convex. They are supplied in packs containing blisters with 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: +370 5 236 27 40

България
КРКА България ЕООД
Teл.: +359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: +420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: +36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: +46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: +356 21 445 885 DeutschlandTAD Pharma GmbH Tel: +49 (0) 4721 606-0 NederlandKRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) EestiKRKA, d.d., Novo mesto Eesti filiaal Tel: +372 (0)6 671 658 NorgeKRKA Sverige AB Tlf: +46 (0)8 643 67 66 (SE) ΕλλάδαKRKA ΕΛΛΑΣ ΕΠΕ Τηλ: + 30 2100101613 ÖsterreichKRKA Pharma GmbH, Wien Tel: +43 (0)1 66 24 300 EspañaKRKA Farmacéutica S.L. Tel: +34 911 61 03 80 PolskaKRKA-POLSKA Sp. z o.o. Tel.: +48 (0)22 573 7500 FranceLaboratoires BIOGARAN Tél: + 33 (0) 800 970 109 PortugalKRKA Farmacêutica, Sociedade Unipessoal Lda. Tel: +351 (0)21 46 43 650 HrvatskaKRKA – FARMA d.o.o. Tel: + 385 1 6312 100 RomâniaKRKA Romania S.R.L., Bucharest Tel: +4 021 310 66 05 IrelandKRKA Pharma Dublin, Ltd. Tel: +353 1 413 3710 SlovenijaKRKA, d.d., Novo mesto Tel: +386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: +354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: +421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: +39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: +357 24 651 882

Sverige
KRKA Sverige AB
Tel: +46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: +371 6 733 86 10

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
353 1 413 3710
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/