75 mg film-coated tablets
clopidogrel
What Clopidogrel Krka is and what it is used for
Clopidogrel Krka contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clots during clotting of the blood (blood clotting). By preventing this clot formation, platelet inhibitors reduce the risk of blood clots forming (a process known as thrombosis or blood clot formation).
Clopidogrel Krka used by adults to prevent blood clots ( thrombosis s) in hardened blood vessels ( artery s), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).
You have been given Clopidogrel Krka to prevent the formation of blood clots and to reduce the risk of these serious events due to:
- You suffer from atherosclerosis (also known as atherosclerosis), and
- You have previously had a heart attack, stroke or suffer from something called peripheral arterial disease, or
- You have had severe angina ( unstable angina ) or heart attack (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed blood vessel to restore effective blood flow. You should also get acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever and also to prevent the formation of blood clots) from your doctor.
- You have an irregular heartbeat, something called atrial fibrillation, and you cannot take blood-thinning drugs orally ( vitamin K antagonists ) that prevent new blood clots from forming and prevent existing blood clots from growing. You should have learned that orally, blood thinners are more effective than acetylsalicylic acid or the combination of Clopidogrel Krka and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Krka and acetylsalicylic acid if you are unable to take blood-thinning medicines orally and you are not at risk of heavy bleeding.
What you need to know before you use Clopidogrel Krka
Do not use Clopidogrel Krka
- If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6)
- If you suffer from any disease that causes you to have active bleeding, such as stomach ulcers or bleeding in the brain
- If you suffer from severe liver disease
If you have any questions about these medicines, or if you have any further questions, ask your doctor before taking Clopidogrel Krka.
Warnings and cautions
If any of the following conditions apply to you, you should inform your doctor before taking Clopidogrel Krka:
- if you are at risk of bleeding such as:
- a disease that puts you at risk of internal bleeding (such as stomach ulcers )
- a blood disease that puts you at risk of internal bleeding (in the body’s tissues, organs, or joints)
- a recent serious injury
- a recent surgery (including dental surgery)
- a planned operation (including dental operations) within the next week
- if you have had a blockage in an artery in your brain (ischemic stroke ) that occurred within the last week
- if you suffer from kidney or liver disease
- if you have had an allergy or reaction to other medicines to treat your illness
While taking Clopidogrel Krka:
- You should inform your doctor if surgery (including dental surgery) is planned.
- You should also inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may occur as red pin-sized dots, with or without unexplained severe weakness, confusion, yellowing of the skin or the 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 linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries, such as if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
- Your doctor may order blood tests.
Children and young people
Do not give this medicine to children as it does not help.
Other medicines and Clopidogrel Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some other medicines may affect the use of Clopidogrel Krka or vice versa.
It is especially important that you tell your doctor if you are taking
- medicines that may increase your bleeding risk such as:
- blood-thinning drugs taken orally, drugs used to reduce the formation of blood clots
- non-steroidal anti-inflammatory drugs ( NSAIDs ), commonly used in the treatment of painful and/or inflammatory conditions in muscles and joints
- heparin or any other medicine that is injected to reduce the formation of blood clots
- ticlopidine, another antiplatelet agent
- selective serotonin reuptake inhibitors (including but not limited to fluoxetine or fluvoxamine), medicines commonly used to treat depression
- rifampicin (used to treat severe infections )
- omeprazole or esomeprazole, medicines used to treat stomach problems
- fluconazole or voriconazole, medicines used to treat fungal infections
- efavirenz or other antiretroviral drugs (used to treat HIV – infection s)
- carbamazepine, a drug used to treat various 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: when you are being treated with clopidogrel, you should inform your doctor before receiving treatment with opioids (used to treat severe pain).
If you have had severe chest pain ( unstable angina or heart attack), you can be prescribed Clopidogrel Krka in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and lower fever. Temporary use of acetylsalicylic acid (not more than 1000 mg for 24 hours) is not generally considered a problem, but long-term use under other conditions should be discussed with your doctor.
Clopidogrel Krka with food, drink, and alcohol
Clopidogrel Krka can be taken with or without food.
Pregnancy, breastfeeding, and fertility
This medicine should preferably not be taken during pregnancy.
If you are pregnant or suspect you may be pregnant, tell your doctor or pharmacist before taking Clopidogrel Krka. If you become pregnant while taking Clopidogrel Krka, you should contact your doctor immediately as it is not recommended to take clopidogrel during pregnancy.
You should not breast-feed while taking this medicine.
If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Clopidogrel Krka is unlikely to affect your ability to drive or use machines.
How to use Clopidogrel Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose, including for patients with a condition called atrial fibrillation (irregular heartbeat), is one 75 mg tablet of Clopidogrel Krka per day taken orally, with or without food, and at the same time each day.
If you have had severe chest pain ( unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Krka (4 tablets of 75 mg) to start treatment. After this, the recommended dose is one of 75 mg Clopidogrel Krka per day as described above.
You should take Clopidogrel Krka for as long as your doctor prescribes it.
If you use more Clopidogrel Krka then you should
Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.
If you forget to use Clopidogrel Krka
If you forget to take a dose of Clopidogrel Krka and discover it within 12 hours, take the tablet as soon as you notice and take the next tablet at the usual time. If it takes more than 12 hours before you discover it, simply take the next daily dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Clopidogrel Krka
Do not stop treatment unless your doctor tells you to. Contact a doctor or pharmacist before stopping treatment.
If you have any further questions on the use of this product, 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 have:
- fever, signs of infection, or severe weakness. This may be due to a rare decrease in certain blood cells.
- signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without concomitant small punctate hemorrhages under the skin (visible as red dots), and/or confusion (see section 2 “Warnings and precautions”).
- swelling of the mouth or skin problems such as rash and itching, blisters on the skin. This may be a sign of an allergic reaction.
The most common side effect is bleeding.
Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In a few cases, bleeding in the eye, internal bleeding in the head, lungs or joints have also been reported.
If you experience prolonged bleeding while taking Clopidogrel Krka
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries, such as if you cut yourself when shaving. However, if you are concerned about your 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, increased gas formation in the stomach or intestines, rash, itching, dizziness, feeling of tingling, and numbness
Rare side effects (may affect up to 1 in 1,000 patients):
Dizziness, enlarged breasts in men.
Very rare side effects (may affect up to 1 in 10,000 patients):
Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes with cough, generalized (widespread) allergic reactions (eg a feeling of warmth with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy, pain in the mouth ( stomatitis ), decrease in blood pressure, confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste.
Adverse reactions that have been reported (affects an unknown number of users):
Hypersensitivity reaction you with chest pain or abdominal pain, signs of persistent low blood sugar.
In addition, your doctor may detect changes in your blood or urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Clopidogrel Krka
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 carton and on the blister after EXP. The expiration date is the last day of the specified month.
Store in the original package.
Sensitive to light. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
- Other ingredients are microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), m macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E 172), yellow iron oxide (E 172), talc, and m akrogol 3000 the film coating.
What the medicine looks like and the contents of the pack
The film-coated tablets are pink, round, and slightly convex.
Cartons of 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 film-coated tablets in blisters are available.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Contact the representative of the marketing authorization holder to find out more about this medicine: