75 mg film-coated tablets
clopidogrel
What Clopidogrel STADA is and what it is used for
Clopidogrel Stada contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clots ( clots ) during coagulation of the blood (blood clotting). By preventing this clot formation , platelet inhibitors reduce the risk of blood clots forming (a process called thrombosisor blood clot formation).
What it is used for
Clopidogrel STADA 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 Stada 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 are suffering from something called peripheral arterial disease, or
- you have had a 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 Stada and acetylsalicylic acidfor this disease. Your doctor should have given you Clopidogrel Stada and acetylsalicylic acid if you are unable to take blood-thinning medicines orally and you are not at risk of heavy bleeding.
Clopidogrel contained in Clopidogrel Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Clopidogrel STADA
Do not use Clopidogrel STADA
- 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 an active bleeding, such as. gastric ulcer or bleeding in the brain
- if you suffer from severe liver disease.
If you have any of these symptoms or if you have any further questions, ask your doctor before taking Clopidogrel Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Clopidogrel Stada
- if you are at risk of bleeding such as:
- a disease that puts you at risk for 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 Stada
- 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 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 will not help them.
Other medicines and Clopidogrel STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some other medicines may affect the use of Clopidogrel Stada and 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 to treat 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 fluoxetineor fluvoxamine), medicines commonly used to treat depression
- 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 (human immunodeficiency virus), – infections 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.
- antiretroviral drugs (drugs for the treatment of HIV infections)
- opioids: when you are being treated with clopidogrel, tell your doctor before you are treated with opioids (used to treat severe pain).
If you have had severe chest pain ( unstable angina or heart attack), you can be prescribed Clopidogrel Stada 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 STADA with food, drink and alcohol
Clopidogrel Stada 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 think you may be pregnant, tell your doctor or pharmacist before taking Clopidogrel Stada. If you become pregnant while taking Clopidogrel Stada, 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 Stada is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Clopidogrel STADA contains lactose and hydrogenated castor oil
Clopidogrel Stada contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Clopidogrel Stada contains hydrogenated castor oil
This can cause stomach upset or diarrhea.
How to use Clopidogrel STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
The recommended dose , including for patients with a condition called atrial fibrillation (irregular heartbeat), is one 75 mg tablet of Clopidogrel Stada per day.
If you have had severe chest pain ( unstable angina or heart attack), your doctor may give you Clopidogrel Stada 300 mg (4 tablets of 75 mg) to start treatment. After this, the recommended dose is one of 75 mg Clopidogrel Stada per day as described above.
Method of administration
To be swallowed with or without food and at the same time each day.
Treatment time
You should take Clopidogrel Stada for as long as your doctor prescribes it.
If you forget to use Clopidogrel STADA
If you forget to take a dose of Clopidogrel Stada 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 doseat the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Clopidogrel STADA
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 rare decrease of some blood s
- signs of liver problems such as yellowing of the skin and / or eyes (jaundice), with or without concomitant small spotty bleeding 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 reported with clopidogrel 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 Stada
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 (may affect up to 1 in 10 people):
- diarrhea
- abdominal pain
- indigestion or heartburn.
Uncommon (may affect up to 1 in 100 people):
- headache
- gastric ulcer
- vomiting, nausea
- constipation
- increased gas formation in the stomach or intestines
- rash, itching
- dizziness
- feeling of tingling and numbness.
Rare (may affect up to 1 in 1,000 people):
- dizziness
- enlarged breasts in men.
Very rare (may affect up to 1 in 10,000 people):
- jaundice
- severe abdominal pain with or without back pain
- fever, difficulty breathing sometimes while coughing
- generalized (widespread) allergic reactions (eg a feeling of heat with sudden discomfort until fainting)
- swelling in the mouth
- blisters on the skin
- skin allergy
- sore mouth ( stomatitis )
- reduction in blood pressure
- confusion, hallucinations
- joint pain, muscle aches
- taste changes or 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 STADA
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 or blister after EXP. The expiration date is the last day of the specified month.
For HDPE cans: opened packaging must be used within 6 months.
Do not store above 30 ° C.
Do not use this medicine if you notice any visible signs of deterioration.
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 hydrogen sulphate).
The other ingredients in the tablet core are mannitol (E421), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), macrogol 6000 (E1521), crospovidone (E1202), hydrogenated castor oil.
The other ingredients in the film coating are lactose monohydrate , hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172).
What the medicine looks like and contents of the pack
Clopidogrel Stada are pink, round, biconvex film-coated tablets with bevelled edges and 9 mm in diameter.
Clopidogrel Stada tablets are sold in cartons containing: 10, 14, 28, 30, 50, 56, 84, 90, 98 or 100 film-coated tablets or 10×1 14×1, 28×1, 30×1, 50×1, 56×1, 84×1, 90×1, 98×1 or 100×1 film-coated tablets (single-dose pack) in PVC / Aclar-Al or PVC / Aclar / PVC-Al or oPA / Al / PVCA1 blister packs.
Clopidogrel Stada tablets are sold in HDPE cans containing 28, 30, 50, 90, 100, 300, 500 or 1000 film-coated tablets, closed with a white opaque polypropylene cap with desiccant or in HDPE cans with silica gel bags, closed with a white opaque polypropylene cap .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADA Arzneimittel GmbH
Muthgasse 36, 1190 Vienna
Austria
Centrafarm Services BV
Nieuwe Donk 9, 4879 AC Etten-Leur
Netherlands
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary
Ireland
STADA Nordic ApS
Marielundvej 46A, 2730 Herlev
Denmark
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark