75 mg film-coated tablets
clopidogrel
What Clopidogrel Teva is and what it is used for
Clopidogrel Teva 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 Teva used by adults to prevent blood clots ( thrombosis s) in hardened blood vessels ( artery s), a process is known as atherothrombosis, which can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).
You have been given Clopidogrel Teva 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 Teva and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Teva 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 take Clopidogrel Teva
Do not take Clopidogrel Teva
- If you are allergic (hypersensitive) 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 of these symptoms or if you have any further questions, ask your doctor before starting Clopidogrel Teva.
Warnings and cautions
Talk to your doctor or pharmacist before taking Clopidogrel Teva:
- 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 Teva:
- 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 does not help.
Other medicines and Clopidogrel Teva
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 Teva 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 by mouth, 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 fluoxetine or 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 – infection s)
- antiretroviral drugs (drugs for the treatment of HIV infections)
- 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 Teva 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 1,000 mg for 24 hours) is not generally considered a problem, but long-term use under other conditions should be discussed with your doctor.
Clopidogrel Teva with food and drink
Clopidogrel Teva can be taken with or without food.
Pregnancy and breastfeeding
This medicine should preferably not be taken during pregnancy.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Clopidogrel Teva, 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 Teva is unlikely to affect your ability to drive or use machines.
Clopidogrel Teva contains lactose and sodium
Clopidogrel Teva 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 Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Clopidogrel Teva
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 a 75 mg tablet of Clopidogrel Teva 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 prescribe Clopidogrel Teva 300 mg (one 300 mg tablet or 4 75 mg tablets) to start treatment. After this, the recommended dose is one of 75 mg Clopidogrel Teva per day as described above.
You should take Clopidogrel Teva for as long as your doctor prescribes it.
If you take more Clopidogrel Teva then you should
Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.
If you forget to take Clopidogrel Teva
If you forget to take a dose of Clopidogrel Teva 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.
For the pack size of 28×1 tablets, you can check which day you last took a Clopidogrel Teva tablet by looking at the calendar printed on the blister pack.
If you stop taking Clopidogrel Teva
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 bleeding under the skin (visible as red dots), and/or confusion (see section 2 “Warnings and precautions”).
- Swelling in 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 Teva is bleeding.
Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, or 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 Teva
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 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.
Adverse reactions that have been reported (occurring in an unknown number of users): Hypersensitivity reactions with chest pain or abdominal pain and 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 Teva
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 carton, jar, or blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 sulfate).
- For the other ingredients see section 2 (Clopidogrel Teva contains lactose and sodium):
- Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose (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), indigo carmine aluminum lake (E132).
What the medicine looks like and the contents of the pack
- The film-coated tablets are light pink to pink, film-coated, capsule-shaped tablets, debossed with “93” on one side and “7314” on the other side.
- Clopidogrel Teva is supplied in:
- Removable perforated blisters of aluminum / aluminum containing 14×1, 28×1, 30×1, 50×1, 84×1, 90×1 and 100×1 tablets.
- Perforated aluminum / aluminum blisters containing 14×1, 28×1, 30×1, 50×1, 84×1, 90×1 or 100×1 tablets.
- HDPE jars with polypropylene lids or child-resistant lids made of polypropylene and desiccant (silica gel ) containing 30 or 100 tablets.
- Calendar packaging with perforated aluminum-aluminum blisters with 28×1 tablets.
Not all pack sizes may be marketed.
Note that instructions on how to remove the tablet from the blister strip are given on the outer carton of peelable blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Teva BV
Swensweg 5
2031GA Haarlem
Netherlands
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi from 13
4042 Debrecen
Hungary
TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne
East Sussex,
BN22 9AG
United Kingdom
GALIEN LPS
98 rue Bellocier
89100 Sens
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 38207373 | LithuaniaUAB Teva BalticsTel: +370 52660203 |
| BulgariaOctavis FADTel: +359 24899585 | Luxembourg / Luxemburgratiopharm GmbHGermany / GermanyTel: +49 73140202 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 12886400 |
| DenmarkTeva Denmark A / STel: +45 44985511 | MaltaTeva Pharmaceuticals Ireland-IrelandTel: +353 19630330 |
| GermanyTEVA GmbHTel: +49 73140208 | The NetherlandsTeva Nederland BVTel: +31 8000228400 |
| EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66775590 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 2118805000 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070 |
| SpainTEVA PHARMA, SLUTel: +34 913873280 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 223459300 |
| FranceTeva HealthTel: +33 155917800 | PortugalTeva Pharma – Pharmaceutical Products LdaTel: +351 214767550 |
| CroatiaPliva Hrvatska dooTel: +385 13720000 | RomaniaTeva Pharmaceuticals SRLTel: +40 212306524 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 19630330 | SloveniaPliva Ljubljana dooTel: +386 15890390 |
| IcelandTeva Finland OyFinlandPhone: +358 201805900 | Slovak RepublicTeva Pharmaceuticals Slovakia sroTel: +421 257267911 |
| ItalyTeva Italia SrlTel: +39 028917981 | Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900 |
| ΚύπροςTeva Αλλάς Α.Ε.Greece:Ηλ: +30 2118805000 | |
| LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 | United KingdomTeva UK LimitedTel: +44 1977628500 |