Patient Leaflet Updated 16-Mar-2023 | Zentiva
Clopidogrel Zentiva 75mg Film-Coated Tablets
Package leaflet: Information for the user
Clopidogrel Zentiva 75 mg film-coated tablets
clopidogrel
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Clopidogrel Zentiva is and what it is used for
2. What you need to know before you take Clopidogrel Zentiva
3. How to take Clopidogrel Zentiva
4. Possible side effects
5 How to store Clopidogrel Zentiva
6. Contents of the pack and other information
1. What Clopidogrel Zentiva is and what it is used for
Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting.
By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Clopidogrel Zentiva is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
You have been prescribed Clopidogrel Zentiva to help prevent blood clots and reduce the risk of these severe events because:
2. What you need to know before you take Clopidogrel Zentiva
Do not take Clopidogrel Zentiva:
If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Zentiva.
Warnings and precautions
If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Zentiva:
While you are taking Clopidogrel Zentiva:
Children and adolescents
Do not give this medicine to children because it does not work.
Other medicines and Clopidogrel Zentiva
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 influence the use of Clopidogrel Zentiva or vice versa.
You should specifically tell your doctor if you take
If you have experienced severe chest pain (unstable angina or heart attack), transient ischemic attack or ischemic stroke mild in severity, you may be prescribed Clopidogrel Zentiva in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel Zentiva with food and drink
Clopidogrel Zentiva may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to take this product during pregnancy.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Zentiva. If you become pregnant while taking Clopidogrel Zentiva, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
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 Zentiva is unlikely to affect your ability to drive or to use machines.
Clopidogrel Zentiva contains lactose
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
Clopidogrel Zentiva contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.
3. How to take Clopidogrel Zentiva
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Zentiva per day to be taken orally with or without food, 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 600mg of Clopidogrel Zentiva (1or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) once at the start of treatment.
Then, the recommended dose is one 75-mg tablet of Clopidogrel Zentiva per day as described above.
If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity, your doctor may give you 300 mg of Clopidogrel Zentiva (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment.
Then, the recommended dose is one 75 mg tablet of Clopidogrel Zentiva per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Clopidogrel Zentiva alone or acetylsalicylic acid alone.
You should take Clopidogrel Zentiva for as long as your doctor continues to prescribe it.
If you take more Clopidogrel Zentiva than you should
Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
If you forget to take Clopidogrel Zentiva
If you forget to take a dose of Clopidogrel Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Clopidogrel Zentiva by referring to the calendar printed on the blister.
If you stop taking Clopidogrel Zentiva
Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.
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:
The most common side effect reported with Clopidogrel Zentiva is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
If you experience prolonged bleeding when taking Clopidogrel Zentiva
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern.
However, if you are concerned by your bleeding, you should contact your doctor straightaway (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, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effect (may affect up to 1 in 1000 people):
Vertigo, enlarged 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, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.
Side effects with frequency not known (frequency cannot be estimated from the available data):
Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.
In addition, your doctor may identify changes in your blood or urine test results.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Clopidogrel Zentiva
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 expiry date refers to the last day of that month.
Refer to the storage conditions on the carton.
If Clopidogrel Zentiva is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
If Clopidogrel Zentiva is supplied in all aluminium blisters, it does not require any special storage conditions.
Do not use this medicine if you notice any visible sign of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Clopidogrel Zentiva contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose’ and ‘Clopidogrel Zentiva contains hydrogenated castor oil’):
What Clopidogrel Zentiva looks like and contents of the pack
Clopidogrel Zentiva 75 mg film-coated tablets are round, biconvex, pink, engraved on one side with the number ‘75’ and on the other side with the number ‘1171’. Clopidogrel Zentiva is supplied in cardboard cartons containing:
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in April 2022.
First Floor, Andrews House, College Road, Guildford, Surrey, GU1 4QB, UK
+44 (0)844 8793 188
https://www.zentiva.co.uk/contact/mi-form
+44 (0)800 090 2408