Clopidogrel Ranbaxi

1. What is Clopidogrel Ranbaxy and what is it used for

Clopidogrel Ranbaxy belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells which clump together during blood clotting. By preventing this clumping, antiplatelet agents reduce the chance of blood clots forming (a process known as thrombosis).

Clopidogrel Ranbaxy is given to adults to prevent blood clots forming in hardened blood vessels. Blood clots in the blood vessels can lead to a stroke or a heart attack.

You have been given Clopidogrel Ranbaxy to prevent the formation of blood clots and reduce the risk of these serious events because you have had a condition causing your blood vessels to narrow (such as a heart attack, stroke, or peripheral arterial disease) or you have had a severe chest pain known as unstable angina or a heart attack (myocardial infarction). In this case, your doctor may also give you acetylsalicylic acid (a substance that is present in many medicines used to relieve pain and reduce inflammation, as well as to prevent blood clotting);

or you have had a mini-stroke (transient ischaemic attack) or a mild stroke. Your doctor may also give you acetylsalicylic acid within the first 24 hours;

or you have an irregular heartbeat (known as atrial fibrillation) and cannot take oral anticoagulant medicines (vitamin K antagonists) that prevent the formation of blood clots. Oral anticoagulant medicines are more effective in treating this condition than acetylsalicylic acid or acetylsalicylic acid and clopidogrel. Your doctor has prescribed Clopidogrel Ranbaxy and acetylsalicylic acid if you cannot take oral anticoagulant medicines and do not have a high risk of major bleeding.

• you have narrowed blood vessels (peripheral arterial disease) and
• you have had a heart attack, stroke, or peripheral arterial disease or
• you have had severe chest pain (unstable angina) or a heart attack (myocardial infarction). To treat this condition, your doctor may also insert a stent in the blocked or narrowed blood vessel. Your doctor may also prescribe acetylsalicylic acid;
• you have had a mini-stroke (transient ischaemic attack) or a mild stroke. Your doctor may also prescribe acetylsalicylic acid within the first 24 hours;
• you have an irregular heartbeat (atrial fibrillation) and cannot take oral anticoagulant medicines (vitamin K antagonists) that prevent the formation of blood clots. Oral anticoagulant medicines are more effective in treating this condition than acetylsalicylic acid or acetylsalicylic acid and clopidogrel. Your doctor has prescribed Clopidogrel Ranbaxy and acetylsalicylic acid if you cannot take oral anticoagulant medicines and do not have a high risk of major bleeding.

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2. Important information before taking Clopidogrel Ranbaxy

When not to take Clopidogrel Ranbaxy:

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
• if you have a condition that is currently causing bleeding (such as a stomach ulcer or bleeding in the brain);
• if you have severe liver disease.

If you think any of these apply to you, or if you are in any doubt, consult your doctor before taking Clopidogrel Ranbaxy.

Warnings and precautions

If any of the following apply to you, tell your doctor before taking Clopidogrel Ranbaxy:

• if you have a risk of bleeding due to:
• a condition that may cause internal bleeding (such as a stomach ulcer);
• a blood disorder that makes you prone to internal bleeding (bleeding in tissues, organs, or joints);
• a recent severe injury;
• a recent surgical procedure (including dental surgery);
• a planned surgical procedure (including dental surgery) within the next 7 days;
• if you have had a blood clot in a brain blood vessel (ischaemic stroke) within the last 7 days;
• if you have kidney or liver disease;
• if you have had an allergy or intolerance to any medicines used to treat this condition;
• if you have had a non-traumatic brain haemorrhage.

While taking Clopidogrel Ranbaxy:

• tell your doctor if a surgical procedure (including dental surgery) is planned;
• also immediately tell your doctor if you experience: fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells;
• if you cut or injure yourself, it may take longer than usual for bleeding to stop. This is due to the way the medicine works, as it prevents the blood from clotting. This usually causes no problems with minor cuts or injuries, such as cuts from shaving. However, if the bleeding is worrying, you should contact your doctor (see section 4 "Possible side effects");
• your doctor may ask you to have blood tests.

Children and adolescents

Do not give this medicine to children, as it has not been shown to be effective in this age group.

Clopidogrel Ranbaxy with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those you have bought without a prescription.

• medicines that may increase the risk of bleeding, including:
• oral anticoagulants (used to prevent blood clotting);
• non-steroidal anti-inflammatory medicines (usually taken for pain or inflammation of muscles or joints);
• heparin or other injectable medicines used to prevent blood clotting;
• ticlopidine or other antiplatelet agents;
• selective serotonin reuptake inhibitors (such as fluoxetine or fluvoxamine, medicines usually used to treat depression);
• rifampicin (used to treat severe infections);
• omeprazole or esomeprazole (medicines used to treat stomach disorders);
• fluconazole or voriconazole (used to treat fungal infections);
• efavirenz or other antiretroviral medicines (used to treat HIV infection);
• carbamazepine (a medicine used to treat certain types of epilepsy);
• moclobemide (used to treat depression);
• repaglinide (a medicine used to treat diabetes);
• paclitaxel (used to treat cancer);
• opioids: while being treated with clopidogrel, you should tell your doctor before being prescribed any opioid (medicines used to treat severe pain);
• rosuvastatin (used to lower cholesterol levels).

Patient with severe chest pain (unstable angina) or a heart attack (myocardial infarction) or a mini-stroke (transient ischaemic attack) or a mild stroke may be given Clopidogrel Ranbaxy with acetylsalicylic acid (a substance that is present in many medicines used to relieve pain and reduce inflammation, as well as to prevent blood clotting). Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) should not normally cause a problem, but long-term use should be discussed with your doctor.

Clopidogrel Ranbaxy with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or think you might be pregnant.

If you become pregnant while taking Clopidogrel Ranbaxy, you should immediately inform your doctor, as the use of clopidogrel during pregnancy is not recommended.

Do not take this medicine if you are breastfeeding.

If you are breastfeeding or planning to breastfeed, consult your doctor before taking Clopidogrel Ranbaxy.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Clopidogrel Ranbaxy is unlikely to affect your ability to drive or use machines.

Clopidogrel Ranbaxy 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 Ranbaxy also contains hydrogenated castor oil.

This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel Ranbaxy

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Clopidogrel Ranbaxy is 75 mg once daily, to be taken orally with or without food, at the same time each day.

This dosage also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).

If you have had severe chest pain (unstable angina) or a heart attack (myocardial infarction), your doctor may give you a starting dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of Clopidogrel Ranbaxy). Then, the recommended dose of Clopidogrel Ranbaxy is one 75 mg tablet per day, taken as described above.

If you have had a mini-stroke (transient ischaemic attack) or a mild stroke, your doctor may give you a single dose of 300 mg of clopidogrel (4 tablets of Clopidogrel Ranbaxy) at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel Ranbaxy per day, taken as described above, with acetylsalicylic acid for 3 weeks. Then, your doctor may prescribe Clopidogrel Ranbaxy or acetylsalicylic acid separately.

Take the medicine for as long as your doctor recommends.

If you take more Clopidogrel Ranbaxy than you should

Due to the increased risk of bleeding, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Clopidogrel Ranbaxy

If you forget to take a dose, but remember within 12 hours of the time you normally take it, take the dose as soon as you remember, then take the next dose 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 dose.

If you stop taking Clopidogrel Ranbaxy

Do not stop treatment unless your doctor tells you to do 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, Clopidogrel Ranbaxy can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells;

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• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), whether or not associated with bleeding, which appears as red pinpoint dots under the skin and/or confusion (see section 2 "Warnings and precautions");
• swelling of the mouth or changes in the skin, such as rashes and itching, blisters. This may be a sign of an allergic reaction.

The most common side effect reported with Clopidogrel Ranbaxy is bleeding.

Bleeding may occur as stomach or bowel bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also been reports of bleeding in the eye, inside the head, lungs, or joints.

If you experience prolonged bleeding when taking Clopidogrel Ranbaxy

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is due to the way the medicine works, as it prevents the blood from clotting. This usually causes no problems with minor cuts or injuries, such as cuts from shaving. However, if the bleeding is worrying, you should contact your doctor (see section 4 "Possible side effects").

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, flatulence
Rare side effects (may affect up to 1 in 1,000 people):
vertigo, gynecomastia (breast enlargement in men)
Very rare side effects (may affect up to 1 in 10,000 people):
jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing sometimes with cough; generalised allergic reactions (for example, overall feeling of heat with sudden general discomfort until fainting); swelling in the mouth; blisters; allergic reactions on the skin; mouth ulcers (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
hypersensitivity reactions with chest or abdominal pain, prolonged low blood sugar levels.

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported to the national reporting system via the Medicines Agency website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder.

5. How to store Clopidogrel Ranbaxy

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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 blister after "EXP". The expiry date refers to the last day of that month.

No special precautions for storage are necessary.

Do not use this medicine if you notice any 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 protect the environment.

6. Contents of the pack and other information

What Clopidogrel Ranbaxy contains

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrochloride).
• The other ingredients are: tablet core: mannitol, microcrystalline cellulose, Macrogol 6000, hydrogenated castor oil, and hypromellose tablet coating: Opadry II Pink 33K84841, hypromellose 6 cp, lactose, titanium dioxide (E 171), triacetin, red iron oxide (E 172).

What Clopidogrel Ranbaxy looks like and contents of the pack

Clopidogrel Ranbaxy 75 mg is a round, pink, biconvex, film-coated tablet, smooth on both sides.

The medicine is packed in cardboard boxes containing 28 or 84 tablets in cold-formed blisters of Aluminium/PA/PVC/Aluminium.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Street, 400632 Cluj-Napoca
Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Clopidogrel Basics
Romania: Clopidogrel Terapia
Spain: Clopidogrel SUN
Poland: Clopidogrel Ranbaxy
Date of last revision of the package leaflet: 24.03.2024