Package leaflet: Information for the user

Clopidogrel Ranbaxy, 75 mg, coated tablets
Clopidogrelum
Please read carefully all of this leaflet before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

What Clopidogrel Ranbaxy is and what it is used for
What you need to know before you take Clopidogrel Ranbaxy
How to take Clopidogrel Ranbaxy
Possible side effects
How to store Clopidogrel Ranbaxy
Contents of the pack and other information

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

Clopidogrel Ranbaxy belongs to a group of medicines called antiplatelet agents. Platelets are very small components in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).
Clopidogrel Ranbaxy is given to adults to help prevent blood clots forming in hardened arteries (atherosclerosis). Blood clots can lead to stroke, heart attack, or death.
You have been prescribed Clopidogrel Ranbaxy to help prevent blood clots and reduce the risk of these serious events because:

you have hardening of the arteries (atherosclerosis), and
you previously had a heart attack, stroke, or have peripheral arterial disease, or
you had severe chest pain known as unstable angina or a heart attack (‘heart attack’). To treat this condition and restore blood flow, your doctor may have inserted a stent into a blocked or narrowed artery. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting);
you experienced transient ischaemic attack (TIA) or mild ischaemic stroke. Your doctor may also have prescribed acetylsalicylic acid within the first 24 hours;
you have an irregular heartbeat (known as atrial fibrillation) and cannot take oral anticoagulant medicines (vitamin K antagonists), which prevent clots from growing and new clots from forming. Oral anticoagulants are more effective in treating this condition than acetylsalicylic acid alone or acetylsalicylic acid combined with clopidogrel. Your doctor has prescribed Clopidogrel Ranbaxy and acetylsalicylic acid if you cannot take oral anticoagulants and you do not have a high risk of serious bleeding.

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2. Important information before using Clopidogrel Ranbaxy

When not to use Clopidogrel Ranbaxy:

if the patient is allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
if the patient currently has a disease causing bleeding, such as a stomach ulcer, or has bleeding within the brain;
if the patient has severe liver disease.

If the patient thinks any of these apply or has any other
doubts, they should consult their doctor before taking Clopidogrel Ranbaxy.
Warnings and precautions
If any of the situations listed below apply to the patient, they must inform their doctor before taking
Clopidogrel Ranbaxy:

if they are at risk of bleeding for any of the reasons listed below:
- a disease that increases the risk of internal bleeding (such as a stomach ulcer);
- a blood disorder that predisposes to internal bleeding (bleeding within tissues, organs or body joints);
- recent severe injury;
- recent surgery (including dental surgery);
- planned surgery (including dental surgery) within the next seven days;
if the patient has had a cerebral arterial thrombosis (ischaemic stroke) within the last seven days;
if the patient has kidney or liver disease;
if the patient has previously had an allergy or hypersensitivity to any of the medicines used to treat this condition;
if the patient has previously experienced a non-traumatic intracranial haemorrhage.

While taking Clopidogrel Ranbaxy:

inform the doctor if surgery (including dental surgery) is planned;
also inform the doctor immediately if any of the following occur: fever and red, pinpoint spots (petechiae), with or without extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (a condition called thrombotic thrombocytopenic purpura) (see section 4 "Possible side effects");
if the patient cuts or injures themselves, bleeding may take longer than usual to stop. This is due to the way the medicine works, by inhibiting the blood's ability to clot. This usually does not cause problems with minor cuts or injuries, for example, when shaving. However, if bleeding is concerning, the patient should contact their doctor immediately (see section 4 "Possible side effects");
the doctor may order blood tests.

Children and adolescents
This medicine should not be used in children, as it has not been shown to be effective in this patient group.
Clopidogrel Ranbaxy with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some other medicines may affect the use of Clopidogrel Ranbaxy or vice versa.
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In particular, inform the doctor if the patient is taking:

medicines that may increase the risk of bleeding, including:
- oral anticoagulants – used to reduce blood clotting;
- non-steroidal anti-inflammatory drugs, usually used to treat pain and (or) inflammation of muscles or joints;
- heparin or another medicine given by injection to reduce blood clotting;
- ticlopidine or other antiplatelet medicines;
- selective serotonin reuptake inhibitors (e.g. fluoxetine or fluvoxamine), medicines usually used to treat depression;
- rifampicin (used to treat serious infections);
omeprazole or esomeprazole – medicines used for stomach problems;
fluconazole or voriconazole – used to treat fungal infections;
efavirenz or other antiretroviral medicines (used to treat HIV infection);
carbamazepine – a medicine used in certain types of epilepsy;
moclobemide – used to treat depression;
repaglinide – a medicine used in diabetes;
paclitaxel – used in cancer treatment;
opioids: during treatment with clopidogrel, the patient should inform the doctor before being prescribed any opioid (medicines used to treat severe pain);
rosuvastatin (used to lower cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or "heart attack"), transient ischaemic attack, or mild ischaemic stroke may be prescribed Clopidogrel Ranbaxy together with acetylsalicylic acid (a substance present in many medicines, used to relieve pain and reduce fever). Occasional use of acetylsalicylic acid (not more than 1000 mg within 24 hours) should not usually cause a problem, but long-term use should be discussed with the doctor.
Clopidogrel Ranbaxy with food and drink
The medicine can be taken with or without food.
Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended.
If the patient is pregnant or suspects she may be pregnant, she should consult her doctor or
pharmacist before taking Clopidogrel Ranbaxy. If the patient becomes pregnant while taking
Clopidogrel Ranbaxy, she should consult her doctor immediately, as use of clopidogrel during
pregnancy is not recommended.
This medicine should not be used during breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Clopidogrel Ranbaxy is unlikely to affect the ability to drive or operate machinery.
Clopidogrel Ranbaxy contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars (e.g. lactose), they should consult their doctor before taking this medicine.
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Clopidogrel Ranbaxy also contains hydrogenated castor oil.
It may cause gastrointestinal discomfort or diarrhoea.

3. How to take Clopidogrel Ranbaxy

This medicine should always be taken exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Clopidogrel Ranbaxy is 75 mg once daily, taken orally at the same time
each day, with or without food. This dose also applies to patients with a condition known as
"atrial fibrillation" (irregular heartbeat).
If a patient has experienced severe chest pain (unstable angina or heart attack), the doctor may
prescribe an initial dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of Clopidogrel Ranbaxy).
Afterwards, the recommended dose of Clopidogrel Ranbaxy is one 75 mg tablet daily, taken as
described above.
If a patient has experienced symptoms of stroke that resolve quickly (also known as transient
ischaemic attack) or mild ischaemic stroke, the doctor may prescribe an initial single dose of
300 mg clopidogrel (4 tablets of Clopidogrel Ranbaxy). This is followed by the recommended dose
of one 75 mg tablet of Clopidogrel Ranbaxy daily, as described above, together with acetylsalicylic
acid for 3 weeks. After that, the doctor may prescribe either Clopidogrel Ranbaxy or acetylsalicylic
acid alone.
This medicine should be taken for as long as your doctor recommends.
Taking more Clopidogrel Ranbaxy than recommended
Due to the increased risk of bleeding, contact your doctor or the nearest hospital emergency
department immediately.
Missing a dose of Clopidogrel Ranbaxy
If the patient forgets to take the medicine but remembers within 12 hours of the usual time, they
should take the tablet immediately and then take the next tablet at the usual time.
If more than 12 hours have passed, the patient should simply take the next single dose at the
usual time. Do not take a double dose to make up for a missed tablet.
Stopping Clopidogrel Ranbaxy
Do not stop treatment unless advised by your doctor. Before stopping, consult your doctor or
pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should contact your doctor immediately if any of the following occur:

fever, signs of infection or feeling extremely tired. This may be due to a rare reduction in the number of certain blood cells;

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symptoms of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red pinpoint spots and/or confusion (see section 2 "Warnings and precautions");
swelling of the mouth or skin changes such as rash and itching, blisters. These may be signs of allergic reactions.

The most commonly reported adverse effect during treatment is bleeding.
Bleeding may occur in the stomach or intestines, as bruises, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. There have also been reports of a small number of cases of bleeding in the eye, inside the head, lungs or joints.
If prolonged bleeding occurs during treatment
If you cut or injure yourself, stopping the bleeding may take longer than usual. This is related to the way the medicine works, which inhibits the blood's ability to clot. This usually does not cause problems with minor cuts or injuries, such as while shaving. However, if bleeding is concerning, you should contact your doctor immediately (see section 4 "Possible adverse effects").
Other adverse effects include:
common adverse effects (occur in 1 to 10 people out of 100):
diarrhoea, abdominal pain, indigestion or heartburn
uncommon adverse effects (occur in 1 to 10 people out of 1,000):
headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines,
rash, itching, dizziness, tingling and numbness
rare adverse effects (occur in 1 to 10 people out of 10,000):
vertigo, gynaecomastia (enlargement of the breasts in men)
very rare adverse effects (occur in less than 1 person out of 10,000):
jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing sometimes with cough; generalized allergic reactions (e.g. general feeling of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters; allergic skin changes; ulceration of the oral mucosa (inflammation of the oral mucosa); hypotension (low blood pressure); confusion; hallucinations; joint pain; muscle pain; disturbances or loss of taste sensation.
Adverse effects with unknown frequency (frequency cannot be determined from available data):
hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar.
Additionally, changes in blood or urine laboratory test results may occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported directly to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Clopidogrel Ranbaxy

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Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the blister.
The expiry date refers to the last day of the stated month.
No special precautions for storage of the medicinal product.
Do not use the medicine if signs of deterioration are observed.
Medicines must 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. One tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
The other ingredients are: tablet core: mannitol, microcrystalline cellulose, Macrogol 6000, hydrogenated castor oil, and low-substituted hydroxypropylcellulose; tablet coating: Opadry II Pink 33K84841, hypromellose 6 cp, lactose, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Clopidogrel Ranbaxy looks like and contents of the pack
Clopidogrel Ranbaxy 75 mg are round, pink, biconvex film-coated tablets, smooth on both sides.
The medicine is packed in cardboard boxes containing 28 or 84 tablets in cold-formed blisters made 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
The Netherlands
Terapia S.A.
124 Fabricii Street, 400632 Cluj-Napoca
Romania
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Germany: Clopidogrel Basics
Romania: Clopidogrel Terapia
Spain: Clopidogrel SUN
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Poland: Clopidogrel Ranbaxy