Clopidogrel and acetylsalicylic acid Doc Generici
Italy
Table of Contents
Package leaflet: Information for the user
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC 75 mg/100 mg film-coated tablets
Generic medicine
Please read this leaflet carefully 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if their
symptoms are the same as yours, because it could be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is and what it is used for
- What you need to know before taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
- How to take CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
- Possible side effects
- How to store CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
- Contents of the pack and other information
1. What CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is and what it is used for
This medicine contains clopidogrel and acetylsalicylic acid (ASA), and belongs to a group of
medicines called platelet aggregation inhibitors. Platelets are microscopic components of the blood
that clump together during blood clotting. By preventing this clumping in certain types of blood vessels
(called arteries), platelet aggregation inhibitors reduce the likelihood of blood clot formation (a process known as atherothrombosis).
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is taken by adults to prevent the formation of blood clots in hardened arteries, which can cause atherothrombotic events (such as stroke, heart attack, or death).
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC has been prescribed for you instead of two separate medicines, clopidogrel and ASA, to help prevent blood clot formation because you have previously suffered from a severe type of chest pain known as “unstable angina” or heart attack (myocardial infarction). To treat this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore blood flow.
2. What you should know before taking CLOPIDOGREL and ACETYLSALICYLIC ACID
DOC
Do not take CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
If you are allergic to clopidogrel, acetylsalicylic acid (ASA), or any of the other ingredients
of this medicine (listed in section 6).
If you are allergic to other medicines called non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to
treat painful and/or inflammatory conditions of muscles or joints.
If you have a medical condition involving the combination of asthma, nasal discharge
(runny nose), and nasal polyps (a type of growth in the nose).
If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
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If you have severe liver disease.
If you have severe kidney disease.
If you are in the third trimester of pregnancy.
Warnings and precautions
If any of the following situations apply to you, inform your doctor before taking
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC:
if you have a risk of bleeding such as:
- a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer),
- a blood disorder that makes you prone to internal bleeding (bleeding within any tissue, organ, or joint of the body),
- a recent serious 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 artery (ischaemic stroke) within the last 7 days,
- if you have kidney or liver disease,
- if you have previously suffered from asthma or had allergic reactions, including a reaction to any medicine used to treat your condition,
- if you have gout,
- if you consume alcohol, due to an increased risk of gastrointestinal bleeding or injury,
- if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of a specific type of anaemia (low red blood cell count).
While taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC:
You must inform your doctor
- if you need to undergo surgery (including dental surgery),
- if you experience stomach or abdominal pain, or bleeding in the stomach or intestines (red or black stools). You must contact your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura (TTP), which includes fever and skin bruising appearing as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4). If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to how the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving or minor cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 “Possible side effects”). Your doctor may order blood tests. Inform your doctor immediately if you develop symptoms or signs of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which may include flu-like symptoms and a rash with fever, swollen lymph nodes, and an increase in a type of white blood cell (eosinophilia). Other abnormal blood test results may include (but are not limited to) increased levels of liver enzymes (see section 4 “Possible side effects”).
Children and adolescents
The use of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is not recommended in children and
adolescents under 18 years of age. There is a possible association between acetylsalicylic acid (ASA)
and Reye's syndrome when medicines containing ASA are taken by children or adolescents
with a viral infection. Reye's syndrome is a very rare disease that can be fatal.
Other medicines and CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Some medicines can affect the use of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
or vice versa.
You must especially inform your doctor if you are taking:
medicines that may increase your risk of bleeding such as:
- oral anticoagulants, medicines used to reduce blood clotting,
- ASA or another non-steroidal anti-inflammatory medicine, commonly used to treat painful and/or inflammatory conditions of muscles or joints,
- heparin or any other injectable medicine used to reduce blood clotting,
- ticlopidine or other antiplatelet agents,
- a selective serotonin reuptake inhibitor (including, but not limited to, fluoxetine or fluvoxamine), medicines commonly used to treat depression,
- rifampicin (used to treat serious infections), omeprazole or esomeprazole, medicines used to treat stomach problems, methotrexate, a medicine used to treat a serious joint disease (rheumatoid arthritis) or a skin condition (psoriasis), acetazolamide, a medicine used to treat glaucoma (increased eye pressure) or epilepsy or to increase urine flow, probenecid, benzbromarone or sulfinpyrazone, medicines used to treat gout, fluconazole or voriconazole, medicines used to treat fungal infections, efavirenz or tenofovir, or other antiretroviral medicines (used to treat HIV infection), valproic acid, valproate or carbamazepine, medicines used to treat certain forms of epilepsy, the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC, or if you currently have an infection caused by chickenpox or shingles (see section 2 "Children and adolescents"), moclobemide, a medicine used to treat depression, repaglinide, a medicine used to treat diabetes, paclitaxel, a medicine used to treat cancer, nicorandil, a medicine used to treat heart-related chest pain, opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain), rosuvastatin (used to lower cholesterol levels).
While taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC, you must stop
any other treatment containing clopidogrel.
Occasional use of ASA (not exceeding 1,000 mg in 24 hours) should generally not cause
problems, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.
Pregnancy and breastfeeding
Do not use CLOPIDOGREL and ACETYLSALICYLIC ACID DOC during the third trimester of
pregnancy.
It is preferable not to use this medicine during the first and second trimesters of pregnancy.
If you are pregnant or suspect you may be pregnant, inform your doctor or pharmacist before taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC. If you become pregnant while taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC, consult your doctor immediately, as it is recommended not to take CLOPIDOGREL and ACETYLSALICYLIC ACID DOC during pregnancy.
You must not breastfeed while using this medicine.
If you are breastfeeding, or plan to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that CLOPIDOGREL and ACETYLSALICYLIC ACID DOC will affect your ability to
drive or operate machinery.
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC contains lactose
If your doctor has informed you of an intolerance to certain sugars (e.g. lactose), consult your
doctor before taking this medicine.
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC contains hydrogenated castor oil
This may cause gastrointestinal disturbances and diarrhoea.
3. How to take CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC daily,
taken orally with a glass of water, either during or apart from meals.
You should take the medicine at the same time every day.
Depending on your condition, your doctor will determine the duration of treatment with CLOPIDOGREL and ACETYLSALICYLIC ACID DOC. If you have had a heart attack, the medicine should be prescribed for
at least 4 weeks.
In any case, it should be taken for as long as your doctor prescribes it.
If you take more CLOPIDOGREL and ACETYLSALICYLIC ACID DOC than you should
Contact your doctor or the nearest hospital emergency department due to the increased risk of
bleeding.
If you forget to take CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
If you forget to take a dose of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC but
remember within 12 hours of the usual time, take one tablet immediately and then take the next dose
at the regular time.
If more than 12 hours have passed, simply take the next dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.
You can check the date on which the last tablet of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC was taken by referring to the calendar printed on the blister pack.
If you stop taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
Do not stop treatment unless instructed by your doctor. Before stopping or restarting treatment, contact your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience:
fever, signs of infection or severe weakness. These effects may be due to a rare reduction in certain blood cells,
signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots, and/or confusion (see section 2 "Warnings and precautions"),
swelling in the mouth or skin disorders such as rash, itching, blisters. These may be signs of an allergic reaction,
a serious reaction affecting the skin, blood and internal organs (DRESS) (see section 2 "Warnings and precautions").
The most common side effect reported with CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is bleeding.
Bleeding may present as bleeding in the stomach or intestines, easy bruising, haematomas (unusual or bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding (especially in the elderly), in the lungs and in the joints has also been reported.
If you experience prolonged bleeding while taking CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 2 "Warnings and precautions").
Other side effects include:
Common side effects (may occur in up to 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion and stomach burning.
Uncommon side effects (may occur in up to 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, skin rash, itching, dizziness, tingling and numbness sensations.
Rare side effects (may occur in up to 1 in 1,000 patients):
Dizziness, breast enlargement in males.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Jaundice (yellowing of the skin and/or eyes); burning in the stomach and/or oesophagus (throat), severe abdominal pain with or without back pain; fever, difficulty breathing sometimes associated with cough; generalized allergic reactions (for example: widespread sensation of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth burning (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste, inflammation of small arteries.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Perforated ulcer, ringing in the ears, hearing loss, sudden life-threatening allergic reactions or hypersensitivity reactions with abdominal or chest pain, nephropathy, hypoglycaemia, gout (a condition characterized by joint pain and swelling caused by uric acid crystals), worsening of food allergies, and a particular type of anaemia (low number of red blood cells in the blood) (see section 2 "Warnings and precautions"), swelling.
Additionally, your doctor may detect changes in blood or urine tests.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store CLOPIDOGREL and ACETYLSALICYLIC ACID DOC
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack, following
Exp./EXP. The expiry date refers to the last day of that month.
Store this medicine at a temperature below 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What CLOPIDOGREL and ACETYLSALICYLIC ACID DOC contains
The active substances are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of
clopidogrel (as hydrogen sulfate) and 100 mg of acetylsalicylic acid.
The other components are:
- Tablet core: mannitol, microcrystalline cellulose, polyethylene glycol, hydrated colloidal silica, low-substituted hydroxypropylcellulose, corn starch, hydrogenated castor oil (see section 2 “CLOPIDOGREL and ACETYLSALICYLIC ACID DOC contains hydrogenated castor oil”), yellow iron oxide (E172), stearic acid.
- Tablet coating: hypromellose (E464), lactose monohydrate (see section 2 “CLOPIDOGREL and ACETYLSALICYLIC ACID DOC contains lactose”), titanium dioxide (E171), triacetin, red iron oxide (E172).
Description of the appearance of CLOPIDOGREL and ACETYLSALICYLIC ACID DOC and contents of the package
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC 75 mg/100 mg tablets are film-coated, light pink to pink in colour, oval-shaped, with "II" engraved on one side and smooth on the other.
CLOPIDOGREL and ACETYLSALICYLIC ACID DOC is available in cardboard boxes containing
28 tablets in OPA/Al/desiccant PE-Al/PE blisters.
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Filippo Turati 40, 20121 Milan - Italy
Manufacturers:
Pharmadox Healthcare Ltd. - KW20A Kordin Industrial Park - Paola PLA 3000 - Malta
MSN Labs Europe Ltd. - KW20A Corradino Park, Paola PLA 3000 - Malta
This medicinal product is authorized in the European Economic Area countries under the following names:
Iceland: Clopidogrel/Acetylsalicylic acid Doc 75 mg/100 mg film-coated tablets
Italy: CLOPIDOGREL and ACETYLSALICYLIC ACID DOC