Package leaflet: Information for the user

Clopidogrel Almus Pharma 75 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start 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. Do not pass it on to others, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Clopidogrel Almus Pharma is and what it is used for

Clopidogrel Almus Pharma contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are microscopic blood components that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots forming (a process known as thrombosis).
Clopidogrel Almus Pharma is taken by adults to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Almus Pharma has been prescribed to you to help prevent blood clots and to reduce the risk of these serious events because:

you have a condition known as hardening of the arteries (also called atherosclerosis), and
you have previously had a heart attack, stroke, or a condition known as peripheral arterial disease, or
you have previously suffered from severe chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
you have experienced stroke symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may prescribe you acetylsalicylic acid starting within the first 24 hours,
you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) which prevent the formation of new clots and the growth of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Clopidogrel Almus Pharma and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you Clopidogrel Almus Pharma plus acetylsalicylic acid.

2. What you need to know before taking Clopidogrel Almus Pharma

Do not take Clopidogrel Almus Pharma

If you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6).
If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
If you suffer from severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before using
Clopidogrel Almus Pharma.
Warnings and precautions
If any of the following conditions apply to you, inform your doctor before taking
Clopidogrel Almus Pharma:

if you have an increased risk of bleeding, such as:
- a medical condition that puts you at risk of internal bleeding (e.g. 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 severe injury,
- recent surgery (including dental surgery),
- planned surgery (including dental surgery) within the next 7 days
if you have had a blood clot in an artery of the brain (ischaemic stroke) that occurred within the last 7 days
if you have kidney or liver disease
if you have had an allergy or reaction to any medicine used to treat your condition,
if you have previously had a non-traumatic brain haemorrhage.

While taking Clopidogrel Almus Pharma:

You must inform your doctor if you are scheduled for surgery (including dental surgery).
You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising appearing as small red spots, with or without unexplained extreme fatigue, 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 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 4 “Possible side effects”).
Your doctor may prescribe blood tests for you.

Children and adolescents
Do not give this medicine to children as it is not effective.
Other medicines and Clopidogrel Almus Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
Some medicines may affect the use of Clopidogrel Almus Pharma or vice versa.
You must inform your doctor precisely if you are taking:

medicines that may increase your risk of bleeding, such as:
oral anticoagulants, medicines used to reduce blood clotting,
a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles or joints,
heparin or any other injectable drug used to reduce blood clotting,
ticlopidine, other antiplatelet agents,
a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression,
rifampicin (used to treat serious infections),
- omeprazole or esomeprazole, medicines used to treat stomach problems,
- fluconazole or voriconazole, medicines used to treat fungal infections,
- efavirenz or other antiretroviral medicines (used to treat HIV infection),
- carbamazepine, a medicine used to treat certain 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: while taking clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
- rosuvastatin (used to lower cholesterol levels).

If you have experienced severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a
mild ischaemic stroke, you may have been prescribed Clopidogrel Almus Pharma in combination
with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce
fever. Occasional use of acetylsalicylic acid (not exceeding 1,000 mg within 24 hours) should generally
not cause problems, but prolonged use in other circumstances should be discussed with your doctor.
Clopidogrel Almus Pharma with food and drink
Clopidogrel Almus Pharma can be taken with or without food.
Pregnancy and breastfeeding
It is advisable not to take this medicine during pregnancy.
If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Clopidogrel Almus Pharma.
If you become pregnant while taking Clopidogrel Almus Pharma, consult your doctor immediately, as it is recommended not to take Clopidogrel Almus Pharma during pregnancy.
You must not breastfeed while taking this medicine.
If you are breastfeeding or planning 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 Almus Pharma will affect your ability to drive or use machines.
Clopidogrel Almus Pharma contains lactose
If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact your doctor
before taking this medicine.

3. How to take Clopidogrel Almus Pharma

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Almus Pharma daily, taken orally either during or apart from meals, at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you an initial dose of 300 mg or 600 mg of Clopidogrel Almus Pharma (4 or 8 tablets of 75 mg) once at the beginning of treatment.
Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Almus Pharma daily, as described above.
If you have experienced stroke symptoms that disappear within a short time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you an initial single dose of 300 mg of Clopidogrel Almus Pharma (4 tablets of 75 mg). Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Almus Pharma daily, as described above, in combination with acetylsalicylic acid for 3 weeks. Thereafter, your doctor will prescribe either Clopidogrel Almus Pharma alone or acetylsalicylic acid alone.
Clopidogrel Almus Pharma should be taken for as long as your doctor considers it necessary.
If you take more Clopidogrel Almus Pharma than you should
Contact your doctor or go to the nearest hospital emergency department due to the risk of increased bleeding.
If you forget to take Clopidogrel Almus Pharma
If you forget to take a dose 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 missed tablet.
If you stop taking Clopidogrel Almus Pharma
Do not stop treatment unless instructed by your doctor. Before stopping, consult your doctor or pharmacist.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Contact your doctor immediately if you experience:

fever, signs of infection, or severe feeling of 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, skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with Clopidogrel Almus Pharma is bleeding.
Bleeding may occur as gastrointestinal bleeding (in the stomach or intestines), bruising, haematomas (unusual bleeding or subcutaneous bruising), nosebleeds, or blood in the urine. In rare cases, bleeding into the eye, intracranial bleeding, lungs, or joints has also been reported.
If you experience prolonged bleeding while taking Clopidogrel Almus Pharma
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 or heartburn.
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, 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, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes associated with cough, generalized allergic reactions (for example, widespread feeling of warmth with sudden general malaise up to fainting), mouth swelling, skin blisters, skin allergy, mouth pain (stomatitis), decrease in blood pressure, confusion, hallucinations, joint pain, muscle pain, changes or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia.
Additionally, your doctor may detect changes in blood and urine test results.
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 Almus Pharma

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 packaging and on the blister.
After Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clopidogrel Almus Pharma contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
The other components are:

Tablet core: anhydrous lactose, pregelatinized starch, macrogol 6000, microcrystalline cellulose, hydrogenated vegetable oil
Tablet coating [Opadry II 33G34629 Pink]: hypromellose, titanium dioxide (E171), monohydrate lactose, macrogol, triacetin, red iron oxide (E172).

Description of the appearance of Clopidogrel Almus Pharma and contents of the pack
Clopidogrel Almus Pharma 75 mg film-coated tablets are round and pink in colour.
Clopidogrel Almus Pharma is supplied in cardboard boxes containing 28 and 30 tablets in blisters
PCTFE+PE+PVC/aluminum.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua De Tapada Grande, n. 2 - Abrunheira, 2710-228 Sintra
Portugal