CLOPIDOGREL 75 mg Tabletki Powlekane

Treść ulotki

1. Clopidogrel Almus Pharma 75 mg film-coated tablets
   1. What is Clopidogrel Almus Pharma and what is it used for
   2. What you need to know before taking Clopidogrel Almus Pharma
   3. How to take Clopidogrel Almus Pharma
   4. Possible side effects
   5. How to store Clopidogrel Almus Pharma
   6. Contents of the pack and other information

Clopidogrel Almus Pharma 75 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Clopidogrel Almus Pharma is and what it is used for
• 2. What you need to know before you take Clopidogrel Almus Pharma
• 3. How to take Clopidogrel Almus Pharma
• 4. Possible side effects
• 5. How to store Clopidogrel Almus Pharma
• 6. Contents of the pack and other information

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

Clopidogrel Almus Pharma contains clopidogrel and belongs to a group of medicines called
antiplatelet agents. Platelets are microscopic elements of the blood that clump together during blood
coagulation. By preventing this aggregation, antiplatelet agents decrease the possibility of blood
clot formation (a phenomenon called 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
cause atherothrombotic events (such as stroke, heart attack, or death).
Clopidogrel Almus Pharma has been prescribed to you to help prevent the formation of 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 obliterating 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 placed a stent in the blocked or narrowed artery to restore blood flow. Your doctor may have also prescribed acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• you have had symptoms of stroke that disappear in a short period of time (also known as a transient ischemic attack) or mild to moderate ischemic stroke. Your doctor may also prescribe acetylsalicylic acid starting from the first 24 hours,
• you have an irregular heartbeat, a condition called “atrial fibrillation”, and cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) that prevent the formation of new clots and the development of existing ones. You have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of Clopidogrel Almus Pharma and acetylsalicylic acid in the treatment of this condition. If you cannot take “oral anticoagulants” and do not have a higher risk of bleeding, your doctor may have prescribed 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 other ingredients of this medicine (listed in section 6).
• If you have ongoing bleeding, such as a stomach ulcer or bleeding in the brain.
• If you suffer from a severe liver disease.

If 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 situations mentioned below apply to you, tell your doctor before taking Clopidogrel Almus Pharma:

• if you are at 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 inside any tissue, organ or joint of the body),
• a recent serious injury,
• recent surgery (including dental surgery),
• surgery (including dental surgery) planned in the next 7 days
• if you have had a blood clot in an artery in the brain (ischemic stroke) that occurred in 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 brain hemorrhage of non-traumatic origin.

While you are taking Clopidogrel Almus Pharma:

• You must inform your doctor if you need to undergo surgery (including dental surgery).
• You must immediately inform your doctor if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruises under the skin that appear as red dots, 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 and injuries, such as cutting yourself shaving, this usually does not cause problems. However, if you are concerned about the bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may prescribe blood tests.

Children and adolescents
Do not give this medicine to children because it is not effective.

Other medicines and Clopidogrel Almus Pharma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Some medicines can affect the use of Clopidogrel Almus Pharma or vice versa.
You must tell your doctor accurately if you are taking:

• medicines that can increase your risk of bleeding such as:
• oral anticoagulants, medicines used to reduce blood clotting,
• a non-steroidal anti-inflammatory drug, usually used to treat pain and/or inflammation 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 anti-retroviral medicines (used for the treatment of HIV infection),
• carbamazepine, a medicine used to treat some 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 you are being treated with clopidogrel, you must inform your doctor before any opioid is prescribed to you (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischemic attack or a mild ischemic 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 (no more than

• 1,000 mg in 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 preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be, tell 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.
Do 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 and use machines.

Clopidogrel Almus Pharma contains lactose
If your doctor has told you that you have an intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

3. How to take Clopidogrel Almus Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose, even for patients diagnosed with “atrial fibrillation” (an irregular heartbeat), is one 75 mg tablet of Clopidogrel Almus Pharma per day, taken orally during or away from meals, and at the same time each day.
If you have had severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg or 600 mg of Clopidogrel Almus Pharma (4 or 8 tablets of 75 mg) once at the beginning of treatment. Subsequently, the recommended dose is one 75 mg tablet of Clopidogrel Almus Pharma per day as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of Clopidogrel Almus Pharma (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Clopidogrel Almus Pharma per day, as described above, in combination with acetylsalicylic acid for 3 weeks. Following this, your doctor will prescribe Clopidogrel Almus Pharma alone or acetylsalicylic acid alone.
Clopidogrel Almus Pharma must 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 the emergency room of the nearest hospital 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 your usual time, take one tablet immediately and then take the next one at your usual time.
If more than 12 hours have passed, simply take your normal dose at the usual time.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clopidogrel Almus Pharma
Do not stop treatment unless your doctor has told you to. Before stopping it, contact your doctor or pharmacist.
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:

• fever, signs of infection or a severe feeling of weakness. These effects may be due to a rare decrease in certain blood cells
• signs of liver disorders 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.

The most common side effect reported with Clopidogrel Almus Pharma is bleeding.The
bleeding may manifest as bleeding in the stomach or intestine, the formation of
bruises, hematomas (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine.
In rare cases, bleeding in the eye, intracranial, in the lungs and in the
joints has also been reported.

If you experience prolonged bleeding while taking Clopidogrel Almus Pharma
If you cut yourself or get injured, it may take longer than usual
for the bleeding to stop. This is due to the way the medicine works as
it prevents the formation of blood clots. For minor cuts and wounds, such as cutting yourself or shaving,
this usually does not create problems. However, if you are concerned about the bleeding,
contact your doctor immediately (see section 2 “Warnings and precautions”).

Other side effects include:
Common side effects (may affect up to 1 in 10 people):
Diarrhea, abdominal pain, indigestion or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or
intestine, rash, itching, dizziness, sensations of tingling and numbness.
Rare side effects (may affect up to 1 in 1,000 people):
Vertigo, increased volume of the 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, difficulty breathing sometimes
associated with cough, generalized allergic reactions (for example, a widespread feeling of heat with
sudden general malaise up to fainting), swelling in the mouth, blisters, skin allergy,
mouth pain (stomatitis), decreased blood pressure, confusion,
hallucinations, joint pain, muscle pain, changes or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated based on available data):
hypersensitivity reactions with chest or abdominal pain, persistent hypoglycemia symptoms.
In addition, your doctor may have identified changes in blood and urine tests.

Reporting ofside effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

Description of the appearance of Clopidogrel Almus Pharma and contents of the pack
The film-coated tablets of Clopidogrel Almus Pharma 75 mg are round and pink in color.
Clopidogrel Almus Pharma is supplied in cardboard boxes containing 28 and 30 tablets in blisters
PCTFE+PE+PVC/aluminium.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n. 2 - Abrunheira, 2710-089 Sintra
Portugal