CLOPIDOGREL 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clopidogrel Bluefish, 75 mg, Coated Tablets
   1. Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Clopidogrel Bluefish and what is it used for
4. Important information before taking Clopidogrel Bluefish
   1. When not to take Clopidogrel Bluefish:
   2. Warnings and precautions
   3. Children and adolescents
   4. Clopidogrel Bluefish and other medications
   5. Clopidogrel Bluefish with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Clopidogrel Bluefish contains lactose
   9. Clopidogrel Bluefish contains sodium
5. How to take Clopidogrel Bluefish
   1. Taking more than the recommended dose of Clopidogrel Bluefish
   2. Missing a dose of Clopidogrel Bluefish
   3. Stopping treatment with Clopidogrel Bluefish
6. Possible side effects
   1. The patient should immediately contact their doctor if they experience:
   2. The most common side effect reported during treatment with Clopidogrel Bluefish is bleeding.
   3. If prolonged bleeding occurs while taking Clopidogrel Bluefish
   4. Other side effects include:
   5. Reporting side effects
7. How to store Clopidogrel Bluefish
8. Contents of the pack and other information
   1. What Clopidogrel Bluefish contains
   2. What Clopidogrel Bluefish looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Clopidogrel Bluefish, 75 mg, Coated Tablets

Clopidogrel

Before Taking the Medication, Read the Contents of the Leaflet, as it Contains Important Information for the Patient.

• This leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Clopidogrel Bluefish and what is it used for
• 2. Important information before taking Clopidogrel Bluefish
• 3. How to take Clopidogrel Bluefish
• 4. Possible side effects
• 5. How to store Clopidogrel Bluefish
• 6. Contents of the pack and other information

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

Clopidogrel Bluefish contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small structures that clump together during blood clotting. By preventing this clumping, antiplatelet agents reduce the risk of blood clots (a process known as thrombosis).
Clopidogrel Bluefish is used in adults to prevent blood clots (thrombi) in hardened arteries (arteries with atherosclerosis), which can lead to atherosclerotic events (such as stroke, heart attack, or death).
The patient has been prescribed Clopidogrel Bluefish to prevent blood clots and reduce the risk of these severe events, because:

• the patient has atherosclerosis (also known as arteriosclerosis) and
• the patient has previously had a heart attack, stroke, or has a condition known as peripheral arterial disease, or
• the patient has had severe chest pain (known as "unstable angina" or "myocardial infarction" - a heart attack). To treat this condition, the doctor may place a stent in the blocked or narrowed artery to restore blood flow. The patient may also receive acetylsalicylic acid (a substance found in many medications, used to relieve pain and reduce fever, as well as to prevent blood clotting), as recommended by the doctor.
• the patient has had symptoms of a stroke that resolve quickly (called a "transient ischemic attack" or "TIA") or a mild ischemic stroke. The doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• the patient has an irregular heartbeat, known as "atrial fibrillation," and cannot take medications called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new blood clots and the growth of existing ones. The doctor should inform the patient that oral anticoagulants are more effective in these cases than acetylsalicylic acid or the combination of acetylsalicylic acid and Clopidogrel Bluefish.

When oral anticoagulants cannot be used and there is no risk of severe bleeding, the doctor should prescribe Clopidogrel Bluefish with acetylsalicylic acid.

2. Important information before taking Clopidogrel Bluefish

When not to take Clopidogrel Bluefish:

• if the patient is allergic to clopidogrel or any of the other ingredients of this medication (listed in section 6).
• if the patient has a condition that is currently causing bleeding, such as a stomach ulcer or bleeding in the brain.
• if the patient has severe liver disease. If the patient thinks they may have any of these problems or has any other doubts, they should consult their doctor before taking Clopidogrel Bluefish.

Warnings and precautions

If any of the following situations apply to the patient, they should discuss them with their doctor before taking Clopidogrel Bluefish:

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (e.g., stomach ulcer).
• a blood disorder that increases the risk of internal bleeding (bleeding into 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 seven days.
• if the patient has had a blood clot in the brain (ischemic stroke) within the last seven days.
• if the patient has kidney or liver disease.
• if the patient has had an allergy or hypersensitivity to any medications used to treat this condition.
• if the patient has had a non-traumatic brain hemorrhage.

While taking Clopidogrel Bluefish:

• The patient should inform their doctor if they are scheduled to have surgery (including dental surgery).
• The patient should also immediately inform their doctor if they experience a condition known as thrombotic thrombocytopenic purpura (TTP), which includes fever and bruising under the skin, appearing as red, pinpoint spots with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• In case of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way the medication works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. However, in case of any doubts about bleeding, the patient should immediately contact their doctor (see section "Warnings and precautions").
• The doctor may order blood tests.

Children and adolescents

This medication should not be used in children, as it has not been shown to be effective in this patient group.

Clopidogrel Bluefish and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription.
Some other medications may affect the use of Clopidogrel Bluefish or vice versa.
The patient should inform their doctor, especially if they are taking:

• medications that may increase the risk of bleeding, such as: oral anticoagulants, medications used to inhibit blood clotting, nonsteroidal anti-inflammatory drugs (NSAIDs), usually used to treat painful and/or inflammatory conditions of muscles or joints, heparin or other injectable medications used to reduce blood clotting, ticlopidine and other antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs), including fluoxetine and fluvoxamine, medications usually used to treat depression, rifampicin (used to treat severe infections).
• omeprazole or esomeprazole, medications used to treat stomach disorders.
• fluconazole or voriconazole, medications used to treat fungal infections.
• efavirenz or other antiretroviral medications (used to treat HIV infection).
• carbamazepine, a medication used to treat certain types of epilepsy.
• moclobemide, a medication used to treat depression.
• repaglinide, a medication used to treat diabetes.
• paclitaxel, a medication used to treat cancer.
• opioids: during treatment with clopidogrel, the patient should inform their doctor before prescribing any opioid (medications used to treat severe pain).
• rosuvastatin (used to reduce cholesterol levels).

Patient who have had severe chest pain (unstable angina or heart attack), transient ischemic attack, or mild ischemic stroke may be prescribed Clopidogrel Bluefish in combination with acetylsalicylic acid, a substance found in many medications, used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) should not usually cause a problem, but prolonged use in other circumstances should be discussed with the doctor.

Clopidogrel Bluefish with food and drink

Clopidogrel Bluefish can be taken with or without food.

Pregnancy and breastfeeding

The use of this medication is not recommended during pregnancy.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. If the patient becomes pregnant while taking Clopidogrel Bluefish, they should immediately consult their doctor, as the use of clopidogrel during pregnancy is not recommended.
The patient should not breastfeed while taking this medication.
If the patient is breastfeeding or plans to breastfeed, they should consult their doctor before taking this medication.
Before taking any medication, the patient should consult their doctor or pharmacist.

Driving and using machines

It is unlikely that Clopidogrel Bluefish will affect the patient's ability to drive or use machines.

Clopidogrel Bluefish contains lactose

If the doctor has informed the patient that they have an intolerance to some sugars, the patient should consult their doctor before taking this medication.

Clopidogrel Bluefish contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medication is considered "sodium-free".

3. How to take Clopidogrel Bluefish

This medication should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Clopidogrel Bluefish is one 75 mg tablet per day, taken orally at the same time every day, with or without food. This dosage also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).
If the patient has had severe chest pain (unstable angina or heart attack), the doctor may prescribe an initial dose of 300 mg or 600 mg of Clopidogrel Bluefish (4 or 8 tablets of 75 mg). Then, the usual recommended dose of Clopidogrel Bluefish is one 75 mg tablet per day, as described above.
If the patient has had symptoms of a stroke that resolve quickly (also known as a transient ischemic attack) or a mild ischemic stroke, the doctor may prescribe a single dose of 300 mg of Clopidogrel Bluefish (4 tablets of 75 mg) at the start of treatment. Then, the recommended dose is one Clopidogrel Bluefish tablet, 75 mg per day, as described above, with acetylsalicylic acid for 3 weeks. Then, the doctor may prescribe clopidogrel or acetylsalicylic acid separately.
Clopidogrel Bluefish should be taken for as long as the doctor prescribes it.

Taking more than the recommended dose of Clopidogrel Bluefish

The patient should contact their doctor or the nearest hospital emergency department due to the increased risk of bleeding.

Missing a dose of Clopidogrel Bluefish

If the patient forgets to take a dose of Clopidogrel Bluefish 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 the patient forgets for more than 12 hours, they should simply take the next single dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Clopidogrel Bluefish

The patient should not stop treatment unless advised by their doctor.Before stopping, the patient should consult their doctor or pharmacist.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Clopidogrel Bluefish can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of certain blood cells.
• symptoms of liver dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears under the skin as red, pinpoint spots and/or confusion (see "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rash and itching, blisters. These may be signs of allergic reactions.

The most common side effect reported during treatment with Clopidogrel Bluefish is bleeding.

Bleeding may occur as stomach or intestinal bleeding, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also been reports of a small number of cases of bleeding in the eye, brain, lungs, or joints.

If prolonged bleeding occurs while taking Clopidogrel Bluefish

In case of a cut or injury, the time it takes for the bleeding to stop may be slightly longer than usual. This is related to the way the medication works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts and injuries, such as cuts while shaving. However, in case of any doubts about bleeding, the patient should immediately contact their doctor (see "Warnings and precautions").

Other side effects include:

Frequent side effects (may affect up to 1 in 10 people):
Diarrhea, stomach pain, indigestion, or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcers, vomiting, nausea, constipation, gas in the stomach or intestines, rash, itching, dizziness, tingling, or numbness.
Rare side effects (may affect up to 1 in 1,000 people):
Vertigo of labyrinthine origin, gynecomastia (breast enlargement in men).
Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice, severe stomach pain with or without back pain, fever, difficulty breathing sometimes associated with cough, generalized allergic reactions (e.g., feeling of heat with sudden general discomfort up to fainting), swelling of the mouth, blistering skin, skin allergy, painful mouth (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disorders, or loss of taste.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Hypersensitivity reactions associated with chest pain or stomach pain, persistent symptoms of low blood sugar.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medication.

5. How to store Clopidogrel Bluefish

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the carton and blister after "Expiration Date (EXP)". The expiration date refers to the last day of the specified month.
The patient should read the storage conditions on the carton.
Store at a temperature below 25°C.
The medication should not be used if there are any visible signs of damage.
Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clopidogrel Bluefish contains

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as besylate).
• The other ingredients are: Core:microcrystalline cellulose, hydroxypropylcellulose, mannitol, crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid (type 50), sodium stearyl fumarate. Coating:hypromellose, iron oxide red (E172), lactose monohydrate, triacetin, titanium dioxide (E171).

What Clopidogrel Bluefish looks like and contents of the pack

Clopidogrel Bluefish coated tablets are pink, round, and biconvex. They are packaged in cardboard boxes containing 14, 28, 56, 84, or 112 coated tablets in PVC/PE/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer

Pharmathen S.A.
6, Dervenakion Street
Pallini 15351
Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece
Docpharma NV
Ambachtenlaan 13 H/Interleuvenlaan 66, 3001 Heverlee
Belgium
Heumann Pharma GmbH & Co. Generica KG
Suedwestpark 50, 90449 Nuernberg
Germany
Mylan B.V.,
Dieselweg 25, 3752 LB Bunschoten,
Netherlands

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

Germany
Clopidogrel Bluefish 75 mg Filmtabletten
Poland
Clopidogrel Bluefish, 75 mg, coated tablets
Italy
Clopinovo 75 mg film coated tablets
Date of last revision of the leaflet:April 2024