Clopidogrel bluefish

Package leaflet: Information for the user

Clopidogrel Bluefish, 75 mg, film-coated tablets
Clopidogrelum
Please read all of 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 further questions, ask your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of the leaflet:

1. What Clopidogrel Bluefish is and what it is used for
2. What you need to know before you take 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 Clopidogrel Bluefish is and what it is used for

Clopidogrel Bluefish contains the active substance clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small components in the blood that clump together during clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).
Clopidogrel Bluefish is used in adults to help prevent blood clots (thrombi) in hardened blood vessels (arteries) due to atherosclerosis, a condition which can lead to atherothrombotic events (such as stroke, heart attack or death).
Clopidogrel Bluefish has been prescribed for you to help prevent blood clots and reduce the risk of such serious events because:

• you have atherosclerosis (also known as hardening of the arteries), and
• you have previously had a heart attack, stroke, or have peripheral arterial disease, or
• you have had severe chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, your doctor may have inserted a stent into a blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used both to relieve pain and reduce fever, as well as to prevent blood clotting), as recommended by your doctor;
• you have experienced temporary symptoms of stroke that quickly disappeared (known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also prescribe acetylsalicylic acid within the first 24 hours;
• you have an irregular heartbeat known as “atrial fibrillation” and you cannot take medicines called “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and the growth of existing ones. Your doctor should inform you that oral anticoagulants are more effective in such cases than acetylsalicylic acid alone or the combination of acetylsalicylic acid with Clopidogrel Bluefish.
  If oral anticoagulants cannot be used and there is no high risk of severe bleeding, your doctor should prescribe Clopidogrel Bluefish together with acetylsalicylic acid.

2. Important information before using Clopidogrel Bluefish

When not to use Clopidogrel Bluefish:

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

Warnings and precautions
If any of the situations listed below apply to the patient, they should discuss them with their doctor before starting treatment with Clopidogrel Bluefish:

• if there is a risk of bleeding, such as:
  • a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer);
  • a blood disorder predisposing to internal bleeding (bleeding within tissues, organs or joints);
  • recent severe injury;
  • recent surgical procedure (including dental surgery);
  • planned surgical procedure (including dental surgery) within the next seven days;
• if the patient has been diagnosed with a blood clot in the brain (ischaemic stroke) that occurred 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 in treating this condition;
• if the patient has previously experienced a non-traumatic intracranial haemorrhage.

While using Clopidogrel Bluefish:

• The patient should inform their doctor if they are scheduled for any surgical procedure (including dental surgery).
• The patient should also inform their doctor immediately if they develop a medical condition called thrombotic thrombocytopenic purpura (TTP), which may include fever and skin bruising appearing as red, pinpoint spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is related to how the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as those occurring during shaving. However, if bleeding occurs, the patient should contact their doctor immediately (see section 4 “Possible side effects”).
• The treating doctor may order blood tests.

Children and adolescents
Clopidogrel Bluefish should not be used in children, as it has not been shown to be effective in this patient group.

Clopidogrel Bluefish and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those obtained without a prescription.

Some medicines may affect the use of Clopidogrel Bluefish or vice versa. The patient should inform their doctor, especially if they are taking:

• medicines that may increase the risk of bleeding, such as:
  • oral anticoagulants, medicines used to inhibit blood clotting;
  • non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints;
  • heparin or other injectable medicines used to reduce blood clotting;
  • ticlopidine and other antiplatelet medicines;
  • selective serotonin reuptake inhibitors (SSRIs) (including, but not limited to, fluoxetine and 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 types of epilepsy;
• moclobemide, a medicine used to treat depression;
• repaglinide, a medicine used to treat diabetes;
• paclitaxel, a medicine used to treat cancer;
• opioids: during treatment with clopidogrel, the patient should inform their 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 Bluefish in combination 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) usually should not cause problems, but prolonged use in other circumstances should be discussed with the treating doctor.

Clopidogrel Bluefish with food and drink
Clopidogrel Bluefish may be taken with or without food.

Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. If the patient becomes pregnant while taking Clopidogrel Bluefish, she should contact her doctor immediately, as use of clopidogrel during pregnancy is not recommended.

Breastfeeding is not recommended while taking this medicine.

If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using this medicine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
It is unlikely that Clopidogrel Bluefish will affect the ability to drive or operate machinery.

Clopidogrel Bluefish contains lactose.
If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Clopidogrel Bluefish contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Clopidogrel Bluefish

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

4. Possible adverse reactions

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

• fever, signs of infection, or feeling extremely tired. This may be due to a rare reduction in the number of 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 pinpoint spots, and/or confusion (see section “Warnings and precautions”);
• mouth swelling or skin disorders such as rashes and itching, or skin blisters. These may be symptoms of allergic reactions.

The most common adverse reaction reported during treatment with Clopidogrel Bluefish is bleeding.
Bleeding may occur as gastrointestinal bleeding (in the stomach or intestines), bruising, 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, intracranial bleeding, bleeding into the lungs, or into joints.
If prolonged bleeding occurs while taking Clopidogrel Bluefish
When you have 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 medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as small cuts during shaving. However, if you have any concerns about bleeding, contact your doctor immediately (see section “Warnings and precautions”).

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling and numbness.

Rare adverse reactions (may affect up to 1 in 1,000 people):
Vertigo, breast enlargement in men.

Very rare adverse reactions (may affect up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain, fever, breathing difficulties sometimes associated with cough, generalized allergic reactions (e.g. feeling of warmth with sudden general discomfort up to fainting), swelling of the lips, skin blisters, skin allergy, mouth pain (stomatitis), low blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disturbances or loss of taste.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Hypersensitivity reactions associated with chest pain or abdominal pain, persistent symptoms of low blood sugar.

Additionally, your doctor may detect changes in blood or urine test results.

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Clopidogrel Bluefish

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 after
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Please read the storage conditions provided on the carton.
Store below 25°C.
Do not use this medicine if there are any signs of damage.
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 packaging and other information

What Clopidogrel Bluefish contains

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate).
• The other ingredients are: Core: microcrystalline cellulose, hydroxypropylcellulose, mannitol, crospovidone (type A), monohydrate citric acid, 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, biconvex tablets. They are packed in
cardboard boxes containing 14, 28, 56, 84 or 112 coated tablets in blisters made of
PVC/PE/PVDC/Aluminium.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturers
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,
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Clopidogrel Bluefish 75 mg Filmtabletten
Poland Clopidogrel Bluefish, 75 mg, coated tablets
Italy Clopinovo 75 mg film coated tablets