Clopidogrel Viatris Italia

PATIENT LEAFLET: INFORMATION FOR THE USER

Flodigrel 75 mg film-coated tablets
clopidogrel
equivalent 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as 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:

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

1. What Flodigrel is and what it is used for

Flodigrel contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are microscopic blood components that clump together during blood clotting. By preventing this clumping, platelet aggregation inhibitors reduce the likelihood of blood clots forming (a process known as thrombosis).
Flodigrel 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).
Flodigrel has been prescribed to help prevent blood clots and 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 a severe type of 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 also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting).
• you have an irregular heartbeat, a condition called 'atrial fibrillation', and you cannot take medicines such as 'oral anticoagulants' (vitamin K antagonists) that prevent the formation of new clots and prevent existing clots from growing. You have been informed that 'oral anticoagulants' are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor has prescribed Flodigrel plus acetylsalicylic acid if you are unable to take 'oral anticoagulants' and do not have a higher risk of bleeding.

2. What you need to know before taking Flodigrel

Do not take Flodigrel

• if you are allergic (hypersensitive) to clopidogrel or to any of the other ingredients 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, inform your doctor before taking Flodigrel.

Warnings and precautions

If any of the following situations apply to you, speak to your doctor before taking Flodigrel:

• if you have a 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 serious injury.
  • a recent surgical procedure (including dental surgery).
  • a surgical procedure (including dental surgery) scheduled 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.

While taking Flodigrel:

• You must inform your doctor if you are due to undergo surgery (including dental surgery).
• You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura, TTP) that includes fever and bruising under the skin appearing as 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 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 prescribe blood tests for you.

Children and adolescents

Do not give this medicine to children as it is not effective.

Other medicines and Flodigrel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may affect the use of Flodigrel 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 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 usually used to treat depression,
  • omeprazole or esomeprazole, medicines for treating stomach problems,
  • fluconazole or voriconazole, medicines for treating fungal infections,
  • efavirenz, a medicine used to treat HIV (human immunodeficiency virus) infections,
  • carbamazepine, a medicine for treating certain types of epilepsy,
  • moclobemide, a medicine for treating depression,
  • repaglinide, a medicine for treating diabetes,
  • paclitaxel, a medicine for treating cancer.

If you have had severe chest pain (unstable angina or heart attack), you may have been prescribed Flodigrel 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 1,000 mg in 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Flodigrel with food and drink

Flodigrel 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 suspect you may be pregnant, consult your doctor or pharmacist before taking Flodigrel. If you become pregnant while taking Flodigrel, contact your doctor immediately, as clopidogrel is not recommended during pregnancy.
Breastfeeding is not recommended while taking 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 Flodigrel will affect your ability to drive or use machines.

Flodigrel contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Flodigrel

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose, even for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg tablet of Flodigrel daily, taken orally with or without food, at the same time each day.

If you have had severe chest pain (unstable angina or heart attack), your doctor may give you an initial dose of 300 mg of Flodigrel (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg tablet of Flodigrel daily, as described above.

Flodigrel should be taken for as long as your doctor considers it necessary.

If you take more Flodigrel than you should

Contact your doctor or the nearest hospital emergency department due to the risk of increased bleeding.

If you forget to take Flodigrel

If you forget to take a dose of Flodigrel but remember within 12 hours of the usual time, take one tablet immediately and then take the next dose at the usual time.
If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Flodigrel

Do not stop taking Flodigrel unless your doctor tells you to. Before stopping, contact your doctor or pharmacist.

If you have any doubts about using this medicine, consult 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 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, or skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with Flodigrel is bleeding.
Bleeding may occur as bleeding in the stomach or intestines, bruising, haematomas (unusual or excessive bruising under the skin), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, lungs, or joints has also been reported.

If you experience prolonged bleeding while taking Flodigrel
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 or minor 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, stomach ulcer, vomiting, nausea, constipation, excess 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, breathing difficulties sometimes associated with cough; generalized allergic reactions, for example, a general feeling of warmth with sudden widespread discomfort up to fainting; swelling in the mouth; skin blisters; skin allergy; mouth inflammation (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste.

Side effects with unknown frequency (frequency cannot be determined from available data): hypersensitivity reactions with chest or abdominal pain.

In addition, your doctor may have identified changes in blood and urine test results.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects via:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clopidogrel Splendiris

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, after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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. Contents of the pack and other information

What Flodigrel contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other components are:

• Tablet core: silicified microcrystalline cellulose (microcrystalline cellulose, anhydrous colloidal silica), low-substituted hydroxypropylcellulose, hydrogenated castor oil.
• Tablet coating: white Opadry Y-1-7000 (hypromellose (E464), titanium dioxide (E171), Macrogol 400).

Description of the appearance of Flodigrel and contents of the pack

Flodigrel 75 mg film-coated tablets are round, biconvex, white to off-white in colour.

Flodigrel is supplied in cardboard boxes containing 28, 84, and 100 tablets in OPA/Al/PVdC//Al blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM)
Italy

Manufacturer
Splendris Pharmaceuticals GmbH
Frankfurten Strasse 39
63303 Dreieich
Germany

This medicine is authorised in the European Economic Area Member States under the following names:

Austria: Clopidogrel-Splendris 75 mg film-coated tablets
Denmark: Clopidogrel-Splendris 75 mg film-coated tablets
Germany: Clopidogrel-Splendris 75 mg film-coated tablets
Greece: DEMOGREL 75 mg film-coated tablets
Ireland: Clopidogrel-Splendris 75 mg film-coated tablets
Italy: Flodigrel 75 mg film-coated tablets
Portugal: Clopidogrel-Splendris 75 mg film-coated tablets
United Kingdom: Clopidogrel 75 mg film-coated tablets
Sweden: Clopidogrel Splendris 75 mg film-coated tablets
Hungary: Clopidogrel Splendris 75 mg film-coated tablets