Averelix

Patient Information Leaflet: Information for the patient

Averelix 75 mg film-coated tablets

Clopidogrel
Generic medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Averelix is and what it is used for

Averelix contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small components in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the likelihood of blood clots forming (a process known as thrombosis).

Averelix is taken by adults to help 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).

Averelix has been prescribed to you 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 had a heart attack, stroke, or a condition known as peripheral arterial disease, or

• You have experienced a severe type of 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 had 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 cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which would prevent the formation of new clots and the growth of existing ones. You should have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Averelix and acetylsalicylic acid for this condition. Your doctor may have prescribed you Averelix plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have an increased risk of bleeding.

2. What you need to know before taking Averelix

Do not take Averelix

• If you are allergic to clopidogrel or to any of the other ingredients of this medicine (listed in section 6);
• If you have a medical condition that is currently causing bleeding, such as a stomach ulcer or bleeding in part of the brain;
• If you have severe liver disease.

If you think any of these situations apply to you, or if you are unsure, consult your doctor before taking Averelix.

Warnings and precautions

If any of the following situations apply to you, inform your doctor before taking Averelix:

• If you have an increased risk of bleeding, such as:
  • A medical condition that carries a 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 procedures);
  • A planned surgical procedure (including dental procedures) within the next seven days;
• If you have had a blood clot in an artery of the brain (ischaemic stroke) within the last seven days;
• If you have kidney or liver disease;
• If you have had an allergic reaction or adverse reaction to any medicine used to treat your condition;
• If you have previously experienced a non-traumatic brain haemorrhage.

While taking Averelix:

• Inform your doctor if you are scheduled to undergo any surgical procedure (including dental procedures);
• Also inform your doctor immediately if you develop a medical condition known as thrombotic thrombocytopenic purpura (TTP), which includes fever and subcutaneous bruising that may appear as small red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “POSSIBLE SIDE EFFECTS”);
• If you cut yourself or sustain an injury, it may take longer than usual for 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 certain blood tests.

Children and adolescents
Do not give this medicine to children, as it is not effective in this population.

Other medicines and Averelix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Averelix works, or Averelix may affect how other medicines work.
You must inform your doctor 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 (NSAID), generally used to treat pain and/or inflammation 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 (SSRI) (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 disorders;
• 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, 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 (TIA), or a mild ischaemic stroke, you may have been prescribed Averelix in combination with acetylsalicylic acid, a substance found in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not exceeding 1000 mg within a 24-hour period) is generally not expected to cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Averelix with food and drink
Averelix can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you become pregnant while taking Averelix, contact your doctor immediately, as Averelix is not recommended 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 Averelix will affect your ability to drive or operate machinery.

Averelix contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Averelix contains hydrogenated castor oil
This may cause gastrointestinal disturbances and diarrhoea.

3. How to take Averelix

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

The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg Averelix tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe an initial dose of 300 mg or 600 mg of Averelix (1 or 2 tablets of 300 mg, or 4 or 8 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Averelix tablet daily, as described above.

If 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 an initial dose of 300 mg of Averelix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. This should then be followed by the recommended daily dose of one 75 mg Averelix tablet, as described above, in combination with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Averelix alone or acetylsalicylic acid alone.

You must continue taking Averelix for as long as your doctor continues to prescribe it.

If you take more Averelix than you should:

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

If you forget to take Averelix:

If you forget to take a dose of Averelix but remember within 12 hours of your usual time, take one tablet immediately, then take the next tablet at your usual time.

If more than 12 hours have passed, simply take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Averelix:

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

If you have any doubts about how to use 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 extreme fatigue. These symptoms may be due to rare reductions in certain blood cells.
• Signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing as red spots under the skin and/or confusion (see section 2 “Warnings and precautions”).
• Swelling in the mouth or skin disorders such as rash and itching, or formation of skin blisters. These may be signs of an allergic reaction.

The most commonly reported side effect with Averelix is bleeding. Bleeding may affect the stomach or intestines, and may appear as bruising, haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In rare cases, ocular, intracranial, pulmonary, or joint bleeding have also been reported.
If you experience prolonged bleeding while taking Averelix
If you are cut or injured, 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, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and numbness sensations.
Rare side effects (may occur in up to 1 in 1,000 patients):
Vertigo, 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 coughing, generalized allergic reactions (e.g., widespread feeling of warmth with sudden general malaise up to fainting); mouth swelling, skin blisters, skin allergies, mouth pain (stomatitis), decreased blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disturbances or loss of taste.
Side effects with unknown frequency (the frequency cannot be determined from 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 Averelix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack 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 any medicine 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 Averelix contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
The other components are (see section 2 "Clopidogrel tablets contain lactose" and "Clopidogrel tablets contain hydrogenated castor oil"):
Core: lactose monohydrate, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, hydrogenated castor oil, dimethicone
Coating: hypromellose (E464), Macrogol 400, titanium dioxide (E171), red iron oxide (E172)
Description of the appearance of Averelix and package contents
Averelix tablets are biconvex, round, pink in colour, with "LII" engraved on one side only.
What does the Averelix pack contain?
The tablets are supplied in blisters of 28, 50 and 100 units.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
F.I.R.M.A. S.p.A., Via di Scandicci 37 - Florence
Manufacturer
Synoptis Industrial Sp. z o.o
ul. Rabowicka 15, Swarzędz,
62-020,
Poland