Clopinovo

Italy
Brand name Clopinovo
Form tablets, film-coated
Active substance / Dosage
CLOPIDOGREL
Prescription type Prescription only
ATC code
B01AC04
Registration number 039494
Manufacturer ERREKAPPA EUROTERAPICI S.P.A.

Table of Contents

Patient Information Leaflet: Information for the User

CLOPINOVO 75 mg film-coated tablets

clopidogrel
Generic Medicine
Please read 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 questions, ask 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 CLOPINOVO is and what it is used for
  2. What you need to know before taking CLOPINOVO
  3. How to take CLOPINOVO
  4. Possible side effects
  5. How to store CLOPINOVO
  6. Contents of the pack and other information

1. What CLOPINOVO is and what it is used for

CLOPINOVO contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, platelet aggregation inhibitors reduce the likelihood of blood clots forming (a process known as thrombosis).
CLOPINOVO 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).
CLOPINOVO has been prescribed to you to help prevent blood clots and reduce the risk of these serious events because:

  • you have a disease causing hardening of the arteries (also known as atherosclerosis), and
  • you have already had a heart attack, stroke, or have a condition known as peripheral 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 inserted a stent into 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 had stroke symptoms that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may prescribe acetylsalicylic acid starting within the first 24 hours,
  • you have an irregular heartbeat, a condition called “atrial fibrillation”, and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists) which prevent the formation of new clots and the progression of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of CLOPINOVO and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have a high risk of bleeding, your doctor may have prescribed CLOPINOVO plus acetylsalicylic acid.

2. What you need to know before taking CLOPINOVO

Do not take CLOPINOVO:

  • 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 currently causing you to bleed, such as a stomach ulcer or bleeding in the brain
  • if you suffer from severe liver disease

If you think any of these conditions apply to you, or if you have any doubts, consult your doctor before taking CLOPINOVO.

Warnings and precautions

If any of the situations listed below apply to you, speak to your doctor before taking CLOPINOVO:

  • if you are at risk of bleeding, such as
  • a medical condition that puts you at risk of internal bleeding (e.g. stomach ulcer)
  • a blood disorder that makes you prone to internal bleeding (bleeding in any tissue, organ, or joint of the body)
  • a recent severe injury
  • a recent surgical procedure (including dental surgery)
  • a surgical procedure (including dental surgery) scheduled within the next seven days
  • if you have had a blood clot in an artery of the brain (ischaemic stroke) occurring within the last seven 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 experienced a non-traumatic brain haemorrhage.

While taking CLOPINOVO:

  • You must inform your doctor if you have scheduled a surgical procedure (including dental surgery).
  • You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising that may appear 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, bleeding may take longer to stop. This is due to how the medicine works, as it prevents the formation of blood clots. For minor cuts or injuries, e.g. cuts, shaving cuts, this is usually not a cause for concern. 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 CLOPINOVO

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Some medicines may affect the use of CLOPINOVO or vice versa. You must especially inform your doctor if you are taking:

  • medicines that may increase the 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, another antiplatelet medicine,
    • a selective serotonin reuptake inhibitor (including but not limited to fluoxetine or fluvoxamine), medicines normally used to treat depression,
    • rifampicin (used to treat serious infections),
  • omeprazole, esomeprazole, medicines used to treat stomach problems,
  • fluconazole, 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 being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
  • rosuvastatin (used to lower cholesterol levels).

If you have suffered from severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a mild ischaemic stroke, you may be prescribed CLOPINOVO 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 within a 24-hour period) generally should not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

CLOPINOVO with food and drink

CLOPINOVO can be taken regardless of meals.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. If you become pregnant while taking CLOPINOVO, consult your doctor immediately, as clopidogrel 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 CLOPINOVO will affect your ability to drive or operate machinery.

CLOPINOVO contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Clopidogrel contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically 'sodium-free'.

3. How to take CLOPINOVO

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 CLOPINOVO 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 give you
300 mg or 600 mg of CLOPINOVO (4 or 8 tablets of 75 mg) once at the beginning of treatment. Afterwards,
the recommended dose is one 75 mg CLOPINOVO tablet daily, as described above.
If you have experienced symptoms of a stroke that disappear within a short period of time (also known as
transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you 300 mg of
CLOPINOVO (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose
is one 75 mg CLOPINOVO tablet daily as described above, in combination with acetylsalicylic acid for
3 weeks. After this period, your doctor will prescribe either CLOPINOVO alone or acetylsalicylic acid alone.
You must continue taking CLOPINOVO for as long as your doctor continues to prescribe it.
If you take more CLOPINOVO than you should
Contact your doctor or go to the nearest hospital emergency department due to the risk of increased
bleeding.
If you forget to take CLOPINOVO
If you forget to take a dose of CLOPINOVO but remember within 12 hours of your usual dosing time, take
the tablet immediately and then take the next tablet at your usual time.
If you forget to take the medicine for more than 12 hours, simply take the next single dose at your usual
time. Do not take a double dose to make up for the forgotten dose.
If you stop taking CLOPINOVO:
Do not stop treatment unless your doctor has told you to do so. 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 notice any of the following:

  • fever, signs of infection, or extreme tiredness. These symptoms could be caused by 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 of the mouth or skin disorders such as rash and itching, skin blisters. These may be signs of an allergic reaction.

The most common side effect reported with CLOPINOVO is bleeding.
Bleeding may occur as gastrointestinal or intestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. In a small number of cases, bleeding in the eyes, inside the head, in the lungs or in the joints has also been reported.
If you experience prolonged bleeding while taking Clopinovo
If you cut or injure yourself, bleeding may take longer to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, e.g. small cuts, shaving cuts, this is usually not a cause for concern.
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 affect up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or stomach burning.
Uncommon side effects (may affect up to 1 in 100 people):
headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rash, itching, dizziness, tingling and numbness sensations.
Rare side effects (may affect up to 1 in 1,000 people):
dizziness, breast enlargement 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, breathing difficulties sometimes associated with cough; generalized allergic reactions (e.g., widespread sensation of warmth with sudden general malaise up to fainting); mouth swelling; skin blisters; skin allergy; mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.

Side effects with unknown frequency (frequency cannot be estimated from the available data):
hypersensitivity reactions with chest or abdominal pain; persistent symptoms of hypoglycaemia.
Additionally, your doctor may detect changes in laboratory test results (blood or urine).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 CLOPINOVO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister, following
"EXP." The expiry date refers to the last day of that month.
Refer to the storage conditions reported on the carton.
If CLOPINOVO is supplied in PVC/PE/PVDC/aluminium blisters, store it below 25°C.
If CLOPINOVO is supplied in PA/AL/PVC/aluminium blisters, no special storage conditions are required.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What CLOPINOVO contains

  • The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besylate).
  • The other components are: Core: microcrystalline cellulose, hydroxypropylcellulose, mannitol (E421), crospovidone, citric acid monohydrate, macrogol 6000, stearic acid, sodium stearyl fumarate. Coating: hypromellose, red iron oxide (E172), lactose monohydrate, triacetin, titanium dioxide (E171)

Description of the appearance of CLOPINOVO and package contents
CLOPINOVO film-coated tablets are pink, round and biconvex.
They are supplied in PVC/PE/PVDC-Alu blisters packed in cartons containing 14, 28, 30, 50, 56, 84, 90, 100 or 112 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Errekappa Euroterapici S.p.A.
Via Ciro Menotti 1/A
20129 Milano
Italy

Manufacturers
Pharmathen S.A.
6, Dervenakion str.
15351 Pallini Attiki
Greece
or
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture Block n. 5
Rodopi 69300
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany Clopidogrel Heumann 75mg Film Tablets
Netherlands Clopidogrel Mylan 75 mg, film-coated tablets
Italy CLOPINOVO 75 mg film-coated tablets
Poland Clopidogrel Bluefish, 75 mg, tablets coated