Nogreg

Package leaflet: Information for the user

NOGREG 75 mg film-coated tablets

Clopidogrel (as besilate)
Equivalent 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NOGREG is and what it is used for

NOGREG contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors.
Platelets are very small 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).
NOGREG 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).
NOGREG 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 previously had a heart attack, stroke or 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 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 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 growth of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of NOGREG and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you NOGREG plus acetylsalicylic acid.

2. What you should know before taking NOGREG

Do not take NOGREG

• 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 situations applies to you, or if you are unsure, consult your doctor before using NOGREG.

Warnings and precautions

If any of the conditions listed below apply to you, inform your doctor before taking NOGREG:

• if you are at 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); or a planned surgical procedure (including dental surgery) within the next 7 days;
• if you have had a blood clot in a brain artery (ischemic 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;
• if you have previously had a non-traumatic brain hemorrhage.

While taking NOGREG:

• You must inform your doctor if you are scheduled to undergo surgery (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 bruising under the skin appearing as small 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 bleeding to stop. This is due to how 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 in this population.

Other medicines and NOGREG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may affect how NOGREG works or vice versa. You must inform your doctor exactly 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, other antiplatelet agents;
• a selective serotonin reuptake inhibitor (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 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 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 had severe chest pain (unstable angina or heart attack), you may have been prescribed NOGREG in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever.

Occasional use of acetylsalicylic acid (not exceeding 1000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

NOGREG with food and drink
NOGREG 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 think you may be, inform your doctor or pharmacist before taking NOGREG. If you become pregnant while taking NOGREG, consult your doctor immediately, as it is recommended not to take NOGREG 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 NOGREG will affect your ability to drive or operate machinery.

NOGREG contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take NOGREG

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 NOGREG 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 NOGREG (1 or 2 tablets of 300 mg, or 4 or 8 tablets of 75 mg) at the beginning of treatment. After this initial dose, the recommended maintenance dose is one 75 mg NOGREG tablet daily, as described above.

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

If you take more NOGREG than you should
Contact your doctor or the nearest hospital emergency department immediately, as there is an increased risk of bleeding.

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

For packs containing 7, 14, 28, and 84 tablets, you can check the calendar printed on the blister to identify the day on which the last tablet was taken.

If you stop taking NOGREG
Do not stop treatment unless your doctor has instructed you to do so. Before stopping, consult your doctor or pharmacist.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 commonly reported side effect with NOGREG is bleeding.
Bleeding may occur in the stomach or intestines, bruising, haematomas (unusual or subcutaneous bleeding), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs, or in the joints has also been reported.
If you experience prolonged bleeding while taking NOGREG
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 the formation of blood clots. For minor cuts or injuries, such as shaving cuts or small 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 people): Diarrhoea, abdominal pain, indigestion, or stomach burning.
Uncommon side effects (may occur in up to 1 in 100 people): Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare side effects (may occur in up to 1 in 1,000 people): Dizziness, breast enlargement in males.
Very rare side effects (may occur in up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (for example, widespread sensation of warmth with sudden general malaise up to fainting); swelling in the mouth; skin blisters; skin allergy; mouth pain (stomatitis); decreased 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 have detected changes in blood or urine test results.
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 NOGREG

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
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 NOGREG contains

• The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel besilate).
• The other components are:

Tablet core:
Pregelatinized starch
Microcrystalline cellulose
Crospovidone
Anhydrous colloidal silica
Stearic acid

Tablet film coating:
Carnauba wax
Opadry II Pink Powder 31 K34111 consisting of:
Monohydrate lactose
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Red iron oxide (E172)

Description of the appearance of NOGREG and pack contents
NOGREG film-coated tablets are pink-colored, round, biconvex, film-coated tablets,
with "75" engraved on one side and a diameter of approximately 8.3 mm.
NOGREG is available in blisters of:
28, 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group s.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
PharmaPath S.A.
28is Oktovriou 1,
Agia Varvara, 12351
Greece