- WHAT NAFAMEDIL IS AND WHAT IT IS USED FOR
Clopidogrel, the active substance of the Nafamedil tablets, belongs to a group of medicines called antiplatelet medicinal products. 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, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
Nafamedil is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death).
You have been prescribed Nafamedil to help prevent blood clots formation and reduce the risk of these severe events because:
- You have a condition of hardening of arteries (also known as atherosclerosis)
- You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (PAD)
- BEFORE YOU TAKE NAFAMEDIL
DO NOT TAKE NAFAMEDIL:
- If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Nafamedil;
- If you have an active bleeding, such as a stomach ulcer or brain bleeding;
- If you suffer from severe liver disease;
If you think that any of these problems apply to you, or if you are in any doubt at all, consult your doctor before taking Nafamedil
Take special care with Nafamedil: If any of the situations mentioned below apply to you, you should tell your doctor before taking Nafamedil:
- If you have a risk of haemorrhage such as:
- A medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
- A blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
- A recent serious injury
- A recent surgery (including dental)
- A planned surgery (including dental) in the next seven days
- If you have had a clot in your brain artery (stroke) that occurred in the last seven days
- If you are taking another type of medication. (See “Taking Nafamedil with other medicines”).
- If you have kidney or liver disease.
Taking Nafamedil with food and drink: Clopidogrel Aba may be taken with or without food.
Pregnancy and lactation: It is preferable not to use this medicinal product during pregnancy and even breast-feeding.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Nafamedil. If you become pregnant while taking Nafamedil, you should consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
While taking Nafamedil, consult your doctor about the breast-feeding of a baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines: Nafamedilis unlikely to affect your ability to drive or to use machines.
- HOW TO TAKE NAFAMEDIL
Always take Nafamedil following the directions of your doctor. You should talk with your doctor or pharmacist if you are not sure.
If you have experienced a severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Nafamedil (4 tablet of 75 mg) once at the start of treatment. Then, the usual dose is one 75-mg tablet of Nafamedil per day to be taken orally with or without food, and at the same time each day.
You should take Nafamedil for as long as your doctor prescribes it.
If you take more Nafamedil than you should: Contact your doctor or the nearest emergency department because of the increased risk of bleeding.
If you forget to take Nafamedil: If you forget to take a dose of Nafamedil, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet 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 dose that you missed.
If you stop taking Nafamedil: Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you have any further questions, on the use of this medicine, ask your doctor or pharmacist.
- POSSIBLE SIDE EFFECTS
Like all medicines, Nafamedil can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience:
Fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
Signs of liver alterations, such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see Take special care with Nafamedil).
Swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin.
These may be the signs of an allergic reaction.
The most common side effect (affects 1 to 10 patients in 100) reported with Nafamedil is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
If you experience prolonged bleeding when taking Nafamedil: If you cut or injure yourself, it may take longer than usual for bleeding to stop. This fact is related to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries (e.g., cutting yourself, shaving), this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see Take special care with Nafamedil).
Other side effects reported with Nafamedil are: Common side effects (affects 1 to 10 patients in 100): Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (affects 1 to 10 patients in 1,000): headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness and abnormal touch sensation.
Rare side effect (affects 1 to 10 patients in 10,000): vertigo.
Very rare side effects (affects less than 1 patient in 10,000): jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint and muscular pain; taste disorders.
In addition, your doctor may identify changes in your blood or urine test results.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- HOW TO STORE NAFAMEDIL
Keep out of the reach and sight of children.
Does not require any special storage conditions.
Do not use Nafamedil after the expiry date printed on the carton after EXP. The expiry date refers to the last day of the indicated month.
Do not use Nafamedil if you verify that the packing is damaged or with visible signals of adulteration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Marketing Authorisation Holder and Manufacturer
Atlantic Pharma
Zona Industrial da Abrunheira
Rua da Tapada Grande, nº2
Abrunheira
2710-089 Sintra
Portugal