Complavin 75 mg/100 mg 30 tablets

Complavin 75 mg/100 mg 30 tablets

Composition:

Active substances:
Clopidogrel 75 mg (97.88 mg as clopidogrel sulfate), Acetylsalicylic acid100 mg
Excipients:
Anhydrous lactose, partly pregelatinized starch, hydroxypropylcellulose, macrogol, tocopherol, microcrystalline cellulose, hydrogenated oil, sucrose esters of fatty acids, hypromellose, titanium dioxide, talc, dimethylpolysiloxane, silicon dioxide, carnauba wax, corn starch, stearic acid, light anhydrous silicic acid, methacrylic acid copolymer LD, sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Description:

ComPlavin® is a combined antiplatelet medicinal product containing clopidogrel and acetylsalicylic acid (ASA).
It inhibits platelet aggregation and reduces the risk of thrombus formation in arteries (atherothrombosis).

Indications for Use:

Indicated in adult patients for the prevention of atherothrombotic events in:

• Stable angina pectoris;
• Unstable angina pectoris;
• Myocardial infarction.
• Prescribed as a substitute for the separate administration of clopidogrel and acetylsalicylic acid, including patients with coronary stent implantation.

Method of Administration and Dosage:

• The recommended dose is one tablet once daily.
• The tablet should be taken orally with a glass of water, with food.
• The tablet must be swallowed whole and must not be crushed or chewed.
• Duration of treatment is determined by the physician.
• After myocardial infarction, treatment should continue for at least four weeks.

Contraindications:

ComPlavin is contraindicated in patients with:

• Hypersensitivity to clopidogrel, acetylsalicylic acid, or excipients;
• Allergy to non-steroidal anti-inflammatory drugs;
• Active bleeding (e.g. gastrointestinal ulcer, intracranial haemorrhage);
• Asthma combined with rhinitis and nasal polyps;
• Severe hepatic impairment;
• Severe renal impairment;
• Planned medical management or open-heart surgery for unstable angina or myocardial infarction;
• Third trimester of pregnancy.

Precautions:

• Caution is required in patients with:
• Increased bleeding risk;
• Gastrointestinal ulcers;
• Blood disorders;
• Recent trauma or surgery;
• Recent ischaemic stroke;
• Liver or kidney disease;
• Asthma or allergic conditions;
• Gout;
• G6PD deficiency;
• Hypertension;
• Alcohol consumption;
• Not intended for use in children and adolescents under 18 years due to the risk of Reye’s syndrome.

Side Effects:

Common: bleeding, diarrhoea, abdominal pain, heartburn.
Uncommon: headache, dizziness, nausea, vomiting, skin reactions.
Rare and very rare: jaundice, severe allergic reactions, anaemia, hearing disturbances, renal disorders, hypoglycaemia, gout.

Pregnancy and Breastfeeding:

• Contraindicated during the third trimester of pregnancy
• Not recommended during the first and second trimesters
• Breastfeeding should be discontinued during treatment.

Storage Conditions:

Store below 30 °C.
Keep out of the sight and reach of children.

Packaging:

Carton box containing 30 film-coated tablets in aluminium blisters and a package leaflet.