Acefein, 10 tablets, TEVA

PRODUCT INFORMATION

Ingredients: Drugs: Paracetamol 250 mg, Acetylsalicylic acid 250 mg, Caffeine 50 mg, Codeine phosphate 10 mg.

Excipients: microcrystalline cellulose, maize starch, crospovidone, glycerol distearate, povidone, anhydrous colloidal silicon.

PHARMACEUTICAL FORM AND PACKAGING: Acefein tablets 10 pieces in a cardboard box.

ACTION: Acefein is a combined product with analgesic, antipyretic and anti-inflammatory action. Contains acetylsalicylic acid (aspirin), paracetamol, codeine and caffeine. Codeine has a calming, antitussive and analgesic effect. Caffeine enhances the effect of the other three components of the product, facilitating their passage through the blood-brain barrier. It has its own analgesic effect on migraines. After oral administration, Acefein is absorbed quickly and easily by the body.

INFORMATION REQUIRED BEFORE USING THE MEDICINAL PRODUCT
INDICATIONS:
Pain of low to medium intensity
• headache - migraine and tension headache;
• toothache;
• postoperative pain;
• inflammatory and degenerative diseases of the musculoskeletal system;
• peripheral nervous diseases - radiculitis, plexitis, radiculoplexitis, neuritis;
• inflammatory processes of the upper respiratory tract, accompanied by cough and fever.

CONTRAINDICATIONS:
The product is not used for:
• hypersensitivity to the active substances and excipients;
• hypersensitivity to non-steroidal anti-inflammatory drugs;
• ulcer of the stomach and duodenum;
• existing hemorrhagic diathesis;
• liver failure;
• in renal failure;
• surgical interventions with heavy bleeding.

SPECIAL PRECAUTIONS FOR USE: The product should be used with caution in patients with bronchial asthma. Blood pressure, liver and kidney function should be monitored during treatment with Acefein. Patients should also be monitored for occult gastrointestinal bleeding. The product is used with caution in exhausted and elderly patients with gastroduodenitis, ischemic heart disease, hypertension, peripheral circulatory disorders, uterine bleeding. Acefein may affect laboratory results in uric acid and blood sugar tests. Prolonged use of the product may lead to drug dependence on codeine.

DRUGS AND OTHER INTERACTIONS: Acefein potentiates the central depressant effect of MAO inhibitors, tricyclic antidepressants, barbiturates, sulphonylureas, penicillins and 6-mercaptopurine. The product reduces the blood pressure lowering effect of guanethidine, methyldopa and reserpine and the diuretic effect of spironolactone and furosemide. Concomitant use with diuretics requires hydration due to the risk of renal failure. Acefein reduces absorption and enhances the ulcerogenic action of non-steroidal anti-inflammatory products. Concomitant use with alcohol and hepatotoxic products leads to an increased risk of liver damage and the formation of toxic metabolites due to enzyme induction. The product should not be combined with high doses of methotrexate (above 15 mg daily) due to increased haematotoxicity due to decreased renal clearance of methotrexate from acetylsalicylic acid. The product potentiates the action of anticoagulants and antiplatelet agents. Alcohol enhances the depressant effect of Acefein on the CNS. Combined use of the product with phenytoin may cause liver damage. The combination with glucocorticoids as well as with valproic acid derivatives increases the risk of gastrointestinal bleeding.

SPECIAL WARNING (S), FOR USE IN SPECIFIC PATIENT GROUPS: Acefein is not recommended during pregnancy and lactation.
Use with caution in exhausted and elderly patients.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES: The product may change the reactions, therefore it should be used with caution by persons whose activity requires increased attention and quick reflexes.

INFORMATION ON CORRECT USE:
DOSAGE: For adults and children over 15 years - 1 tablet every 4 hours, no more than 6 tablets per day. The product is not suitable for children under 15 years of age. The duration of treatment is no more than 5-7 days.

METHOD OF ACTION IN OVERDOSE: Overdose causes nausea, vomiting, diarrhea, vomiting of blood, headache, euphoria, hallucinations, tremors, seizures, tachycardia. In more severe cases - blood in the stool, urinary retention, muscle relaxation, hypostatic or aspiration pneumonia, respiratory arrest, coma. Symptomatic agents, enhanced diuresis, respiratory resuscitation, anti-shock and antihypovolemic therapy are used for treatment. N-acetylcysteine ​​is used as an antidote to paracetamol.

SIDE EFFECTS: The following side effects may occur:
• on the part of the CNS - tinnitus and acute hearing loss, insomnia, headache, usually at high doses;
• on the part of the gastrointestinal tract - ulcers of the stomach and duodenum, bleeding from the stomach and intestines (as well as hidden); liver damage;
• on the part of hematopoiesis - bleeding from the nose and gums, skin bleeding;
• hypersensitivity reactions - Quincke's edema, rash, asthma, severe allergic reactions.

STORAGE: Store in a dry and protected from light place at a temperature not higher than 25oС.

SHELF LIFE: 2 / two / years from the date of production.

Manufacturer: TEVA