Doliprane Paracetamol 1000mg, Adults, 8 suppositories for pain and fever, Sanofi

1. NAME OF DRUG DOLIPRANE ADULTS 1000mg, suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol..................................................................................................................................... 1000 mg Per suppository. To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Suppository. 4. CLINICAL DATA 4.1. Therapeutic Indications Symptomatic treatment for light to moderate pain and/or feverish states. 4.2. Dosage and how to use How to use Rectal administration. Dosage: Warning: this dose contains 1000mg of paracetamol: do not take 2 units at a time. Suitable for adults and children over 50 kg (approximately from the age of 15 years old). The usual dosage is 1x1000 mg suppository each time, and depending on the level of pain they can be taken minimum every 4 hours. It is not necessary to take more than 3g of paracetamol a day, roughly 3 suppositories per day. However in the case of severe pain and from your doctors recommendation, the total dose can be increased up to 4g per day, roughly 4 suppositories per day. Do not take more often than every 4 hours. In the case of diarrhoea, taking the suppositories is not recommended. Maximum daily doses: see section 4.4. Frequency of dose Regular doses avoid pain and fever fluctuations. For adults doses need to be spaced out at a minimum of 4 hours. In the case of severe renal insufficiency (creatinine clearance less than 10ml/mn, the gap between 2 doses should be minimum 8 hours. Length of administration Rectal administration should be as short as possible in case of local toxicity risk. Renal insufficiency In the case of severe renal insufficiency (creatinine clearance less than 10ml/mn, the gap between 2 doses should be minimum 8 hours. Do not take more than 3g of paracetamol per day (3 suppositories). 4.3. Contraindications: · Known allergy to paracetamol, or one of its components, - Hepatic insufficiency. - Previous proctitis, anitis or rectal bleeding. 4.4. Special warnings and side effects Cautions: To avoid the risk of an overdose, check the paracetamol content in other drugs. Maximum recommended dose: suitable for adults and children over 50 kg (from the age of 15 years old). Do not take more than 3g of paracetamol per day (3 suppositories). However the dose can be increased up to 4g (4 suppositories) if 3g per day is not enough for the pain making sure each dose has a gap of 4 hours. THE PARACETAMOL DOSE MUST NOT EXCEED 4 GRAMS PER DAY (see section 4.9). With all suppositories there is the risk of local infection and the risk is increased if the treatment is extended and the way it is administered. Do not use the suppositories if you have diarrhoea. 4.5. Interactions with other drugs Interactions with clinical tests Taking paracetamol may distort the blood glucose test by the glucose oxidase-peroxidase method in abnormally high concentrations. Taking paracetamol can distort the dosage of blood uric acid by the phosphotungstic acid method. Combinations to be aware of + Oral anticoagulants Risk of increase in the effect of oral anticoagulant and haemorrhagic risk if paracetamol is taken at maximum doses (4 g / d) for at least 4 days. Frequent control. Possible adaptation of the dosage of oral anticoagulant during treatment with paracetamol and after discontinuation. 4.6. Pregnancy and breast feeding Pregnancy: Studies in animals have not shown a teratogen effect. In clinical studies, the results of epidemiological studies seem to exclude a particular malformative or faetotoxic effect of paracetamol. As a result, paracetamol, under normal conditions of use, may be prescribed throughout pregnancy. Breast feeding: This drug can be taken whilst breast-feeding. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects RELATED TO PARACETAMOL: - Rare cases of reactions such as an anaphylactic shock, angioedema, erythema, urticaria and rashes have been reported. Treatment must be stopped if any of these appear. - Very exceptional cases of thrombopenia and neutropenia have been reported. RELATED TO THE PHARMACEUTICAL FORM: - Rectal & anal irritation. 4.9. Overdose Intoxication by elderly and younger patients can be fatal. Symptoms - Nausea, vomiting, anorexia, paleness, abdominal pains - all in the first 24 hours. An overdose with 10 g of paracetamol in adults and 150 mg / kg of body weight in a single dose in children results in hepatic cytolysis that may result in complete and irreversible necrosis. Resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy, which can lead to coma and death. At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, biliburin and decreased prothrombin levels that may occur 12 to 48 hours after administration. Emergency - Immediately take the patient to hospital - Blood test to analyse the paracetamol dosage - Quick removal of the drug by a stomach pump. - The treatment of overdosage conventionally comprises the administration as early as possible of the antidote N-acetylcysteine by I.V. route or orally if possible before the tenth hour. - Symptomatic treatment. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmaco-dynamic properties OTHER PAIN-KILLERS 1 ANTI-PYRETICS. Code ATC: N02BE01. N: Central nervous system 5.2. Pharmacokinetics properties Absorption By rectal administration, the absorption of paracetamol is slower than by taking it orally. Complete treatment. The plasma concentration reaches its maximum after 2-3 hours. Distribution Paracetamol spreads out quickly over the tissue. Concentrations are equal in the blood, saliva and plasma. Link with plasma proteins is weak. Metabolism The paracetamol is metabolised in the liver. The two major metabolic pathways are glucuronidation and sulphoconjugation. The latter pathway is rapidly saturated at dosages above therapeutic doses. A minor route, catalysed by cytochrome P 450, is the formation of a reactive intermediate (N-acetyl benzoquinone imine), which under normal conditions of use is rapidly detoxified by reduced glutathione and eliminated in the urine after conjugation with cysteine and mercaptopuric acid. On the other hand, during mass poisoning, the quantity of this toxic metabolite is increased. Elimination Elimination is through the urine. 90% of the dose is eliminated by the kidney in the first 24 hours mainly in glycuroconjugate (60-80%) and sulfoconjugate (20-30%) form. Less than 5% is eliminated in an unchanged form. The half-life is approximately 4-5 hours. Physiopathological Variations - Renal impairment: In patients with severe renal insufficiency (creatinine clearance below 10 ml / min), the elimination of paracetamol and its metabolites is delayed. Elderly: the conjugation capacity is not modified. 5.3. Preclinical safety data Not applicable. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Solid hemi-synthetic glycerides (Witepsol). 6.2. Incompatibilities Not applicable. 6.3. Shelf life 2 years. 6.4. Storage precautions Keep away from direct heat. 6.5. Nature and contents of outside packaging 8 suppositories in a heat-sealed film (PVC/PE). 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER SANOFI-AVENTIS FRANCE 82 AVENUE RASPAIL 94250 GENTILLY 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 330 474-6: 8 suppositories in a heat-sealed film (PVC/PE). 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.