País: Malta
Idioma: inglés
Fuente: Medicines Authority
PARACETAMOL
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1, 53757 Sankt Augustin / Bonn, Germany
N02BE01
PARACETAMOL 125 mg
SUPPOSITORY
PARACETAMOL 125 mg
OTC
ANALGESICS
Withdrawn
2006-11-24
1 Package Insert FOR THE TREATMENT OF PAIN AND FEVER ENELFA® SUPPOSITORIES 125/250 Active Ingredient: Paracetamol Composition: ENELFA® 125: 1 suppository contains: _Active ingredient: paracetamol 125 mg. _ _ Excipient: _ _solid _ _fat _ ENELFA® 250: 1 suppository contains: _Active ingredient: paracetamol 250 mg. _ _ Excipient: _ _solid _ _fat _ PHARMACOTHERAPEUTIC GROUP: Pain-relieving and antipyretic agent. INDICATIONS: Mild to moderate pain and fever. Enelfa® suppositories should not be used over a prolonged period or at increased doses without advice of a physician or dentist. CONTRAINDICATIONS: This drug must not be administered in cases of known hypersensitivity to the active ingredient paracetamol or to any of the excipients. Patients suffering from renal or hepatic insufficiency (e. g. due to chronic abuse of alcohol, hepatitis) or Gilbert´s syndrome (Meulengrachts´s disease) should use Enelfa® only upon medical advice and in reduced doses or at prolonged administration intervals. Same applies to newborn. PREGNANCY AND LACTATION: Enelfa® should be administered during pregnancy only under strict consideration of the benefit-risk-ratio. During pregnancy, paracetamol suppositories should not be administered over a prolonged period, at high doses or in combination with other drugs, since safety of administration has not been established in these cases. Paracetamol penetrates into the mother´s milk. Since negative effects for the infant have not become known so far, nursing needs normally not be discontinued. SIDE EFFECTS: In rare cases erythema and very seldom allergic reactions with exanthema. In extremely rare cases dyshaematophoiesis (thrombocytopenia, leucopenia, in individual cases agranulocytosis, pancytopenia). In individual cases bronchospasm with dyspnoea (analgesics asthma) in predisposed patie Leer el documento completo
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enelfa® 125, suppositories Enelfa® 250, suppositories Active ingredient: Paracetamol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ENELFA® 125, SUPPOSITORIES 1 suppository contains 125 mg of paracetamol ENELFA® 250, SUPPOSITORIES 1 suppository contains 250 mg of paracetamol For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Suppositories 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - mild to moderate pain - fever 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ENELFA® 125, SUPPOSITORIES: for nurslings up to 1 year of age ENELFA® 250, SUPPOSITORIES: for children as from 1 – 6 years of age 4.3 CONTRAINDICATIONS Enelfa suppositories must not be used in case of known hypersensitivity to the active ingredient, paracetamol or to the excipient. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients suffering from - renal or hepatic insufficiency (e. g. due to chronic abuse of alcohol, hepatitis), - Gilbert´s syndrome (Meulengracht´s disease) Page 2 of 7 should use Enelfa® only upon medical advice and in reduced doses or at prolonged administration intervals. Same applies to newborn. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Simultaneous administration of drugs causing a so-called enzyme induction in the liver, e. g. certain sleeping agents and anti-epileptics (among others phenobarbital, phenytoin, carbamazepine) as well as rifampicin may cause hepatic damage even at paracetamol standard doses. Same applies to the abuse of alcohol. Combination with chloramphenicol may lead to a distinct delay in the elimination of chloramphenicol, thus increasing the toxicity of this drug. Interac Leer el documento completo