Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Paracetamol
Ricesteele Manufacturing Ltd
N02BE; N02BE01
Paracetamol
180 milligram(s)
Suppository
Product not subject to medical prescription
Anilides; paracetamol
Marketed
1988-12-30
PATIENT INFORMATION LEAFLET PARALINK 180MG SUPPOSITORIES Paracetamol In THIS LEAFLET: 1. What Paralink Suppositories are and what they are used for 2. Before you give Paralink Suppositories 3. How to give Paralink Suppositories 4. Possible side effects 5. How to store Paralink Suppositories 6. Further information. Paralink Suppositories contain the active ingredient paracetamol. Paracetamol is a pain killer and can reduce high temperatures (fever). It provides effective relief of fever and pain associated with colds and flu, headaches, rheumatism and teething. Paralink Suppositories may also be used after an operation. Paralink 180mg Suppositories can be used in children from 3 months to 6 years of age. It is a smooth, white, tapered cylindrical medicine which is inserted into the back passage (rectum) and is recommended for use in children who may find it difficult to take paracetamol by mouth. DO NOT GIVE PARALINK 180MG SUPPOSITORIES TO YOUR CHILD IF: • Your child is allergic to paracetamol or to any of the other ingredients listed (see ingredients section) • Your child is under 3 months of age • Your child is taking any other paracetamol containing products. YOU MUST BE ESPECIALLY CAREFUL. SPEAK TO YOUR DOCTOR OR PHARMACIST BEFORE GIVING PARALINK SUPPOSITORIES IF: • Your child has kidney or liver problems. OTHER SPECIAL WARNINGS: • Contains paracetamol. Do not give with any other paracetamol containing products • Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage • Do not exceed the stated dose • If symptoms persist, consult your doctor • Using Paralink 180mg Suppositories for a long period of time without medical supervision can be harmful to your child. DO NOT GIVE THIS MEDICINE TO YOUR CHILD FOR LONGER THAN 3 DAYS WITHOUT SPEAKING to YOUR DOCTOR OR PHARMACIST FIRST. If ANY OF THE ABOVE APPLIES, PLEASE TALK TO A DOCTOR OR PHARMACIST BEFORE GIVING THIS MEDICINE. If ADULTS USE THIS MEDICINE: THE FOLLOWING WARNINGS ALSO APPLY Đọc toàn bộ tài liệu
Health Products Regulatory Authority 17 February 2020 CRN0095YK Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paralink 180mg Suppositories 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each suppository contains Paracetamol 180 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suppository White, tapered cylindrical suppositories. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in the management of pain and fever associated with such conditions as influenza, the common cold, headache, rheumatism, teething, post-operative pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For rectal use only 3 months - 1 year (5 - 10kg): ½ Suppository 1 - 3 years (10 - 15kg): 1 Suppository 3 - 6 years (15 - 20kg): 1½ Suppositories Dose may be repeated 6 hourly as necessary or as directed by the physician. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol or any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Paralink suppositories should be administered with caution to patients with known liver or renal impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the recommended dose. Do not take other paracetamol-containing products. If symptoms persist, consult your doctor. Keep out of the reach and sight of children. Prolonged use except on doctor's advice can be harmful. Maximum duration of continued use without medical advice: 3 days. Immediate medical advice should be sought in the event of overdosage, because of the risk of irreversible liver damage. This product should be used only when clearly necessary. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased bleeding; occasional doses have no significant effect. Health Products Regulatory Authority 17 February 2020 CRN0095YK Page 2 of 4 The rate of absorption of paracetamol may be inc Đọc toàn bộ tài liệu