Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Caffeine; Paracetamol
Galpharm Healthcare Limited
N02BE; N02BE51
Caffeine; Paracetamol
500/65 milligram(s)
Tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Not marketed
2013-05-17
1.3 PRODUCT INFORMATION. 1.3.1 SPC, LABELLING AND PACKAGE LEAFLET. PARACETAMOL 500MG AND CAFFEINE 65MG TABLETS / MODULE 1.3.1 / APRIL 2013 PACKAGE LEAFLET : INFORMATION FOR THE USER PARACETAMOL & CAFFEINE GALPHARM 500MG & 65MG TABLETS PARACETAMOL / CAFFEINE _ _ READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL NEED TO TAKE PARACETAMOL & CAFFEINE GALPHARM CAREFULLY TO GET THE BEST RESULTS FROM IT. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve within 3 days for fever and 5 days for pain. • If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: _ _ 1. WHAT PARACETAMOL & CAFFEINE GALPHARM IS AND WHAT IT IS USED FOR. 2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE GALPHARM. 3. HOW TO TAKE PARACETAMOL & CAFFEINE GALPHARM. 4. POSSIBLE SIDE EFFECTS. 5. HOW TO STORE PARACETAMOL & CAFFEINE GALPHARM. 6. FURTHER INFORMATION. 1. WHAT PARACETAMOL & CAFFEINE GALPHARM IS AND WHAT IT IS USED FOR. Paracetamol & Caffeine Galpharm contain PARACETAMOL which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever and CAFFEINE which helps to increase the pain relief from paracetamol and makes you more alert. This medicine is for the symptomatic treatment of mild to moderate pain and fever in conditions such as headache, toothache and period pains. 2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE GALPHARM DO NOT TAKE PARACETAMOL & CAFFEINE GALPHARM IF: • You are ALLERGIC to paracetamol, caffeine or any of the other ingredients. • If you are under 15 years of age or weigh less than 50kg. DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICINE. TAKE SPECIAL CARE WITH PARACETAMOL & CAFFEINE GALPHARM. CHECK WITH YOUR DOCTOR BEFORE TAKING THIS MEDICINE: Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol & Caffeine Galpharm 500 mg & 65 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500 mg and Caffeine 65 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, capsule-shaped tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever in adults and children aged 15 years or over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including elderly) and adolescents aged 15-18 years weighing more than 50kg:_ 1 - 2 tablets according to needs up to 3 times daily. The single dose of 1 tablet is appropriate for individuals weighing less than 60 kg while the single dose of 2 tablets is appropriate only for individuals weighing 60 kg and more. The maximum single dose is 1 g of paracetamol (2 tablets), the maximum daily dose is 3 g of paracetamol (6 tablets). The specific dose interval depends on the symptoms and the maximum daily dose. Depending on the reoccurrence of symptoms (fever and/or pain), repeated administration is allowed. It should, however, preferably never fall below 6 hours and in no case fall below 4 hours. If the pain persists for more than 5 days or the fever lasts for more than 3 days, or gets worse or other symptoms appear, the patient should stop the treatment and consult a doctor. Paediatric Population Adolescents of 15 to 18 years and weighing more than 50 kg: as adults. In children it is imperative to respect the posology defined on the basis of body weight and thus to use the appropriate presentation. Approximate ages based on body weight are given for information. The product is not suitable for children younger than 15 years. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Pročitajte cijeli dokument