Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate; Diphenhydramine hydrochloride; Phenylephrine hydrochloride; Caffeine; Ascorbic acid
Phoenix Labs
N02BE; N02BE51
Paracetamol; Codeine phosphate hemihydrate; Diphenhydramine hydrochloride; Phenylephrine hydrochloride; Caffeine; Ascorbic acid
30 mg/10 mg/15 mg/500 mg/10 milligram(s)
Film-coated tablet + tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
1998-10-30
PACKAGE LEAFLET: INFORMATION FOR THE USER WITH VITAMIN C TABLETS Paracetamol 500mg • Codeine Phosphate Hemihydrate 10mg Diphenhydramine Hydrochloride 15mg Phenylephrine Hydrochloride 10mg Caffeine 30mg • Ascorbic Acid 300mg 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 Uniflu Plus with Vitamin C Tablets 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 after 3 days. • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Uniflu Plus with Vitamin C Tablets are and what they are used for 2. Before you take Uniflu Plus with Vitamin C Tablets 3. How to take Uniflu Plus with Vitamin C Tablets 4. Possible side effects 5. How to store Uniflu Plus with Vitamin C Tablets 6. Further information 1. WHAT UNIFLU PLUS WITH VITAMIN C TABLETS ARE AND WHAT THEY ARE USED FOR Uniflu Plus Tablets are for the symptomatic relief from the discomfort associated with influenza and colds i.e. nasal and sinus congestion, headache, fever, aching limbs, coughing and running nose. Vitamin C Tablets are used as a Vitamin C supplement during cold and influenza (flu) infections 2. BEFORE YOU TAKE UNIFLU PLUS WITH VITAMIN C TABLETS Do not take Uniflu Plus Tablets • If you are under 12 years of age • if you are already taking other paracetamol- containing products • if you are allergic to paracetamol or any of the other ingredients • if you have an over-active thyroid, high blood pressure or heart disease • if you know that you metabolise very rapidly codeine into morphine • if you are currently taking monoamine oxidase inhibitors (MAOIs) (a type of antidepressant) or within 14 days of stopping such treatment • if you a Прочетете целия документ
Health Products Regulatory Authority 23 June 2022 CRN00CZ1S Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Uniflu Plus with Vitamin C Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Each Uniflu Plus tablet contains:_ Caffeine 30.0 mg Codeine phosphate hemihydrate 10.0 mg Diphenhydramine hydrochloride 15.0 mg Paracetamol 500.0 mg Phenylephrine hydrochloride 10.0 mg For a full list of excipients, see section 6.1 _Each Vitamin C tablet contains:_ Ascorbic acid 300.0 mg (as ascorbic acid/sodium ascorbate) Excipients: contains 5.00mg lactose and 270.0mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Uniflu Plus:_ Film-coated tablet. White, oblong, film-coated tablet. _Vitamin ‘C’:_ Chewable tablet. Yellow, biconvex, circular, plain, lemon flavoured chewable tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Uniflu Plus:_ For the symptomatic relief from the discomforts associated with influenza and colds i.e. nasal and sinus congestion, headache, fever, aching limbs, coughing and runny nose. _Vitamin ‘C’:_ For use as a vitamin C supplement during cold and influenza infections. Health Products Regulatory Authority 23 June 2022 CRN00CZ1S Page 2 of 11 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Uniflu Plus:_ Adults: One Uniflu Plus tablet to be swallowed whole with water, followed by one tablet every six hours. Not more than four tablets of Uniflu Plus to be taken in 24 hours. Elderly: As adult dose. Children: Under 12 years – Not recommended. Over 12 years – One tablet every eight hours. Not more than three tablets of Uniflu Plus to be taken in 24 hours. _Vitamin ‘C’_ Adults: One Vitamin ‘C’ tablet to be swallowed whole, sucked or chewed every six hours. Elderly: As Adult dose. Children: Over 12 years – One tablet to be swallowed whole, sucked or chewed every eight hours. Under 12 years – Not recommended. Codeine should be used at the lowest effective dose for the shortest period of time. The duration of treatment should Прочетете целия документ