Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Pholcodine
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N02BE; N02BE51
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Pholcodine
500 mg/30 mg/5 milligram(s)
Capsule, hard
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2003-11-04
INFORMATION FOR THE USER DAY NURSE CAPSULES PARACETAMOL 500MG PSEUDOEPHEDRINE HYDROCHLORIDE 30MG PHOLCODINE 5MG PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Day Nurse capsules carefully to get the best results from them. • Keep this leaflet, you may need to read it again. • If you have any further questions, ask your pharmacist. IN THIS LEAFLET: 1. What Day Nurse capsules are and what they are used for 2. Check before you take Day Nurse capsules 3. How to take Day Nurse capsules 4. Possible side effects 5. How to store Day Nurse capsules 6. Further information 1. WHAT DAY NURSE CAPSULES ARE AND WHAT THEY ARE USED FOR DAY NURSE CAPSULES ARE USED FOR THE RELIEF OF THE MAJOR SYMPTOMS OF COLD AND FLU INCLUDING FEVER, PAINS, COUGHING AND NASAL CONGESTION. Day Nurse capsules contain three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Pseudoephedrine Hydrochloride is a decongestant that unblocks your nose and sinuses helping you to breathe more easily. Pholcodine is a cough suppressant that helps relieve dry or tickly coughs. 2. CHECK BEFORE YOU TAKE DAY NURSE CAPSULES [X] DO NOT TAKE DAY NURSE CAPSULES: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, pseudoephedrine hydrochloride, pholcodine or any of the other ingredients (listed in Section 6). • if you have ever developed a SEVERE SKIN RASH or skin that PEELS, BLISTERS OR SORES IN THE MOUTH after taking Day Nurse capsules or other pseudoephedrine or pholcodine-containing medicinal products. • if you have HIGH BLOOD PRESSURE or HEART DISEASE. • if you have SEVERE KIDNEY DISEASE. • if you have DIFFICULTY BREATHING or LUNG PROBLEMS. • if you are taking APPETITE SUPPRESSANTS or STIMULANT DRUGS called amphetamines (sometimes used to treat ADHD). • if you have taken MONOAMINE OXIDASE INHIBITORS (MAOIs) in the last two weeks. • if you are UNDER 16 YEARS. • if you are taking an antib Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 20 December 2022 CRN00CY3S Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Day Nurse Capsules Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg Pholcodine 5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients Quantity mg/cap Paracetamol 500 Pseudoephedrine hydrochloride 30 Pholcodine 5 Also contains Allura Red (E129). For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (Capsule) The capsule has an orange cap and yellow body, printed with an identifier in black ink. It contains a white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the major symptoms of colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. To be taken during the day. Adults and children aged 16 years and over: Two capsules every four to six hours, up to a maximum of 4 doses (8 capsules) in 24 hours if needed. Other products containing paracetamol may be taken at night, but the total daily dose of paracetamol must not exceed 4000mg (including this product) in any 24 hour period. Maximum daily dose: 8 capsules for a total of 4000 mg Paracetamol, 240 mg Pseudoephedrine, 40 mg Pholcodine Children under 16 years: Not to be given to children under 16 years of age. Elderly: There is no specific requirement for dosage reduction in the elderly. Maximum duration of continued use without medical advice: 7 days. Minimum dosing interval: 4 hours. Do not exceed the stated dose. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Should not be used with other paracetamol containing products, decongestants or cough and cold medicines. If symptoms persist consult a doctor. Hepatic Impairment: Patients who have been diagnosed with hepatic impairment must seek medical advice before taking this medication. Renal Impairment: Pseudoephedrine is primarily excreted renally. This product should not be used by those with severe renal impairment Olvassa el a teljes dokumentumot