מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
The Boots Company Plc
N02BE; N02BE51
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
500/5/30 milligram(s)
Capsule, hard
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Not marketed
2003-11-04
INFORMATION FOR THE USER DAY COLD & FLU RELIEF HARD CAPSULES (Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride 30 mg) PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription to treat minor conditions. However, you still need to take it 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 WHAT THIS MEDICINE IS FOR This medicine contains Paracetamol, an analgesic, which relieves pain and reduces fever, Pseudoephedrine, a decongestant to relieve a blocked nose and Pholcodine, a cough suppressant to relieve coughing. It can be used to relieve the major symptoms of colds and flu including aches and pains, fever, blocked nose and dry, tickly coughs. Dry coughs do not produce phlegm or mucus on the chest. For children, simple treatments should be tried first before you give this medicine. Further information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided at the end of this leaflet. BEFORE YOU TAKE THIS MEDICINE This medicine can be taken by adults and children of 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first. DO NOT TAKE: IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see “What is in this medicine”) IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS IF YOU HAVE SEVERE KIDNEY PROBLEMS OR LIVER FAILURE IF YOU HAVE HEART OR BLOOD VESSEL DISEASE IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near your kidneys) IF YOU HAVE DIFFICULTY BREATHING IF YOU HAVE LONG-TERM LUNG PROBLEMS OR AN INFECTION which produces lots of phlegm on the chest IF YOU HAVE DIABETES IF YOU HAVE AN OVERACTIVE THYROID IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma) IF YOU ARE HYPERACTIVE IF YOU HAVE DIFFICULTY IN PASSING URINE IF YOU ARE TAKING ANY OF THESE MEDICIN קרא את המסמך השלם
Health Products Regulatory Authority 10 July 2020 CRN009S05 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules Paracetamol 500 mg Pholcodine 5 mg Pseudoephedrine Hydrochloride 30 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients Quantity mg/capsule Paracetamol 500 Pseudoephedrine hydrochloride 30 Pholcodine 5 Excipients: Allura Red (E129) 0.53 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard The capsule has an orange cap and yellow body, printed axially in black ink ‘BOOTS’ on the cap and ‘0580’ on the body. 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 Take during the day. For oral administration. Adults and children over 16 years: Two capsules every four hours, up to a maximum of 4 doses in 24 hours if needed. Elderly: There is no specific requirement for dosage reduction in the elderly. Warning: Do not exceed the stated dose. Keep all medicines out of the sight and reach of children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or any of the excipients. Severe renal impairment. Cardiovascular disease including hypertension and ischaemic heart disease Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Avoid in patients with hyperexcitability or liver failure. Prostatic enlargement (patients with prostatic hypertrophy may have increased difficulty in micturation) Urinary retention Health Products Regulatory Authority 10 July 2020 CRN009S05 Page 2 of 7 Pholcodine should not be given to subjects in, or at risk of developing respiratory failure. Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention. Use in patients who are currently receiving other sympathomimetic drugs (such as other decongestants). Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping קרא את המסמך השלם