Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
The Boots Company Plc
N02BE51
Paracetamol; Pseudoephedrine hydrochloride; Pholcodine
33.33mg/1ml ; 2mg/1ml ; 333.33microgram/1ml
Oral solution
Oral
Schedule 5 (CD Inv)
Never Valid To Prescribe As A VMP
BNF:
BRANDING 12/07/2022 5481 CATEGORY: SYNERGIST JOB NO: BRAND: RANGE: PROJECT NO.: PRODUCT TITLE: FILE NAME: PROOF NUMBER: PROOF DATE: ARTWORKER: PACK TYPE: Artwork Only ITEM CODE: BARCODE TYPE: BARCODE NO.: COMPONENT CODE: PHARMA CODE NO.: ARTWORK IF YOU TAKE OTHER MEDICINES THIS MEDICINE CONTAINS PARACETAMOL. Do not take with any other paracetamol-containing products. Before you take this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following: • Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (high anion gap metabolic acidosis) that must have urgent treatment and which may occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used. • Water tablets (diuretics) and medicines to treat high blood pressure • Medicines for heart problems (e.g. digoxin) • Medicines that may make you feel sleepy or drowsy such as strong painkillers, medicines for epilepsy or medicines for mental health conditions • Medicines which may cause a dry mouth (e.g. tricyclic antidepressants), medicines to reduce your appetite or stimulant medicines • Ergot alkaloids (for migraine) • Oxytocin (to induce labour and stop excessive bleeding after the birth) • Domperidone or metoclopramide (for feeling sick or being sick) • Colestyramine (for lowering blood fat levels) • Warfarin or other coumarins (for thinning the blood) – if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself including herbal and homeopathic remedies. HOW TO TAKE THIS MEDICINE Check the seal is not broken before fi Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Almus Cold and Flu Day Liquid Boots Day Cold & Flu Relief Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient % w/v Paracetamol Ph Eur Pseudoephedrine Hydrochloride BP Pholcodine Ph Eur 3.333 0.200 0.033 Excipients of known effect %w/v Glycerol Propylene glycol Sucrose Glucose Alcohol 96% Sodium benzoate 33.33 25.00 20.00 5.00 5.00 0.10 For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM An Oral Solution 4.1 THERAPEUTIC INDICATIONS Combination product for the relief of the symptoms of colds and influenza. Decongestant for the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold. Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infection. Analgesic for the relief of aches, pains and fever associated with colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Take during the day. Adults and children over 16 years: 30ml every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night liquid is taken before bedtime. Elderly: There is no specific requirement for dosage reduction in the elderly. This medicine is contraindicated in children under 16 years of age (see section 4.3). 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 peripheral vascular disease. Diabetes mellitus. Phaeochromocytoma. Hyperthyroidism. Closed angle glaucoma. Avoid in patients with prostatic enlargement or liver failure. 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. Concomitant use of Lesen Sie das vollständige Dokument