Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
PSEUDOEPHEDRINE HYDROCHLORIDE; Guaiphenesin
The Boots Company Plc
R01BA; R01BA52
PSEUDOEPHEDRINE HYDROCHLORIDE; Guaiphenesin
100/30 mg/5ml
Oral solution
Product not subject to medical prescription
Sympathomimetics; pseudoephedrine, combinations
Marketed
2000-05-12
INFORMATION FOR THE USER Chesty Cough & Congestion Relief Oral Solution (Guaifenesin 100 mg/5 ml, Pseudoephedrine Hydrochloride 30 mg/5 ml) 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 Pseudoephedrine, a decongestant, which acts to relieve a blocked nose. It also contains Guaifenesin, an expectorant, which acts to loosen and relieve phlegm on the chest. It can be used to relieve the symptoms of a chesty cough, catarrh and a blocked nose without causing drowsiness. 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 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first. X 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 IF YOU HAVE HEART OR BLOOD VESSEL DISEASE IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near your kidney) IF YOU HAVE DIABETES IF YOU HAVE AN OVERACTIVE THYROID IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma) IF YOU HAVE DIFFICULTY IN PASSING URINE IF YOU ARE TAKING ANY OF THESE MEDICINES: - Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them in the last 14 days - Medicines which may cause a dry mouth (e.g. tricyclic antidepressants) - Medicines to reduce your appetite or stimulant medicines - Medicines called beta-blockers ( Baca dokumen lengkapnya
Health Products Regulatory Authority 14 October 2020 CRN009V6X Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Pharmaceuticals Chesty Cough & Congestion Relief Oral Solution Guaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains Guaifenesin 100 mg Pseudoephedrine hydrochloride 30 mg Excipients: contains 1.77g sucrose and 0.3mg carmoisine per 5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, bright purple syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An expectorant for the relief of chesty coughs, nasal congestion and catarrh without causing drowsiness. For children aged 6 to12 years: An expectorant for the relief of chesty coughs, nasal congestion and catarrh (without causing drowsiness) when simple measures have failed. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Adults and children 12 years and over: 10ml four times a day. Elderly: There is no need for dosage reduction in the elderly. Children 6-12 years: 5ml three times a day. This medicine is contraindicated in children under 6 years of age (see section 4.3). Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child's condition deteriorates during treatment. Warning: Do not exceed the stated dose. Keep 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. Health Products Regulatory Authority 14 October 2020 CRN009V6X Page 2 of 5 Hyperthyroidism. Closed angle glaucoma. Prostatic enlargement (patients with prostatic hypertrophy may have increased difficulty in micturition). Urinary retention Use in patients who are currently receiving other sympathomimetic drugs (such Baca dokumen lengkapnya