国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Bromhexine hydrochloride
Sanofi-Aventis Ireland Limited T/A SANOFI
R05CB; R05CB02
Bromhexine hydrochloride
4 mg/5ml
Oral solution
Product subject to prescription which may be renewed (B)
Mucolytics; bromhexine
Marketed
1984-11-14
PACKAGE LEAFLET: INFORMATION FOR THE USER BISOLVON ® 4 MG/5 ML ORAL SOLUTION ( bromhexine hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What BISOLVON 4 mg/5 ml Oral Solution is and what it is used for 2. Before you take BISOLVON 4 mg/5 ml Oral Solution 3. How to take BISOLVON 4 mg/5 ml Oral Solution 4. Possible side effects 5. How to store BISOLVON 4 mg/5 ml Oral Solution 6. Further information 1. WHAT BISOLVON 4 MG/5 ML ORAL SOLUTION IS AND WHAT IT IS USED FOR The name of your medicine is BISOLVON 4 mg/5 ml Oral Solution (called BISOLVON in this leaflet). BISOLVON contains a medicine called bromhexine. This belongs to a group of medicines called mucolytic agents. BISOLVON helps you to breathe more easily when you have breathing problems such as bronchitis or sinusitis. It works by making your mucus thinner so that you can get rid of it more easily. 2. BEFORE YOU TAKE BISOLVON 4 MG/5 ML ORAL SOLUTION DO NOT TAKE BISOLVON IF: • You are allergic (hypersensitive) to bromhexine or any of the other ingredients of BISOLVON (listed in Section 6 below) • You are pregnant, likely to get pregnant or are breast-feeding Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist. IF YOU THINK THIS MEDICINE IS NOT WORKING WELL ENOUGH If your medicine does not seem to be working for you, talk to your doctor as soon as possible. Do not take extra BISOLVON unless your doctor tells you to. IF YOU TAKE MORE BISOLVON THAN YOU SHOULD If you take more of this medicine than you should, talk to a d 完全なドキュメントを読む
Health Products Regulatory Authority 19 March 2020 CRN009J5T Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisolvon 4mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains bromhexine hydrochloride 4 mg. Excipients: contains maltitol liquid For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution A clear to almost clear, colourless to almost colourless solution with a fruity aromatic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a mucolytic in the management of viscid mucoid secretions associated with bronchitis, bronchiectasis, sinusitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. _Adults and children over 12 years: _ Recommended total daily dose Recommended maximum daily dose 10 ml (8 mg) three times daily 15 ml (12 mg) four times daily The recommended maximum daily dose which may be needed at the commencement of treatment should not be exceeded. _Children over 5 to ≤ 12 years: _ Recommended total daily dose 5 ml (4 mg) four times daily. _Children 2 to ≤ 5 years: _Recommended total daily dose 5 ml (4 mg) twice daily. The measuring cup provided should be used for dosing. _ _ BISOLVON can be taken with or without food (see section 5.2). Additional information on specific populations BISOLVON Oral Solution is sugar free and therefore suitable for diabetes patients. 4.3 CONTRAINDICATIONS Bisolvon Oral Solution is contraindicated in patients known to be hypersensitive to bromhexine or other excipients of the formulation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bromhexine should be used with caution in patients with a history of, or existing, peptic ulceration. Health Products Regulatory Authority 19 March 2020 CRN009J5T Page 2 of 5 There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/ toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of bromhexine hydrochloride. If symptoms or 完全なドキュメントを読む