Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALBUTAMOL SULPHATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
SALBUTAMOL SULPHATE
100 ml
PT. Sterling Products Indonesia
_Consumer Medication Information Leaflet (RiMUP) _ 1 VENTOLIN SYRUP Salbutamol sulphate (2 mg /5 ml) WHAT IS IN THIS LEAFLET 1. What VENTOLIN is used for 2. How VENTOLIN works 3. Before you use VENTOLIN 4. How to use VENTOLIN 5. While you are using it 6. Side Effects 7. Storage and Disposal of VENTOLIN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT VENTOLIN IS USED FOR VENTOLIN is used for the relief of: • bronchial asthma • chronic bronchitis (inflammation of the airways that carry air to your lungs). • emphysema (damages to the air sacs (alveoli) in your lungs) The syrup is used when children and adults cannot use an inhaler device. HOW VENTOLIN WORKS VENTOLIN Syrup contains a medicine called salbutamol. This belongs to a group of medicines called bronchodilators. Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. They help to relieve chest tightness, wheezing and cough. BEFORE YOU USE VENTOLIN - _When you must not use it _ _ _ Do not take VENTOLIN Syrup: • if you are allergic to salbutamol sulphate or any of the other ingredients of this medicine. • If you unexpectedly go into early labour (premature labour) or threatened abortion. - _Before you start to use it _ _ _ Talk to your doctor, nurse or pharmacist before taking VENTOLIN Syrup if: • you have hypoxia (deficiency in the amount of oxygen reaching the tissues) • you are diabetic • you have an overactive thyroid gland • you have severe heart disease (such as ischaemic heart disease, irregular heart rhythm, severe heart failure). Tell your doctor if you experience symptoms such as chest pain, dyspnoea (shortness of breath) or other symptoms of worsening heart disease. If you are pregnant or breast- feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine - _Taking other medicines _ _ _ Tell your doctor, nurse or pharmacist if you are taking, have recently Baca dokumen lengkap
[GSK LOGO] VENTOLIN SYRUP SALBUTAMOL SULPHATE 1. NAME OF THE MEDICINAL PRODUCT Ventolin Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 2 mg Salbutamol (as Salbutamol Sulphate). Excipient with known effect: Sodium For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of bronchospasm in bronchial asthma of all types, chronic bronchitis and emphysema. Ventolin Syrup is suitable oral therapy for children and adults who are unable to use an inhaler device. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral Adults The minimum starting dose is 2mg three times a day given as 5ml syrup. The usual effective dose is 4mg (10ml syrup) three or four times a day, which may be increased to a maximum of 8mg (20ml syrup) three or four times a day if adequate bronchodilation is not obtained. Elderly In elderly patients or in those known to be unusually sensitive to beta- adrenergic stimulant drugs, it is advisable to initiate treatment with the minimum starting dose. _Paediatric Population_ 2 - 6 years: the minimum starting dose is 1mg as 2.5ml of syrup three times daily. This may be increased to 2mg as 5ml of syrup three or four times daily. 6 - 12 years: the minimum starting dose is 2mg as 5ml syrup three times daily. This may be increased to four times daily. Over 12 years: the minimum starting dose is 2mg three times daily given as 5ml syrup. This may be increased to 4mg as 10ml syrup three or four times daily. Ventolin is well tolerated by children so that, if necessary, these doses may be cautiously increased to the maximum dose. For lower doses the syrup may be diluted with freshly prepared purified water BP. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Non-i.v. formulations of VENTOLIN must not be used to arrest uncomplicated premature labour or threatened abortion. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bronchodilators should no Baca dokumen lengkap