国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Salbutamol sulfate
Accord-UK Ltd
R03CC02
Salbutamol sulfate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010101; GTIN: 5012617008930
50996926 BBBB0444 50996926 BBBB0444 OPEN TEXT POSITION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT SALBUTAMOL TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALBUTAMOL TABLETS 3. HOW TO TAKE SALBUTAMOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SALBUTAMOL TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SALBUTAMOL TABLETS ARE AND WHAT THEY ARE USED FOR Salbutamol tablets belong to a group of medicines called selective beta-2-adrenergic agonists, which can be used to relax the muscles of the airways and womb. Salbutamol tablets may be used in: • asthma, to relieve the narrowing of the airways • chronic bronchitis • emphysema. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SALBUTAMOL TABLETS DO NOT TAKE Salbutamol tablets and TELL your doctor if you: • are ALLERGIC to salbutamol or any of the other ingredients of this medicine (listed in section 6). • have THREATENED ABORTION (POTENTIAL MISCARRIAGE) during the FIRST SIX MONTHS of pregnancy. • are taking BETA-BLOCKERS such as propranolol. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST before taking Salbutamol tablets if you have: • an OVERACTIVE THYROID gland (thyrotoxicosis). • DIABETES. • a history of HEART DISEASE, IRREGULAR HEART RHYTHM or ANGINA. Although it is not known exactly how often this happens, some people occasionally experience chest pain (due to heart problems such as angina) or difficulty breathing. Tell your doctor/midwife if you develop these 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salbutamol Tablets BP 4mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4.8mg salbutamol sulfate equivalent to 4mg salbutamol. Excipients with known effect: Each 4mg tablet contains: - 120.10mg Lactose monohydrate - Carmoisine (E122) For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets for oral administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salbutamol Tablets are indicated in adults, adolescents and children aged 2 to 12 years. 1. For the relief of bronchospasm in bronchial asthmas of all types. 2. Chronic bronchitis. 3. Emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ The usual effective dose is 4mg three or four times per day. If adequate bronchodilation is not obtained each single dose may be gradually increased to as much as 8mg. However, it has been established that some patients obtain adequate relief with 2mg three or four times daily. In elderly patients or in those known to be unusually sensitive to beta-adrenergic stimulant drugs, it is advisable to initiate treatment with 2mg three or four times per day. _ _ _Children:_ The following doses should be administered three or four times daily. 2-6 years: 1-2mg 6-12 years: 2mg Over 12 years: 2-4mg The product is not recommended for children under 2 years of age. The drug is well tolerated by children so that, if necessary, these doses may be cautiously increased. Method of administration For oral use. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment including lung function testing as patients are at risk of severe attacks and even death 阅读完整的文件