国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolbutamide
A A H Pharmaceuticals Ltd
A10BB03
Tolbutamide
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5012252102628
Accord logo Package Leaflet: Information for the user TOLBUTAMIDE 500MG TABLETS 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 TOLBUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE TOLBUTAMIDE TABLETS 3. HOW TO TAKE TOLBUTAMIDE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TOLBUTAMIDE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT TOLBUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR Tolbutamide is one of a group of medicines called oral hypoglycaemics. These medicines are used to control blood sugar levels in some types of diabetes. Tolbutamide tablets may be used to control blood sugar in patients with mild to moderate diabetes which cannot be controlled by diet alone. Tolbutamide should only be used to treat diabetes which occurs mainly in adults (type 2 or non-insulin dependent diabetes). If you are overweight treatment with Tolbutamide tablets should not replace your dietary restrictions. 2 2. BEFORE YOU TAKE TOLBUTAMIDE TABLETS DO NOT TAKE TOLBUTAMIDE TABLETS IF YOU: • are ALLERGIC to Tolbutamide tablets or any of the other ingredients of this medicine (listed in section 6) • have ever had a severe DIABETIC REACTION (such as “acidosis” or diabetic coma) • have diabetes that needs to be treated by INSULIN (type 1 or insulin dependent diabetes) • have severe KIDNEY, LIVER, THYROID or ADRENAL GLAND disease • are experiencing UNUSUAL STRESS or are BREAST-FEEDING. • need an OPERATION • suffer from a condition called PORPHYRIA (a heredita 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tolbutamide Tablets BP 500mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg tolbutamide BP For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Round, biconvex white tablets, marked on one side with “T” above a scoreline and “500” below it. The scoreline is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of non - insulin dependent diabetes in patients who respond inadequately to dietary treatment. It should not be used to replace dietetic therapy in the obese diabetic patient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY_ The tablets may be taken as a single dose with, or immediately after, the first main meal of the day, or as a divided dose for optimum control of blood sugar. _Treatment of previously untreated diabetes_: stabilisation can be achieved commencing with 2 tablets (1 g) daily, and adjusting in the light of the patient's individual response. The average daily dose is 1-3 tablets (0.5 – 1.5 g) which can be taken as a single or divided dose. In general, patients who do not respond to 4 tablets (2 g) do not respond to higher doses. _Change over from other oral hypoglycaemics:_ It is possible to freely inter- change hypoglycaemic agents (including chlorpropamide) without a break in treatment, starting with 2 tablets (1 g) daily, followed by a maintenance dose depending on response. _Combination with biguanides_: If adequate control is not achieved with diet and 4 tablets (2 g) of tolbutamide daily, it can often be achieved by combined administration with a biguanide derivative. _Change over from insulin_: Some patients with non - insulin dependent diabetes and who are already taking insulin may be changed to tolbutamide. Low insulin doses (less than 20 units) can be replaced immediately. With higher doses a gradual change is advisable by giving insulin and tolbutamide concurrently and gradually reducing the dose of insuli 完全なドキュメントを読む