Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Gliclazide
Actavis UK Ltd
A10BB09
Gliclazide
60mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5012617025555 5012617025562
_Continued top of next column_ AAAJ1992 BILXONA 30MG AND 60MG MODIFIED-RELEASE TABLETS Gliclazide _Continued over page_ 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 BILXONA IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA 3 HOW TO TAKE BILXONA 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE BILXONA 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT BILXONA IS AND WHAT IT IS USED FOR Bilxona is a medicine that reduces blood sugar levels (oral anti- diabetic medicine belonging to the sulphonylurea group). Bilxona is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE BILXONA DO NOT TAKE BILXONA: • if you are allergic to gliclazide or any of the other ingredients of this medicine (listed in section 6), or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides) • if you have insulin-dependent diabetes (type 1) • if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma • if you have severe kidney or liver disease • if you are taking medicines to treat fungal infections (miconazole, see section ‘Other medicines and Bilxona’) • if you are breastfeeding (see Section ‘Pregnancy and breastfeeding’). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacis Прочитать полный документ
OBJECT 1 BILXONA 60MG MODIFIED-RELEASE TABLETS Summary of Product Characteristics Updated 30-Aug-2016 | Accord-UK Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Bilxona 60mg Modified-release Tablets 2. Qualitative and quantitative composition Each modified-release tablet contains 60 mg gliclazide. Excipient with known effect: Each modified-release tablet contains 108 mg lactose (as the monohydrate) (see section 4.4) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Modified-release tablet. Bilxona 60 mg modified-release tablets are white, oval, biconvex 7 x 15 mm tablets scored on both sides, marked with G on one side of the score and 60 on the other side of the score. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 Posology and Прочитать полный документ