Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glipizide
Viatris UK Healthcare Ltd
A10BB07
Glipizide
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010201; GTIN: 5016695330013 5016695002804
No. of colours Colours Non-Print Colours Date: Time: Equate CMYK with Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Pharma Code SAP No. Vendor Job No. Proof No. Client Market Keyline/Drawing No. Barcode Info Dimensions Main Font Body Text Size Page Count 03 Dec 2014 1/2 11:12 Glipizide 5mg 56 Leaflet 521715 316069 521715 04569/0308 N/A LT1324AH TBC N/A 242271 1 UK N/A N/A 1 Black Myriad Pro 8 pt 170 x 240mm 1211122 1211122 TBC TBC PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GLIPIZIDE 5 MG TABLETS (glipizide) 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 Glipizide is and what it is used for 2. What you need to know before you take Glipizide 3. How to take Glipizide 4. Possible side effects 5. How to store Glipizide 6. Contents of the pack and other information 1. WHAT GLIPIZIDE IS AND WHAT IT IS USED FOR Glipizide is one of a group of medicines called sulfonylureas. Glipizide is used to reduce blood sugar levels (antidiabetic medicine taken by mouth). Glipizide is used in a certain form of diabetes (type 2 diabetes mellitus), when diet, exercise and weight loss alone do not have an adequate effect. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLIPIZIDE DO NOT TAKE GLIPIZIDE IF YOU: • are allergic to glipizide, other sulfonylureas or any of the other ingredients of this medicine (listed in section 6) • suffer from kidney or liver disease • suffer from thyroid problems • have insulin- Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glipizide 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains glipizide 5 mg Excipient with known effect Each tablet contains 152 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White oval biconvex uncoated tablets. Tablets are identified by ‘GP’, a breakline and ‘5’ on one side and ‘G’ on the reverse. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glipizide is indicated in the control of blood glucose levels in addition to the control of diet for patients with non insulin dependent diabetes mellitus (Type II NIDDM), when hyperglycaemia cannot be controlled by diet alone and advice has been given on weight reduction and exercise. Stable patients with non insulin dependent diabetes mellitus not controlled by regulation of their diet alone are likely to be controlled by glipizide. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology As for any hypoglycaemic agent, dosage must be adapted for each individual case. Short term administration of glipizide may be sufficient during periods of transient loss of control in patients usually controlled well on diet. Initial dose The recommended starting dose is 5 mg, given before breakfast or the midday meal. Mild diabetics, elderly or those with liver disease may be started on 2.5 mg. Titration Dosage adjustments should ordinarily be in increments of 2.5 mg or 5 mg, as determined by blood glucose response. At least several days should elapse between titration steps. The maximum recommended single dose is 15 mg. If this is not sufficient, splitting the daily dosage may prove effective. Doses above 15 mg should ordinarily be divided. Maintenance Some patients may be effectively controlled on a once-a-day regimen. Total daily dosages above 15 mg should ordinarily be divided. The maximum recommended daily dosage is 20 mg. Paediatric population Safety and effectiveness in childre Read the complete document