- Approval Id
- a2339e318b0eb302
- Drug Approval Emc Name
- Metformin 500mg prolonged release tablets
- Drug Name
- Metformin 500mg prolonged release tablets
- Company Address
- Morningside House, Unit C Harcourt Way, Meridian Business Park, Leicester, LE19 1WP
- Company Website
- http://www.morningsidehealthcare.com
- Company Telephone
- +44 (0)116 204 5950
- Company Medical Info Direct Line
- +44 (0)116 478 0322
- Company Medical Info Email
- [email protected]
- Company Customer Care Direct Line
- +44 (0)116 204 5950
- Company Stock Availability
- +44 (0)1509 217 705
- Atc Code
- A10BA02
- Legal Category
- Prescription only medicine
- Authorisation Holder
- 7. Marketing authorisation holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester LE19 1WP United Kingdom
- Authorisation Number
- 8. Marketing authorisation number(s) PL 20117/0173
- Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 11/11/2024
- Instruction Authorisation Holder
- 7. Marketing authorisation holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester LE19 1WP United Kingdom
- Instruction Authorisation Number
- 8. Marketing authorisation number(s) PL 20117/0173
- Instruction Authorisation Date
- 9. Date of first authorisation/renewal of the authorisation 11/11/2024
- Instruction Composition
- 2. Qualitative and quantitative composition Each prolonged release tablet contains: Metformin hydrochloride 500 mg corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- 3. Pharmaceutical form Prolonged release tablet . Off-white coloured, oval, biconvex film-coated tablets plain on both sides.
- Instruction Clinical Particulars
- 4. Clinical particulars 4.1 Therapeutic indications • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG*, and/or increased HbA1C who are: - at high risk for developing overt type 2 diabetes mellitus (see section
- Instruction Pharmacology
- 5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic Group: Blood Glucose lowering drugs, excluding Insulins Biguanides. ATC code: A10BA02 Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. Mechanism of action: Metformin may act via 3 mechanisms: (1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; (2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; (3) delay of intestinal glucose absorption. Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUT). Pharmacodynamic effects: In clinical studies, the major non glycaemic effect of metformin is either weight stability or modest weight loss. In humans, independently of its action on glycaemia, immediate release metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: immediate release metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. A similar action has not been demonstrated with the prolonged release formulation, possibly due to the evening administration, and an increase in triglycerides may occur. Clinical efficacy: Reduction in the risk or delay of type 2 diabetes mellitus The Diabetes Prevention Program (DPP) was a multicenter randomised controlled clinical trial in adults assessing the efficacy of an intensive lifestyle intervention or metformin to prevent or delay the development of type 2 diabetes mellitus. Inclusion criteria were age ≥25 years, BMI ≥24 kg/m2 (≥22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 95 – 125 mg/dl (or ≤125 mg/dl for American Indians). Patients were either treated with intensive lifestyle intervention, 2x850 mg metformin plus standard lifestyle change, or placebo plus standard lifestyle change. The mean baseline values of the DPP participants (n=3,234 for 2.8 years) were age 50.6±10.7 years, 10
- Instruction Pharmaceutical Particulars
- 6. Pharmaceutical particulars 6.1 List of excipients Core Stearic Acid Shellac (Refined bleached) Povidone K-30 Silica, colloidal anhydrous Magnesium Stearate Film-Coating Hypromellose Hydroxy Propyl cellulose Titanium dioxide Propylene Glycol Macrogol 6000 Talc 6.2 Incompatibilities Not Applicable 6.3 Shelf life 3 years 6.4 Special precautions for storage Do not store above 30°C 6.5 Nature and contents of container PVC/PVDC/Aluminium blister- Blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100 and 112 tablets. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements
- Instruction Content
- ## Composition
2. Qualitative and quantitative composition Each prolonged release tablet contains: Metformin hydrochloride 500 mg corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1.
## Pharmaceutical Form
3. Pharmaceutical form Prolonged release tablet . Off-white coloured, oval, biconvex film-coated tablets plain on both sides.
## Clinical Particulars
4. Clinical particulars 4.1 Therapeutic indications • Reduction in the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with IGT* and/or IFG*, and/or increased HbA1C who are: - at high risk for developing overt type 2 diabetes mellitus (see section
## Pharmacological Properties
5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic Group: Blood Glucose lowering drugs, excluding Insulins Biguanides. ATC code: A10BA02 Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. Mechanism of action: Metformin may act via 3 mechanisms: (1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; (2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; (3) delay of intestinal glucose absorption. Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase. Metformin increases the transport capacity of all types of membrane glucose transporters (GLUT). Pharmacodynamic effects: In clinical studies, the major non glycaemic effect of metformin is either weight stability or modest weight loss. In humans, independently of its action on glycaemia, immediate release metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: immediate release metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. A similar action has not been demonstrated with the prolonged release formulation, possibly due to the evening administration, and an increase in triglycerides may occur. Clinical efficacy: Reduction in the risk or delay of type 2 diabetes mellitus The Diabetes Prevention Program (DPP) was a multicenter randomised controlled clinical trial in adults assessing the efficacy of an intensive lifestyle intervention or metformin to prevent or delay the development of type 2 diabetes mellitus. Inclusion criteria were age ≥25 years, BMI ≥24 kg/m2 (≥22 kg/m2 for Asian-Americans), and impaired glucose tolerance plus a fasting plasma glucose of 95 – 125 mg/dl (or ≤125 mg/dl for American Indians). Patients were either treated with intensive lifestyle intervention, 2x850 mg metformin plus standard lifestyle change, or placebo plus standard lifestyle change. The mean baseline values of the DPP participants (n=3,234 for 2.8 years) were age 50.6±10.7 years, 10
## Pharmaceutical Particulars
6. Pharmaceutical particulars 6.1 List of excipients Core Stearic Acid Shellac (Refined bleached) Povidone K-30 Silica, colloidal anhydrous Magnesium Stearate Film-Coating Hypromellose Hydroxy Propyl cellulose Titanium dioxide Propylene Glycol Macrogol 6000 Talc 6.2 Incompatibilities Not Applicable 6.3 Shelf life 3 years 6.4 Special precautions for storage Do not store above 30°C 6.5 Nature and contents of container PVC/PVDC/Aluminium blister- Blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100 and 112 tablets. Not all pack sizes may be marketed. 6.6 Special precautions for disposal and other handling No special requirements
- Company Detail Path
- /organization/morningside-healthcare-ltd
