Glucophage 1000mg film-coated tablets

  • Name:

    Glucophage 1000mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Metformin Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/09/19

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Summary of Product Characteristics last updated on medicines.ie: 1/8/2018

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Merck

Merck

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 9 September 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 1 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 1 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 January 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

 

Posology

 

Adults with normal renal function (GFR≥ 90 mL/min)

 

Monotherapy and combination with other oral antidiabetic agents

 

The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.

The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.

If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.

 

Combination with insulin

 

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

 

Elderly

 

Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).

 

Renal impairment

 

A GFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at an increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

 

GFR (mL/min)

 

Total maximum daily dose

(to be divided into 2-3 daily doses)

 

Additional considerations

60-89

3000 mg

 

Dose reduction may be considered in relation to declining renal function.

 

45-59

2000 mg

 

 

Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin.

The starting dose is at most half of the maximum dose.

 

30-44

1000 mg

<30

 

-

Metformin is contraindicated.

 

Paediatric population

 

Monotherapy and combination with insulin

 

·                Glucophage can be used in children from 10 years of age and adolescents.

·                The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.

 

 

4.3         Contraindications

 

·                Hypersensitivity to metformin or to any of the excipients listed in section 6.1.

·                Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis).

·                Diabetic pre-coma.

·                Severe renal failure  (GFR < 30 mL/min).

·                Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.

·                Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.

·                Hepatic insufficiency, acute alcohol intoxication, alcoholism.

 

4.4     Special warnings and precautions for use

 

Lactic acidosis

 

Lactic acidosis, a very rare, but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis..

 

In case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.

 

Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients. Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).

 

Patients and/or care-givers should be informed of the risk of lactic acidosis. Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma. In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention. Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (>5 mmol/L) and an increased anion gap and lactate/pyruvate ratio.

 

Renal function

 

GFR should be assessed before treatment initiation and regularly thereafter, see section 4.2. Metformin is contraindicated in patients with GFR<30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.

 

Cardiac function

 

Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function.

 

For patients with acute and unstable heart failure, metformin is contraindicated (see section 4.3).

 

Administration of iodinated contrast agents

 

Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis. Metformin should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5.

 

Surgery

 

Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.

 

Paediatric population

 

The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.

 

No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

 

Children aged between 10 and 12 years

 

Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although efficacy and safety of metformin in these children did not differ from efficacy and safety in older children and adolescents, particular caution is recommended when prescribing to children aged between 10 and 12 years.

 

Other precautions

 

All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.

 

The usual laboratory tests for diabetes monitoring should be performed regularly.

 

Metformin alone does not cause hypoglycaemia, but caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides).

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Concomitant use not recommended

 

Alcohol

 

Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment.

 

Iodinated contrast agents

 

Metformin must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.

 

Combinations requiring precautions for use

 

Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. When starting or using such products in combination with metformin, close monitoring of renal function is necessary.

 

Medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local routes) and sympathomimetics)

 

More frequent blood glucose monitoring may be required, especially at the beginning of treatment. If necessary, adjust the metformin dosage during therapy with the respective medicinal product and upon its discontinuation.

 

 

Organic cation transporters (OCT)

 

Metformin is a substrate of both transporters OCT1 and OCT2.

 

Co-administration of metformin with

·         Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.

·    Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.

·    Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.

·    Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.

Caution is therefore advised, especially in patients with renal impairment, when these drugs are co-administered with metformin, as metformin plasma concentration may increase. If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 5 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 4 January 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5 Interaction with other medicinal products and other forms of interaction:
..........

Organic cation transporters (OCT)

 

Metformin is a substrate of both transporters OCT1 and OCT2.

 

Co-administration of metformin with

·         Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.

·    Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.

·    Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.

·    Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.

Caution is therefore advised, especially in patients with renal impairment, when these drugs are co-administered with metformin, as metformin plasma concentration may increase. If needed, dose adjustment of metformin may be considered as OCT inhibitors/inducers may alter the efficacy of metformin.

 

Section 10 Date of revision of the text

12/2016

Updated on 27 February 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Addition of information on reporting a side effect.
  • Change to side-effects

Updated on 23 January 2015 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

3.       PHARMACEUTICAL form

 

Film-coated tablet.

 

Glucophage 500 mg: White, circular, convex film-coated tablets, 11 mm in diameter and 5.7 mm high, engraved with GL 500.

 

Glucophage 850 mg: White, circular, convex film-coated tablets, 13.5 mm in diameter and 6.6 mm high, engraved with GL 850.

 

Glucophage 1000 mg: White, oval, biconvex film-coated tablets of dimensions 19 mm x 10.5 mm and 6.4 mm high with a score line on both sides with « 1000 » engraved on one side. The tablet can be divided into equal halves.

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

17 January 2015


10.     DATE OF REVISION OF THE TEXT

 

01/2015

Updated on 6 January 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5 - Pharmacological properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

There are extensive updates throughout the SPC.

Updated on 18 March 2014 PIL

Reasons for updating

  • Change of manufacturer

Updated on 18 September 2013 PIL

Reasons for updating

  • Change of distributor details

Updated on 10 April 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 October 2010 SmPC

Reasons for updating

  • Change to joint SPC covering all presentations

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

To consolidate all SmPC's for the range so that details for tablets and powders are as similar as possible.

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following statement added to section 5.1

'In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss'

Updated on 21 June 2010 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following text updated:

7. MARKETING AUTHORISATION HOLDER

Merck Serono

 

 

Ltd

 

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX

UK

 

8. MARKETING AUTHORISATION NUMBER(S)

PA 654/19/1-3

 

10. DATE OF REVISION OF THE TEXT

June 2010

Updated on 26 October 2009 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following paragraph was in the wrong place - it was in the childrens section, but it should be in the adults section as sepcified below:

In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg film-coated tablets with one Glucophage 1000 mg film-coated tablet.

 

Adults:

 

 

Monotherapy and combination with other oral antidiabetic agents:

The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.

In patients receiving a high metformin hydrochloride dose (2 to 3 grams per day), it is possible to replace two Glucophage 500 mg film-coated tablets with one Glucophage 1000 mg film-coated tablet.

 

 

The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.

 

If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin hydrochloride at the dose indicated above.

Updated on 9 December 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

address change of MA Holder:
 

Lipha Pharmaceuticals Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX

UK

Updated on 27 May 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

typographical errors in section 7 and section 8

Updated on 25 April 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following statements added to section 4.4:
 

"The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders as abdominal pain and severe asthenia."

and also:

"...spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established."

Updated on 26 July 2007 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Added to section 3 concerning the 1000 mg tablet:
 
"The tablet can be divided into equal halves."

Updated on 3 May 2006 SmPC

Reasons for updating

  • Introduction of new strength

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 2 September 2005 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)