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Gliclazide oral modified release

Updated 2 Feb 2023 | Sulfonylureas


Modified release tablets containing gliclazide.

Drugs List

  • DACADIS 30mg modified release tablet
  • DIAMICRON MR 30mg tablets
  • EDICIL MR 30mg tablets
  • gliclazide 30mg modified release tablet
  • gliclazide 60mg modified release tablet
  • LAAGLYDA MR 60mg tablets
  • LAMZARIN 30mg modified release tablet
  • LAMZARIN 60mg modified release tablet
  • NAZDOL MR 30mg tablets
  • ZICLASEG 30mg modified release tablet
  • Therapeutic Indications


    Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone


    As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbA1c).

    Daily dose should be taken in a single intake at breakfast time.


    Initial dose: 30mg daily with breakfast.

    The dose may be increased in steps of 30mg if necessary.

    Maximum dose: 120mg daily with breakfast.

    The interval between each dose increment should be at least one month. However, in patients whose blood glucose has not reduced after two weeks at a particular dose, the dose may be increased at the end of the second week of treatment.

    Additional Dosage Information

    Switching from gliclazide standard release tablets to modified release tablets
    1 tablet of gliclazide 80mg is comparable to 1 modified release tablet of gliclazide 30mg. Consequently the switch can be performed provided careful blood monitoring is carried out.

    Switching from another oral antidiabetic agent to gliclazide modified release tablets
    Gliclazide 30mg modified release tablets can be used to replace other antidiabetic agents. The dosage and the half-life of the previous agent should be taken into account when switching to gliclazide modified release tablets. A transitional period is not generally necessary. A starting dose of 30mg should be used and this should be adjusted to suit the patient's blood glucose response.

    When switching from a sulfonylurea with a prolonged half-life
    A treatment free period of a few days may be necessary to avoid an additive effect of the two products, which may cause hypoglycaemia. A starting dose of 30mg daily is recommended, followed by a stepwise increase in dose, depending on the metabolic response.

    Combination treatment with other antidiabetic agents
    Modified release gliclazide may be given in combination with biguanides, alpha glucosidase inhibitors or insulin. Patients not adequately controlled with modified release gliclazide may receive concomitant insulin therapy, initiated under close medical supervision.

    Missed doses
    If a dose is missed, continue with scheduled regimen, with no additional dose.


    Children under 18 years
    Cholestatic jaundice
    Diabetic coma
    Diabetic ketoacidosis
    Diabetic pre-coma
    Severe hepatic impairment
    Severe renal impairment

    Precautions and Warnings

    Adrenal insufficiency
    G6PD deficiency
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Lactose intolerance
    Pituitary insufficiency
    Renal impairment

    Advise ability to drive or operate machinery may initially be impaired
    Advise patient to take precautions to avoid hypoglycaemia whilst driving
    Some formulations contain lactose
    Monitor dosage closely in presence of renal or hepatic impairment
    Consider dose reduction to prevent hypoglycaemia if dietary intake reduced
    Discontinue if hepatitis develops
    May induce severe hypoglycaemia
    Risk of hypoglycaemia may be increased by exercise or ingestion of alcohol
    Discontinue if cholestatic jaundice occurs
    Pregnancy confirmed: Change patient to insulin treatment
    Advise patient not to take St John's wort concurrently
    Advise patient they have to inform the DVLA of antidiabetic medication
    Advise patients of the warning signs of hypoglycaemia
    Advise patients on adequate dietary control

    This treatment should only be prescribed if the patient is likely to have a regular food intake (including breakfast). Missed meals, low food consumption and consuming food with a low carbohydrate content can increase the risk of hypoglycaemia. Hypoglycaemia is also more likely to occur following prolonged or strenuous exercise, alcohol intake and during low calorie intake diets.

    Efficacy of gliclazide treatment may diminish over time (secondary failure) and may require dosage adjustment. This may be due to a reduced response to treatment or to progression in the severity of diabetes.

    A hypoglycaemic episode occurring in patients with renal and hepatic impairment may be prolonged, so appropriate management should be initiated. In patients with hepatic impairment or severe renal impairment, the use of insulin is recommended as treatment for non-insulin dependent diabetes mellitus.

    Some manufacturers contraindicate its use in porphyria, but the Drug Database for Acute Porphyria states that there is insufficient evidence for it to be classified.

    Pregnancy and Lactation


    Gliclazide is contraindicated during pregnancy.

    The manufacturer does not recommend using gliclazide during pregnancy. There is no experience with the use of gliclazide during human pregnancy, although some data is available for other sulfonylureas. Animal studies have shown no risk of teratogenic effects, however reproductive toxicity has been observed.

    Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at


    Gliclazide is contraindicated during breastfeeding.

    The manufacturers note that it is not known whether gliclazide or its metabolites are excreted in breast milk. Other sulfonylureas are excreted in breast milk, therefore there is a possibility of hypoglycaemia in the infant.


    Patients and family members should be advised on the signs and symptoms of hypoglycaemia, as well as the conditions that predispose to its development.

    Patient should be reminded of the importance of following dietary advice, taking regular exercise and regular monitoring of blood glucose levels.

    Caution is advised when driving or operating machinery, especially at the beginning of treatment, due to the possibility of hypoglycaemia (e.g. poor concentration, confusion, poor reactions etc.)

    Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing website.

    Advise patient not to take St John's wort concurrently.

    Side Effects

    Abdominal pain
    Bullous reactions
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Increases in hepatic enzymes
    Maculopapular rash
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: January 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Bilxona 60mg Modified-release Tablets. Accord UK Ltd. Revised November 2019.

    Summary of Product Characteristics: Bilxona 30mg Modified-release Tablets. Accord UK Ltd. Revised November 2019.

    Summary of Product Characteristics: Dacadis MR 30mg Tablets. Generics UK Limited. Revised May 2019.

    Summary of Product characteristics: Diamicron 30mg MR. Servier Laboratories Limited. Revised October 2016.

    Summary of Product Characteristics: Edicil MR 30 mg modified-release tablets. Ratiopharm GmbH. Revised October 2011.

    Summary of Product characteristics: Laaglyda MR 60mg modified-release tablets. Consilient Health Ltd. Revised January 2013.

    Summary of Product characteristics: Lamzarin MR 30mg modified-release tablets. Key Pharmaceuticals Ltd. Revised October 2018.

    Summary of Product characteristics: Lamzarin MR 60mg modified-release tablets. Key Pharmaceuticals Ltd. Revised October 2018.

    Summary of Product Characteristics: Nazdol MR 30mg Tablets. Consilient Health Ltd. Revised December 2012.

    Summary of Product Characteristics: Vamju 30 mg & 60 mg modified release tablets. Advanz. Revised September 2014.

    Summary of Product characteristics: Ziclaseg 30mg prolonged release tablets. Lupin (Europe) Ltd. Revised February 2016.

    Summary of Product characteristics: Zicron PR 30 mg prolonged-release tablets. Bristol Laboratories Ltd. Revised August 2017.

    NICE Evidence Services Available at: Last accessed: 16 January 2020

    The Norwegian Porphyria Centre (NAPOS).
    Available at:
    Last accessed: 16 January 2020

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