srmp DK/H/2377/ /DC Gliclazid Sigillata

Transcription

1 srmp DK/H/2377/ /DC Gliclazid Sigillata VI.2 VI.2.1 Elements for a public summary Overview of disease epidemiology Diabetes is a disease which causes patients blood sugar levels to be high. Gliclazide decreases blood sugar levels by helping the production of insulin (a hormone which regulates the amount of sugar in the blood). High blood sugar levels (Non-insulin dependent diabetes (type 2)) Reference: One adult in ten will have diabetes by International Diabetes Federation. November 14, 2011 Increased blood sugar levels are less common in countries where the people have a low calorie diet and a high level of exercise. However, if people have a lifestyle of decreased activity and increase calorie consumption, there is a larger likely hood of developing weight gain and increased blood sugar levels. Rates of high blood sugar level are increasing worldwide. The International Diabetes Federation predicts that the number of people living with a high blood sugar level will rise from 366 million in 2011 to 552 million by VI.2.2 Summary of treatment benefits Based on the available data from clinical studies and clinical experience of several years, gliclazide represents an effective drug in the treatment of low blood sugar (non-insulin dependent diabetes type 2). The efficacy of the sulphonylurea gliclazide was assessed in 229 patients with high blood sugar levels. Gliclazide reduced mean random blood glucose in all groups, particularly those who previously had received previous treatment (either via diet or medication). Mean body weight was reduced, particularly in obese and elderly subjects. Side effects were mild and only two patients were withdrawn for this reason. One study focused on efficacy and safety in 411 patients with high blood sugar levels (non-insulindependent diabetes mellitus). Adverse effects were recorded in 30 (7.3%) of patients and led to the withdrawal of 1.2% from the study. Gliclazide was found to be safe and well tolerated in the majority of patients. If administered as indicated in the Summary of Product Characteristics and taking into account the contra-indications, the warnings and precautions, gliclazide can be considered effective in the approved indications and generally well tolerated.

2 VI.2.3 Unknowns relating to treatment benefits Based on the currently available data, no gaps in knowledge about efficacy in the target population were identified, that would warrant post-authorisation efficacy studies. Furthermore, there is no evidence to suggest that treatment results would be different in any subgroup of the target population, for any of the indications, taking into account factors such as age, sex, race or organ impairment. However as stated in the proposed SmPC, long term safety and outcomes in children and adolescents and use in pregnancy and breast feeding has not yet been established.

3 VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Use in patients with severe kidney and liver damage This medication can aggravate or increase the risk of kidney and liver damage This medication should not be administered to patients who have kidney or liver damage (Use in patients with severe renal and hepatic impairment) Low blood sugar levels Hypoglycaemia (as an individual reaction or as a consequence of drug interaction) Allergic skin reactions, including bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) Use in patients with a different type of increased blood sugar levels (type 1 diabetes) Increase in blood sugar levels following use with certain other medications. (Increase in blood glucose levels following concomitant use of danazol, chlorpromazine, glucocorticoids, ritodrine, salbutamol, terbutaline (I.V)) Liver disorders This medication reduces blood sugar levels This medication is known to cause allergic skin reactions. This medication should only be used to treat patients with type 2 diabetes (increase blood sugar levels) Gliclazide and certain other medicines may influence each other (interaction). When taken with certain other medicines, an increase in blood glucose may occur. This medication has been rarely known to cause liver disorders. Symptoms can include yellow skin and eyes. Patients with low blood sugar levels should not use this medication Patients should immediately tell their doctor if they experience any skin reactions. This medication should not be used by patients unless prescribed by a doctor Patients should tell their doctor or pharmacist if they are taking, have recently taken, or might take any other medicines. Patients should tell their doctor if they experience symptoms of a liver disorder. Important potential risks

4 Risk Decreased red blood cell count in patient with an inherited low level of the enzyme that breaks down sugar in the body. (Haemolytic anaemia in patients with glucose-6- phosphate (G6PD)- deficiency) Weight gain What is known (Including reason why it is considered a potential risk) There is an increased risk of developing a decreased red blood cell count in patients taking this medication who suffer from an inherited abnormally low level of the enzyme that breaks down sugar in the body. It is recommended not the take this medication if a patients has an inherited abnormally low level of the enzyme that breaks down sugar in the body. No known risk for weight gain. Treatment with medication used to reduce blood clotting (Concomitant use of gliclazide with anticoagulant therapy) This medication increases the effect of medicines which reduce blood clotting (e.g. warfarin) and a dose adjustment of the antiblood clotting medication may be required. It is recommended that a doctor is consulted before taking another medicinal product. Missing Information Risk Use in children and adolescents Use during pregnancy and breast feeding What is known The safety of this medication in children and adolescents has not been established, therefore the use of this medication in children and adolescents is not recommended. The safety of this medication during pregnancy and breast feeding has not been established, therefore the use of this medication while pregnant or breast feeding is not recommended. (Use during pregnancy and lactation) VI.2.5 Summary of additional risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for

5 minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan (if applicable) There are no studies in the post authorisation development plan. VI.2.7 Summary of changes to the risk management plan over time Table 1. Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment Version 1 Under Review Important identified risks N/A Use in patients with severe renal insufficiency Use in patients at risk of hypoglycaemia Use in patients with hypersensitivity to gliclazide, other sulphonylureas, sulphonamides, or any of the excipients Use in patients with type 1 diabetes Use in patients with diabetic pre-coma and coma, and diabetic keto-acidosis. Use in patients with hepatic insufficiency Interactions with miconazole, phenylbutazone, alcohol, other antidiabetic agents (insulins, acarbose, biguanides), betablockers, fluconazole, angiotensin converting enzyme inhibitors (captopril, enalapril), H2- receptor antagonists, MAOIs, sulfonamides, and nonsteroidal anti-inflammatory agents, danazol,

6 Version Date Safety Concerns Comment chlorpromazine, glucocorticoids, ritodrine and anticoagulant therapy. Use in patients with poor blood glucose control Haemolytic anaemia in patients with G6PD-deficiency Use during breastfeeding Missing information Use in children and adolescents Use during pregnancy and breastfeeding Version 1.1 Under review Important identified risks Use in patients with severe renal or hepatic insufficiency Hypoglycaemia (as an individual reaction or as a consequence of drug interaction) Allergic skin reactions, including bullous reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) Increase in blood glucose levels following concomitant use of danazol, chlorpromazine, glucocorticoids, ritodrine, salbutamol, terbutaline (I.V) Liver disorders Important potential risks Haemolytic anaemia in patients with glucose-6-phosphate (G6PD)-deficiency Weight gain Concomitant use of gliclazide with anticoagulant therapy.

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