Diamicron MR 30/Diamicron MR 60

Diamicron MR 30/Diamicron MR 60

gliclazide

Manufacturer:

Servier

Distributor:

Maxxcare
Full Prescribing Info
Contents
Gliclazide.
Description
Each modified-release tablet also contains the following excipients: Lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, anhydrous colloidal silica.
Gliclazide is 1-(3-azabicyclo[3.3.0]oct-3-yl)-3-(p-tolylsulfonyl) urea.
Action
Oral antidiabetic.
Pharmacology: Gliclazide is a hypoglycaemic sulfonylurea which stimulates insulin secretion by the pancreas. Its action on insulin secretion is mainly due to the restoration of the early phase, resulting in a physiological release of insulin. Thus, gliclazide restores glycaemic control throughout 24 hrs. It normalizes fasting and postprandial blood sugar.
In man, apart from having hypoglycaemic effect, gliclazide has been shown to reduce platelet hyperadhesiveness and hyper-aggregation and to increase fibrinolytic activity. Moreover, it has been demonstrated that gliclazide possesses specific antioxidant properties. As such, gliclazide scavenges free radicals, and therefore, decreases the oxidative stress, to which the diabetic patient is commonly exposed. (These factors are thought to be implicated in the pathogenesis of the long-term complications of diabetes mellitus.)
Indications/Uses
Reduction of blood sugar levels.
Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.
Dosage/Direction for Use
Diamicron MR 30 mg tab: Usual Daily Dose: 1-4 tabs/day as a single dose. It is recommended that the drug be taken at breakfast. In the elderly (>65 years), Diamicron MR 30 should be prescribed using the same dosing regimen recommended for patients <65 years. In patients with mild to moderate renal insufficiency, the same dosing regimen can be used as in patients with normal renal function with careful patient monitoring. These data have been confirmed in clinical trials.
The once-daily administration of Diamicron MR 30 must always be accompanied by a meal.
Do not take a double dose to compensate for the single dose that was not taken.
If the treatment is discontinued, there is a risk of an imbalance in diabetes (hyperglycemia). In all cases, strictly comply with the doctor's prescription.
Switching Diamicron to Diamicron MR 30 should be done on a tablet for tablet basis. For example, 1 tab with breakfast and 1 tab in the evening of Diamicron has to be switched to 2 tabs of Diamicron MR 30 in the morning.
Diamicron MR 60 mg tab: The dose is determined by the physician, depending on the blood and possibly urine sugar levels.
Change in external factors (eg, weight reduction, change in lifestyle, stress) or blood sugar control improvement may require changed gliclazide doses.
Usual Dose: ½-2 tabs in a single intake at breakfast time. This depends on the response to treatment. Maximum Dose: 120 mg.
Proper dosage of combination therapy by Diamicron MR 60 and metformin, an α-glucosidase inhibitor, or an insulin will be determined by the physician.
If Diamicron MR 60 is an inadequate therapy, consult the physician immediately.
In case of a missed dose, take the next dose at the usual time. Do not double a dose to make up for the forgotten dose.
As treatment for diabetes is usually life-long, consult the physician before discontinuation since abrupt stopping of treatment may cause hyperglycemia.
Administration: Diamicron MR 60 mg is taken orally with food and non-alcoholic drinks. Swallow ½ tab or whole tablet(s) in one piece. Do not chew or crush.
Take the tablets with a glass of water at breakfast time (and preferably at the same time each day).
Always eat a meal after taking the tablets.
Overdosage
Symptoms: The symptoms of overdosage are those of low blood sugar (hypoglycemia) described in Precautions.
Treatment: The symptoms can be relieved by taking sugar (4-6 lumps) or sugary drinks right away, followed by substantial snack or meal. If the patient is unconscious, immediately inform a physician and call the emergency. The same should be done if somebody eg, a child, has taken Diamicron MR unintentionally.
Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a physician in case of emergency.
Contraindications
Hypersensitivity to gliclazide, sulfonylureas, hypoglycaemic sulphonamides or to any of the excipients of Diamicron MR.
Insulin-dependent diabetes (type 1), diabetic ketoacidosis, diabetic pre-coma or coma; severe kidney or liver disease.
Drugs for treating fungal infections (miconazole).
Unless the doctor advises the patient on the contrary, it is generally inadvisable to combine gliclazide with phenylbutazone or danazol (see also Interactions).
Use in lactation: Do not take Diamicron MR while breastfeeding.
Special Precautions
Observe the treatment plan prescribed by the physician to achieve proper blood sugar levels. This means, apart from regular tablet intake, the patient must observe the dietary regimen, have physical exercise, and where necessary, reduce weight.
During gliclazide treatment, regular monitoring of blood (and possibly urine) sugar level and also glycated haemoglobin (HbA1c) is necessary.
In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. Particular close medical monitoring is necessary.
Hypoglycemia may occur if irregular meals or skipping meals, fasting, malnourished, changing the diet, increased physical activity and carbohydrate intake, drinking alcohol in combination with skipped meals, concomitant use with other drugs or natural remedies, high doses of gliclazide, suffering from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex), and decreased severe kidney or liver function.
Symptoms of Low Blood Sugar: Headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.
The following signs and symptoms may also occur: Sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop, the patient may suffer from considerable confusion (delirium), develop convulsions, lose self control, shallow breathing, slowed heart beat and unconsciousness.
In most cases, the symptoms of low blood sugar vanish very quickly when some form of sugar eg, glucose tablets, sugar cubes, sweet juice, sweetened tea are consumed.
Symptoms of low blood sugar may be absent, less obvious or develop very slowly, or not aware in time that the blood sugar level has dropped. This may happen if an elderly patient is taking certain drugs (eg, those acting on the central nervous system and β-blockers).
Hyperglycemia: If in stress situations (eg, accidents, surgical operations, fever, etc), the physician may temporarily switch into insulin therapy.
Symptoms of hyperglycemia may occur when gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by the physician or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
In the presence of family history or known hereditary condition of glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), low haemoglobin level and breakdown of red blood cells (haemolytic anemia) can occur.
Diamicron MR contains lactose. Patients with lactose/sucrose intolerance should consult the physician before taking the drug product.
Effects on the Ability to Drive or Operate Machinery: Ability to concentrate or react may be impaired if the blood sugar is too low (hypoglycemia) or too high (hyperglycemia), or may develop visual problems as a result of such conditions. The patient may be endangered when driving a car or using machines. Consult a physician if the patient have frequent episodes of hypoglycemia, and few or no warning signal of hypoglycemia.
Avoid alcohol and alcoholic drinks.
Use in pregnancy: Diamicron MR is not recommended during pregnancy. If planning a pregnancy or may become pregnant, inform the physician for prescription of a more suitable treatment.
Use in children: Diamicron MR is not recommended for use in children due to a lack of data.
Use In Pregnancy & Lactation
Use in pregnancy: Diamicron MR is not recommended during pregnancy. If planning a pregnancy or may become pregnant, inform the physician for prescription of a more suitable treatment.
Use in lactation: Do not take Diamicron MR while breastfeeding.
Adverse Reactions
Like all drugs, Diamicron MR can cause side effects, although not everybody gets them.
The most commonly observed side effects is hypoglycaemia (see Precautions).
If left untreated, these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, consult the physician immediately.
Liver Disorders: There have been isolated reports of abnormal liver function which can cause yellow skin and eyes. Consult the physician immediately, whenever this occurs. The symptoms generally disappear if the medicine is discontinued. The physician will decide whether to discontinue the treatment or not.
Skin Disorders: Skin reactions eg, rash, redness, itching and hives have been reported. Severe skin reactions may also appear.
Blood Disorders: Decreased number of cells in the blood (eg, platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.
Digestive Disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These effects are reduced when Diamicron MR is taken with a meal as recommended.
Eye Disorders: The vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
With sulfonylurea, cases of severe changes in the number of blood cells and allergic inflammation of the blood vessels wall have been described. Symptoms of liver impairment (eg, jaundice) have been observed, which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.
Drug Interactions
The blood sugar-lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following drugs is taken: Other drugs used to treat high blood sugar (oral antidiabetics or insulin); antibiotics (eg, sulphonamides); drugs to treat high blood pressure or heart failure (β-blockers, angiotensin-converting enzyme inhibitors eg, captopril or enalapril); drugs to treat fungal infections (miconazole, fluconazole); drugs to treat ulcers in the stomach or duodenum (H2-receptor antagonist); drugs to treat depression (monoamine oxidase inhibitors); painkiller or antirheumatics (phenylbutazone, ibuprofen); drugs containing alcohol.
The blood glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following drugs is taken: Drugs to treat central nervous system disorders (chlorpromazine); drugs reducing inflammation (corticosteroids); drugs to treat asthma or used during labour (salbutamol IV, ritodrine and terbutaline); Saint John's Wort (Hypericum perforatum) preparations; Risk of dysglycaemia - use with caution: fluoroquinolones, drugs to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
Diamicron MR may increase the effects of drugs which reduce blood clotting (eg, warfarin).
Consult the physician before starting to take another drug.
Caution For Usage
Instructions for Proper Disposal: Drugs should not be disposed of via waste water or household waste.
Storage
Store at temperature not exceeding 30°C.
MIMS Class
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Diamicron MR 30: MR tab 30 mg (white, oblong tablet engraved on both faces, 'DIA 30' on one face and
Click on icon to see table/diagram/image
on the other) x 60's.
Diamicron MR 60: MR tab 60 mg (white, oblong, tablet 15 mm long and 7 mm wide, scored and engraved "DIA 60" on both faces) x 60's.
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