Normodiab

Gliclazide.

One tablet contains either 30 mg or 60 mg of gliclazide in a modified-release formulation.
Excipients/Inactive Ingredients: The other ingredients are: lactose monohydrate, hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

Normodiab is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group).
Normodiab is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Always take this medicine exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if unsure.
Dosage: The dose is determined by the doctor, depending on the blood and possibly urine sugar levels. Change in external factors (e.g. weight reduction, change in lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.
The recommended starting dose is 30 mg. For 30 mg tablets, the usual dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. For 60 mg tablets, the tablet can be divided into equal doses. The usual dose is half to two tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment.
If a combination therapy of Normodiab with metformin (an alpha glucosidase inhibitor) or insulin is initiated, the doctor will determine the proper dose of each medicine individually.
Please talk to the doctor or pharmacist if having the impression that Normodiab is acting too strongly or not strongly enough.
Methods and routes of administration: Oral use. For 30 mg tablets, swallow the whole tablet(s) in one piece. For 60 mg tablets, swallow the half tablet or whole tablet(s) in one piece.
Do not chew or crush. Take the tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). A meal must always be eaten after taking the tablet(s).
Forgotten intake of Normodiab: It is important to take the medicine every day as regular treatment works better. However, if intake of a dose of Normodiab is forgotten, the next dose should be taken at the usual time. Do not take a double dose to make up for a forgotten dose.
Switching from gliclazide 80 mg tablets or from other antidiabetics to Normodiab: The doctor will decide the initial dose and conduct more close monitoring for a short time.
Stopping intake of Normodiab: As the treatment for diabetes is usually lifelong, discuss with the doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia).

If too many tablets are taken, contact the doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in Precautions. The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious, immediately inform a doctor and call the emergency services. The same should be done if somebody, e.g. a child, has taken the product 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 doctor in case of emergency.

Do not take Normodiab: if allergic to gliclazide or any of the other ingredients of this medicine (listed in Description), or to other medicines of the same group (sulphonylureas), or to other related medicines (hypoglycaemic sulphonamides); if with insulin-dependent diabetes (type 1); if with ketone bodies and sugar in the urine (diabetic ketoacidosis may be present), a diabetic pre-coma or coma; if with severe kidney or liver disease; if taking medicines to treat fungal infections (miconazole, see Interactions); if breastfeeding (see Use in Pregnancy & Lactation).

Talk to the doctor or pharmacist before taking Normodiab.
Observe the treatment plan prescribed by the doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, observe the dietary regimen, have physical exercise and where necessary, reduce weight.
During gliclazide treatment, regular monitoring of the blood (and possibly urine) sugar level and also the glycated haemoglobin (HbA1c) is necessary. It may also be useful to monitor own blood sugar levels, although only following instruction from the doctor.
In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.
Low blood sugar (hypoglycaemia) may occur: if meals are taken irregularly or skipped altogether; if fasting; if malnourished; if changing diet; if physical activity is increased and carbohydrate intake does not match this increase; if drinking alcohol, especially in combination with skipped meals; if taking other medicines or natural remedies at the same time; if taking too high doses of gliclazide; if suffering from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex); if kidney function or liver function is severely decreased; if intake of corticosteroids (medicines that reduce inflammation) have been stopped recently following prolonged and/or high dose use; if a severe blood circulation disorder, such as coronary heart disease, severe carotid artery impairment or diffuse vascular disease, is present.
If low blood sugar is present, the following symptoms may occur: 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 heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).
If blood sugar levels continue to drop, considerable confusion (delirium) may be experienced, convulsions may develop, self-control may be lost, breathing may be shallow and heartbeat slowed down, and unconsciousness may occur.
In most cases, the symptoms of low blood sugar vanish very quickly when some form of sugar is consumed, e.g. glucose tablets, sugar cubes, sweet juice, sweetened tea. Therefore, always carry some form of sugar (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective.
Please contact the doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.
Symptoms of low blood sugar may be absent, less obvious or develop slowly, or there may be no awareness in time that the blood sugar level has dropped. This may happen in an elderly patient taking certain medicines (e.g. those acting on the central nervous system and beta-blockers).
In case of stress situations (e.g. accidents, surgical operations, fever etc.), the doctor may temporarily switch to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar, when there is no compliance with the treatment plan prescribed by the doctor, or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.
If these symptoms occur, the doctor or pharmacist must be contacted.
If there is a family history of or existing hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact the doctor before taking this medicinal product.
Normodiab contains lactose: If informed to have an intolerance to some sugars by the doctor, contact the doctor before taking this medicine.
Driving and using machines: The ability to concentrate or react may be impaired if the blood sugar is too low (hypoglycaemia) or too high (hyperglycaemia) or if visual problems develop as a result of such conditions. Bear in mind that the self or others could be endangered (e.g. when driving a car or using machines). Ask the doctor whether a car can be driven if: having frequent episodes of low blood sugar (hypoglycaemia); having few or no warning signals of low blood sugar (hypoglycaemia).
Use in Children: Normodiab is not recommended for use in children and adolescents due to a lack of data.

If pregnant or breastfeeding, possibly pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: Normodiab is not recommended for use during pregnancy.
Breastfeeding: Normodiab must not be taken while breastfeeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed side effect is low blood sugar (hypoglycaemia). For symptoms and signs, 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, immediate medical attention should be sought.
Liver disorders: There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If this is experienced, see the doctor immediately. The symptoms generally disappear if the medicine is stopped. The doctor will decide whether to stop the treatment.
Skin disorders: Skin reactions such as rash, redness, itching, hives and angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. The rash may progress to widespread blistering or peeling of the skin.
Blood disorders: Decrease in the number of cells in the blood (e.g. 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: Stomach pain or discomfort, nausea, vomiting, indigestion, diarrhoea and constipation. These effects are reduced when Normodiab is taken with a meal as recommended (see Dosage & Administration).
Eye disorders: Vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.
The following adverse events have been observed with other sulphonylureas: Severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels; reduction in blood sodium (hyponatraemia); and symptoms of liver impairment (e.g. jaundice), which in most cases disappeared after withdrawal of the sulphonylurea, but may lead to life-threatening liver failure in isolated cases.
Reporting of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not previously listed. By reporting side effects, more information can be provided on the safety of this medicine.

Other medicines and Normodiab: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken: Other medicines used to treat high blood sugar (oral antidiabetics or insulin); Antibiotics (e.g. sulphonamides or clarithromycin); Medicines to treat high blood pressure or heart failure (beta-blockers, ACE inhibitors such as captopril or enalapril); Medicines to treat fungal infections (e.g. miconazole, fluconazole; see Contraindications); Medicines to treat ulcers in the stomach or duodenum (H₂ receptor antagonists); Medicines to treat depression (monoamine oxidase inhibitors); Painkillers or antirheumatics (phenylbutazone, ibuprofen); Medicines containing alcohol.
The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar may occur when one of the following medicines is taken: Medicines to treat disorders of the central nervous system (chlorpromazine); Medicines reducing inflammation (corticosteroids or tetracosactrin); Medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline); Medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
Normodiab may increase the effects of medicines which reduce blood clotting (e.g. warfarin).
Consult the doctor before starting intake of another medicinal product. If going to the hospital, tell the medical staff that Normodiab is being taken.
Normodiab with food, drink and alcohol: Normodiab can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of diabetes in an unpredictable manner.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Store below 25°C.

Antidiabetic Agents

A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.

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