Normodiab Special Precautions

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.