Daonil® 5 mg
Glibenclamide scored tablet
Please read all of the leaflet carefully, before taking this medicine
– Keep this leaflet you may need to read it again.
– If you have any questions or doubts, ask your doctor or pharmacist for further information.
– This medicine has been prescribed personally for you. Do not give it to anybody else, even if he/she has identical symptoms since it might cause harm to him/her.
IDENTIFICATION OF THE MEDICINE
Glibenclamide 5 mg for one scored tablet.
Excipients lactose monohydrate, maize starch, pregelatinized maize starch, talc, anhydrous colloidal silica, magnesium stearate.
Pharmaceutical form and presentation
Scored tablet, box of 20 or 100.
SULFONYLUREA – ORAL ANTI DIABETIC
(A: gastrointestinal tract and metabolism)
WHEN SHOULD THIS MEDICINE BE USED
This medicine is indicated in case of non-insulin diabetes, if a diet has failed.
WHEN THIS MEDICINE SHOULD NOT BE USED
This medicine SHOULD NOT BE USED in the following cases:
– allergy to glibenclamide,
– diabetes requiring insulin therapy,
– diabetic ketoacidosis, precomatose diabetes,
– severe liver or kidney disease,
– treatment with miconazoIe (cf. Drug interactions and other interactions),
– porphyria: accumulation of pigments (porphyrin) in the body,
Unless otherwise specified by your doctor, the combination of this medicine with phenylbutazone or danazol is generally inadvisable.
IN CASE OF DOUBT, YOU MUST ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Hypoglycaemia (reduced levels of sugar in the blood):
During your treatment, you may suffer from hypoglycaemia. If this occurs, it may be necessary for you to go to the hospital to restore your sugar levels.
Following an episode of hypoglycaemia, your doctor will monitor you closely for at least 24 hours.
In order to avoid episodes of hypoglycaemia, the following information is important:
– you should always eat regular meals, including breakfast, because of the increased risk of hypoglycaemia if a meal is missed or if your diet contains insufficient or unbalanced levels of sugars;
– age, kidney failure, liver failure and certain adrenal or pituitary disorders may favor the onset of hypoglycaemia, the onset of hypoglycaemia is promoted by a severe or poorly balanced diet, by strenuous or prolonged physical exertion, by the consumption of alcohol or during combination with other hypoglycaemic drugs (cf. Drug interactions and other interactions).
In the event of surgery, trauma, fever or infection, your doctor may stop this treatment and prescribe insulin.
The levels of glucose in your blood and urine should be monitored regularly.
Precautions for use
Your doctor will explain to you and your family how to avoid hypoglycaemia, how to recognize the early symptoms and how to treat them.
Your doctor will also explain about the conditions under which you may become resistant to glibenclamide therapy; under these circumstances, other medicine may be prescribed to replace it.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Drug interactions and other interactions
IN ORDER TO AVOID POSSIBLE INTERACTIONS WITH OTHER MEDICINE, YOU MUST ALWAYS INFORM YOUR DOCTOR OR PHARMACIST ABOUT ANY OTHER CURRENT TREATMENT, and particularly:
1. Medicine which may cause hypoglycaemia: miconazole, phenylbutazone, betablockers, fluconazole, angiotensin converting enzyme inhibitors, alcohol.
2. Medicine which may cause hyperglycaemia through lowering of the efficacy of the antidiabetic: danazol, chlorpromazine, glucocorticosteroids, progestogens, salbutamol, terbutaline, ritodrine.
Pregnancy – Lactation
In the event of pregnancy, the treatment of diabetes is always based on insulin.
If you discover that you are pregnant while taking this medicine, your treatment should be discontinued.
Tell your doctor so that your hypoglycaemic treatment may be adapted accordingly. This medicine is contraindicated during lactation.
Driver and machine operators
The attention of drivers must be stressed on hypoglycaemia symptoms and on their effect on vigilance.
List of Excipients which must be specified for the safe use of this medicine in certain patients
HOW TO USE THIS MEDICINE
The usual dosage is 1/2 to 3 tablets a day.
Method and route of administration
Oral use. The tablets should be swallowed with about half a glass of water, immediately before a meal.
Management of overdose
In all cases, contact a doctor immediately. If you experience mild signs of hypoglycaemia: weakness, sweating, appetite urge, tremor, drowsiness, dizziness, headache or visual disturbances, eat or drink something which contains sugar.
Management in the event of omission of one or several doses
Take a tablet during the next meal.
Do not double the dose.
UNWANTED AND UNPLEASANT EFFECTS
LIKE ANY ACTIVE SUBSTANCE, THIS MEDICINE MAY, IN SOME PATIENTS, HAVE MORE OR LESS UNPLEASANT EFFECTS:
– Hypoglycaemia (lowering of the levels of sugar in the blood, cf. Warnings and overdose).
– Skin symptoms urticaria, itching, skin rashes.
– Gastrointestinal disorders: nausea, diarrhoea, stomach discomfort, jaundice, hepatitis.
– Porphyria : accumulation of pigments (porphyrin) in the body.
– Abnormal biological tests results, concerning the liver; kidneys or blood.
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE AND TO REPORT ANY UNWANTED AND UNPLEASANT EFFECT NOT MENTIONED IN THIS LEAFLET.
DO NOT EXCEED THE EXPIRY DATE INDICATED ON THE OUTER PACKAGING.
Special precautions for storage
Do not store above 25°C.
DATE OF LEAFLET REVISION
Market Authorisation Holder
Sanofi-Aventis Nigeria Limited,
Plot 1205 Amodu Ojikutu Street,
Victoria Island, Lagos State,
swiss pharma nigeria Ltd,
5, Dopemu Road,
Agege, Lagos State,