GLITISOL Tablet (2016)
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Περιεχόμενα
1. Name of the medicinal product
Glitisol 5 mg tablets.
2. Qualitative and quantitative composition
Each Glitisol 5 mg tablet contains 5 mg glibenclamide. <u>Excipients with known effect:</u> Each Glitisol 5 mg tablet contains 93.3 mg lactose. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, oblong, flat, scored tablets. The tablet can be divided into equal doses.
4.1. Therapeutic indications
Glitisol is a sulphonylurea hypoglycaemic agent indicated for the oral treatment of patients with non-insulin dependent diabetes who respond inadequately to dietary measures alone.
4.2. Posology and method of administration
Posology The dosage of glibenclamide is governed by the desired blood glucose level. The dosage of glibenclamide must be the lowest possible dose which is effective. Mistakes, e.g. forgetting to take a ...
4.3. Contraindications
Glitisol should not be used in patients who have or have ever had diabetic ketoacidosis or diabetic coma/precoma or in patients who have insulin-dependent diabetes mellitus, serious impairment of renal, ...
4.4. Special warnings and precautions for use
Epidemiological studies suggest that the administration of glibenclamide is associated with an increased risk of cardiovascular mortality, when compared to treatment with metformin or gliclazide. This ...
4.5. Interaction with other medicinal products and other forms of interaction
Glitisol is mainly metabolised by CYP 2C9 and to a lesser extent by CYP 3A4. This should be taken into account when glibenclamide is co-administered with inducers or inhibitors of CYP 2C9. Potentiation ...
4.6. Fertility, pregnancy and lactation
Pregnancy Glitisol must not be taken during pregnancy. The patient must change over to insulin during pregnancy. Animal studies showed some teratogenic effects. Fertility Patients planning a pregnancy ...
4.7. Effects on ability to drive and use machines
Alertness and reactions may be impaired by hypo- or hyperglycaemic episodes, especially when beginning or after altering treatment, or when Glitisol is not taken regularly. This may affect the ability ...
4.8. Undesirable effects
<u>Hypoglycaemia:</u> Hypoglycaemia, sometimes prolonged and even life-threatening, may occur as a result of the blood glucose lowering action of glitisol tablets. Possible symptoms of hypoglycaemia include ...
4.9. Overdose
Signs and Symptoms Acute overdose as well as long-term treatment with too high a dose of glibenclamide may lead to severe, protracted, life-threatening hypoglycaemia. Management As soon as an overdose ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs used in diabetes; Blood glucose lowering drugs, excl. insulins <b>ATC Code:</b> A10BB01 The pharmacodynamic effect of glibenclamide is to lower blood glucose levels. ...
5.2. Pharmacokinetic properties
A sulphonylurea hypoglycaemic agent rapidly absorbed and inducing its effect within 3 hours with a duration of up to 15 hours although the T<sub>½</sub> of drug is 5 to 10 hours. The drug is metabolised ...
5.3. Preclinical safety data
None of clinical relevance.
6.1. List of excipients
Microcrystalline cellulose Povidone Lactose Starch Sodium starch glycolate Colloidal silicon dioxide Magnesium stearate Talc
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
PVC/Aluminium blisters. Pack-sizes of 40, 100, and 1000 tablets. PP containers with PE closure. Pack sizes of 1000 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str.,Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
19878
9. Date of first authorization / renewal of the authorization
Date of first authorization: 13 December 2005 Date of latest renewal: 01 December 2014
10. Date of revision of the text
10/06/2016
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