SIOFOR Prolonged-release tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Siofor SR 500 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet. White to off-white, capsule shaped tablet, debossed on one side with SR 500 and plain on the other side. <u>Tablet dimensions:</u> length 16.50 mm, breadth 8.20 mm, thickness ...
4.1. Therapeutic indications
Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Siofor SR may be used as ...
4.2. Posology and method of administration
Posology Adults with normal renal function (GFR ≥90 mL/min) Monotherapy in Type 2 diabetes mellitus and combination with other oral antidiabetic agents The usual starting dose is one tablet of Siofor SR ...
4.3. Contraindications
Hypersensitivity to metformin or to any of the excipients listed in section 6.1. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). Diabetic pre-coma. Severe renal failure ...
4.4. Special warnings and precautions for use
Lactic acidosis Lactic acidosis, a very rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use not recommended Alcohol Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment. Iodinated contrast ...
4.6. Fertility, pregnancy and lactation
Pregnancy Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality. A limited amount of data from the use ...
4.7. Effects on ability to drive and use machines
Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines. However, patients should be alerted to the risk of hypoglycaemia when metformin ...
4.8. Undesirable effects
In post marketing data and in controlled clinical studies, adverse event reporting in patients treated with metformin prolonged-release was similar in nature and severity to that reported in patients treated ...
4.9. Overdose
Hypoglycaemia has not been seen with metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose or concomitant risks of metformin may lead to lactic acidosis. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Blood glucose lowering drugs, excl. insulins, Biguanides <b>ATC code:</b> A10BA02 Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial ...
5.2. Pharmacokinetic properties
Absorption After an oral dose of the prolonged-release tablet, metformin absorption is significantly delayed compared to the immediate release tablet with a T<sub>max</sub> at 7 hours (T<sub>max</sub> ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity reproduction.
6.1. List of excipients
Magnesium stearate Silica colloidal anhydrous Carmellose sodium Hypromellose Water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
15, 30, 60, 90 or 120 prolonged-release tablets in blister strips composed of aluminium foil and PVC. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
A. Menarini Pharmaceuticals Ireland Ltd, Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co Dublin, Ireland
8. Marketing authorization number(s)
PA1833/002/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 3<sup>rd</sup> May 2019
10. Date of revision of the text
09 May 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
