METFORAL Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
METFORAL 500 mg film-coated tablets. METFORAL 850 mg film-coated tablets.
2. Qualitative and quantitative composition
METFORAL 500 mg film-coated tablets <u>Each film-coated tablet contains:</u> 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin. METFORAL 850 mg film-coated tablets <u>Each film-coated ...
3. Pharmaceutical form
Film-coated tablets. <u>METFORAL 500 mg film-coated tablets:</u> White, round film-coated tablet, shallow biconvex, beveled edges. <u>METFORAL 850 mg film-coated tablets:</u> White, oblong film-coated ...
4.1. Therapeutic indications
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone do not result in adequate blood glucose control. In adults: METFORAL 500 mg/METFORAL ...
4.2. Posology and method of administration
Posology Adults with normal renal function (GFR≥ 90 mL/min) Monotherapy and combination with other oral antidiabetic agents The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times ...
4.3. Contraindications
Hypersensitivity to metformin hydrochloride 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. ...
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 cases ofFasting, malnutrition orhepatic impairment. The consumption ...
4.6. 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 hydrochloride monotherapy has no effects on the ability to drive and use machines. However, patients should be alerted of the risks of hypoglycaemia when metformin hydrochloride is administered ...
4.8. Undesirable effects
The following undesirable effects may occur under treatment with metformin. The prevalence is defined as follows: very common ≥1/10; common >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; ...
4.9. Overdose
Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin hydrochloride or concomitant risk ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> hypoglycaemising agents, excluding insulins, biguanides <b>ATC code:</b> A10BA02 Mechanism of action Metformin may act through 3 mechanisms: reduction of hepatic glucose ...
5.2. Pharmacokinetic properties
Absorption After an oral dose of metformin hydrochloride, Tmax is reached in 2.5 hours. The absolute bioavailability of a 500 mg or 850 mg tablet of metformin hydrochloride is approximately 50–60% in healthy ...
5.3. Preclinical safety data
Preclinical data reveal no specific hazards for humans based on conventional trials regarding pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential, and reproduction toxicity. ...
6.1. List of excipients
Colloidal anhydrous silica Povidone Macrogol 4000 Magnesium stearate Opadry II 85F29116 Clear (polyvinyl alcohol, macrogol 3350, talc)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store in a dry place.
6.5. Nature and contents of container
Rigid thermoformed PVC/PVDC/aluminium blister strips, thermo-sealed with thermoforming resin-lacquered aluminium film, packed in lithographed cardboard packets. <u>METFORAL 500 mg film-coated tablets: ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste materials deriving from the same must be disposed of in compliance with local regulations.
7. Marketing authorization holder
Laboratori Guidotti S.p.A, Via Livornese 897, La Vettola 56122, PISA, Italy Local Representative, Menarini Hellas S.A., An. Damvergi 7, Athens, Greece, Τel.: 210-8316111
8. Marketing authorization number(s)
Metforal 500 mg: 017499 Metforal 850 mg: 018663
9. Date of first authorization / renewal of the authorization
<u>Date of first authorisation:</u> Metforal 500 mg: 11/12/1997 Metforal 850 mg: 15/02/2000
10. Date of revision of the text
May 2021
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