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SPC: FORXIGA Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Forxiga 5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin. Excipient with known effect: Each 5 mg tablet contains 25 mg of lactose anhydrous. For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet (tablet). Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with 5 engraved on one side and 1427 engraved on the other side.

Therapeutic indications

Forxiga is indicated in adults for the treatment of insufficiently controlled: type 2 diabetes mellitus as an adjunct to diet and exercise, to improve glycaemic control,as monotherapy when metformin is ...

Posology and method of administration

Posology Type 2 diabetes mellitus The recommended dose is 10 mg dapagliflozin once daily for monotherapy and add-on combination therapy with other glucose-lowering medicinal products, including insulin. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Renal impairment The glycaemic efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and is likely absent in patients with severe ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions Diuretics Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4). Insulin and ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of dapagliflozin in pregnant women. Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters ...

Effects on ability to drive and use machines

Forxiga has no or negligible influence on the ability to drive and use machines. Patients should be alerted to the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or ...

Undesirable effects

Summary of the safety profile Type 2 diabetes mellitus In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with ...

Overdose

Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose). These subjects had detectable glucose in the urine for a dose-related ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, Sodium-glucose co-transporter 2 (SGLT2) inhibitors ATC code: A10BK01 Mechanism of action Dapagliflozin is a highly potent (K<sub>i</sub>: 0.55 nM), selective ...

Pharmacokinetic properties

Absorption Dapagliflozin was rapidly and well absorbed after oral administration. Maximum dapagliflozin plasma concentrations (C<sub>max</sub>) were usually attained within 2 hours after administration ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility. Dapagliflozin did ...

List of excipients

Tablet core: Microcrystalline cellulose (E460i) Lactose Crospovidone (E1202) Silicon dioxide (E551) Magnesium stearate (E470b) Film-coating: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Alu/Alu blister. Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters. Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters. Not all pack sizes ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization number(s)

EU/1/12/795/001 14 film-coated tablets EU/1/12/795/002 28 film-coated tablets EU/1/12/795/003 98 film-coated tablets EU/1/12/795/004 30 1 (unit dose) film-coated tablets EU/1/12/795/005 90 1 (unit dose) ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 12 November 2012 Date of latest renewal: 28 August 2017

Πηγαίο έγγραφο

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