VIPDOMET Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Vipdomet 12.5 mg/850 mg film-coated tablets.
Vipdomet 12.5 mg/1,000 mg film-coated tablets.
2. Qualitative and quantitative composition
Vipdomet 12.5 mg/850 mg film-coated tablets:
Each tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Vipdomet 12.5 mg/1,000 mg film-coated tab...
3. Pharmaceutical form
Film-coated tablet (tablet).
Vipdomet 12.5 mg/850 mg film-coated tablets:
Light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with "12.5/850"...
4.1. Therapeutic indications
Vipdomet is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycaemic control in adult patients, in...
4.2. Posology and method of administration
Posology
For the different dose regimens Vipdomet is available in strengths of 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets.
Adults (≥18 years old) with normal renal function (glomerular...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, a...
4.4. Special warnings and precautions for use
General
Vipdomet should not be used in patients with type 1 diabetes mellitus. Vipdomet is not a substitute for insulin in insulin-requiring patients.
Lactic acidosis
Lactic acidosis, a very rare b...
4.5. Interaction with other medicinal products and other forms of interaction
Co-administration of 100 mg alogliptin once daily and 1,000 mg metformin hydrochloride twice daily for 6 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogl...
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of Vipdomet in pregnant women. Studies in pregnant rats with alogliptin plus metformin as combination treatment have shown reproductive toxicity (see sectio...
4.7. Effects on ability to drive and use machines
Vipdomet has no or negligible influence on the ability to drive and use machines. However, patients should be alerted to the risk of hypoglycaemia especially when used in combination with insulin o...
4.8. Undesirable effects
Summary of the safety profile
Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Vipdomet (see section 4.4). Hypersensitivity reactions, including Ste...
4.9. Overdose
No data are available with regard to overdose of Vipdomet.
Alogliptin
The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 4...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Drugs used in diabetes; combinations of oral blood glucose lowering drugs
ATC code:
A10BD13
Mechanism of action and pharmacodynamic effects
Vipdomet combines two antih...
5.2. Pharmacokinetic properties
The results of bioequivalence studies in healthy subjects demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as ...
5.3. Preclinical safety data
Concomitant treatment with alogliptin and metformin did not produce new toxicities and no effects on the toxicokinetics of either compound were observed.
In rats no treatment-related foetal abnorma...
6.1. List of excipients
Tablet core:
Mannitol
Microcrystalline cellulose
Povidone K30
Crospovidone Type A
Magnesium stearate
Film-coating:
Hypromellose
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
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
Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil. Pack sizes of 10, 14, 20, 28, 56, 60, 98, 112, 120, 180, 196, 200 or multipacks conta...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
8. Marketing authorization number(s)
EU/1/13/843/001-026
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 September 2013
Date of latest renewal: 24 May 2018
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