Vamju 60mg modified-release tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Gliclazide

Boleh didapati daripada:

Advanz Pharma

Kod ATC:

A10BB09

INN (Nama Antarabangsa):

Gliclazide

Dos:

60mg

Borang farmaseutikal:

Modified-release tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 06010201; GTIN: 5021691032748

Ciri produk

OBJECT 1
Vamju 60mg modified-release tablets
Summary of Product Characteristics Updated 01-Jul-2021 | ADVANZ Pharma
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1. Name of the medicinal product
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2. Qualitative and quantitative composition
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3. Pharmaceutical form
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4. Clinical particulars
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4.1 Therapeutic indications
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4.2 Posology and method of administration
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4.3 Contraindications
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4.4 Special warnings and precautions for use
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4.5 Interaction with other medicinal products and other forms of
interaction
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4.6 Fertility, pregnancy and lactation
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4.7 Effects on ability to drive and use machines
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4.8 Undesirable effects
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4.9 Overdose
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5. Pharmacological properties
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
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6.1 List of excipients
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6.2 Incompatibilities
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6.3 Shelf life
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6.4 Special precautions for storage
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6.5 Nature and contents of container
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6.6 Special precautions for disposal and other handling
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7. Marketing authorisation holder
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8. Marketing authorisation number(s)
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9. Date of first authorisation/renewal of the authorisation
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10. Date of revision of the text
1. Name of the medicinal product
Vamju 60 mg modified-release tablets
2. Qualitative and quantitative composition
Vamju 60 mg: Each modified-release tablet contains 60 mg gliclazide.
Excipients with known effect: Lactose
Vamju 60 mg: Each 60 mg tablet contains 163.8 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet.
Vamju 60 mg
White, biconvex, oval-shaped tablet, with a deep break-line on both
sides and engraved with “GLI” and “60”
on either side of the break-line on both sides, with dimensions 15.0 x
7.0 mm.
The 60 mg tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Vamju is indicated in adults for treatment of non-insulin dependent
diabetes (type 2) when dietary measures,
physical exercise and weight loss alone are