Vamju 30mg modified-release tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Gliclazide

Sẵn có từ:

Advanz Pharma

Mã ATC:

A10BB09

INN (Tên quốc tế):

Gliclazide

Liều dùng:

30mg

Dạng dược phẩm:

Modified-release tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 06010201; GTIN: 5021691032724 5021691032731

Đặc tính sản phẩm

OBJECT 1
Vamju 30 mg 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 30 mg modified-release tablets
2. Qualitative and quantitative composition
Vamju 30 mg: Each modified-release tablet contains 30 mg gliclazide.
Excipients with known effect: Lactose
Vamju 30 mg: Each 30 mg tablet contains 81.9 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablet.
Vamju 30 mg
White, biconvex, capsule-shaped tablet, engraved with “GLI 30” on
one side and plain on the other side, with
dimensions 10.0 x 4.5 mm.
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 not sufficient to control
blood glucose.
4.2 Posology and method of administration
Posology
The daily do