Aartmin 850 Tablets 850 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Metformin Hydrochloride

Available from:

PINNACLE LIFE SCIENCE PRIVATE LIMITED, INDIA

INN (International Name):

Metformin Hydrochloride

Dosage:

850 mg

Pharmaceutical form:

Tablets

Manufactured by:

PINNACLE LIFE SCIENCE PRIVATE LIMITED, INDIA

Product summary:

Physical description: White coloured caplet shaped biconvex film coated tablet with central break line; Local technical representative: Abacus Pharma Africa Limited

Authorization status:

Registered/Compliant

Authorization date:

2017-11-08

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
AARTMIN 850 mg (Metformin Tablets BP 850 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
AARTMIN 850 mg tablets:
Each film-coated tablet contains metformin hydrochloride 850 mg
corresponding to 662.9 mg
metformin base.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, caplet shaped, biconvex film coated tablet with
central break line.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment
of
type
2
diabetes
mellitus,
particularly
in
overweight
patients,
when
dietary
management and exercise alone does not result in adequate glycaemic
control
• In adults, Metformin Hydrochloride may be used as monotherapy or
in combination with
other oral antidiabetic agents or with insulin.
• In children from 10 years of age and adolescents, Metformin may be
used as monotherapy or
in combination with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult
patients treated with metformin as first-line therapy after diet
failure (see section 5.1).
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 daily given
during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A
slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided
doses.
2
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and
initiate metformin at the dose indicated above.
COMBINATION WITH INSULIN
Metformin and insulin may be used in combination therapy to achieve
better blood glucose
control. Metformin hydrochloride is given at the usual starting dose
of 500 mg or 850 mg 2 or 3
times daily, while insulin