COMPOSITION :

Each f/c tablet of Glucolow 500 contains : Metformin hydrochloride 500 mg.

Each f/c tablet of Glucolow 850 contains : Metformin hydrochloride 850 mg.

Each f/c tablet of Glucolow 1000 contains : Metformin hydrochloride 1000 mg.

DESCRIPTION :

Glucolow ( Metformin ) is a biguanide antidiabetic agent, lowering both basal and postprandial plasma

glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia ,it acts by

reduction of hepatic glucose production ,increasing insulin sensitivity in muscles ,hence improving peripheral

tissue for glucose uptake and delay intestinal glucose absorption. Glucolow reduces also cholesterol level.

After an oral dose of metformin the maximum plasma concentration is reached in approximately 2.5 hours.

Plasma protein binding is negligible. Metformin is excreted unchanged in the urine with elimination half-life

is approximately 6.5 hours.

INDICATIONS :

Glucolow is used for treatment of type 2 diabetes mellitus (Insulin independent), particularly in overweight

patients, when dietary management and exercise alone does not result in adequate glycaemic control.

In adults, Metformin can be used as monotherapy or in combination with insulin or with other oral

antidiabetic agents.

In children from 10 years of age and adolescents, Metformin can be used as monotherapy or in combination

with insulin only.

DOSAGE & ADMINISTRATION :

The tablet to be swallowed with a glass of water without chewing during or after the meals daily without

cessation. In case of missing dose , do not take two tablets and take the next dose as usual.

Children from 10 years of age and adolescents : One tablet of Glucolow 500 mg or 850 mg once daily, as

starting usual dose . The dose can be increased gradually after 10 - 15 days according to level of blood sugar.

The maximum dose is 2g daily, taken as 2 or 3 divided doses.

Adults : One tablet of Glucolow 500 mg or 850 mg two or three times daily, as starting usual dose . The

dose can be increased gradually after 10 - 15 days according to level of blood sugar. The maximum dose is 3g

daily, taken as 3 divided doses.

Combination of Glucolow with Insulin : In combination therapy of Glucolow with Insulin , take Glucolow

as starting usual dose either for children or adults and adjust Insulin dose according to blood sugar level.

Patients with renal impairment and elderly patients: The dose should be adjusted on the basis of renal

function.

RESTRICTIONS ON USE :

Contraindication

- Hypersensitivity to Metformin.

- Diabetic ketoacidosis (symptoms include abdominal pain, fast and deep breathing, sleepiness or unusual

fruity odor of the breath ) and diabetic pre-coma.

- Renal failure or renal dysfunction (creatinine clearance less than 60 ml/min), hepatic insufficiency ,

excessive consumption of alcohol.

- Cases that accompanied by renal function change such as dehydration, severe infection such as respiratory

or urinary tract infections, X-ray examination involving the injection of iodinated contrast media , shock.

- Diseases which cause hypoxia such as cardiac respiratory failure, recent myocardial infarction or shock.

- Lactation.

Precautions :

- The treatment of Metformin should be stopped immediately and consult the doctor ,if lactic acidosis

symptoms appear which include vomiting, abdominal pain with muscle cramps ,fatigue and difficulty in

breathing, this case occurs due to Metformin accumulation especially in patients with renal impairment.

- The treatment of Metformin should be stopped , in case of X- ray examination by injection of iodinated

contrast media and the treatment should not be resumed until 48 hours after the test , after ensuring that

kidney function is normal.

- Regular tests should be done to assess blood glucose level and kidney function before treatment initiation

with Metformin and regularly thereafter, since Metformin is excreted by kidneys , caution should be taken

when initiating antihypertensive treatment , diuretic or NSAIDs due to the probability of alteration of renal

function.

- In case of undergoing a major surgery ,the treatment of Metformin should be stopped 48 hours before the

surgery and 48 hours after the surgery , the treatment should not be resumed unless after ensuring that

kidney function is normal.

- The patient should inform the doctor of taking any other treatment or any infection.

- It is recommended that to follow up the effect of Metformin on growth and puberty in children especially

in pre-pubescent children .

Use in pregnancy and Lactation

Glucolow should not be taken by women who are pregnant or planning to get pregnant for treatment of type

2 diabetes and they should consult the doctor for replacement of Glucolow by Insulin . Glucolow is

contraindicated during breast-feeding .

Effects on ability to drive vehicles and use machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or

use machines, hypoglycaemia may occur when metformin is used in the same time with other antidiabetic

agents , hence the mental concentration may be impaired.

DRUGS INTERACTIONS :

Caution should be taken when co-administration of Metformin with corticosteroids, NSAIDs ,antihypertensive agents of ACEI class , diuretics, Beta 2 agonists such as salbutamol, alcohol containing medicaments.

ADVERSE EFFECTS :

The most common : Nausea, vomiting, diarrhea, abdominal pain and loss of appetite may occur especially

at the beginning of treatment .These effects can be reduced by taking the treatment with meals.

Common effects : Taste disturbances.

Very rare : Lactic acidosis , itching , red skin , decrease in vitamin B12 level.

OVERDOSAGE :

Symptoms : Overdose of Metformin may lead to lactic acidosis.

Treatment : Lactate and Metformin can be removed by hemodialysis.

STORAGE INSTRUCTIONS :

Store below 30OC, in a dry place.

PRESENTATION :

Glucolow 500 mg : Blisters of 30 tablets and hospital pack of different sizes.

Glucolow 850 mg : Blisters of 30 tablets and hospital pack of different sizes.

Glucolow 1000 mg : Blisters of 30 tablets and hospital pack of different sizes.

Mfd. By

P.O. Box : 4265 Sana’a /Yemen.

INSTRUCTIONS TO THE PATIENT

- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.

- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.

- The doctor and the pharmacist are experts in medicine, its benefits and risks.

- Do not by yourself interrupt the period of treatment prescribed for you.

- Do not repeat the same prescription without consulting your doctor.

Keep medicament out of reach of children

Council of Arab Health Ministers

012-06-116 2/17 Union of Arab Pharmacists