COMPOSITION :

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

Each f/c tablet of Glucolow XR 750 contains : Metformin hydrochloride 750 mg prolonged release.

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

DESCRIPTION :

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

Glucolow XR 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. After an oral dose of Glucolow XR tablet the absorption does not

effected by meals, the maximum plasma concentration is reached in approximately 7 hours. Plasma protein binding is

negligible. It is excreted unchanged in the urine with elimination half-life is approximately 6.5 hours.

INDICATIONS :

Glucolow XR 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, in combination with insulin or with other oral antidiabetic agents.

DOSAGE & ADMINISTRATION :

• Adults : The usual starting dose is one tablet of Glucolow XR 500 at evening meal once daily. After 10 - 15 days the

dose should be adjusted on the basis of blood glucose test then every 10 - 15 days the dose should be adjusted . The

maximum recommended dose is 4 tablets of Glucolow XR 500 daily.

• Glucolow XR 750 and Glucolow XR 1000 are intended for patients who are already treated with metformin tablets

(prolonged or immediate release). And the dose of them should be equivalent to the daily dose of metformin tablets

(prolonged or immediate release), up to a maximum recommended dose of 2 tablets daily given with the evening

meal.

• Elderly patients : The dose should be adjusted on the based on renal function test.

• Combination with insulin : given at the usual starting dose (one tablet of Glucolow XR 500 once daily ) while

insulin dosage must be adjusted on the bases of blood glucose measurement.

Children : should not use Glucolow XR.

RESTRICTIONS ON USE :

Contraindication

- Hypersensitivity to Metformin.

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

and diabetic pre-coma.

- Renal failure or renal dysfunction (creatinine clearance rate 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 and shock.

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

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 ( Iodinated Radiographic dye use to show the organs and vessels in X-ray photo) 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 monitor blood glucose level and kidney function before initiation and during

treatment with Metformin. Metformin is excreted by kidneys, caution should be taken when start taking

antihypertensive drugs, 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 drug 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 XR 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 XR by Insulin . Glucolow XR is not

recommended 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 confused.

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 .

Common effects : Taste disturbances.

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

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 XR 500 Tablet : Pack of 30 tablets.

Glucolow XR 750 Tablet : Pack of 30 tablets.

Glucolow XR 1000 Tablet : Pack of 30 tablets.

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

012-06-130 8/17 Union of Arab Pharmacists