1-FORM AND PRESENTATION

GLUCOBAS XR

(strengths) are white to off-white tablets.

Box of 30.

2-COMPOSITION

Each extended-release tablet of GLUCOBAS XR

contains:

-Metformin Hydrochloride 750 mg

- Metformin Hydrochloride 1000 mg

Inactive ingredients: Carmellose Sodium, Cellulose, Microcrystalline,

Hypromellose, Isopropyl Alcohol, Magnesium Stearate, Silica, Colloidal

Anhydrous.

GLUCOBAS XR

extended- release tablets are specially made to release

the drug slowly in your body and therefore are different to many other

types of tablets containing metformin.

3-INDICATIONS

GLUCOBAS XR

extended-release tablets belong to a group of medicines

called biguanides, used in the treatment of Type 2 (non-insulin

dependent) diabetes mellitus.

GLUCOBAS XR

is used together with diet and exercise to lower the risk of

developing Type 2 diabetes in overweight adults, when diet and exercise

alone for 3 to 6 months have not been enough to control blood glucose

(sugar). You are at high risk of developing Type 2 diabetes if you have

additional conditions like high blood pressure, age above 40 years, an

abnormal amount of lipids (fat) in the blood or a history of diabetes during

pregnancy.

The medicine is particularly effective if you are aged below 45 years, are

very overweight, have high blood glucose levels after a meal or developed

diabetes during pregnancy.

GLUCOBAS XR

is used for the treatment of Type 2 diabetes when diet and

exercise changes alone have not been enough to control blood glucose

(sugar). Insulin is a hormone that enables body

tissues to take glucose

from the blood and to use it for energy or for storage for future use. People

with Type 2 diabetes do not make enough insulin in their pancreas or their

body does not respond properly to the insulin it does make. This causes a

build-up of glucose in the blood which can cause a number of serious

long-term problems so it is important that you continue to take your

medicine, even though you may not have any obvious symptoms.

GLUCOBAS XR

makes the body more sensitive to insulin and helps return

to normal the way your body uses glucose.

GLUCOBAS XR

is associated with either a stable body weight or modest

weight loss.

Polycystic ovary syndrome (PCOS) is a health condition that affects a

woman's hormone levels, menstrual cycle, and ability to have children.

GLUCOBAS XR

is used in women with PCOS to stimulate ovulation

(release of an egg from the ovaries) and subsequently the chance of

getting pregnant, alone or together with other treatment options.

4-POSOLOGY

Your doctor may prescribe GLUCOBAS XR

for you to take on its own, or in

combination with other oral antidiabetic medicines or insulin. Always take

this medicine exactly as your doctor has told you. You should check with

your doctor or pharmacist if you are not sure.

Recommended dose

Usually you will start treatment with 500 milligrams GLUCOBAS XR daily.

After you have

been taking GLUCOBAS XR for about 2 weeks, your doctor

may measure your blood sugar and adjust the dose. The maximum daily

dose is 2000 milligrams of GLUCOBAS XR

If you have reduced kidney

function, your doctor may prescribe a lower dose.

Normally, you should take the tablets once a day, with your evening meal. In

some cases, your doctor may recommend that you take the tablets twice a

day. Always take the tablets with food. Polycystic ovary syndrome (PCOS)

The usual dose is 1500-2000 mg metformin hydrochloride taken once a day

with the evening meal. You should check with your doctor or pharmacist

when to stop taking the medicine.

If you take more GLUCOBAS XR

than you should

If you take extra tablets by mistake you need not worry, but if you have

unusual symptoms, contact your doctor. If the overdose is large, lactic

acidosis is more likely( see section 5). If you experience some of these

symptoms, you should immediately seek medical attention, as lactic

acidosis may lead to coma. Stop taking GLUCOBAS XR

immediately and

contact a doctor or the nearest hospital straightaway.

If you forget to take GLUCOBAS XR

Take it as soon as you remember with some food. Do not take a double

dose to make up for a forgotten dose

Monitoring

• Your doctor will perform regular blood glucose tests and will adapt your

dose of GLUCOBAS XR

to your blood glucose levels. Make sure that you talk

to your doctor regularly. This is particularly important for children and

adolescents or if you are an older person.

• Your doctor

will also check at least once a year how well your kidneys work.

You may need more frequent checks if you are an older person or if your

kidneys are not working normally.

Take GLUCOBAS XR

with or after a meal. This will avoid you having side

effects affecting your digestion.

• Do not crush or chew the tablets. Swallow each tablet with a glass of

water.

• If you take one dose a day, take it in the morning (breakfast).

• If you take two divided doses a day, take them in the morning (breakfast)

and evening (dinner).

• If you take three divided doses a day, take them in the morning

(breakfast), at noon (lunch) and in the evening (dinner) If, after some time,

you think that the effect of GLUCOBAS XR

is too strong or too weak, talk to

your doctor or pharmacist.

5- WARNINGS and PRECAUTIONS

Do not take GLUCOBAS XR

if:

• you are allergic to metformin or to any of the other ingredients of this

medicine (listed in section 2). An allergic reaction may cause a rash, itching

or shortness of breath.

• you have liver problems

• you have severely reduced kidney function

• you have uncontrolled diabetes, with, for example, severe hyperglycemia

(high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic

acidosis (see ‘Risk of lactic acidosis’ below) or ketoacidosis. Ketoacidosis is

a condition in which substances called “ketone bodies” accumulate in the

blood and which can lead to diabetic pre-coma. Symptoms include

stomach pain, fast and deep

breathing, sleepiness or your breath

developing an unusual, fruity smell.

• you have lost too much water from your body (dehydration). Dehydration

may lead to kidney problems, which can put you at risk for lactic acidosis.

• you have a severe infection, such as an infection affecting your lung or

bronchial system or your kidney. Severe infections may lead to kidney

problems, which can put you at risk for lactic acidosis.

• you have been treated for acute heart problems or have recently had a

heart attack or have severe circulatory problems or breathing difficulties.

This may lead to a lack in oxygen supply to tissue which can put you at risk

for lactic acidosis.

• you are a heavy drinker of alcohol.

• you are under 18 years of age.

Risk of lactic acidosis

GLUCOBAS XR

may cause a very rare, but very serious side effect called

lactic acidosis, particularly if your kidneys are not working properly. The risk

of developing lactic acidosis is also increased with uncontrolled diabetes,

serious infections, prolonged fasting or alcohol intake, dehydration, liver

problems and any medical conditions in which a part of the body has a

reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking GLUCOBAS XR

for a short time if you have a condition that

may be associated with dehydration (significant loss of body fluids) such

as severe vomiting, diarrhea, fever, exposure to heat or if you drink less

fluid than normal. Talk to your doctor for further instructions. Stop taking

GLUCOBAS XR

and contact a doctor or the nearest hospital immediately

if you experience

some of the symptoms of lactic acidosis, as this

condition may lead to coma.

Symptoms of lactic acidosis include:

-Vomiting

-Stomach ache (abdominal pain)

-Muscle cramps

- A general feeling of not being well with severe tiredness

- Difficulty in breathing

- Reduced body temperature and heartbeat

6-DRUG INTERACTIONS

• If you need to have an injection of a contrast medium that contains

iodine into your bloodstream, for example in the context of an X-ray or

scan, you must stop taking GLUCOBAS XR

before or at the time of the

injection. Your doctor will decide when you must stop and when to restart

your treatment with GLUCOBAS XR

• Tell your doctor if you are taking, have recently taken or might take any

other medicines. You may need more frequent blood glucose and kidney

function tests, or your doctor may need to adjust the dosage of

GLUCOBAS XR

. It is especially important to mention the following:

- Medicines which increase urine production (diuretics).

- Medicines used to treat pain and inflammation (NSAID and

COX-2-inhibitors, such as ibuprofen and celecoxib).

- Certain medicines for the treatment of high blood pressure (ACE

inhibitors and angiotensin II receptor antagonists).

- Beta-2 agonists such as salbutamol or terbutaline (used to treat

asthma).

- Corticosteroids (used to treat a variety of conditions, such as severe

inflammation of the skin or in asthma).

- Medicines that may change the amount of GLUCOBAS XR

in your blood,

especially if you have reduced kidney function (such as verapamil,

rifampicin; cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib,

isavuconazole, crizotinib, olaparib).

- other medicines used to treat diabetes.

7-ADVERSE REACTIONS

Like all medicines, this medicine can cause side effects, although not

everybody gets them. The following side effects may occur:

Very common side effects (may affect more than 1 in 10 people):

• Digestive problems, such as feeling sick (nausea), being

sick (vomiting),

diarrhea, bellyache (abdominal pain) and loss of appetite. These side

effects most often happen at the beginning of the treatment with

GLUCOBAS XR

. It helps if you spread the doses over the day and if you

take GLUCOBAS XR

with or straight after a meal. If symptoms continue,

stop taking GLUCOBAS XR

and talk to your doctor.

Common side effects (may affect up to 1 in 10 people):

• Changes in taste.

• Decreased or low vitamin B12 levels in the blood (symptoms may include

extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and

needles (paresthesia) or pale or yellow skin). Your doctor may arrange

some tests to find out the cause of your symptoms because some of

these may also be caused by diabetes or due to other unrelated health

problems.

Very rare side effects (may affect up to 1 in 10,000 people):

• Lactic acidosis. If this happens, you must stop taking GLUCOBAS XR

and

contact a doctor or the nearest hospital immediately, as lactic acidosis

may lead to coma.

• Abnormalities in liver function tests or hepatitis (inflammation of the liver;

this may cause tiredness, loss of appetite, weight loss, with or without

yellowing of the skin or whites of the eyes). If this happens to you, stop

taking GLUCOBAS XR

and talk to your doctor.

• Skin reactions such as redness, itching and hives.

Children and adolescents:

Limited data in children and adolescents showed that adverse events

were similar in nature and severity to those reported in adults.

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible

side effects not listed in this leaflet.

8-STORAGE CONDITIONS

Keep this medicine out of the reach of children.

Store below 30°C in a dry place.

If a child is treated with GLUCOBAS XR

, parents

and caregivers are advised to oversee how this

medicine is used.

Do not use this medicine after the expiry date

which is stated on the carton or the bottle or the

blister after expiry date. The expiry date refers to

the last day of that month.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines you

no longer use. These measures will help to

protect the environment.

Manufacturer:

Athena Drug Delivery Solutions Pvt. Ltd. Plot

A1-A5, MIDC, Chemical Zone, Ambernath (West),

Maharashtra, 421 501, India

Marketing Authorization Holder, Packed by:

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

* Keep this leaflet. You may need to read it again.

* If you have any further questions, ask your doctor or

pharmacist.

* This medicine has been prescribed for you only.

Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

* If you get any side effects talk to your doctor or

pharmacist. This includes any possible side effects not listed

in this leaflet.

Metformin Hydrochloride 750 mg / 1000 mg

Extended-release tablet

750mg 30 Extended release tablets Reg. N°: 105425/1

1000mg 30 Extended release tablets Reg. N°:

105325/1

Date of Revision: June 20, 2025

Council of Arab Health Ministers

Union of Arab pharmacists

This is a medicine:

- A medicine is a product which

affects your health and its consump-

tion contrary to instructions is

dangerous for you.

- Follow strictly the doctor's

prescription, the method of use and

the instructions of the pharmacist who

dispensed the medicine.

- The doctor and the pharmacist are

the experts in medicine, their benefits

and risks.

- Do not by yourself interrupt the

period of treatment prescribed.

- Do not repeat the same prescription

without consulting your doctor.

- Keep all medicine out of reach of

children.

PI012/01