Glucophage XR 750 mg. 60 tablets

What Glucophage XR is and what it is used for

Glucophage XR extended-release tablets contain the active substance metformin hydrochloride and belong to a group of medicinal products called biguanides, used to treat type 2 (non-insulin-dependent) diabetes mellitus.

Glucophage XR is used in combination with diet and exercise to reduce the risk of developing type 2 diabetes in overweight adults when diet and exercise alone for 3 to 6 months have not sufficiently controlled the level of diabetes. the glucose in your blood. You are at high risk of developing type 2 diabetes if the following conditions are also present, such as age over 40, abnormal amount of lipids (fats) in the blood, or a history of diabetes during pregnancy.

Glucophage XR is used to treat type 2 diabetes (also called non-insulin-dependent diabetes) when diet and exercise are not enough to control the level of glucose in your blood. Insulin is a hormone produced by the pancreas that helps absorb glucose (sugar) from the blood to produce energy or store it as a reserve. If you have diabetes, your pancreas does not produce enough insulin or your body cannot fully use the insulin it produces. This leads to an increased level of glucose in the blood, which leads to a number of serious long-term problems, which is why it is important to continue taking your medicine, even in the absence of visible symptoms. Glucophage XR makes your body more sensitive to insulin and helps reduce blood glucose to normal levels.

Glucophage XR is associated with either stable weight maintenance or moderate weight loss.

Glucophage XR extended-release tablets are specially designed for a slow release of the medicinal substance in your body, which is why they differ from other types of tablets containing metformin.

2. What you need to know before you use Glucophage XR

Do not use Glucophage XR

If you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause a rash, itching or shortness of breath.

If you have impaired liver function.

If you have severely reduced kidney function.

If you have uncontrolled diabetes, for example with severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is a condition where substances called 'ketone bodies' build up in the blood and this can lead to diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity smell on your breath.

With a large loss of fluids (dehydration), both due to prolonged or severe diarrhea, and after continuous vomiting. Dehydration can lead to kidney complications, increasing the risk of lactic acidosis (See Warnings and Precautions).

In cases of severe infection, e.g. pulmonary, bronchial or renal. Severe infections can lead to kidney problems, increasing the risk of lactic acidosis (See Warnings and Precautions).

In case of acute heart failure or recent myocardial infarction, serious circulatory problems (eg shock) or breathing difficulties. This may lead to insufficient tissue oxygenation, increasing the risk of lactic acidosis (See Warnings and Precautions).

With increased consumption of alcoholic beverages.

If you are under 18 years of age.

Warnings and precautions

Risk of lactic acidosis

Glucophage XR can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis also increases with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and any condition where part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above applies to you, talk to your doctor for further guidance.

Stop taking Glucophage XR for a short time if you have an illness that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Glucophage XR and contact a doctor or the nearest hospital immediately if you have any of the symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:

vomiting

stomach pain (abdominal pain)

muscle spasms

a general feeling of malaise, accompanied by severe fatigue

difficulty breathing

lower

Glucophage XR with food, drink and alcohol

Avoid excessive alcohol consumption while taking Glucophage XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions")

Pregnancy, lactation and fertility

Tell your doctor if you are pregnant, think you are pregnant or are planning to become pregnant so that your treatment can be adjusted or your blood sugar levels can be monitored. The use of this medicine is not recommended while breastfeeding or about to breastfeed.

Driving and using machines

If taken alone, Glucophage XR does not cause hypoglycaemia (too low a blood glucose level with symptoms such as weakness, confusion and excessive sweating), which means it will not affect your ability to drive or use machines.

However, caution is required if you take Glucophage XR together with other antidiabetic drugs, as it may cause hypoglycaemia, in which case you should take precautions when driving or operating machinery.

Important information about some of the excipients included in Glucophage XR:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, te. it can be said to be practically sodium-free.

3. How to take Glucophage XR

Your doctor may prescribe Glucophage XR alone or in combination with other oral antidiabetic medicines or insulin.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Take the tablets whole, without chewing them, with a glass of water.

Recommended dose

Usually, the starting dose is 500 mg of Glucophage XR once a day. After you have been taking Glucophage XR for about 2 weeks, your doctor may measure your blood sugar level and change your dose. The maximum daily dose is 2000 mg, Glucophage XR.

If you have reduced kidney function, your doctor may prescribe a lower dose.

Usually, you should take the tablets once a day with your dinner.

In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with a meal.

If you have taken more than the required dose of Glucophage XR

If you have taken more than the required number of tablets, do not worry, but if you have unusual symptoms contact your doctor. If you have taken much more Glucophage XR than you should, you may experience signs of lactic acidosis. Symptoms of lactic acidosis are non-specific such as vomiting, abdominal pain with muscle spasms, general malaise with feeling very tired and difficulty breathing.

Additional symptoms are decreased body temperature and heart rate.

If you notice any of these signs, you should seek medical attention immediately, as lactic acidosis can lead to coma. Stop taking Glucophage XR and contact a doctor or the nearest hospital immediately.

If you forget to take Glucophage XR

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.

If you have any further questions related to the use of this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Glucophage XR can cause a very rare (may affect up to 1 in 10,000 patients) but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens, you must stop taking Glucophage XR and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Glucophage XR can cause liver function test abnormalities and hepatitis (inflammation of the liver) which may lead to jaundice (may affect up to 1 in 10,000 people).

Other side effects are listed by frequency as follows:

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

diarrhea or abdominal pain and loss of appetite. If these symptoms appear, do not stop taking the tablets, as they usually go away in about 2 weeks. It will be beneficial in these cases to take the tablets during or immediately after a meal.

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

taste changes.

reduced or low levels of vitamin B12 in the blood (symptoms may include feeling very tired (fatigue), a sore and red tongue (glossitis), a pins-and-needles sensation on the skin (paraesthesia) or pale or yellow skin). Your doctor may schedule/perform some tests to find out the cause of your symptoms, as some of them may be caused by diabetes or due to other unrelated health problems.

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

skin reactions such as reddening of the skin (erythema), itching or an itchy rash.

More about GLUCOPHAGE XR

5. How to store Glucophage XR

Keep out of the reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date corresponds to the last day of the month indicated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Glucophage XR contains

Each extended-release tablet contains 500, 750 or 1000 mg metformin hydrochloride. The other ingredients are: magnesium stearate, sodium carboxymethylcellulose, hypromellose.

What Glucophage XR looks like and what it contains

The 500 mg tablets are white to off-white, round, biconvex, debossed with "500" on one side.

The 750 mg tablets are white to off-white, oblong, biconvex, debossed with “750” on one side and “MERCK” on the other side.

The 1000 mg tablets are white to off-white, oblong, biconvex, debossed with “1000” on one side and “MERCK” on the other side.

The tablets are packed in blisters of 30 or 60 pieces.

Not all types of packaging can be put on sale.