Glucophage xr

Patient Information Leaflet

GLUCOPHAGE XR, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Glucophage XR is and what it is used for
2. Important information before taking Glucophage XR
3. How to take Glucophage XR
4. Possible side effects
5. How to store Glucophage XR
6. Contents of the pack and other information

1. What Glucophage XR is and what it is used for

Glucophage XR contains metformin, a medicine used in the treatment of diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In people with diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to abnormally high levels of glucose in the blood. Glucophage XR helps lower blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Glucophage XR also reduces the risk of diabetes-related complications. Treatment with Glucophage XR is associated with weight maintenance or modest weight reduction.
Glucophage XR is used in the treatment of patients with type 2 diabetes (also known as "non-insulin-dependent" diabetes). It is particularly used in overweight patients.
Adults may take Glucophage XR as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
For the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before using Glucophage XR

When not to use Glucophage XR:

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver dysfunction,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney dysfunction, which may increase the risk of lactic acid游戏副本 (see below "Warnings and precautions"),
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of alcohol abuse,
• if the patient is under 18 years of age.

If any of the above situations apply, the patient should consult a doctor before taking this medicine.
It is essential to consult a doctor if:

• a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent is necessary,
• a major surgical procedure is planned.

Glucophage XR must be discontinued for a certain period before and after such examination or surgery.
The doctor will decide whether alternative treatment is necessary during this time. It is important to follow the doctor's instructions exactly.

Warnings and precautions
Risk of lactic acidosis
Glucophage XR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, the patient should consult a doctor for further instructions.

The use of Glucophage XR should be temporarily discontinued if the patient develops a medical condition that may lead to dehydration (significant fluid loss from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for further instructions.

The use of Glucophage XR should be discontinued and the patient should immediately contact a doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disease (energy-producing structures in cells), such as MELAS (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is to undergo a major surgical procedure, Glucophage XR must not be used during the procedure and for a certain time afterwards. The doctor will decide when the patient should stop and resume treatment with Glucophage XR.

Glucophage XR does not cause hypoglycaemia (low blood glucose levels).
However, if Glucophage XR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Glucophage XR, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has deteriorating kidney function.

The patient should follow the dietary recommendations provided by the doctor.

It is common for the tablet shell to be visible in the stool. This is normal with this type of tablet and should not be a cause for concern.

Glucophage XR and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray examination or computed tomography, the patient must stop taking Glucophage XR before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Glucophage XR.

The patient should inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Glucophage XR by the doctor. It is especially important to inform the doctor about the following medicines:

• diuretics (medicines that increase urine production),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used in the treatment of asthma),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter Glucophage XR blood levels, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used in the treatment of diabetes.

Glucophage XR and alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Glucophage XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should talk to her doctor about whether any changes in treatment or monitoring of blood glucose levels are necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and operating machinery
Glucophage XR does not cause hypoglycaemia (low blood glucose levels). This means that it does not affect the patient's ability to drive or operate machinery.
However, particular caution should be exercised if Glucophage XR is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

Glucophage XR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning that the medicine is considered "sodium-free".

3. How to take Glucophage XR

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Glucophage XR does not replace the benefits of a healthy lifestyle. You should continue to follow any dietary and regular physical activity advice given by your doctor.

Recommended dose
Children: Due to lack of adequate safety data, Glucophage XR should not be used in children.
Adults: Treatment is usually started with 1 tablet of Glucophage XR 500 mg once daily with the evening meal. After 10–15 days, the dose will be adjusted by your doctor based on blood glucose measurements. Once the appropriate dose is established, your doctor may consider switching you to Glucophage XR 1000 mg.
The maximum daily dose is 2000 mg, taken once daily with the evening meal.

For patients already being treated with metformin, the starting dose of Glucophage XR should be equivalent to the daily dose of metformin in immediate-release tablets.

When switching from another oral antidiabetic medicine to Glucophage XR 1000 mg, your doctor should discontinue the previously used medicine and initiate Glucophage XR 1000 mg at the dose specified above.

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

Switching antidiabetic treatment to Glucophage XR is not recommended for patients currently taking more than 2000 mg of metformin daily in the form of immediate-release tablets.

If you are also taking insulin, your doctor will advise you on how to start treatment with Glucophage XR.

Monotherapy (prediabetes state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily with the evening meal. Your doctor will assess whether treatment should continue based on regular blood glucose monitoring and risk factors.

Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily with the evening meal.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Glucophage XR according to blood glucose levels. You should attend regular follow-up appointments with your doctor. This is particularly important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or if your kidneys are not functioning properly.

How to take Glucophage XR
Glucophage XR should be taken with a meal or immediately after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.
If at any time you feel the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Taking more Glucophage XR than prescribed
If you take more Glucophage XR than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, you must seek immediate medical attention, as lactic acidosis can lead to coma. You must stop taking Glucophage XR immediately and contact your doctor or go to the nearest hospital.

Missing a dose of Glucophage XR
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur are listed below.
The medicine Glucophage XR may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious side effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Glucophage XR must be stopped and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.

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

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. These side effects most commonly occur at the beginning of treatment with Glucophage XR and in most cases resolve spontaneously. Taking Glucophage XR with a meal or immediately after a meal may be helpful. If symptoms do not resolve, Glucophage XR should be discontinued and the doctor informed.

Common side effects (may affect less than 1 in 10 people)

• Taste disturbances.
• Decreased or low levels of vitamin B__ in the blood (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellow skin). Your doctor may order several tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare side effects (may affect less than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, particularly when kidneys are not functioning properly. Symptoms of lactic acidosis – see section "Warnings and precautions".
• Abnormal liver function test results or symptoms of hepatitis (associated with fatigue, loss of appetite, weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Glucophage XR must be discontinued immediately and the doctor informed.
• Skin reactions such as redness of the skin (flushing), itching, or itchy rash (urticaria).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Glucophage XR

Keep this medicine out of the sight and reach of children.
No special storage conditions apply for this medicine.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Glucophage XR contains

• The active substance is metformin hydrochloride. One Glucophage XR tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
• The other ingredients are: magnesium stearate, sodium carmellose, hypromellose 100 000 cPs.

What Glucophage XR looks like and contents of the pack

Glucophage XR tablets are white or almost white, elongated, biconvex, with the imprint “1000” on one side and “MERCK” on the other.
Each pack contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merck Sante s.a.s.
37 rue Saint-Romain
69008 Lyon
France
(logo of the marketing authorisation holder)

Manufacturer
Merck Sante s.a.s.
Centre de Production de Semoy
2 rue du Pressoir Vert
45400 Semoy
France
Merck Healthcare KGaA
Frankfurter str.250
64293 Darmstadt
Germany
Merck, S.L.
Poligono Merck
Mollet Del Vallés, 08100 Barcelona
Spain