Glucophage xr
Poland
Table of Contents
Patient Information Leaflet
GLUCOPHAGE XR, 750 mg, prolonged-release tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before 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 symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet Contents
- What Glucophage XR is and what it is used for
- What you need to know before taking Glucophage XR
- How to take Glucophage XR
- Possible side effects
- How to store Glucophage XR
- 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 to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows 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 reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Glucophage XR also reduces the risk of diabetes-related complications. Treatment with Glucophage XR is associated with stable body weight or moderate weight reduction.
Glucophage XR is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent" diabetes). It is particularly used in patients who are overweight.
Adults may take Glucophage XR alone or in combination with other antidiabetic medicines (oral medications or insulin).
Glucophage XR is also used to prevent type 2 diabetes in patients with prediabetes.
It is also used in polycystic ovary syndrome.
2. Important information before taking Glucophage XR
When not to take 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 result in 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 result in lactic acid游戏副本
3. How to take Glucophage XR
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Glucophage XR does not replace the benefits of a healthy lifestyle. You should continue to follow
your doctor's advice regarding diet and regular physical activity.
Recommended dose
Children: Glucophage XR should not be used in children due to lack of adequate safety data.
Adults: treatment is usually started at 1 tablet of Glucophage XR 750 mg once daily with the evening
meal. After 10–15 days, the dose will be adjusted by your doctor based on blood glucose measurements.
Gradual dose escalation may improve gastrointestinal tolerance.
Your doctor may increase the dose up to a maximum of 2 tablets of Glucophage XR 750 mg, taken
once daily with the evening meal.
For patients already treated with metformin, the starting dose of Glucophage XR 750 mg should be
equivalent to the daily dose of metformin in immediate-release tablets.
When switching from another oral antidiabetic medicine to Glucophage XR 750 mg, your doctor
should discontinue the previously used medicine and initiate Glucophage XR 750 mg at the dose
described above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Switching antidiabetic treatment to Glucophage XR is not recommended in patients receiving
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 be continued, based on regular monitoring of
blood glucose levels 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 all scheduled follow-up appointments. 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 in elderly patients or if your kidneys do not function properly.
How to take Glucophage XR
Glucophage XR should be taken during or immediately after a meal to reduce gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.
If you feel that the medicine's effect is too strong or too weak, 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.
Missed 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, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get 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 people) 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 disturbances 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. It may be helpful to take Glucophage XR with a meal or immediately after a meal. 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.
- Reduced or low blood levels of vitamin B_(12) (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensation (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 stopped immediately and the doctor informed.
- Skin reactions such as redness of the skin (erythema), 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 sight and reach of children.
There are no special storage instructions 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 tablet of Glucophage XR contains 750 mg of metformin hydrochloride, corresponding to 585 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
"750" on one side and "MERCK" on the other side.
Each pack contains 30, 60, 90 or 120 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