Glucophage xr
Poland
Table of Contents
Patient Information Leaflet
GLUCOPHAGE XR, 500 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 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 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).
For the prevention of type 2 diabetes in patients with prediabetes.
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 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 acidosis (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. These conditions may cause tissue hypoxia, which may increase the risk of 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: 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. Gradual dose escalation may improve gastrointestinal tolerance.
Your doctor may increase the dose up to a maximum of 4 tablets daily (2000 mg), taken once daily
with the evening meal.
For patients already being treated with metformin, the starting dose of Glucophage XR 500 mg
should be equivalent to the daily dose of immediate-release metformin.
When switching from another oral antidiabetic medicine to Glucophage XR 500 mg, your doctor
should discontinue the previously used medicine and initiate Glucophage XR 500 mg at the dose
specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Switching from immediate-release metformin at doses above 2000 mg daily to Glucophage XR is
not recommended.
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 accordingly. You should attend regular 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 for 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. 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 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 low body temperature and slowed heart rate. If any of these symptoms occur, you must seek
medical help immediately, as lactic acidosis can lead to coma. You must stop taking Glucophage XR
immediately and contact your doctor or go to the nearest hospital.
If you miss a dose of Glucophage XR
Do not take a double dose to make up for a missed dose. Take the next dose at your 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 everyone will experience them.
The possible side effects are listed below.
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 a patient develops this condition, treatment with Glucophage XR must be stopped and medical advice must be sought immediately from 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 usually resolve spontaneously in most cases. 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 should be informed.
Common side effects (may affect less than 1 in 10 people)
- Taste disturbances.
- Decreased or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order several tests to determine the cause of these 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 the 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 must be 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
Phone: +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 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.
There are no special requirements for storage of 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 month indicated.
Medicines should not be disposed of via the sewage system 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 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
- The other ingredients are: magnesium stearate, sodium carmellose, hypromellose.
What Glucophage XR looks like and contents of the pack
Glucophage XR tablets are white or almost white, round, biconvex, with the inscription "500" embossed on one side.
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