Glucophage 500 mg

Package leaflet: Information for the user

GLUCOPHAGE 500 mg, 500 mg, coated tablets
(Metformini hydrochloridum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Glucophage is and what it is used for

Glucophage 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, which 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 blood glucose levels. Glucophage helps lower blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Glucophage also reduces the risk of diabetes-related complications. Treatment with Glucophage is associated with maintenance of body weight or even moderate weight reduction.
Glucophage is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") in whom adequate blood glucose control cannot be achieved by diet and physical exercise alone. It is particularly used in overweight patients.
Adults may take Glucophage either as monotherapy or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and adolescents may take Glucophage either as monotherapy or in combination with insulin.

2. Important information before using Glucophage

When not to use Glucophage:

• 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 may lead to a diabetic pre-coma state. 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 impaired kidney function, 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 impaired kidney function, 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 (see below "Warnings and precautions"),
• in case of alcohol abuse.

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

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

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

Warnings and precautions
Risk of lactic acidosis
Glucophage may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. 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 a 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.

Glucophage should be temporarily discontinued if the patient develops any medical condition associated with 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 patient should stop taking Glucophage and immediately contact a doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may progress to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with profound fatigue,
• difficulty breathing,
• 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 disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• after starting metformin, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is scheduled for a major surgical procedure, Glucophage must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Glucophage.

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

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

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

Tell the doctor about all medicines currently being taken, recently taken, or planned to be taken. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Glucophage 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 asthma treatment),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter Glucophage 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 diabetes treatment.

Glucophage and alcohol
Avoid consuming excessive amounts of alcohol while taking Glucophage, 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 a pregnancy, 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 patients who are breastfeeding or planning to breastfeed.

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

3. How to use Glucophage

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt,
you should consult your doctor or pharmacist.
Glucophage does not replace the benefits of a healthy lifestyle.
You should continue to follow all dietary and regular physical activity recommendations provided by your doctor.

Recommended dose
Children aged 10 years and adolescents: treatment usually starts with a dose of 500 mg or 850 mg of
Glucophage once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses.
Treatment of children aged 10 to 12 years should only be initiated on specific medical advice, as experience with Glucophage in this age group is limited.
Adults: treatment usually starts with a dose of 500 mg or 850 mg of Glucophage, taken two or three times
daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you have impaired kidney function, your doctor may prescribe a lower dose.
If you are also using insulin, your doctor will advise you on how to start taking Glucophage.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Glucophage according to blood glucose levels. You should attend regular follow-up visits with your doctor. This is particularly important for children, adolescents, and 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
Glucophage 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 taking one dose per day, take the medicine in the morning (with breakfast).
• If taking two doses per day, take one in the morning (with breakfast) and one in the evening (with dinner).
• If taking three doses per day, take one in the morning (with breakfast), one at midday (with lunch), and one in the evening (with dinner).

If, after some time, you feel that the effect of the medicine is too strong or too weak,
you should consult your doctor or pharmacist.
Taking more Glucophage than recommended
If you take more Glucophage than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis
are non-specific and include vomiting, abdominal pain 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 immediate medical attention, as lactic acidosis can lead to coma. You must stop taking Glucophage immediately and contact your doctor or go to the nearest hospital.
Missed dose of Glucophage
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The adverse reactions that may occur are listed below.
The medicine Glucophage may very rarely cause (in up to 1 patient in 10,000) a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Glucophage must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.

Very common adverse reactions (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 adverse reactions most commonly occur at the beginning of Glucophage treatment. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take Glucophage with or immediately after meals. If symptoms do not resolve, Glucophage should be discontinued and the doctor informed.

Common adverse reactions (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 sensations (paraesthesiae), or pale or yellowish skin). The 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 adverse reactions (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 are non-specific (see section “Warnings and precautions”).
• Abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, and weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Glucophage should be discontinued and the doctor informed.
• Skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents indicate that adverse reactions occurring in these populations are of similar nature and frequency to those observed in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Glucophage

Keep this medicine out of sight and reach of children. If Glucophage is being used in a child,
it is recommended that parents or caregivers supervise the treatment.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton after the "EXP" mark.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Glucophage contains

• The active substance is metformin hydrochloride. One Glucophage 500 mg film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The other ingredients are: povidone K 30, magnesium stearate, hypromellose.

What Glucophage looks like and contents of the pack
Glucophage 500 mg film-coated tablets are white, round and convex.
Each pack contains 30 or 100 film-coated 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.
2, rue du Pressoir Vert
45400 Semoy
France
Merck S.L.
Poligono Merck
Mollet Del Vallés 08100 Barcelona
Spain
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Finland, France, Germany, Greece, Iceland,
Ireland, Italy, Latvia, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Sweden, United Kingdom (Northern Ireland): Glucophage.
Hungary: Merckformin