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Use GLUCOPHAGE CAUTION if:

• You have a risk of developing lactic acidosis. GLUCOPHAGE is very rare especially if your kidneys are not working regularly; but it can cause lactic acidosis, which can cause serious discomfort and death. Symptoms of lactic acidosis include vomiting, abdominal cramps, abdominal pain, severe fatigue, and poor general breathing. If you have this discomfort, you may need emergency treatment.

Stop using GLUCOPHAGE immediately and tell your doctor.

• GLUCOPHAGE alone does not cause hypoglycemia (very low blood sugar level). On the other hand, there is a risk of hypoglycemia if you use GLUCOPHAGE together with other drugs (sulfonylureas, insulin, glinides) used in the treatment of diabetes that can cause hypoglycemia. If you have symptoms of hypoglycemia, such as fatigue, dizziness, increased sweating, rapid heartbeats, visual disturbances or impaired concentration, this will help consume foods and drinks containing sugar to correct the condition.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of GLUCOPHAGE with food and drink: GLUCOPHAGE may be taken with or after meals. Do not drink alcohol while using GLUCOPHAGE. Alcohol can increase the risk of lactic acidosis, especially if you have liver problems or have no food. This also applies to drugs containing alcohol.

pregnancy

Consult your doctor or pharmacist before usingmedication. If you are pregnant or plan to become pregnant, inform your doctor before using GLUCOPHAGE; in this case, your doctor may change your treatment. If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

breastfeeding.

Consult your doctor or pharmacist before using lac  Do not use GLUCOPHAGE if you are breastfeeding or if you plan to breastfeed.

Use of tools and machines GLUCOPHAGE alone does not cause hypoglycemia (very low blood sugar level). Therefore, GLUCOPHAGE does not affect your ability to drive and use machines.

On the other hand, you should be careful if you use GLUCOPHAGE together with other drugs (sulfonylureas, insulin, glinides) used in the treatment of diabetes that can cause hypoglycemia. Symptoms of hypoglycemia; weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or impaired concentration. Do not use tools and machinery if you begin to feel these symptoms.

Important information on some of the ingredients in GLUCOPHAGE If you do not have an extreme sensitivity to the excipients contained in GLUCOPHAGE, no adverse effect on these substances is expected.

Use with other drugs If you are going to take any X-Ray device or any imaging-related treatment that requires the introduction of iodinated contrast media, which is a kind of drug, into your bloodstream, you should stop using GLUCOPHAGE for a period of time before and after the procedure.

If you use GLUCOPHAGE together with the following drugs, your blood glucose tests may need to be done more frequently or your doctor should adjust the GLUCOPHAGE dose:

• Angiotensin converting enzyme inhibitors (drugs used in the treatment of cardiovascular diseases such as high blood pressure or heart failure),

• Diuretics (diuretics),

• Beta-2-agonists (such as salbutamol or terbutaline),

used in the treatment of asthma• Corticosteroids for the treatment of severe skin inflammation or asthma.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use GLUCOPHAGE?

GLUCOPHAGE cannot replace the benefits of a healthy lifestyle. continue to apply the diet and regular exercises recommended by your doctor when using your medicine.

Instructions for proper use and dose / frequency of administration:

• In adults, the standard starting dose is 500 mg or 850 mg GLUCOPHAGE twice a day, unless your doctor makes a different recommendation. The maximum dose that can be taken is 3000 mg in three divided doses.

• Your doctor will determine the dose of GLUCOPHAGE according to your blood glucose levels.

• If you use insulin, your doctor will tell you how to get to GLUCOPHAGE.

• Monitoring: During your treatment, your doctor will want to check how your kidneys work at least once a year. If your kidneys don't work normally, your doctor may want to check your kidneys more frequently.

Method and method of administration: GLUCOPHAGE may be taken with meals or after meals. Taking GLUCOPHAGE with or after meals prevents the side effects of this medicine that affect your digestive system. Do not chew or crush tablets. Swallow the GLUCOPHAGE tablet with sufficient amount of water.

• If you take a dose of GLUCOPHAGE per day, take it in the morning (for breakfast).

• If you are taking two divided doses of GLUCOPHAGE per day, take it in the morning (at breakfast) and at dinner (dinner).

• If you are taking three divided doses of GLUCOPHAGE per day, take in the morning (at breakfast), at noon (at lunch) and at dinner (dinner).

Different age groups:

Use in children: In children and adolescents aged 10 and over, the standard starting dose of GLUCOPHAGE isdaily

500 mg or 850 mg once. The maximum dose available is 2000 mg, in two or three divided doses. The treatment of children between 10 and 12 years of age is recommended only on the special recommendation of your doctor as there is not enough experience in this age group.

• Monitoring: Your doctor will determine the dose of GLUCOPHAGE which should be used in children and adolescents according to your blood sugar level. Contact your doctor regularly.

Use in the elderly: With age, kidney function may be impaired. Your doctor will adjust the dose of GLUCOPHAGE according to your kidney function. Contact your doctor regularly.

• Monitoring: Your doctor will determine the dose of GLUCOPHAGE you should use according to your blood glucose level. Contact your doctor regularly. Your doctor will want to check how your kidneys work at least once a year.

Special Use:

ConditionsKidney Failure: GLUCOPHAGE should not be used in patients with renal failure.

Hepatic impairment: GLUCOPHAGE should not be used in patients with hepatic impairment.

Talk to your doctor or pharmacist if you have an impression that GLUCOPHAGE is too strong or weak.

If you have used more GLUCOPHAGE than you should use: If you use more GLUCOPHAGE than you should use, you may develop lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal cramps, abdominal pain, severe fatigue, and poor general breathing.

Talk to a doctor or pharmacist if you have used more than you should use from GLUCOPHAGE.

If you forget to use GLUCOPHAGE: Do not double-dose to compensate for forgotten doses.

if you forget to take your next, take your next dose at the usual time.

Effects after cessation of treatment with GLUCOPHAGE: Do not stop receiving GLUCOPHAGE unless your doctor tells you to discontinue treatment.

4. What are the possible side effects?

As with all medications, people who are sensitive to substances found in GLUCOPHAGE may have side effects.

If it is one of the following, stop using GLUCOPHAGE and IMMEDIATELY tell your doctor or contact your nearest hospital emergency department: - Lactic acidosis. Lactic acidosis is very rare, especially if your kidneys do not work regularly; but it is a serious discomfort. If this happens, you may need emergency treatment. Symptoms of lactic acidosis include vomiting, abdominal cramps, abdominal pain, severe fatigue, and poor general breathing.

These are all very serious side effects. If you have one of these, you may need emergency medical care or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, report to your doctor immediately or contact the emergency department of your nearest hospital: - Low B12 vitamin level in the blood - Abnormalities in liver function test - Hepatitis (fatigue, loss of appetite, weight loss, yellowing of the skin or white parts of the eye) - Skin reactions such as rash on the skin (erythema), itching, hives, etc.

These are all serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor:

• Evidence of taste

• Digestive problems such as patient feeling (nausea), sickness (vomiting), diarrhea, abdominal pain (abdominal pain) and loss of appetite. These side effects are usually at the beginning of treatment. If you spread the doses throughout the day and take the tablets together with the meals or after meals, this will reduce your complaints.

These are the mild side effects of GLUCOPHAGE.

Different age groups: In

children and adolescents: Limited information from children and adolescents shows that side effects are similar in terms of content and severity to reported side effects in adults.

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

• Store theKeep the GLUCOPHAGE in a place

GLUCOPHAGEwhere children cannot and cannot reach them.

Store at room temperature below 25 ° C.

Use in accordance with expiration dates. Do not use GLUCOPHAGE after the expiration date. Do not use GLUCOPHAGE if you notice any defects in the product and / or its packaging.

License holder: DAIICHI SANKYO laç Ticaret Limited Şirketi Kayışdağı Cad. No: 47 Kar Plaza E Block Floor: 3

çerenköy- Kadıköy- stanbul

Manufacturer: Eczacıbaşı Sağlık Ürünleri Sanayi ve Ticaret A.Ş. 39780 Small Mixer / Lüleburgaz These instructions for use are approved on .................