500 mg, 850 mg, 1000 mg film-coated tablets
metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
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 ingredients 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 drugs called biguanides.

Insulin is a hormone produced in the pancreas that helps the body absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future needs. If you have diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin that is produced well enough. This leads to high blood glucose levels. Glucophage helps to lower the blood glucose level to a level that is as close to the normal level as possible.

If you are an adult and overweight, taking Glucophage for a long time can also help reduce the risk of complications associated with diabetes. Glucophage is associated with either stable body weight or small weight loss.

Glucophage is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not sufficient to control blood glucose levels, especially for obese patients.

Adults can take Glucophage as the only treatment or together with other medicines to treat diabetes (medicines taken by mouth or insulin ).

Children 10 years of age or older and adolescents can take Glucophage as their sole treatment or with insulin.

Metformin contained in Glucophage may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before taking Glucophage

Do not take Glucophage

  • if you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (see section 6, ‘Contents of contents’).
  • if you have liver problems.
  • if you have severe renal impairment.
  • if you have uncontrolled diabetes with, for example, severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath gets a different, fruity odor.
  • if the body has lost too much water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions”).
  • if you have a severe infection , e.g. an infection that affects the lungs, trachea or kidneys. Severe infections can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions”).
  • if you are being treated for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock ) or difficulty breathing. This can lead to a lack of oxygen in tissue one, which can cause lactic acidosis (see “Warnings and Precautions”).
  • if you drink a lot of alcohol.

If any of these apply to you, do not take this medicine but talk to a doctor.

You need to consult a doctor about

  • you need to have an examination, such as an X-ray or computed tomography scan , which means that you are receiving contrast media containing iodine injected into your blood
  • you will undergo major surgery

You must stop taking Glucophage for some time before and after the examination or operation. Your doctor will decide if you need any other treatment during this time. It is important that you follow your doctor’s instructions carefully.

Warnings and cautions

Risk of lactic acidosis

Glucophage may cause a very rare, but very serious side effect a lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information.

Stop taking Glucophage for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Glucophage and contact a doctor or nearest hospital immediately if you get any of the symptoms of lactic acidosis as the condition may lead to coma .

Symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate .

Lactic acidosis is an acute medical condition that must be treated in a hospital.

If you are going to have a major operation, you must stop taking Glucophage during the operation and for some time after it. Your doctor will decide when you need to stop taking Glucophage and when you should start taking it again.

Glucophage in itself does not cause hypoglycemia (low blood sugar), but if you take Glucophage together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycaemia , such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, it usually helps to eat or drink something that contains sugar.

During treatment with Glucophage, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Other medicines and Glucophage

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Glucophage before or at the time of injection. Your doctor will decide when you need to stop taking Glucophage and when you should start taking it again.

Tell your doctor if you are taking, have recently taken, or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Glucophage. It is especially important that you mention the following:

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

Glucophage with alcohol

Avoid high alcohol intake while taking Glucophage as alcohol may increase the risk of lactic acidosis (see section “Warnings and Precautions”).

Pregnancy and breastfeeding

During pregnancy, you need insulin to treat your diabetes . Tell your doctor if you are or think you may be pregnant or are planning to have a baby so that he or she can change your treatment.
This medicine is not recommended if you are breast-feeding or planning to breastfeed your baby.

Driving and using machines

Glucophage alone does not cause hypoglycaemia (too low a blood glucose level). This means that it does not affect your ability to drive or use machines.

However, you should be especially careful if you take Glucophage together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulfonylureas, insulin , meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, sweating, rapid heartbeat, visual disturbances or difficulty concentrating. Do not drive or use machines if you experience such symptoms.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Glucophage

Always take Glucophage exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Glucophage can not replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

Recommended dose Children 10 years of age or older and adolescents usually start with 500 mg or 850 mg Glucophage once a day. The maximum daily dose is 2000 mg divided into two or three doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

Adults usually start with 500 mg or 850 mg of Glucophage two or three times a day. The maximum daily dose is 3,000 mg divided into three doses.

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

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

Check

  • Your doctor will take regular blood glucose tests and adjust your dose of Glucophage to your blood glucose level. You need to talk to your doctor regularly. This is especially important for children and adolescents or if you are older.
  • Your doctor will also examine your kidney function at least once a year. You may need more frequent check-ups if you are older or if your kidneys are not working properly.

How to take Glucophage

Take Glucophage with or after a meal. This way you avoid side effects that affect digestion.

The tablets must not be crushed or chewed. Swallow each tablet with a glass of water.

  • If you take one dose a day, take it in the morning (breakfast).
  • If you take two dose your day, take one dose in the morning (breakfast) and evening (dinner).
  • If you take three dose your day, take one dose in the morning (breakfast), one at noon (lunch) and evening (dinner).

If after a while you think that Glucophage’s effect is too strong or too weak, talk to your doctor or pharmacist.

If you take more Glucophage than you should

If you take more Glucophage than you should, lactic acidosis may occur. The symptoms of lactic acidosis are non-specific such as vomiting, stomach pain with muscle cramps, general malaise with great tiredness and difficulty breathing. Additional symptoms are decreased body temperature and decreased heart rate. If you experience any of these symptoms, seek immediate medical attention as lactic acidosis may lead to coma. Stop taking Glucophage immediately and contact your doctor or nearest hospital immediately.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital or the Poison Information Center for risk assessment and advice.

If you forget to take Glucophage

Do not take a double dose to make up for a forgotten dose. Take the next dose at the time you would normally take it.

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

4. Possible side effects

Like all medicines, Glucophage can cause side effects, although not everybody gets them. The following side effects may occur:

Glucophage may cause a very rare (may affect up to 1 in 10,000), but very serious side effect a lactic acidosis (see section “Warnings and Precautions”). If this happens to you, you must stop taking Glucophage and contact a doctor or nearest hospital immediately as lactic acidosis may lead to coma.

Very common side effects (affects more than 1 user in 10)

  • Digestive problems, e.g. nausea, vomiting, diarrhea, stomach pain and loss of appetite. These side effects usually occur at the beginning of treatment with Glucophage. It helps if you distribute the doses throughout the day and if you take Glucophage with or immediately after a meal. If symptoms persist, stop taking Glucophage and talk to your doctor.

Common side effects (affects less than 1 user in 10)

  • Taste changes.

Very rare side effects (affects less than 1 user in 10,000)

  • Lactic acid . This is a very rare but serious complication, which can occur especially if the kidneys are not working properly.
    Symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
  • Deviations in liver function tests or hepatitis (this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine and contact your doctor.
  • Skin reactions such as redness, itching or hives .
  • Low levels of vitamin B 12 in the blood.

Children and young people

Limited information shows that the type and severity of side effects are similar for children and adolescents as for adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glucophage

Keep out of sight and reach of children. If a child is being treated with Glucophage, parents and caregivers should monitor the use of this medicine.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton or jar or blister after “Exp. that. ” or “EXP”. The expiration date is the last day of the specified month.

The medicine 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

Glucophage 500 mg

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

Glucophage 850 mg

  • The active substance is metformin hydrochloride. One Glucophage 850 mg film-coated tablet contains 850 mg metformin hydrochloride equivalent to 662.9 mg metformin base.
  • The other ingredients are povidone K 30, magnesium stearate, hypromellose.

Glucophage 1,000 mg

  • The active substance is metformin hydrochloride. One Glucophage 1,000 mg film-coated tablet contains 1,000 mg of metformin hydrochloride equivalent to 780 mg of metformin base.
  • The other ingredients are povidone K 30, magnesium stearate, hypromellose, macrogol 400 and macrogol 8000.

What the medicine looks like and contents of the pack

Glucophage 500 mg
Glucophage 500 mg film-coated tablets are white, round with a diameter of 11 mm, height 5.7 mm, convex and marked GL 500. The
tablets are sold in blister packs of 100×1, 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 and 1000 tablets and in plastic jars with a childproof lid with 21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 and 1000 tablets.

Glucophage 850 mg
Glucophage 850 mg film-coated tablets are white, round with a diameter of 13.5 mm, height 6.6 mm, convex, and marked GL 850. The
tablets are sold in blister packs of 100×1, 8, 9, 10, 14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 and 1000 tablets and in plastic jars with a childproof lid with 30, 60, 200, 300 and 600 tablets.

Glucophage 1,000 mg
Glucophage 1,000 mg film-coated tablets are white, oval, and biconvex with dimensions 19 mm x 10.5 mm and height 6.4 mm with a notch on both sides and “1000” embossed on one side. The tablet can be divided into two equal halves.
The tablets are sold in blister packs of 30×1, 20, 30, 50, 60, 90, 100, 120, 180 and 600 tablets and in plastic jars with childproof lids with 20, 30, 50, 60, 90, 100, 120, 180 and 600 tablets .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Merck Santé sas
37 rue St Romain
F-69379 Lyon-Cedex 08
France

Manufacturer
Merck Santé sas
2 rue du Pressoir Vert
45400 Semoy
France

Merck SL
Poligono Merck
Mollet Del Vallés 08100 Barcelona
Spain

or

Famar Lyon

29 avenue Charles de Gaulle

69230 Saint-Genis Laval

France

For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Merck AB
Box 3033

169 03 Solna

Tel: 08-562 445 00

This medicinal product is authorized under the European Economic Area under the names:

Glucophage 500 mg

Glucophage: Belgium, Bulgaria, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, UK, Czech Republic, Germany, Austria

Merckformin: Hungary

Glucophage 850 mg
Dianben: Spain

Glucophage: Belgium, Bulgaria, Cyprus, France, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Norway, Poland, Romania, Slovakia, Slovenia, Sweden, Great Britain, Czech Republic, Germany, Austria


Merckformin: Hungary

Risidon: Portugal

Glucophage 1000 mg

Glucophage: Bulgaria, Cyprus, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Malta, Norway, Poland, Romania, Slovakia, Slovenia, Sweden, Czech Republic, Germany, Austria


Merckformin: Hungary

Risidon: Portugal

Muhammad Nadeem

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