METFORMIN 500 mg TABLETS

Metformin hydrochloride

'Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.

-    If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

This leaflet contains

1.    What Metformin tablets are and what they are used for

2.    What you need to know before you take Metformin tablets

3.    How to take Metformin tablets

4.    Possible side effects

5.    How to store Metformin tablets

6.    Contents of the pack and other information

Metformin tablets may cause a rare but serious complication called lactic acidosis. This is more likely if your kidneys are not working properly, you have problems with your diabetes, you do not eat for a long period of time or if you drink alcohol excessively. The risk of developing lactic acidosis is also increased if you are dehydrated due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases). It is important that you comply with your medication intake, dietary instructions and regular exercise programme because this can reduce the risk of lactic acidosis. Symptoms of lactic acidosis are unexpected weight loss, nausea, vomiting, very fast breathing which you cannot stop, stomach pains or feeling cold. You may also have a general feeling of not being well with severe tiredness and difficulty breathing. If you experience some of these symptoms, you should seek medical attention immediately, as lactic acidosis may lead to coma. Stop taking Metformin tablets immediately and contact a doctor or the nearest hospital straight away.

1. What Metformin tablets are and what they are used for

Metformin tablets belongs to a group of medicines called the

biguanides. It can be used to treat Type 2 diabetes (non-insulin

dependent diabetes).

How Metformin tablets works

•    In type 2 diabetes, there is too much sugar (glucose) in your blood. This is because your body does not make enough insulin or because it makes insulin that does not work properly.

•    Insulin is a natural body chemical that helps control your blood sugar levels.

•    Metformin tablets helps your body make better use of the insulin it produces. Metformin tablets will help reduce your blood sugar towards a normal level.

Using Metformin tablets

•    This medicine is given when diet and exercise alone has not been able to control your blood sugar levels.

•    Metformin tablets can be given on its own or in combination with other medicines for diabetes or with insulin.

•    In patients who are overweight, long-term use of Metformin tablets also helps to lower the risk of any problems related to diabetes.

•    Children 10 years and over and adolescents can take Metformin tablets on its own or together with insulin.

If you are not sure why you have been prescribed these tablets

then please ask your doctor.

2. What you need to know before you take Metformin tablets

Do not take Metformin tablets

•    If you are allergic to Metformin or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    If you have recently had a heart attack or any other heart problems

•    If you have severe circulation problems or difficulty in breathing

•    If you have liver or kidney problems (glomerular filtration rate below 45 ml/min)

•    If you have had serious problems with your diabetes, which resulted in rapid weight loss, nausea or vomiting (diabetic ketoacidosis)

•    If you have recently had a severe infection, injury or shock (trauma)

•    If you are dehydrated

•    If you are going to have an X-ray where you will be injected with a dye

•    If you drink alcohol excessively (either every day or only from time to time)

•    If you are pregnant, planning a pregnancy or are breast-feeding.

Talk to your doctor before you take this medicine:

•    If you are going to have an X-ray, which involves having a dye injected. You will need to stop taking Metformin tablets 48 hours before the procedure. Do not start to take Metformin tablets again for at least 48 hours after the procedure and only when your doctor has told you your kidneys are working properly.

•    If you are going to have an operation under general anaesthetic, as you may need to stop taking Metformin tablets for a couple of days before and after the operation.

Tests while taking Metformin tablets

•    The amount of sugar in your blood or urine should be checked regularly. This is particularly important for children and adolescents or if you are elderly.

•    At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working properly. Your vitamin B12 levels will also be checked.

Taking other medicines and Metformin tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Metformin tablets work:

•    Other medicines for diabetes such as Sulphonylureas

or Insulin. Taking these medicines with Metformin tablets increases the risk of hypoglycaemia (a blood glucose level which is too low). The signs of hypoglycaemia are weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration. It helps to eat or drink something containing sugar.

•    Medicines for high blood pressure or heart failure such as Diazoxide, Beta-blockers or ACE inhibitors like Captopril or Ramipril

•    Disopyramide to treat irregular heartbeat

•    Medicines to increase urine production

•    Medicines to treat depression or mental health problems such as MAO inhibitors or Phenothiazines

•    Medicines to treat pain, fever and swelling such as Salicylates or Pyrazolones

•    Cimetidine to treat stomach ulcers

•    Lanreotide or Octreotide to treat cancer

•    Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies

•    Hormones such as Testosterone, Oestrogens or Progestogens (including the contraceptive “pill” and hormone replacement therapy).

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Metformin tablets.

Taking Metformin tablets with food and drink

•    You should eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you should continue to follow this.

•    AVOID ALCOHOL when taking Metformin tablets.

Pregnancy and breast-feeding

Do not take Metformin tablets if you are pregnant, think you may be pregnant, planning to have a baby or are breast-feeding. During pregnancy you need insulin to treat your diabetes. Tell your doctor if you are, think you might be or are planning to become pregnant, so that your doctor may change your treatment.

Driving and using machines

Metformin tablets on its own should not affect your ability to drive or operate machinery, but if it is taken with other diabetic medicines you may feel faint, confused and sweaty. If this happens, do not drive or operate machinery.

Metformin tablets contains lactose

If you have been told by your doctor that you have an intolerance to lactose or other sugars contact your doctor before taking this medicine.

3. How to take Metformin tablets

Always take Metformin tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow each tablet whole with a glass of water. Take with or just after food. This lowers the chance of getting an upset stomach.

Dosage

Your doctor will decide your dose, as it depends on your condition.

DO NOT STOP taking the tablets until your doctor tells you to. Adults:

The recommended dose to start with is 500 mg once a day, gradually increased to 500 mg three times a day. The maximum daily dose is 3000 mg in 3 divided doses.

In renal impaired patients with a GRF between 45 and 60 ml/min, the recommended starting dose is 500 mg once a day. The maximum daily dose is 1000 mg in 2 divided doses. Your kidney function should be closely monitored (every 3-6 months).

If you take insulin too, your doctor will tell you how to start taking Metformin tablets

Elderly:

Your doctor will decide your dose after tests have been carried out on your kidney function.

Use in children over 10 years and adolescents:

The recommended dose to start with is 500 mg once a day, gradually increased to 500 mg three times a day. The maximum daily dose is 2000 mg in divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Use in children under 10 years: Not recommended.

If you take more Metformin tablets than you should

Contact your doctor or go to a hospital immediately. You may have something called lactic acidosis (see section 4 of this leaflet). The doctor may use a method called haemodialysis to remove the extra lactate and metformin from your body.

If you forget to take Metformin tablets

Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten tablet.

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

cold. You may also have a general feeling of not being well with severe tiredness and difficulty breathing. Further symptoms are reduced body temperature and heart-beat. Very rarely taking Metformin tablets may lead to liver problems, abnormal liver function tests and hepatitis (inflammation of the liver), which may result in jaundice (yellowing of the skin or white of the eyes). If this happens to you, talk to your doctor.

Other side effects include:

Very common side effects (in more than 1 in 10 people):

•    upset stomach causing nausea, vomiting, diarrhoea, stomach pain or loss of appetite (anorexia).

These side effects are most likely to happen at the start of the treatment. They usually last for a short time. It helps to take the tablets with or after meals.

Common side effects (in less than 1 in 10 people):

•    changes in taste

Very rare side effects (in less than 1 in 10,000 people):

•    skin rash (including redness, itching or hives).

•    low levels of vitamin B12. Over time this may lead to anaemia, a sore mouth or tongue or possibly numbness or tingling in the limbs.

Children and adolescents:

Limited data in children and adolescents showed that side effects were similar in nature and severity to those reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

5. How to store Metformin tablets

Keep this medicine out of the sight and reach of children. If

a child is treated with Metformin tablets, parents and carers should oversee how this medicine is used.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

4. Possible side effects

Like all medicines, Metformin tablets can cause side effects, although not everybody gets them.

Stop taking Metformin tablets and see a doctor immediately if you have an allergic reaction. The signs may include a rash, swallowing or breathing problems, or swelling of your face, eyes, mouth, tongue or throat.

If you get any of the following symptoms you may have the very rare but serious complication called diabetic ketoacidosis or lactic acidosis. STOP TAKING Metformin tablets and seek immediate medical help as lactic acidosis may lead to coma:

What Metformin tablets contains

The active substance in Metformin 500 mg tablets is metformin hydrochloride. The other ingredients are lactose, colloidal anhydrous silica, gelatin, sodium starch glycolate, magnesium stearate, hypromellose, ethylcellulose, titanium dioxide (E171) and diethyl phthalate.

What Metformin tablets looks like and contents of the pack

Metformin 500 mg tablets are round white film-coated tablets with the marking MP8 on one side and METF 500 mg on the other.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 - 43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2016.

GE0006/O/PIL1/GE1

METFORMIN 500 mg TABLETS

Metformin hydrochloride

'Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.

-    If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

This leaflet contains

1.    What Metformin tablets are and what they are used for

2.    What you need to know before you take Metformin tablets

3.    How to take Metformin tablets

4.    Possible side effects

5.    How to store Metformin tablets

6.    Contents of the pack and other information

Metformin tablets may cause a rare but serious complication called lactic acidosis. This is more likely if your kidneys are not working properly, you have problems with your diabetes, you do not eat for a long period of time or if you drink alcohol excessively. The risk of developing lactic acidosis is also increased if you are dehydrated due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases). It is important that you comply with your medication intake, dietary instructions and regular exercise programme because this can reduce the risk of lactic acidosis. Symptoms of lactic acidosis are unexpected weight loss, nausea, vomiting, very fast breathing which you cannot stop, stomach pains or feeling cold. You may also have a general feeling of not being well with severe tiredness and difficulty breathing. If you experience some of these symptoms, you should seek medical attention immediately, as lactic acidosis may lead to coma. Stop taking Metformin tablets immediately and contact a doctor or the nearest hospital straight away.

1. What Metformin tablets are and what they are used for

Metformin tablets belongs to a group of medicines called the

biguanides. It can be used to treat Type 2 diabetes (non-insulin

dependent diabetes).

How Metformin tablets works

•    In type 2 diabetes, there is too much sugar (glucose) in your blood. This is because your body does not make enough insulin or because it makes insulin that does not work properly.

•    Insulin is a natural body chemical that helps control your blood sugar levels.

•    Metformin tablets helps your body make better use of the insulin it produces. Metformin tablets will help reduce your blood sugar towards a normal level.

Using Metformin tablets

•    This medicine is given when diet and exercise alone has not been able to control your blood sugar levels.

•    Metformin tablets can be given on its own or in combination with other medicines for diabetes or with insulin.

•    In patients who are overweight, long-term use of Metformin tablets also helps to lower the risk of any problems related to diabetes.

•    Children 10 years and over and adolescents can take Metformin tablets on its own or together with insulin.

If you are not sure why you have been prescribed these tablets

then please ask your doctor.

2. What you need to know before you take Metformin tablets

Do not take Metformin tablets

•    If you are allergic to Metformin or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    If you have recently had a heart attack or any other heart problems

•    If you have severe circulation problems or difficulty in breathing

•    If you have liver or kidney problems (glomerular filtration rate below 45 ml/min)

•    If you have had serious problems with your diabetes, which resulted in rapid weight loss, nausea or vomiting (diabetic ketoacidosis)

•    If you have recently had a severe infection, injury or shock (trauma)

•    If you are dehydrated

•    If you are going to have an X-ray where you will be injected with a dye

•    If you drink alcohol excessively (either every day or only from time to time)

•    If you are pregnant, planning a pregnancy or are breast-feeding.

Talk to your doctor before you take this medicine:

•    If you are going to have an X-ray, which involves having a dye injected. You will need to stop taking Metformin tablets 48 hours before the procedure. Do not start to take Metformin tablets again for at least 48 hours after the procedure and only when your doctor has told you your kidneys are working properly.

•    If you are going to have an operation under general anaesthetic, as you may need to stop taking Metformin tablets for a couple of days before and after the operation.

Tests while taking Metformin tablets

•    The amount of sugar in your blood or urine should be checked regularly. This is particularly important for children and adolescents or if you are elderly.

•    At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working properly. Your vitamin B12 levels will also be checked.

Taking other medicines and Metformin tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Metformin tablets work:

•    Other medicines for diabetes such as Sulphonylureas

or Insulin. Taking these medicines with Metformin tablets increases the risk of hypoglycaemia (a blood glucose level which is too low). The signs of hypoglycaemia are weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration. It helps to eat or drink something containing sugar.

•    Medicines for high blood pressure or heart failure such as Diazoxide, Beta-blockers or ACE inhibitors like Captopril or Ramipril

•    Disopyramide to treat irregular heartbeat

•    Medicines to increase urine production

•    Medicines to treat depression or mental health problems such as MAO inhibitors or Phenothiazines

•    Medicines to treat pain, fever and swelling such as Salicylates or Pyrazolones

•    Cimetidine to treat stomach ulcers

•    Lanreotide or Octreotide to treat cancer

•    Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies

•    Hormones such as Testosterone, Oestrogens or Progestogens (including the contraceptive “pill” and hormone replacement therapy).

If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Metformin tablets.

Taking Metformin tablets with food and drink

•    You should eat carbohydrates regularly throughout the day. If your doctor has given you advice on your diet, you should continue to follow this.

•    AVOID ALCOHOL when taking Metformin tablets.

Pregnancy and breast-feeding

Do not take Metformin tablets if you are pregnant, think you may be pregnant, planning to have a baby or are breast-feeding. During pregnancy you need insulin to treat your diabetes. Tell your doctor if you are, think you might be or are planning to become pregnant, so that your doctor may change your treatment.

Driving and using machines

Metformin tablets on its own should not affect your ability to drive or operate machinery, but if it is taken with other diabetic medicines you may feel faint, confused and sweaty. If this happens, do not drive or operate machinery.

Metformin tablets contains lactose

If you have been told by your doctor that you have an intolerance to lactose or other sugars contact your doctor before taking this medicine.

3. How to take Metformin tablets

Always take Metformin tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow each tablet whole with a glass of water. Take with or just after food. This lowers the chance of getting an upset stomach.

Dosage

Your doctor will decide your dose, as it depends on your condition.

DO NOT STOP taking the tablets until your doctor tells you to. Adults:

The recommended dose to start with is 500 mg once a day, gradually increased to 500 mg three times a day. The maximum daily dose is 3000 mg in 3 divided doses.

In renal impaired patients with a GRF between 45 and 60 ml/min, the recommended starting dose is 500 mg once a day. The maximum daily dose is 1000 mg in 2 divided doses. Your kidney function should be closely monitored (every 3-6 months).

If you take insulin too, your doctor will tell you how to start taking Metformin tablets

Elderly:

Your doctor will decide your dose after tests have been carried out on your kidney function.

Use in children over 10 years and adolescents:

The recommended dose to start with is 500 mg once a day, gradually increased to 500 mg three times a day. The maximum daily dose is 2000 mg in divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Use in children under 10 years: Not recommended.

If you take more Metformin tablets than you should

Contact your doctor or go to a hospital immediately. You may have something called lactic acidosis (see section 4 of this leaflet). The doctor may use a method called haemodialysis to remove the extra lactate and metformin from your body.

If you forget to take Metformin tablets

Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten tablet.

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

cold. You may also have a general feeling of not being well with severe tiredness and difficulty breathing. Further symptoms are reduced body temperature and heart-beat. Very rarely taking Metformin tablets may lead to liver problems, abnormal liver function tests and hepatitis (inflammation of the liver), which may result in jaundice (yellowing of the skin or white of the eyes). If this happens to you, talk to your doctor.

Other side effects include:

Very common side effects (in more than 1 in 10 people):

•    upset stomach causing nausea, vomiting, diarrhoea, stomach pain or loss of appetite (anorexia).

These side effects are most likely to happen at the start of the treatment. They usually last for a short time. It helps to take the tablets with or after meals.

Common side effects (in less than 1 in 10 people):

•    changes in taste

Very rare side effects (in less than 1 in 10,000 people):

•    skin rash (including redness, itching or hives).

•    low levels of vitamin B12. Over time this may lead to anaemia, a sore mouth or tongue or possibly numbness or tingling in the limbs.

Children and adolescents:

Limited data in children and adolescents showed that side effects were similar in nature and severity to those reported in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

5. How to store Metformin tablets

Keep this medicine out of the sight and reach of children. If

a child is treated with Metformin tablets, parents and carers should oversee how this medicine is used.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use this medicine after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

4. Possible side effects

Like all medicines, Metformin tablets can cause side effects, although not everybody gets them.

Stop taking Metformin tablets and see a doctor immediately if you have an allergic reaction. The signs may include a rash, swallowing or breathing problems, or swelling of your face, eyes, mouth, tongue or throat.

If you get any of the following symptoms you may have the very rare but serious complication called diabetic ketoacidosis or lactic acidosis. STOP TAKING Metformin tablets and seek immediate medical help as lactic acidosis may lead to coma:

What Metformin tablets contains

The active substance in Metformin 500 mg tablets is metformin hydrochloride. The other ingredients are lactose, colloidal anhydrous silica, gelatin, sodium starch glycolate, magnesium stearate, hypromellose, ethylcellulose, titanium dioxide (E171) and diethyl phthalate.

What Metformin tablets looks like and contents of the pack

Metformin 500 mg tablets are round white film-coated tablets with the marking MP8 on one side and METF 500 mg on the other.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Lmited,

41 - 43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 06/2016.

GE0006/O/PIL2/GE1