Metformin Accord

Package leaflet: Information for the user
500 mg/850 mg/1000 mg film-coated 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What metformin hydrochloride is and what it is used for

Metformin hydrochloride contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not make enough insulin or your body is not able to use properly the insulin it produces. This leads to a high level of glucose in your blood.

Metformin hydrochloride helps to lower your blood glucose to as normal a level as possible.

If you are an overweight adult, taking metformin hydrochloride over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin hydrochloride is associated with either a stable body weight or modest weight loss.

Metformin hydrochloride is used to treat patients with type 2 diabetes (also called ‘non-insulin dependent diabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

Adults can take metformin hydrochloride on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Children 10 years and over and adolescents can take metformin hydrochloride on its own or together with insulin.

2. What you need to know before you take

Do not take:

• If you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell
• if you have lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').
• if you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').
• if you are being treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack of oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Warnings and precautions').
• if you drink a lot of alcohol. If any of the above applies to you, talk to your doctor before you start taking this medicine. Make sure you ask your doctor for advice, if:
  • you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
  • you need to have major surgery. You must stop taking [this medicine] for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions
Risk of lactic acidosis
[This medicine] may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking [this medicine] for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking [this medicine] and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.
Talk to your doctor promptly for further instructions if:

• You are known to suffer from a genetically inherited disease affecting mitochondria (the energy-producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).
• You have any of these symptoms after starting metformin: seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

If you need to have major surgery you must stop taking [this medicine] during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with [this medicine].
[This medicine] on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take [this medicine] together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.
During treatment with [this medicine], your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

Other medicines and [this medicine]
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking [this medicine] before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with [this medicine].
Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of [this medicine]. It is especially important to mention the following:

• medicines which increase urine production (diuretics).
• medicines used to treat pain and inflammation (NSAID 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 inflammation of the skin or in asthma).
• medicines that may change the amount of [this medicine] in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.

[This medicine] with alcohol
Avoid excessive alcohol intake while taking [this medicine] since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, speak to your doctor in case any changes will be needed to your treatment or monitoring of your blood glucose levels.
This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines
[This medicine] on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines.
However, take special care if you take [this medicine] together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

Excipients
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take

Always take exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are not sure.
cannot replace the benefits of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and engage in regular physical activity.

Recommended dose
Children aged 10 years and over and adolescents usually start with 500 mg or 850 mg once a day. The maximum daily dose is 2000 mg, taken as 2 or 3 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.
Adults usually start with 500 mg or 850 mg two or three times a day. The maximum daily dose is 3000 mg, taken as 3 divided doses. If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will advise you on how to start .

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your dose of according to your blood glucose levels. Make sure you consult your doctor regularly. This is particularly important for children and adolescents or if you are elderly.
• Your doctor will also check at least once a year how well your kidneys are functioning. You may need more frequent checks if you are elderly or if your kidneys are not working normally.

How much to take
Take with or after a meal. This will help prevent gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (with breakfast).
• If you take two divided doses a day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three divided doses a day, take them in the morning (with breakfast), at noon (with lunch), and in the evening (with dinner).
  If, after some time, you feel that the effect of is too strong or too weak, talk to your doctor or pharmacist.

If you take more than you should
If you have taken more than recommended, you may develop lactic acidosis.
Symptoms of lactic acidosis are non-specific and may include vomiting, abdominal pain with muscle cramps, a general feeling of being unwell, severe tiredness, and difficulty breathing. Additional symptoms may include low body temperature and irregular heartbeat. If you experience any of these symptoms, seek immediate medical attention, as lactic acidosis can lead to coma.
Stop taking immediately and contact a doctor or go to the nearest hospital straight away.

If you forget to take
Do not take a double dose to make up for a missed dose. Take the next dose at your usual scheduled time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The
following side effects may occur:
may cause a very rare (may affect up to 1 user in 10,000), but very serious side
effect called lactic acidosis (see section ‘Warnings and precautions’). If this happens you must stop
taking and contact a doctor or the nearest hospital immediately , as lactic
acidosis may lead to coma.
Very common side effects (may affect more than 1 in 10 people):

• digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of the treatment with . It helps if you spread the doses over the day and if you take with or straight after a meal. If symptoms continue, stop taking Name> and talk to your doctor.

Common side effects (may affect up to 1 in 10 people):

• changes in taste.
• Decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.

Very rare side effects (may affect up to 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly.
• Symptoms of lactic acidosis are non-specific (see section ‘Warning and precautions’)
• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking and talk to your doctor .
• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).

Children and adolescents
Limited data in children and adolescents showed that adverse events 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 or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store X

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on blister, bottle and the carton after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What the medicine contains
The active substance is metformin hydrochloride.
Each film-coated tablet contains 500 mg metformin hydrochloride, equivalent to 390 mg
metformin base.
Each film-coated tablet contains 850 mg metformin hydrochloride, equivalent to 662.9 mg
metformin base.
Each film-coated tablet contains 1000 mg metformin hydrochloride, equivalent to 780 mg
metformin base.
The other ingredients are:
Tablet core: Povidone, Croscarmellose sodium, Colloidal silicon dioxide, Magnesium stearate
Tablet coating: Opadry White containing Hypromellose, Macrogol, Titanium dioxide (E171)

What the medicine looks like and contents of the pack
500 mg:
White to off-white, round, biconvex, film-coated tablets with 'LA15' debossed on one side and plain on the other side.
Blister: Clear PVC-Alu blister containing 7, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 300, 400 tablets.
HDPE Bottle:
White opaque HDPE bottle with white opaque polypropylene child-resistant closure with wad and induction sealing liner, in pack sizes of 90, 100, 300, 400, and 1000 tablets.

850 mg:
White to off-white, capsule-shaped, biconvex, film-coated tablets with 'L01' debossed on one side and plain on the other side.
Blister: Clear PVC-Alu blister containing 7, 30, 40, 50, 56, 60, 90, 100, 120, 200 tablets.
HDPE Bottle:
White opaque HDPE bottle with white opaque polypropylene child-resistant closure with wad and induction sealing liner, in pack sizes of 90, 100, and 200 tablets.

1000 mg:
White to off-white, oval, biconvex, film-coated tablets with a score line on both sides, and 'LA' and '07' debossed on either side of the score line on one side.
The tablet can be divided into equal doses.
Blister: Clear PVC-Alu blister containing 7, 20, 28, 30, 56, 60, 84, 90, 100, 120, 180, 200 tablets.
HDPE Bottle:
White opaque HDPE bottle with white opaque polypropylene child-resistant closure with wad and induction sealing liner, in pack sizes of 60, 100, 200, and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
To be completed nationally

This leaflet was last revised in { month YYYY }.
To be completed nationally