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

1. What is and what it is used for

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.
helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking over a long period of time also helps to lower
the risk of complications associated with diabetes. is associated with either a stable
body weight or modest weight loss.
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 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 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 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 treated for acute heart failure or have recently had a heartattack, have severe problems with your circulation (such as shock) orhave breathing difficulties. This may lead to a lack in 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 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
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 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 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 during and for some time
after the procedure. Your doctor will decide when you must stop and when to restart your treatment
with .
on its own does not cause hypoglycaemia (a blood glucose level which is too low).
However, if you take 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 , 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
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 before or at the
time of the injection. Your doctor will decide when you must stop and when to restart your treatment
with .
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 . 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 in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole, crizotinib, olaparib).
• other medicines used to treat diabetes.

with alcohol
Avoid excessive alcohol intake while taking 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
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 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’.