Metformin hydrochloride 850 mg film-coated tablets (PL 16363/0602)

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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 Metformin hydrochloride
6. Contents of the pack and other information

Metformin hydrochloride tablet 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.

• if you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (see 'What Metformin hydrochloride tablet contains' 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 heart attack, have severe problems with your circulation (such as shock) or have 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 Metformin hydrochloride 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.

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.

Risk of lactic acidosis.

Metformin hydrochloride 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 Metformin hydrochloride 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 Metformin hydrochloride 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.

If you need to have major surgery you must stop taking Metformin hydrochloride during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin hydrochloride.

Metformin hydrochloride on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin hydrochloride 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, visions disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

During treatment with Metformin hydrochloride, 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.

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 Metformin hydrochloride tablets before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin

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 Metformin hydrochloride. 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 Metformin hydrochloride 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

Avoid excessive alcohol intake while taking Metformin hydrochloride since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

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.

Metformin hydrochloride 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 Metformin hydrochloride tablets 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 heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride tablets 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 Metformin hydrochloride tablets 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 take insulin too, your doctor will tell you how to start Metformin hydrochloride tablets.

• Your doctor will perform regular blood glucose tests and will adapt your dose of Metformin hydrochloride tablets to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person
• Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally

Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.

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 (breakfast)
• If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner)
• If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner)

If, after some time, you think that the effect of Metformin hydrochloride is too strong or too weak, talk to your doctor or pharmacist.

If you have taken more Metformin hydrochloride tablets that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.

Further symptoms are reduced body temperature and heartbeat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead tocoma.

Stop taking Metformin hydrochloride tablets immediately and contact a doctor or the nearest hospital straight away.

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

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

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is metformin hydrochloride.

Metformin hydrochloride 500 mg tablets:

Each film-coated tablet contains 500 mg metformin hydrochloride corresponding to 390 mg metformin.

Metformin hydrochloride 850 mg tablets:

Each film-coated tablet contains 850 mg metformin hydrochloride corresponding to 663 mg metformin.

The other ingredients are:

Tablet core: Povidone, magnesium stearate.

Film-coating: Hypromellose, macrogol.

Film-coated tablet.

Metformin hydrochloride 500 mg tablets:

White, round [diametre 11mm], biconvex, film-coated tablets with ‘A’ debossed on one side and ‘60’ debossed on the other side.

Metformin hydrochloride 850 mg tablets:

White, round [diametre 12.70 mm],, biconvex, film-coated tablets with ‘A’ debossed on one side and ‘61’ debossed on the other side.

Metformin hydrochloride tablets are packed in a blister pack (Clear PVC / PVdC / aluminium) or (Clear PVC/ Aluminium) or White opaque HDPE bottle packs with polypropylene closure containing activated carbon.

Metformin hydrochloride 500 mg & 850 mg tablets:

Each box contains 20/28/30/40/42/50/56/60/70/80/84/90/98/100/120/180/200/300/400 film-coated tablets in blister packs, each blister containing 10 or 14 film-coated tablets. White opaque HDPE bottle packs containing 90,100, 400 or 500 film-coated tablets.

Not all pack sizes may be marketed.

or