METFORMIN 850 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Metformin 500 mg and 850 mg film-coated tablets

APOLLO GENERICS LID

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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Metformin is and what it is used for

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

• 3. How to take Metformin

• 4. Possible side effects

• 5. How to store Metformin

• 6. Contents of the pack and other information

1. what metformin is and what it is used for

Metformin 500 mg and 850 mg contain 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 helps to lower your blood glucose to as normal a level as possible.

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

Metformin 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 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 on its own or together with insulin.

2. what you need to know before you take metformin

Do not take Metformin if you:

• are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
• have liver problems.
• have severely reduced kidney function.
• 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.
• lost too much water from your body (dehydration), 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’).
• have a severe infection, such as an infection affecting your lungs or bronchial system or your kidneys. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Warnings and precautions’).
• 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’).
• 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.
• need to have major surgery.

You must stop taking Metformin 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

Talk to your doctor or pharmacist before taking Metformin.

Risk of lactic acidosis

Metformin 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 diseases).

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

It is important for you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.

Stop taking Metformin 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 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 during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin.

During treatment with Metformin, 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 Metformin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin 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.

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

You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin. It is especially important to mention the following:

• medicines which increase urine production (diuretics).
• medicines 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 inflammation of the skin or in asthma).
• medicines that may change the amount of Metformin 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.

Metformin with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. During pregnancy, you need insulin to treat your diabetes instead of Metformin.

This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines

Metformin 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 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.

3. how to take metformin

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

Metformin cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

Recommended dose

Children 10 years and over and adolescents usually start with 500 mg or 850 mg metformin 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 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.

Monitoring

• Your doctor will perform regular blood glucose tests and will adapt your dose of Metformin 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.

How to take Metformin

Take Metformin 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).
• Take two divided doses a day, take them in the morning (breakfast) and evening (dinner).
• 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 is too strong or too weak, talk to your doctor or pharmacist.

500 and 850 mg: The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Metformin than you should

If you have taken more Metformin than 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 immediate medical attention, as lactic acidosis may lead to coma. Stop taking Metformin immediately and contact a doctor or the nearest hospital straight away.

If you forget to take Metformin

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

If you have any further questions on 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:

If the following side effects occur, you should stop taking Metformin and contact a doctor or the nearest hospital immediately:

• Metformin may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
• digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache (abdominal pain) and loss of appetite are very common (may affect more than 1 in 10 people). These side effects most often happen at the beginning of the treatment with Metformin. It helps if you spread the doses over the day and if you take Metformin with or straight after a meal.

If symptoms continue, stop taking Metformin and talk to your doctor.

• 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) are very rare (may affect up to 1 in 10,000 people).

If this happens to you, stop taking Metformin and talk to your doctor.

Other side effects may include the following:

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

• changes in taste.

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

• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).
• low vitamin B12 level in the blood.

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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

5. how to store metformin

Keep this medicine out of the sight and reach of children. If a child is treated with Metformin, parents and caregivers are advised to oversee how this medicine is used.

Do not use this medicine after the expiry date which is stated on the carton or the blister 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 Metformin 500 mg or 850 mg contains

The active substance is metformin hydrochloride.

• One film-coated tablet of Metformin 500 mg contains 500 mg metformin hydrochloride corresponding to 390 mg metformin base.
• One film-coated tablet of Metformin 850 mg contains 850 mg metformin hydrochloride corresponding to 662.9 mg metformin base.
• The other ingredients are povidone (K-25), magnesium stearate, hypromellose (5 mPas), Macrogol 6000, Titanium dioxide (E 171), Talc.

What Metformin looks like and contents of the pack

Metformin 500 mg film-coated tablets are white to off-white, oval film-coated tablets with break mark on one face. The tablets are supplied in blister packs of 28, 84 or 500 tablets.

Metformin 850 mg film-coated tablets are white to off-white, oblong film-coated tablets with break mark on both faces. The tablets are supplied in blister packs of 56 or 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Apollo Generics Limited

Unit 1, 76 Stephenson Way

Formby Business Park

Liverpool

Merseyside

L37 8EG

United Kingdom

This leaflet was last revised in October 2020 V01. PIL41500/01