Patient leaflet - Metformin Hydrochloride 500 mg / 5 ml oral solution

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

Metformin Hydrochloride 500 mg/5 ml Oral Solution (referred to as Metformin Hydrochloride in this leaflet) contains metformin hydrochloride, 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 high level of glucose in your blood. Metformin Hydrochloride helps to lower your blood glucose to as normal level as possible.

If you are an overweight adult, taking Metformin Hydrochloride over a long period of time also helps lower the risk of complications associated with diabetes. This medicine 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 ‘noninsulin 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 Metformin Hydrochloride

Do not take Metformin Hydrochloride

if you are allergic (hypersensitive) 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 of 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 of 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 tissues 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.

Warnings and precautions

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 diseases).

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

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. Stop taking Metformin Hydrochloride for a short time if you have a condition that maybe 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 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 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.

Other medicines and Metformin Hydrochloride

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

Metformin Hydrochloride with alcohol

Avoid excessive alcohol intake while taking Metformin Hydrochloride 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

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 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.

Metformin Hydrochloride contains maltitol liquid (E965)

If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine. It may have a mild laxative effect. The calorific value is 2.3 kcal per gram of maltitol.

Metformin Hydrochloride contains sodium methyl hydroxybenzoate (E219) and sodium propyl hydroxybenzoate (E217)

These ingredients may cause allergic reactions (possibly delayed).

Metformin Hydrochloride contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.

3. How to take Metformin Hydrochloride

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

Metformin Hydrochloride 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 aged 10 years and over and adolescents

The recommended starting dose for children is either 500 mg (5 ml) or 850 mg (7.5 ml) Metformin
Hydrochloride once a day.
The maximum daily dose is 2000 mg (20 ml) 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 knowledge of the effects of this medicine in this age group is limited.

Adults

The recommended starting dose for adults is either 500 mg (5 ml) or 850 mg (7.5 ml) Metformin Hydrochloride two or three times a day.
The maximum daily dose is 3000 mg (30 ml) 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 taking Metformin Hydrochloride.

Monitoring

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

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

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 take more Metformin Hydrochloride than you should

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

If you forget to take Metformin Hydrochloride

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 product, 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:

Metformin Hydrochloride 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 Metformin hydrochloride and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Very common side effects (in 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 Metformin Hydrochloride. It helps if you spread the doses over the day and if you take Metformin Hydrochloride with or straight after a meal. If symptoms continue, stop taking Metformin Hydrochloride and talk to your doctor. Common side effects (in less than 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 (in less than 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 Metformin Hydrochloride 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play Store 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 Hydrochloride

Keep this medicine out of the sight and reach of children. If this medicine is intended for use in a child, administration of the medicine should be supervised by an adult.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the bottle and carton after ‘EXP’. The expiry date refers to the last day of that month.

Once the bottle has been opened, this medicine should be used within 30 days.

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 Hydrochloride contains

The active substance is metformin hydrochloride. Each 5 ml oral solution contains 500 mg of metformin hydrochloride.
The other ingredients are liquid maltitol (E965), sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate (E217), sodium saccharin (15% hq hydrated E954), caramel (E150d), peach flavour (contains propylene glycol), peppermint flavour (contains D-pulegone, estragol, methofuran & propylene glycol), sodium dihydrogen phosphate dihydrate (for pH adjustment), anhydrous disodium hydrogen phosphate (for pH adjustment) and purified water.

What Metformin Hydrochloride looks like and contents of the pack

Metformin Hydrochloride is a clear brown solution with characteristic odour, filled into 125 ml (with a 100 ml fill) or 150 ml (with 150 ml fill) or 300 ml (with 300 ml fill), amber glass bottles fitted with a child resistant, tamper-evident screw cap. (Not all pack sizes may be marketed).

A graduated 10 ml dosing spoon with intermediate graduations of 0.5 ml is also included in the pack.

Marketing Authorisation Holder

Steranco Healthcare UK Limited

Unit 2A, Olympic Way,

Sefton Business Park,

Bootle, Merseyside,

L30 1RD, United Kingdom.

Manufacturer

Medley Pharma Limited