Metformin hydrochloride 500mg/5ml Oral Solution

• 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.

The name of your medicine is Metformin hydrochloride 500mg/5ml Oral Solution but will be referred to as ‘Metformin’ throughout 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. Content of the pack and other information

• 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 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’ below)
• if you have a severe infection, such as an infection affecting your lung 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’ below)
• 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’ below)
• 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 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.

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 disease).

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

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.

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.

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.

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.

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

Methyl parahydroxybenzoate (E218): May cause allergic reactions (possibly delayed).

Liquid Maltitol: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. It may have a mild laxative effect.

This medicinal product also contains 0.93mmol (21.46mg) sodium per dose of 5ml. To be taken into consideration by patients on a controlled sodium diet.

Children 10 years and over and adolescents usually start with 5ml (500mg) or 8.5ml (850mg) of Metformin once a day. The maximum daily dose is 20ml (2g) 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 5ml (500mg) or 8.5ml (850mg) of Metformin two or three times a day. The maximum daily dose is 30ml (3g) 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.

• 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.

Take Metformin 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 is too strong or too weak, talk to your doctor or pharmacist.

This medicinal product must be taken orally.

Use the measuring syringe provided in the pack to deliver the required dose.

1. Open the bottle: press the cap and turn it anticlockwise (figure 1).
2. Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

3. Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (figure 5C).

4. Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B) and leave the syringe adaptor in place after first use.

5. Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

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 heart beat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Metformin 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 side effects 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 the Yellow Card Scheme Website: 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.

Each 1ml of oral solution contains 100mg metformin hydrochloride.

The other ingredients are: methyl parahydroxybenzoate (E218), sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, liquid maltitol, acesulfame potassium (E950), erythrosine (E127), strawberry flavour [contains propylene glycol (E1520)] and purified water.

Metformin is a clear, pink colour solution with strawberry odour supplied in an amber glass bottle with tamper-evident child resistant plastic screw cap and a 10ml oral syringe with 0.5ml graduation marks for measuring the dose.

Metformin is supplied in bottles containing 150ml solution.

If this leaflet is hard to see or read, please call

+44 (0) 208 515 3700 for help.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names United Kingdom (Northern Ireland) and Malta: Metformin hydrochloride 500mg/5ml Oral Solution