What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0543.

Metformin hydrochloride 500mg/5ml Oral Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

METFORMIN HYDROCHLORIDE 500 MG/5 ML ORAL SOLUTION

Read all of this leaflet carefully before you start taking this medicine.

  • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Metformin oral solution is and what it is used for
2. Before you take Metformin oral solution
3. How to take Metformin oral solution
4. Possible side effects
5. How to store Metformin oral solution
6. Further information

1. WHAT METFORMIN ORAL SOLUTION IS AND WHAT IT IS USED FOR

The name of this medicine is Metformin hydrochloride 500 mg/5 ml oral solution, referred to as Metformin oral solution throughout this leaflet. It belongs to a group of medicines called biguanides.

Metformin is used for the treatment of "Type 2 diabetes" (non-insulin dependent diabetes).

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 the insulin it produces properly. 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 oral solution over a long period of time also helps to lower the risk of complications associated with diabetes.

What Metformin oral solution is used for

Metformin oral solution 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 oral solution 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 oral solution on its own or together with insulin.

2. BEFORE YOU TAKE METFORMIN ORAL SOLUTION

Do not take Metformin oral solution if:

  • you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine (see 'What Metformin oral solution contains' in section 6);
  • you have kidney or liver problems;
  • you have uncontrolled diabetes, such as severe hyperglycaemia (high blood glucose) 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 unusual fruity odour of the breath;
  • 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. Dehydration may lead to kidney problems, which can put you at risk of lactic acidosis (see 'Take special care with Metformin oral solution below);
  • 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 of lactic acidosis (see 'Take special care with Metformin oral solution below);
  • you are treated for 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 'Take special care with Metformin oral solution below);
  • 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 an 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 oral solution for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment during this time. It is important that you follow your doctor's instructions precisely.

Take special care with Metformin oral solution

Please note the following particular risk of lactic acidosis.

Metformin oral solution may cause a very rare but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake. Symptoms of lactic acidosis are vomiting, abdominal pain with muscle cramps, a general feeling of not being well with severe tiredness and difficulty in breathing. If this happens to you, you may need immediate treatment as lactic acidosis may lead to coma. Stop taking Metformin oral solution immediately and contact a doctor or your nearest hospital straight away.

Metformin on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin oral solution together with other medicines to treat diabetes such as sulphonylureas, insulin or glinides, there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

Taking Metformin oral solution with other medicines

  • Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as an X-ray or scan, you must stop taking Metformin oral solution for a certain period of time before and after the examination (see 'Make sure you ask your doctor for advice' above).

Tell your doctor if you take any of the following medicines and Metformin oral solution at the same time. You may need more frequent blood glucose tests or your doctor may adjust the dosage of Metformin oral solution:

  • diuretics (used to remove water from the body by making more urine);
  • sympathomimetics 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),
  • other medicines used to treat diabetes.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking metformin.

Taking Metformin oral solution with food and drink

Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or if you are undernourished. This also applies to medicines that contain alcohol.

Pregnancy and breast-feeding

During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment.

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 oral solution 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 oral solution together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin or glinides). 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.

Important information about some of the ingredients of Metformin oral solution

This medicine contains:

  • sodium methyl and propyl hydroxybenzoates, propyl p-hydroxybenzoate and methyl p-hydroxybenzoate. These may cause an allergic reaction such as skin rash and difficulty in breathing. If this happens talk to a doctor straight away;
  • liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before taking this medicine;
  • sodium (5.3 mg in a 5 ml dose). Take this into account if you are on a low sodium diet;
  • potassium (14.5 mg in a 5 ml dose). Take this into account if you have kidney problems or are on a low potassium diet.

3. HOW TO TAKE METFORMIN ORAL SOLUTION

Always take this medicine exactly as your doctor has told you. You should 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.

Taking this medicine

  • This solution contains 500 mg of metformin hydrochloride in 5 ml.

Take Metformin oral solution with or just 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)

Adults

  • The usual starting dose is 500 mg (5 ml) or 850 mg (8.5 ml) of Metformin oral solution two or three times a day.
  • The maximum daily dose is 3000 mg (30 ml) taken as 3 divided doses.

If you take insulin too, your doctor will tell you how to start Metformin oral solution.

Children over 10 years and adolescents

  • The usual starting dose is 500 mg (5 ml) or 850 mg (8.5 ml) of Metformin oral solution 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 experience in this age group is limited.

Monitoring

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

If you take more Metformin oral solution than you should

If you have taken more Metformin oral solution than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, abdominal pain with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Contact a doctor or the nearest hospital straight away.

If you forget to take Metformin oral solution

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

If you stop taking Metformin oral solution

Keep taking this medicine until your doctor tells you to stop. Do not stop taking Metformin oral solution just because you feel better. If you stop your illness may get worse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metformin oral solution can cause side effects, although not everybody gets them. The following side effects may occur:

Very common side effects (affects more than 1 user in 10):

  • digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, abdominal pain and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin oral solution. It helps if you spread the doses over the day and if you take this medicine with or straight after a meal. If symptoms continue, stop taking Metformin oral solution and talk to your doctor.

Common side effects (affects 1 to 10 users in 100):

  • changes in taste.

Very rare side effects (affects less than 1 user in 10,000):

  • lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly.
    Symptoms of lactic acidosis are vomiting, abdominal pain with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin oral solution immediately and tell your doctor straight away;
  • 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 this medicine.
  • skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria);
  • low vitamin B12 levels 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.

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE METFORMIN ORAL SOLUTION

Keep your medicine in a safe place

Keep out of the reach and sight of children

If a child is treated with Metformin oral solution, parents and caregivers are advised to oversee how this medicine is used.

Dispose of any remaining medicine 28 days after opening.

Do not use Metformin oral solution after the expiry date which is stated on the label and carton EXP (month, year). The expiry date refers to the last day of that month.

Do not use Metformin Oral Solution if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Metformin oral solution contains:

The active substance is metformin hydrochloride. Each 5 ml of oral solution contains 500 mg metformin hydrochloride.

The other ingredients are sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), liquid maltitol (E965), sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate anhydrous (E339), acesulfame potassium (E950), caramel (E150), peppermint flavour, peach flavour and purified water.

What Metformin oral solution looks like and contents of the pack

Metformin oral solution is a clear brown liquid which is peach and peppermint flavoured. It comes in a brown glass bottle holding 100 ml or 150 ml of solution with a child resistant screw off cap and a plastic pipette (5ml dose volume graduated every 0.5ml).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

Manufacturer

ONE PHARMA INDUSTRIAL PHARMACEUTICAL SA
60th km National Road Athens-Lamia
Schimatari
P.O. 32009
Greece

This leaflet was updated in July 2012