- metformin hydrochloride
POM: Prescription only medicine
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.
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:
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 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
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:
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:
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
Take Metformin oral solution with or just after a meal. This will avoid you having side effects affecting your digestion.
If you take insulin too, your doctor will tell you how to start Metformin oral solution.
Children over 10 years and adolescents
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.
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):
Common side effects (affects 1 to 10 users in 100):
Very rare side effects (affects less than 1 user in 10,000):
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
This leaflet was updated in July 2012
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