Active ingredient
- metformin hydrochloride
Legal Category
POM: Prescription only medicine
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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0139.
Metformin Hydrochloride 500mg/5ml Oral Solution
Package leaflet: Information for the patient
Metformin Hydrochloride 500mg/5ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Metformin Hydrochloride Oral Solution is and what it is used for
2. What you need to know before you take Metformin Hydrochloride Oral Solution
3. How to take Metformin Hydrochloride Oral Solution
4. Possible side effects
5. How to store Metformin Hydrochloride Oral Solution
6. Contents of the pack and other information
1. What Metformin Hydrochloride Oral Solution is and what it is used for
What Metformin is
Metformin is 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.
What Metformin is used for
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 Hydrochloride Oral Solution
Do not take Metformin Hydrochloride Oral Solution:
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 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 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:
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 sulfonylureas, 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, 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
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 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 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:
Metformin with alcohol
Avoid excessive alcohol intake while taking alcohol since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).
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 when 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 sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.
Metformin Oral Solution contains: sodium methyl and propyl parahydroxybenzoates, liquid maltitol and propylene glycol.
3. How to take Metformin Hydrochloride Oral Solution
Always take Metformin Hydrochloride Oral Solution 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.
Usual Dose
Children over 10 and adolescents
Adults
If you take insulin too, your doctor will tell you how to start Metformin Hydrochloride Oral Solution.
Monitoring
How to take Metformin Hydrochloride Oral Solution
Take the liquid with or after a meal. This will avoid you having side effects affecting your digestion.
If, after some time, you think that the effect of metformin is too strong or too weak, talk to your doctor or pharmacist.
If you take more Metformin Hydrochloride Oral Solution than you should
Talk to a doctor or go to a hospital straight away. If you have taken more metformin that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are 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 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 Oral Solution
Take it as soon as you remember. However, if it is less than 2 hours away from the next dose, skip the missed dose. Then go on as before. Do not take a double dose to make up for the forgotten dose.
If you stop taking Metformin Hydrochloride Oral Solution
Keep taking this medicine until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, metformin can cause side effects, although not everybody gets them. The following side effects may occur:
Metformin 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 and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Other side effects:
Very common (affects more than 1 in 10 people)
Common (affects more than 1 in 100 people)
Very rare (affects less than 1 in 10,000 people)
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Metformin Hydrochloride Oral Solution
6. Contents of the pack and other information
What Metformin Hydrochloride Oral Solution contains
The active substance is Metformin Hydrochloride.
Each 5ml oral solution contains 500mg Metformin Hydrochloride.
1ml of oral solution contains 100mg 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), ammonia caramel (E150c), peppermint flavour (containing propylene glycol (E1520), isopropyl alcohol and pulegone), peach flavour (containing propylene glycol (E1520) and isopropyl alcohol) and purified water.
What Metformin Hydrochloride Oral Solution looks like and contents of the pack
Metformin Hydrochloride Oral Solution is a clear brown liquid which is peach and mint flavoured. It comes in a brown glass bottle holding 100ml or 150ml of solution.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom/Ireland Metformin Hydrochloride 500mg/5ml Oral Solution
Greece Metformin Hydrochloride/Rosemont Πόσιμο διάλυμα 500 mg / 5 ml
The leaflet was last revised in January 2021.
D9H98RBJ5
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)795 762 3515