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Metformin hydrochloride 500mg/5ml Oral Solution
Metformin hydrochloride 500mg/5ml Oral Solution
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
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. Metformin is associated with either a stable body weight or modest weight loss.
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.
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.
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 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:
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.
Always take this medicine exactly as your doctor has told you.
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.
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.
Take Metformin 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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.
Very common side effects (may affect 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. It helps if you spread the doses over the day and if you take Metformin with or straight after a meal. If symptoms continue, stop taking Metformin and talk to your doctor.
Common side effects (may affect up to 1 in 10 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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
This leaflet was last revised in 09/2022.
PIL/UK/MFG025/04/SMD/v2