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METFORMIN HYDROCHLORIDE 500MG/5ML ORAL SOLUTION

Active substance(s): METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE / METFORMIN HYDROCHLORIDE

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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.
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Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your pharmacist.
This medicine has been prescribed only for you. Do not
pass it on to others. It may harm them, even if their
symptoms 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.

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:
n if you are allergic (hypersensitive) to metformin or any of the other ingredients of this liquid (see ‘What Metformin
Hydrochloride Oral Solution contains’ in section 6)
n if you have liver problems.
n if you have severely reduced kidney function.
n 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.
n 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).
n 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).
n if 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 of lactic acidosis (see 'Warnings and Precautions' below).
n 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
n 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.
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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:
n vomiting
n stomach ache (abdominal pain)
n muscle cramps
n a general feeling of not being well with severe tiredness
n difficulty in breathing
n 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 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:
n medicines which increase urine production (diuretics)
n medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
n certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
n beta-2 agonists such as salbutamol or terbutaline (used to treat asthma)
n corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma)
n other medicines to treat diabetes mellitus.
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, sodium and
potassium.
n Sodium methyl and propyl parahydroxybenzoates. These may cause an allergic reaction such as skin rash and
difficulty in breathing. If this happens talk to a doctor straight away.
n Liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, talk to your doctor before
taking this medicine. It may have a mild laxative effect. Calorific value is 2.3kcal/g maltitol.
n Sodium (5.3mg in a 5ml dose). Take this into account if you are on a low sodium diet.
n Potassium (14.5mg in a 5ml dose). Take this into account if you have kidney problems or are on a low
potassium diet.
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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
n The usual dose of metformin is one 5ml spoonful (500mg)
each day.
n Do not give more than a total of four 5ml spoonsful (2g) of
metformin in one day (taken as 2 or 3 divided doses).
n 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
The usual starting dose is one 5ml spoonful (500mg) two
or three times a day.
n Do not take more than a total of six 5ml spoonsful (3g) of
metformin in one day (taken as 3 divided doses). In renal
impaired patients with GFR between 45 and 60 ml/min the
starting dose is 500mg, once daily. The maximum dose is
1000 mg daily given in two divided doses. The renal
function should be closely monitored (every 3-6 months).
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If you take insulin too, your doctor will tell you how to start Metformin Hydrochloride Oral Solution.
Monitoring
Your doctor 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.
n 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.
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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.
n If you take one dose a day, take it in the morning (breakfast).
n If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner).
n 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.
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)
n 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 the medicine with or straight after a meal.
If symptoms continue, stop taking metformin and talk to your doctor.
Common (affects more than 1 in 100 people)
n changes in taste.
Very rare (affects less than 1 in 10,000 people)
n skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).
n abnormalities in liver function test 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 metformin hydrochloride and talk to your doctor.
n 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 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
Yellow Card Scheme. www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 676497
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5. How to store Metformin Hydrochloride Oral Solution
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Keep out of the sight and reach of children.
Do not store above 25°C.
Get rid of the medicine 28 days after opening.
Do not use 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 Hydrochloride 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. 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, isopropyl
alcohol and pulegone), peach flavour (containing propylene glycol 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
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
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
Austria
Metformin Rosemont 500 mg/5 ml Lösung zum Einnehmen
Germany
MetfoLiquid Geriasan 500 mg/5 ml Lösung zum Einnehmen
Greece
Metformin Hydrochloride/Rosemont Πόσιμο διάλυμα 500 mg / 5 ml
Denmark
Metformin Rosemont 100 mg/ml oral opløsning
Norway
Metformin Rosemont 100 mg/ml mikstur, oppløsning
The leaflet was last revised in April 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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