METFORMIN HYDROCHLORIDE 500 MG/5 ML ORAL SOLUTION

Active substance: METFORMIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Metformin Hydrochloride 500 mg/5 ml Oral Solution
Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.
What is in this leaflet:
1. What Metformin Oral Solution is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1.

WHAT METFORMIN ORAL SOLUTION IS AND WHAT IT IS USED FOR

What Metformin Oral Solution is
Your medicine is called ‘Metformin Hydrochloride 500 mg/5 ml Oral Solution’. It will be referred to throughout this leaflet as ‘Metformin Oral Solution’.
Metformin Oral Solution contains metformin, 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 properly use the insulin it produces. This leads to a high level of glucose in
your blood. Metformin Oral Solution 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.
Metformin Oral Solution is associated with either a stable body weight or modest weight loss.

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.

WHAT YOU NEED TO KNOW 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 solution (see section 6 and end of section 2)
have liver or kidney problems
have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, dehydration, rapid weight loss or ketoacidosis which can lead to
a diabetic pre-coma. The symptoms of ketoacidosis include stomach pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath
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 “Take special care with Metformin Oral Solution” below)
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 “Take special care with Metformin Oral Solution” below)
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 of oxygen supply to tissue which can put you at risk of lactic acidosis (see “Take special care with Metformin Oral Solution” below)
drink a lot of alcohol.
If any of the above applies to you, talk to your doctor before you start taking this medicine.

Warnings and Precautions
Tests/Surgery
Talk to your doctor if you need to have
an examination such as X-ray or scan involving iodine contrast medicine injections
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 for 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 mellitus, 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 hospital treatment, as lactic acidosis may lead to coma. Stop taking Metformin Oral Solution immediately and
contact a doctor or the nearest hospital straight away.

Metformin Oral Solution on its own does not cause hypoglycaemia (low blood glucose level). However, if you take Metformin Oral Solution with other medicines to treat
diabetes that can cause hypoglycaemia (such as sulphonylureas e.g. gliclazide, insulin, meglitinides e.g. repaglinide), 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.
Other medicines and Metformin Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you need to have an injection of iodine contrast medicines for examinations such as X-ray or scan, you must stop taking Metformin Oral Solution for a certain
period of time before and after the examination (see “Tests/Surgery” above).

Tell your doctor if you take any of the following medicine. 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)
beta-2 agonists 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 to treat diabetes mellitus.
Metformin Oral Solution with food, drink and alcohol
Do not drink alcohol when you take this medicine. Alcohol may increase the risk of lactic acidosis especially if you have liver problems or are undernourished. This also
applies to medicines that contain alcohol, including those obtained without a prescription.

Pregnancy, breast-feeding and fertility
During pregnancy, insulin rather than metformin is used to treat diabetes. Do not take Metformin Oral Solution and talk to your doctor if you are pregnant, think you might
be pregnant or are planning to become pregnant, so that he/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 (low blood glucose). 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
e.g. gliclazide, insulin, meglitinides e.g repaglinide). 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 methyl and propyl parahydroxybenzoate, liquid maltitol, sodium and ethanol
Methyl and propyl parahydroxybenzoate – 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. May have
a mild laxative effect. Calorific value 2.3 kcal/g of maltitol.
Sodium - 14.19 mg per 5 ml dose. This should be taken into consideration for patients on a controlled sodium diet.
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3.

Ethanol - This medicinal product contains small amounts of ethanol (alcohol) less than 100 mg per 5 ml.

HOW TO TAKE METFORMIN ORAL SOLUTION

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Metformin Oral Solution 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.
If you also take insulin, your doctor will tell you how to start taking Metformin Oral Solution.
The recommended dose is

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

Use in Children 10 years and over and adolescents
The usual starting dose of Metformin Oral Solution is 5 ml (500 mg) or 8.5 ml (850 mg) once a day
The maximum daily dose is 20 ml (2000 mg) taken as two or three 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.

Directions for using the syringe:
1. Open the bottle.
2. Insert the adaptor into the bottle neck and ensure it is well fixed.
3. Push the tip of the syringe firmly into the adaptor plug (hole) in the neck of the bottle. When in position the tip should be partly visible. Do not force it all the way in.
4. To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down slowly drawing the medicine to the correct mark (5 ml,
8.5 ml or 10 ml) on the syringe.
5. Turn the bottle the right way up, and then gently twist the syringe to remove from the adaptor plug.
6. Place the end of the syringe into your mouth, pressing the plunger down to slowly and gently release the medicine.
After use replace the cap on the top of the bottle tightly. The adaptor should remain in the bottle. Wash the syringe in warm water and allow to dry.

Monitoring
Your doctor will perform regular blood glucose tests and will 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.
How to take Metformin Oral Solution
Take Metformin Oral Solution with or after a meal. This will help to avoid any 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).
If you think that the effect of Metformin Oral Solution is too strong or too weak, talk to your doctor or pharmacist.

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 have further questions on the use of this medicine, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:
Serious side effects

Lactic acidosis is a very rare but serious complication particulary 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 contact a doctor or the nearest hospital straight away.
Other side effects

Very common side effects (in more than 1 in 10 people)
digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache (abdominal pain) and loss of appetite. These side effects occur
most often at the beginning of the treatment with Metformin Oral Solution. 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 Oral Solution and talk to your doctor.
Common side effects (in less than 1 in 10 people)
changes in taste

Very rare side effects (in less than 1 in 10,000 people)
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 Metformin Oral Solution and talk to your doctor.
skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives)
low vitamin B12 levels in the blood.
Additional side effects in children and adolescents
Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5.

HOW TO STORE METFORMIN ORAL SOLUTION

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

Keep this medicine out of the sight and reach of children. If a child is treated with Metformin Oral Solution, parents and caregivers are advised to oversee how this
medicine is used. Do not store above 25°C. Do not take Metformin Oral Solution 60 days after opening the bottle and discard any remaining medicine. Do not use this
medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the
appearance or smell of your medicine has changed. Talk to your pharmacist about this. Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Metformin Oral Solution contains
The active substance is: metformin hydrochloride. Each 5 ml dose of Metformin Oral Solution contains 500 mg of metformin hydrochloride.
The other ingredients are: liquid maltitol (E965), glycerol (E422), saccharin sodium (E954), propylene glycol (E1520), propyl parahydroxybenzoate (E216), methyl
parahydroxybenzoate (E218), sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate (E339), peppermint flavour (contains ethanol), peach
flavour (contains propylene glycol and ethanol), hydrochloric acid (for pH adjustment) and purified water (See end of Section 2 for further information).
What Metformin Oral Solution looks like and contents of the pack
Metformin Oral Solution is a clear, colourless peach and peppermint flavoured oral solution presented in 100 ml and 150 ml amber glass bottles with child-resistant
closures. A 10 ml graduated dosing syringe is provided.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: PL 04917/0094

This leaflet was last revised in 01/2014
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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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