METFORMIN HYDROCHLORIDE 500MG/5ML ORAL SOLUTION

Active substance: METFORMIN HYDROCHLORIDE

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Almus Metformin Hydrochloride
500mg/5ml Oral Solution

3083/4/AL

This leaflet contains important information about Almus Metformin hydrochloide Oral Solution (now called
Metformin Oral Solution through out the leaflet). Read all of this leaflet carefully before you start taking this
medicine.
● Keep this leaflet. You may need to read it again.
● If you have further questions, please ask your doctor or your pharmacist.
● This medicine has been prescribed for you personally and you should not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
● If any of the side effects get serious, or if you have any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet
1.
What is Metformin Oral Solution and what is it used for
2.
Before you take Metformin Oral Solution
3.
How to take Metformin Oral Solution
4.
Possible side effects
5.
Storing Metformin Oral Solution
6.
Further information
1.What Metformin Oral Solution is and what is it used for
Metformin is one of a group of medicines called biguanide
hypoglycaemic agents. These medicines work by lowering
the amount of sugar in the blood.

If you see another doctor or go into hospital, let them know
what medicines you are taking. Special care is needed
(check with your doctor) if you are going into hospital for an
operation under general anaesthetic or certain X-ray tests.
You will be given advice to stop Metformin Oral Solution for a
Metformin Oral Solution may be used for the treatment of
while.
non-insulin dependent diabetes (type 2) not controlled by
Driving and using machines
diet and exercise alone. Your doctor may prescribe
When Metformin Oral Solution is taken on its own, it does
Metformin for you or your child to take on its own or in
not cause "hypos" (symptoms of low blood sugar or
combination with other oral antidiabetic medicines or insulin.
hypoglycaemia, such as faintness, confusion and increased
Your doctor or pharmacist will advice you how to take your
sweating). Therefore, it should not affect your ability to drive
medicine.
or use machinery. However, Metformin Oral Solution can
2. Before you take Metformin Oral Solution
cause "hypos" when taken with other antidiabetic medicines,
Do not take Metformin Oral Solution if:
so in this case, you should take extra care when driving or
● you are pregnant, planning to become pregnant or
operating machinery.
breast-feeding.
Pregnancy and Breast-feeding
● you have ever had an allergic reaction to Metformin or
• Do you think you may be pregnant? If so, you should not
any of the ingredients in the solution. (An allergic
take Metformin, it may harm the baby.
reaction may include a rash, itching or difficulty in
• Are you breast-feeding? If so, you should not take
breathing).
Metformin, the active ingredient gets into mothers' milk.
● you suffer from kidney or liver problems.
Let your doctor know if you think you are pregnant. He or she
● you are a heavy drinker of alcohol.
can advise you on how to control your diabetes.
● you have had heart failure or have recently had a heart
attack, or have difficulty in breathing.
Important information about some of the ingredients of
● you have had serious complications with your diabetes
Metformin Oral Solution
(e.g. diabetic coma or ketonesin your urine).
• Sodium methyl parahydroxybenzoate (E219) and sodium
● you are dehydrated (e.g. if you have suffered from
propyl parahydroxybenzoate (E217): May cause allergic
diarrhoea or vomiting recently).
reactions (possibly delayed).
● you have had a serious infection or recently suffered
• This medicinal product contains small amounts of ethanol
trauma (shock).
(alcohol), less than 100mg per10ml.
● you have been told that the amount of oxygen in your
Taking other medicines
blood is low.
Please tell your doctor before you start to take Metformin Oral
● you need to have an X-ray.
Solution if you:
Do not drink excessive alcohol or take medicines that
• Are taking medicines such as steroids (e.g. hydrocortisone,
contain alcohol whilst taking this oral solution.
prednisolone, betamethasone), medicines to treat asthma
If you have diabetes you should have your blood or urine
(e.g. salbutamol, terbutaline, salmeterol, formoterol), "water"
tested for sugar regularly. Your doctor should check the
tablets (diuretics), ACE inhibitors (medicines to lower blood
function of your kidneys at least once a year (more often if
pressure e.g.captopril).
you are elderly or have kidney problems). An annual check
• Are taking any medication you have bought yourself without
on vitamin B12 levels may be carried out.
a prescription.
You should continue to follow any dietary advice that your
Some medicines may not work very well when Metformin Oral
doctor has given you and should make sure that you eat
Solution is also being taken. Does the doctor who prescribed
carbohydrates regularly throughout the day. If you are
Metformin Oral Solution know this? If not, tell your doctor
overweight, you should continue with your energy restricted before taking any solution. He or she will advice you how to
diet.
take the medication.

3. How to take Metformin Oral Solution
Follow your doctor's instructions. Check the pharmacy label
to see how much oral solution should be taken and how
often to take it. If you are not sure how to take it ask your
pharmacist or doctor.
The usual dosage(s) are described below:
The full effects may in some cases be delayed for up to two
weeks.
Adults: Initially, one 5ml spoonful (500mg) 2 or 3 times
daily with, or just after a meal. After you have been
taking the medicine for about 2 weeks, your doctor
may measure your blood sugar and adjust the
dose. Any change in dosage must only be made
on the advice of your doctor.
Elderly: Your doctor may prescribe a different dose.
Children: Not recommended in children under 10 years.

Effects on the skin:
A mild red rash has been reported in some patients.
However, this is very rare (less than 0.01 % of patients
have experienced this effect).
You should consult your doctor if these effects are
troublesome or continue.
If you get any other unusual side effects, tell your doctor
immediately.
5. Storing Metformin Oral Solution
As with all medicines, it is important to keep Metformin Oral
Solution out of the reach and sight of children.
Do not store above 25°C. Store in the original container.
Discard after one month of opening.
Do not use Metformin Oral Solution after the expiry date
printed on the carton or the bottle
Do not keep outdated medicine or medicine that is no longer
wanted. Take it to your pharmacist for safe disposal.
Always keep the medicine in the bottle in which it was
originally given to you.
You may wish to read the leaflet again. Do not throw it away
until you have finished your medicine.

Metformin Oral Solution must be taken with or after food. The
medicine should be taken for as long as your doctor tells
you to as it may be dangerous to stop without their advice.
If you are elderly or have reduced kidney function, it is
6. Further Information
particularly important to take this medicine exactly as
Metformin Oral Solution is a clear solution with a smell of
directed by the doctor.
Oranges.
What to do if you take too much Metformin Oral Solution
Each 5ml of Metformin hydrochloride Oral Solution contains
Do not take more Metformin oral solution than your doctor tells 500mg Metformin hydrochloride as active ingredient.
you to. If you ever take too much go to the nearest hospital
Metformin Oral Solution also contains the following inactive
casualty department or tell your doctor immediately. Take
ingredients: Glycerol, citric acid monohydrate, saccharin
the container and any remaining medicine with you to show
sodium (E954), sodium citrate, sodium methyl
to the doctor.
parahydroxybenzoate (E219), sodium propyl
If you forget to take Metformin Oral Solution
parahydroxybenzoate (E217), orange flavour (containing
If you forget to take a dose, take one as soon as you
ethanol) and purified water.
remember. Then go on as before. DO NOT take two doses
Metformin Oral Solution is available in amber glass bottles
at the same time. If you are worried ask your pharmacist or
fitted with child resistant closures and containing either
doctor for advice.
100ml or 150ml of the oral solution. A double ended 5ml
4. Possible side effects
This medicine sometimes causes unwanted effects in some
people. These effects may include:
Effects on metabolism and nutrition:
Some patients, who have been taking Metformin Oral
Solution for a long time, have experienced reduced levels
of vitamin B12 in their blood. This would be detected by a
blood test. If you start to loss weight unexpectedly, or suffer
from severe nausea or vomiting, uncontrolled rapid
breathing or abdominal pains, stop taking the medicine and
contact a doctor immediately or go to the nearest A&E
department. These symptoms can be severe, quick to
appear and can be signs of serious problems with your
diabetes (known as diabetic ketoacidosis and lactic
acidosis).
Effects on the stomach and intestines:
More than 10% of patients experience diarrhoea, loss of
appetite, nausea, stomach upset and vomiting especially
at the start of treatment. Taking the medicine during or after
meals usually helps to prevent these effects. When an
increase in the dose of Metformin is prescribed, a gradual
change to the higher dose lessens the likelihood of these
symptoms occurring. 3% of patients suffer from a metallic
taste.

and 2.5ml polypropylene spoon is also included to help
measure the dose.

The Marketing Authorisation holder of Metformin hydrochloride
Oral Solution (PL 20249/0008) is:
● Kappin Ltd., Cunard Road Park Royal London
NW10 6PN.
● Manufactured by Orbis Consumer Products Ltd,
Cunard Road Park Royal London NW10 6PN.
● Distributed by Almus Pharmaceuticals Ltd
40 East Street, Epsom, Surrey, KT17 1BH, UK
REMEMBER
This medicine is for you or your child. Never give it to
anybody else, even if their symptoms are the same as yours.
This leaflet does not tell you all about your medicine. If you
have any questions or are not sure about anything then ask
your doctor or pharmacist.
The information in this leaflet only applies to Metformin Oral
Solution.

Contact us at the above address for
information in large print, audio or
braille
This leaflet was updated in April 2012

Orbis

3083/4/AL

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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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