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MANNITOL 20% SOLUTION FOR INFUSION

Active substance(s): MANNITOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mannitol 10% solution for
infusion
Mannitol 20% solution for
infusion
Read all of this leaflet carefully before you are given 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.
• 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 Mannitol infusion is and what it is used for
2. What you need to know before you are given Mannitol infusion
3. How you are given Mannitol infusion
4. Possible side effects
5. How Mannitol infusion is stored
6. Contents of the pack and other information

1. What Mannitol infusion is and what it
is used for
The name of this medicine is:
Mannitol 10% solution for infusion
Mannitol 20% solution for infusion
In this leaflet it is jointly referred to as Mannitol infusion.
Mannitol infusion is used as an osmotic diuretic. Diuretics increase the
amount of urine passed, which causes the body to lose water and salt.
Your doctor will be able to explain this to you.
Mannitol infusion is used on its own or to supplement the action of
other diuretics in order to treat or prevent kidney failure and help
get rid of toxic substances from the body by increasing urine flow.
Mannitol also promotes the excretion of substances such as aspirin and
barbiturates (drugs used in treatment of sleeping problems).
Mannitol infusion is given by intravenous (into a vein) infusion.

2. What you need to know before you
are given Mannitol infusion
You should not receive Mannitol infusion if
• you are allergic (hypersensitive) to mannitol or any of the
ingredients of Mannitol infusion mentioned in Section 6.
• You have abnormally fragile blood vessels (capillary fragility)
• You have fluid on the lungs (pulmonary congestion or pulmonary
oedema)
• You have bleeding inside your head (intracranial bleeding)
• You have heart failure
• You have kidney failure (unless a test dose has produced a diuretic
response)
Warnings and precautions
Care should be taken when being administered with Mannitol infusion
• Tell your doctor if you suffer from abnormal fluid retention in your
body cells (called oedematous conditions) associated with reduced
heart function.
• Mannitol infusion should be administered to you slowly and should
not be mixed with blood. Your doctor or nurse will make sure the
infusion is given to you correctly.
• Kidney cells may be damaged if mannitol is administered simultaneously.
Your doctor or nurse will ensure the solution is clear and free from any
particles before use.
Your doctor may monitor your salt and fluid levels during treatment.
Other Medicines and Mannitol infusion
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Inform your doctor if you take or have recently taken any of the below
medicines:
• Tubocurarine (a medicine used during anesthesia)
• Cyclosporin (used in organ transplantation)
• Electrolyte solutions (salts)
• Corticotrophin (a hormone)
• Barbiturates (sleeping medicines or anaesthetics)
• Noradrennaline (a hormone)
• Metaraminol (a medicine used if you have very low blood pressure)
• Suxamethonium (a muscle relaxant)
• Tetracyclines (antibiotics )
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Mannitol infusion has no effect on driving or using machines.

3. How you are given Mannitol infusion
Mannitol infusion must only be given to you in a hospital by healthcare
professionals
You will receive your medicine by infusion (IV drip).
Dosage
Your doctor will decide on the correct dose for you to receive.
The amount and rate at which the infusion is given depends on your
requirements.
Adults and Children
A dosage of 200g daily by intravenous infusion should not be
exceeded.
Elderly
Elderly patients are more likely to be affected by the side effects
associated with mannitol. This is due to diminished kidney function and
heart capacity
You should therefore be given a test dose as described below for
patients with any kidney impairment.
Kidney Impairment
If you have reduced kidney function you should be given a test dose
of 200 mg per kilogram body weight administered to you over five
minutes. If your body produces 40 ml or more of urine within an hour,
mannitol may then be given to you in smaller doses.
If you receive more Mannitol infusion than you should
It is very unlikely that you will receive more infusion than you should.
If you suspect an overdosage with mannitol you should look for the
symptoms/side effects described below in this leaflet. You should
immediately inform your doctor describing the symptoms.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines Mannitol infusion can cause side effects, although
not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are very rare. If you get any of the following
symptoms after receiving this medicine, you should contact
your doctor immediately:
• Nausea
• Vomiting
• Upper abdomen discomfort
• Headache
• Confusion
• Cramps
• Tachycardia (an increase in heart ratel
• Skin Rash
• Swelling

Rapid intravenous infusion of mannitol may produce:
• Headache
• Chills
• Chest pain
• Breathing difficulties
• Convulsions (fits)
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 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 Mannitol infusion
Keep out of the sight and reach of children.
Your doctor and hospital pharmacist are responsible for the correct
storage, use and disposal of Mannitol infusion.
Mannitol Infusion should be stored between 20°C and 30°C.
The solution must not be used after the expiry date shown on the
label. The expiry date refers to the last day of that month.
Any solution remaining after treatment should be disposed of using
the approved hospital procedures.
The solution should not be diluted before use.

6. Contents of the pack and other
information
What Mannitol Infusion contains
Mannitol 10% solution for infusion contains mannitol 10% w/v.
Mannitol 20% solution for infusion contains mannitol 20% w/v.
The infusions also contain: water for injections, hydrochloric acid, and
sodium hydroxide.
What Mannitol infusion looks like and contents of the pack
Mannitol solution is a clear solution contained in a sealed semi-rigid,
cylindrical neutral polythene container with a 'Twist off' seal at one end
and a ring tab at the opposite end.
The solution is available in 500 ml containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Limited
Cestrian Court, Eastgate Way,
Manor Park, Runcorn,
Cheshire, WA7 1 NT. UK.
Manufacturer:
Terumo BCT Limited,
Old Belfast Road, Millbrook,
Larne, Co. Antrim, BT40 2SH. UK.
LEAF/MAN/O
V003/TM
This leaflet was last revised in August 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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