MANNITOL 20% SOLUTION FOR INFUSION - Patient leaflet, side effects, dosage

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)

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.

This leaflet was last revised in August