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Mannitol 15% w/v Solution for infusion

Active Ingredient:

mannitol

Company:

Baxter Healthcare Ltd See contact details

ATC code:

B05BC01

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Prescription only medicine

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Healthcare Professionals (SmPC) Patient Leaflet (PIL)

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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.

Last updated on emc: 03 Jun 2025

View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00116/0650.

Print patient leaflet as text only

Mannitol 15% w/v Solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mannitol 15% w/v Solution for infusion

mannitol

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.
This medicine has been prescribed 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 nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Mannitol 15% Infusion is and what it is used for
2. What you need to know before you are given Mannitol 15% Infusion
3. How you will be given Mannitol 15% Infusion
4. Possible side effects
5. How to store Mannitol 15% Infusion
6. Contents of the pack and other information

1. What Mannitol 15% Infusion is and what it is used for

Mannitol 15% Infusion is a solution of mannitol in water.

Mannitol 15% Infusion is used to:

produce an increase in your urine production (diuresis) when your kidneys are not working properly.
reduce the pressure within the skull caused by an accumulation of liquid within the brain (oedema) or after a head injury.
reduce pressure in the eye (intraocular pressure).
treat certain types of poisoning or drug overdose.

2. What you need to know before you are given Mannitol 15% Infusion

Do not receive Mannitol 15% Infusion

if you are allergic to mannitol
if you have a high concentration of salts in your blood
if you are severely dehydrated
if your kidneys cannot produce urine
if you have severe heart disease (heart failure)
if you have a build-up of fluid in the lungs (pulmonary oedema) associated with heart failure
if you have bleeding inside the skull (active intracranial bleeding) or if you have some types of recent, severe head injury
if you fail to respond to test dosing, which your doctor or nurse will give you (see section 3)
if your kidney function worsens after initiating mannitol treatment

If you are unsure whether you are affected by any of the conditions above, please ask your doctor.

Warnings and precautions

Talk to your doctor before receiving Mannitol 15% Infusion

if you have kidney disease or poor kidney function
if you are receiving medicines which may be harmful to your kidneys (for example, certain antibiotics or anticancer medicines).
if you are severely dehydrated (a loss of water from the body, e.g. due to vomiting, diarrhoea, profuse sweating or certain medications). Symptoms will include dry mouth and dizziness.
if you have been told by your doctor you have a low level of sodium (salt) in your blood (hyponatremia)
if you have an allergy to mannitol (as mannitol is found in nature and is used in other medical products, you may have developed sensitivity to this substance without having received intravenous treatment with mannitol). The infusion must be stopped if any signs of hypersensitivity develop, see section 4.

When monitoring is required your doctor may want to carry out tests to ensure that your dose is sufficient. These tests may include:

how well your heart, lungs and kidneys are working.
the amount of liquid you are receiving.
the amount of urine you are producing.
the blood pressure in the veins returning blood to your heart (central venous pressure).
the amount of chemicals such as sodium and potassium in your blood and urine (electrolytes).
the acidity of your blood and urine (your acid-base balance).

This solution should not be given through the same needle as blood transfusion. This can damage the red blood cells or cause them to clump together.

Other medicines and Mannitol 15% Infusion

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines are known to affect or be affected by Mannitol 15% Infusion. Please tell your doctor if you are taking any of these medicines:

diuretics (water tablets, to increase the amount of urine you produce).
ciclosporin (used to prevent rejection of a transplant).
lithium (used for mental disorders).
aminoglycoside (a type of antibiotic).
depolarising neuromuscular blocking drugs (used during anaesthesia to cause muscle paralysis). These will be controlled by your anaesthetist.
oral anticoagulants (medicines to thin the blood, for example warfarin).
digoxin (a heart medicine).

Mannitol 15% Infusion with food, drink and alcohol

You should ask your doctor about what you can eat or drink.

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 nurse for advice before taking this medicine.

It is not known whether mannitol could affect your unborn baby or your pregnancy. It is also not known whether mannitol could reach your baby through your breast milk. Your doctor will therefore only give you Mannitol 15% Infusion during pregnancy or breast-feeding if it is clearly needed.

Driving and using machines

There is no information of the effects of this product on the ability to drive or operate other heavy machinery.

3. How you will be given Mannitol 15% Infusion

Your doctor will decide on how much you need and when it is to be given. The doctor(s) make the decision based on your age, weight, medical condition and the medicine(s) you are taking.

Mannitol 15% Infusion will usually be given to you through infusion line that accesses your vein. If your kidneys are not working properly, your doctor may give you a small amount of the solution as a test dose. The amount of urine you produce will then be measured. If your kidneys don’t produce more urine as a response to the test dose, you will be given a different treatment.

Mannitol 15% Infusion can also be used in children and the elderly (over 65 years of age). Your doctor will adjust the dose as needed.

You should NOT be given Mannitol 15% Infusion if there are particles floating in the solution or if the pack is damaged in any way.

If you receive more Mannitol 15% Infusion than you should

If you are given too much Mannitol 15% Infusion (over-infusion) or if it is given too fast, this may lead to the following symptoms:

too much blood in the blood vessels (hypervolaemia). The symptoms include swelling in the arms and legs (peripheral oedema), difficulty breathing (pulmonary oedema and dyspnea) and fluid in the abdomen (ascites), imbalances of chemicals in your body (electrolytes imbalance).
your blood may become too acid (acidosis).
headache
feeling sick (nausea)
shivering
confusion
tiredness
fits (seizures)
reduced consciousness (stupor) and unconsciousness (coma).
kidney failure (acute renal failure)

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment depending on the symptoms.

If a medication has been added to Mannitol 15% Infusion you should read the Package Leaflet of the added medicine for a list of possible symptoms.

Stopping your Mannitol 15% Infusion

Your doctor will decide when to stop giving you this infusion.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you have any of the following symptoms you should tell your doctor or nurse immediately.

These may be signs of a very severe or even fatal (allergic) reaction called anaphylactic shock:

Difficulty breathing.
A low blood pressure (hypotension).
Swelling of the skin of the face and throat.
Hives (urticaria).
Skin rash.

You will be given treatment depending on the symptoms.

Other side effects that you may experience include:

Damage to the kidney, causing difficulty with passing water or affecting the amount of water being passed
Presence of blood in the urine.
Heart failure.
High blood pressure.
A rapid or irregular heartbeat (palpitations, cardiac arrhythmia).
Excess fluid on the lungs causing shortness of breath.
Coma, convulsions, confusion or tiredness (lethargy) due to damage to the central nervous system.
Swelling of ankles, fingers or face due to build up of fluid in the body.
Dehydration.
Increased or decreased amounts of potassium and/or sodium in your blood.
Dryness of the mouth, thirst.
Nausea, vomiting.
Feeling sick (malaise)
Increased amounts of acid in your blood (metabolic acidosis, see “If you receive more Mannitol 15 Infusion than you should” in section 3).
Chest pain.
Chills, fever.
An increase in pressure within the skull (raised intracranial pressure), causing headaches, feeling sick (nausea), being sick (vomiting), back pain, blurred vision and other changes to your sight, such as difficulty moving your eyes (ocular palsy). Dizziness, headache, fatigue and weakness (asthenia)
Cramps.
Blurred vision.
Runny nose.
Skin necrosis.
Reactions due to the administration technique may include swelling, pain, itching, rash or redness at the infusion site or along the path of the vein.
Escape of the infusion solution into the tissues around the vein (extravasation). This might cause swelling and pain at the injection site. In severe cases, the blood flow will be decreased and the surrounding tissue will be injured(compartment syndrome).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL
Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: [email protected]

5. How to store Mannitol 15% Infusion

This product should not be refrigerated or frozen.

Keep this medicine out of the sight and reach of children.

Do not remove Mannitol 15% Infusion from the outer plastic bag until it is to be used.

Mannitol 15% Infusion should NOT be given to you after the expiry date which is stated on the bag after EXP. The expiry date refers to the last day of that month.

After opening, with or without additives:

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

You should not be given Mannitol 15% Infusion if there are particles floating in the solution or if the unit is damaged in any way.

6. Contents of the pack and other information

What Mannitol 15% Infusion contains

The active substance is mannitol.

The only other ingredient is water for injections.

Each 1000 ml of solution contains 150 grams of mannitol.

What Mannitol 15% Infusion looks like and contents of the pack

Mannitol 15% Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/ polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

100 ml
250 ml
500 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

50 bags of 100 ml
60 bags of 100 ml
30 bags of 250 ml
20 bags of 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

United Kingdom

Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

Ireland

Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht
Netherlands

Manufacturers for Great Britain:

Baxter Healthcare Ltd.
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom

Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium

Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
Ireland

Manufacturers for Ireland:

Baxter S.A.
Boulevard René Branquart, 80
7860 Lessines
Belgium

Bieffe Medital S.A.
Ctra de Biescas-Senegüé
22666 Sabiñánigo (Huesca)
Spain

Vantive Manufacturing Limited
Moneen Road
Castlebar
County Mayo
Ireland

This leaflet was revised in September 2024

For information about Mannitol 15% Infusion or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: +44 (0)1635 206345.

Baxter and Viaflo are trademarks of Baxter International Inc.

SA-30-03-011