PATIENT INFORMATION LEAFLET

MANITOL MEIN 20% solution for infusion

Manitol

Read this leaflet carefully before you start using this medicine, because

it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What is MANITOL MEIN 20% and what it is used for

2.What you need to know before starting to use MANITOL MEIN 20%

3.How to use MANITOL MEIN 20%

4.Possible side effects

5.Storage of MANITOL MEIN 20%

6.Contents of the pack and additional information

Manitol Mein 20% belongs to a group of medications called osmotic diuretics, which increase the amount of urine produced by your body.

It is used to eliminate excess fluid from the body in different situations:

-Reduction of the pressure inside the eye (glaucoma) when it cannot be reduced by other means.

-Reduction of the internal pressure of the skull, when the blood-brain barrier is intact, (barrier that separates the nervous system from blood vessels).

-Stimulation of urine production when there are kidney problems and/or fluid accumulation, before irreversible kidney failure is established.

-Intoxications (by toxins that are eliminated by the kidneys).

No use MANITOL MEIN 20%

-If you are allergic to mannitol or any of the other components of this medication (listed in section 6).

-Hypersomolarity (high concentration of salts in the blood).

-If you are unable to urinate or urinate very little due to kidney failure.

-If you have severe heart failure or severe high blood pressure.

-If you are severely dehydrated (have lost a large amount of body fluid, for example due to severe vomiting or diarrhea).

-If you have severe pulmonary congestion or pulmonary edema.

-If you have an active bleeding within the skull (except if it occurs during a skull operation).

-If you have alterations of the blood-brain barrier (barrier that separates the nervous system from the blood vessels).

Warnings and precautions:

-The balance of water and electrolytes may be affected during treatment. Your doctor will perform regular checks of the balance of water and electrolytes, serum osmolarity, and renal function.

-Do not administer mannitol with whole blood.

-Your doctor will evaluate your cardiovascular function before administering mannitol rapidly.

-If your urine production is scarce or nil, precautions should be taken. Your doctor will perform a perfusion test to check if urine is produced. In case of a negative result, do not continue with the perfusion.

-If exposed to low temperatures, the mannitol solution may crystallize (see information for healthcare professionals).

-Your doctor will monitor the functioning of your heart, kidneys, and lungs and interrupt treatment in case of adverse effects.

-Be especially careful if you have congestive heart failure. Accumulation of mannitol may occur if urine production decreases during administration, which can worsen existing congestive heart failure situations.

-Mannitol may mask and intensify the lack of fluids in the body.

The administration of mannitol should always be carried out under strict medical control and should only be used for osmotherapy.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those acquired without a prescription.

Specifically, inform your doctor or pharmacist if you are taking:

-Ciclosporin – used to prevent rejection in transplants, as some studies indicate that it may potentiate renal toxicity.

-Digitalis glycosides – used for the heart, as mannitol may potentiate the toxicity of this type of medication.

-Lithium: mannitol increases its elimination by the kidneys.

-Diuretics: the dose of mannitol should be adjusted when used concurrently with other medications used to eliminate fluids.

Do not administer with whole blood due to the risk of agglutination.

In the absence of compatibility studies, this medication should not be mixed with other medications.

This medication may interfere with laboratory test results, such as the determination of inorganic phosphorus or the determination of ethylene glycol in blood.

Pregnancy and lactation:

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

There are no data, or these are limited, regarding the use of mannitol in pregnant women.

The use of the medication during pregnancy may be considered in cases where it is clinically indicated

Driving and operating machinery:

There is no indication that this medication may affect the ability to drive vehicles or operate complex machinery.

Important information about some of the components of Manitol Mein 20%

This medication contains mannitol, which may result in a positive analytical control for doping.

Manitol Mein 20% will be administered intravenously in a hospital by healthcare professionals. The volume and rate of infusion will depend on your needs. Your doctor will decide what dose you should receive.

If you receive more MANITOL MEIN 20% than you should:

Overdosing manifests as an increase in plasma volume leading to cardiac decompensation, increase in body acidity, water/electrolyte balance alterations, increased osmolarity, cell dehydration, and acute renal insufficiency (especially in cases of additional diuretic administration and pre-existing kidney disorders).

The first signs of overdose may present with headache, nausea, and chills without temperature changes, which can progress to confusion, lethargy, seizures, stupor, and coma.

In the event of any of these effects, immediately stop the medication administration and initiate treatment for the symptoms. Correct the fluid balance and hydroelectrolyte equilibrium.

In case of overdose or accidental ingestion, immediately go to a medical center or call the Toxicological Information Service at tel. 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, MANITOL MEIN 20% may produce adverse effects, although not all people will experience them.

During treatment with mannitol, the following adverse effects may appear, although the frequency has not been established:

-Fluid and electrolyte imbalance with dehydration and loss of potassium salts (loss of fluid and copper salts)

-Pulmonary edema (accumulation of fluid in the lungs)

-Acute renal failure (kidney failure)

-Hypersensitivity reactions (allergic reactions)

-Confusion states

-Cramps

-Tachycardia

-Stomach discomfort

-Nausea and vomiting

The rapid administration of the medication may produce headache, chills, chest pain, and alterations in acid-base and water-electrolyte balance.

The administration of high doses may produce a syndrome similar to water intoxication, elimination of sodium and chloride (salts) through urine, osmotic nephrosis (inflammation of the kidney tubules), and seizures.

Other reactions may also occur due to the solution or administration technique, such as fever, infection at the injection site, venous thrombosis or phlebitis (inflammation of the vein wall), extravasation (passage of fluid to tissues), and hypervolemia (increase in blood volume).

If an undesirable effect appears, mannitol administration should be stopped and appropriate corrective measures established.

If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the solution is not transparent and free of visible precipitates.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

The active principle is mannitol (DCI). Each milliliter of solution contains 100 mg of mannitol. The other components are: water for injection.

Appearance of the product and contents of the package

Mannitol Mein 10% is a transparent and colorless solution, packaged in glass containers. It is available in 250 ml and 500 ml containers.

Holder of the marketing authorization and responsible for manufacturing

FRESENIUS KABI ESPAÑA, S.A.U.

C/ Marina 16 – 18

08005 Barcelona

Fresenius Kabi Italia S.R.L.

Via Camagre, 41/43

37063 Isola della Scala (VR)

Italy

This leaflet was approved in October 2012

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

Mannitol Mein 10% is administered intravenously. The administration schedule will depend on the patient's age, weight, clinical condition, and concomitant therapy. The general dose that is usually administered is 500 – 1000 ml per day, at a rate of 40 – 60 drops / minute.

Reduction of intracranial pressure and reduction of intraocular pressure: 0.25-0.5 g mannitol/kg of body weight (~2.5-5 ml of MANITOL 10%/kg of body weight) in the form of a bolus over a period of 10-30 minutes. Higher doses of mannitol may be necessary.

Daily maximum dose: 1.5 g mannitol/kg of body weight (~15 ml of MANITOL 10%/kg of body weight).

Prevention of acute renal failure (after test perfusion) and stimulation of urine production (diuresis): Test perfusion of 0.15 - 0.25 g mannitol/kg of body weight (~1.5 - 2.5 ml of MANITOL 10%/kg of body weight) in the form of a bolus over a period of 3-5 minutes. If, within the next 3 hours, a diuresis of at least 40 ml/h is achieved, a continuous perfusion of 0.15 - 0.3 g of mannitol/kg of body weight/h (~1.5 - 3 ml of MANITOL 10%/kg of body weight/h) may be administered.

The daily maximum dose should not be exceeded.

If no effect is achieved with the test perfusion, the treatment with mannitol should be discontinued and other measures considered (e.g., dialysis).

Guidelines for correct administration

Use a perfusion system with a filter.

Disinfect the rubber stopper before piercing with the equipment. Do not use started solutions. It is recommended not to add any type of medication to the bottle. Do not use equipment that has already been used and especially not with blood (hemolysis).

The mannitol solution may crystallize, which does not affect the quality of the product. In the event of the presence of crystals in the solution, it is recommended to heat the bottle in a water bath (between 50-70°C) until the crystals are completely dissolved. To prevent the passage into the circulatory system of any small mannitol crystal invisible to the human eye, equipment for infusion with a filter of 12-15 micras may be used. The temperature of the solution to be injected should be ambient.

In the event of excessive perfusion speed or overdose, there is a risk of acute hypervolemia with cardiovascular system involvement.

Maximum perfusion rate:

3 ml/kg of body weight and hour, which corresponds to 0.3 g of mannitol/kg of body weight and hour.

210 ml/70 kg of body weight, which corresponds to 21 g of mannitol/70 kg of body weight

Daily maximum dose:

Approx. 15 ml/kg of body weight, which corresponds to approx. 1.5 g of mannitol/kg of body weight

1,050 ml/70 kg of body weight, which corresponds to 105 g of mannitol/70 kg of body weight

The duration of use is governed by clinical requirements and should be determined by the doctor.

It should not be administered with whole blood due to the risk of agglutination.

In the absence of compatibility studies, this medication should not be mixed with other medications.