Mannitol Bioindustria L.I.M.

Package leaflet: Information for the user

MANNITOLO Bioindustria L.I.M. 5% infusion solution

MANNITOLO Bioindustria L.I.M. 10% infusion solution
MANNITOLO Bioindustria L.I.M. 18% infusion solution
Mannitol
Generic medicine
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What MANNITOLO Bioindustria L.I.M. is and what it is used for
2. What you need to know before using MANNITOLO Bioindustria L.I.M.
3. How to use MANNITOLO Bioindustria L.I.M.
4. Possible side effects
5. How to store MANNITOLO Bioindustria L.I.M.
6. Contents of the pack and other information

1. What MANNITOLO BIOINDUSTRIA L.I.M. is and what it is used for

MANNITOLO Bioindustria L.I.M. contains the active substance mannitol, which belongs to a group of medicines called osmotic diuretics, that facilitate the elimination of excess water from the body.
This medicine is indicated for:

• the prevention and treatment of low urine output (oliguric phase) in cases of severe kidney problems (acute renal failure), before it becomes irreversible and established;
• the treatment of increased pressure (hypertension) in the brain (intracranial, cerebral mass), and in the spinal cord (spinal);
• the reduction of pressure inside the eyes (intraocular);
• increasing the elimination of toxic substances through the kidneys.

2. What you need to know before using MANNITOLO BIOINDUSTRIA L.I.M.

Do not use MANNITOLO BIOINDUSTRIA L.I.M.

• if you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6);
• if you are not producing urine (anuria) due to severe kidney problems (severe renal impairment);
• if you have increased blood in the lungs (pulmonary congestion) or fluid accumulation around the lungs (pulmonary edema);
• if you have bleeding in the brain (cerebral, intracranial hemorrhage);
• if you suffer from severe fluid loss (severe dehydration).

Do not use MANNITOLO Bioindustria L.I.M. mixed with other medicines.
If you require blood transfusions, medical personnel must not administer this medicine through the same catheter as blood, as this may cause serious problems to red blood cells (pseudoagglutination).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using MANNITOLO Bioindustria L.I.M.
This medicine should be administered with caution in the following cases:

• if you suffer from severe heart problems (congestive heart failure) or kidney problems (severe renal failure). In the latter case, your doctor must assess whether you can use this medicine.
• if you experience swelling due to fluid accumulation (edema), poor elimination of fluids and salts (hydrosaline retention), increased levels of acidic substances in the blood (acidosis), or severe fluid loss (marked dehydration);
• if you are taking medicines used to treat inflammation and allergies (corticosteroids) or medicines that stimulate the production of steroid hormones (corticotropins);
• if you are scheduled to receive blood transfusions.

During treatment with MANNITOLO Bioindustria L.I.M., your doctor should monitor:

• fluid, electrolyte, and substance levels in the blood (plasma osmolarity);
• your kidney function to prevent serious complications (irreversible osmotic nephrosis);
• urine output (diuresis) to avoid mannitol accumulation, which could cause serious heart problems (heart failure);
• blood pressure in the brain (cerebral perfusion pressure, above 70 mm Hg).

Children
There are no available data on the use of this medicine in children. However, if necessary, the medicine may be administered to children (see section "Use in children").
Other medicines and MANNITOLO BIOINDUSTRIA L.I.M.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Use caution and inform your doctor if you are taking the following medicines, as mannitol may increase their toxicity:

• aminoglycoside antibiotics, used to treat infections;
• curare agents, used to relax muscles during surgical procedures;
• digoxin, used for heart problems, especially if you have low potassium levels in the blood (hypokalemia).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
This medicine may be administered during pregnancy and breastfeeding only when clearly necessary and under strict medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use MANNITOLO BIOINDUSTRIA L.I.M.

This medicine must be administered to you exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
The dose will be determined by the doctor according to your age, body weight, and health condition.
For intravenous use only.

Adults

Treatment of low urine output (oliguric renal failure)
You will first be given a test dose (200 mg/kg body weight) by infusion over 3–5 minutes. A second test dose may be administered if the response is inadequate.
The usual dose ranges from 50 to 100 g of mannitol, administered at a rate sufficient to promote the excretion of a significant amount of urine (30–50 ml/hour).

Treatment of increased blood pressure in the brain (intracranial pressure) and within the eyes (intraocular pressure)
The recommended dose is 0.5–2 g of mannitol per kg of body weight, administered by infusion over 30–60 minutes.

Increased elimination of toxic substances through the kidneys
In this case, the use of 5% mannitol solution is recommended, administered at a rate sufficient to promote increased urine output (150–500 ml/hour).

Use in children

Treatment of low urine output due to severe kidney problems
The recommended dose is 0.25–2 g of mannitol per kg of body weight (or 60 g/m² body surface area), administered by infusion over 2–6 hours.

Treatment of increased blood pressure in the brain and inside the eye
The recommended dose is 1–2 g of mannitol per kg of body weight (or 30–60 g/m² body surface area).

Use in debilitated patients
In debilitated patients, a reduced dose may be required (500 mg/kg).

If you use more MANNITOLO BIOINDUSTRIA L.I.M. than you should
If an excessive amount of this medicine is administered/infused, stop treatment immediately and contact your doctor or go to the nearest hospital. You will be kept under observation for the onset of any symptoms.

If you forget to use MANNITOLO BIOINDUSTRIA L.I.M.
Do not use a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• allergic reactions (hypersensitivity), skin irritation (urticaria);
• headache (cephalalgia), seizures, feeling faint;
• blurred vision;
• serious heart problems (congestive heart failure), increased heart rate (tachycardia), chest pain (anginal);
• nausea, vomiting, diarrhoea;
• inability of the bladder to empty (urinary retention);
• low blood pressure (hypotension);
• swelling due to fluid accumulation around the lungs (pulmonary edema);
• changes in levels of water, salts and other substances in the blood (electrolyte and acid-base imbalances), reduced levels of sodium in the blood (hyponatremia), dehydration;
• fever, chills, pain and infection at the infusion site, formation of blood clots in veins (venous thrombosis), inflammation of the veins (venous phlebitis), even in areas near the infusion site, tissue damage and death (tissue necrosis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MANNITOLO BIOINDUSTRIA L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP.”. The expiry date refers to the last day of that month.
Store this medicine in the original packaging and in a tightly closed container.
Storage at temperatures below 20°C may cause the formation of precipitates, which dissolve upon warming in hot water. Do not refrigerate or freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What MANNITOLO BIOINDUSTRIA L.I.M. 5% infusion solution contains

• The active substance is mannitol. One litre of solution (1000 ml) contains 50 g of mannitol.
• The other component is water for injections.

What MANNITOLO BIOINDUSTRIA L.I.M. 10% infusion solution contains

• The active substance is mannitol. One litre of solution (1000 ml) contains 100 g of mannitol.
• The other component is water for injections.

What MANNITOLO BIOINDUSTRIA L.I.M. 18% infusion solution contains

• The active substance is mannitol. One litre of solution (1000 ml) contains 180 g of mannitol.
• The other component is water for injections.

Description of the appearance of MANNITOLO BIOINDUSTRIA L.I.M. and contents of the pack
MANNITOLO Bioindustria L.I.M. 5% sterile, pyrogen-free infusion solution: vials of 50, 100,
250, 500 ml; 50 ml in 100 ml vial, 100 ml in 250 ml vial, 250 ml in 500 ml vial.
MANNITOLO Bioindustria L.I.M. 10% sterile, pyrogen-free infusion solution: vials of 50, 100,
250, 500 ml; 50 ml in 100 ml vial, 100 ml in 250 ml vial, 250 ml in 500 ml vial.
MANNITOLO Bioindustria L.I.M. 18% sterile, pyrogen-free infusion solution: vials of 50, 100,
250, 500 ml; 50 ml in 100 ml vial, 100 ml in 250 ml vial, 250 ml in 500 ml vial.
Marketing Authorization Holder and Manufacturer
Bioindustria L.I.M. Laboratorio Italiano Medicinali S.p.A. – Via De Ambrosiis, 2 – Novi Ligure (AL) – Italy

The following information is intended exclusively for physicians or healthcare professionals
Dosage and method of administration
The 5% mannitol solution is isotonic with blood. The 10% and 18% mannitol solutions are
hypertonic with blood and must be administered by intravenous infusion with caution and at a controlled infusion rate; these solutions must not be used unless specifically prescribed. The dose
depends on the patient's age, weight, and clinical condition.
When concomitant blood transfusion is required, mannitol solutions must not be administered through the same infusion catheter used for whole blood due to the possible risk of pseudoagglutination.
Special warnings and precautions for use
The medicinal product must be used with caution in patients with congestive heart failure,
severe renal insufficiency, and conditions associated with edema and hydro-saline retention, acidosis and marked dehydration, as well as in patients receiving corticosteroid and corticotropin therapy.
If administration of the medicinal product is necessary simultaneously with blood transfusion, add 20 mEq of sodium chloride to each litre of mannitol solution.
In patients with severe renal insufficiency, a first and second dose should be administered to test the patient's tolerance.
Shake well before administration. Do not use the medicinal product if the solution is not clear and colourless or if it contains particles. Do not infuse if crystals are present; any precipitate may be dissolved by brief exposure to a temperature of 40–70°C (using a water bath), then allowing the solution to cool before use.
Adopt all standard precautions to maintain sterility before and during intravenous infusion.
Use immediately after opening the container. The container is intended for single, uninterrupted
administration and any residual solution must not be used.
Overdose
In case of accidental excessive infusion, treatment must be discontinued and the patient must be
monitored for the appearance of any signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as required.
Incompatibilities
Do not use as a vehicle for other drugs.
Avoid adding corticotropin hormones, barbiturates, noradrenaline,
metaraminol and suxamethonium, etoposide, aztreonam, filgrastim to the mannitol solution.
Storage
Store in the original packaging and in a tightly closed container. Do not refrigerate or freeze.
Storage at temperatures below 20°C may cause crystalline precipitate formation, which dissolves upon warming in hot water.
For further information, consult the Summary of Product Characteristics.