Mannitol Diaco

Package leaflet: information for the patient

MANNITOL DIACO 5% Solution for infusion, 10% Solution for infusion, 18% Solution for infusion

Generic medicine
Please 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MANNITOL DIACO is and what it is used for
2. What you need to know before receiving MANNITOL DIACO
3. How to receive MANNITOL DIACO
4. Possible side effects
5. How to store MANNITOL DIACO
6. Contents of the pack and other information

1. What MANNITOL DIACO is and what it is used for

MANNITOL DIACO contains the active substance mannitol, which belongs to a class of solutions that promote osmotic diuresis, thereby facilitating the elimination of excess water from the body.
MANNITOL DIACO is indicated:

• in the prevention and/or treatment of the oliguric phase in acute renal failure (a condition characterized by low urine production), before it becomes irreversible and established;
• in the treatment of increased intracranial and spinal pressure and cerebral masses;
• to reduce intraocular pressure;
• to enhance renal excretion of toxic substances.

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking MANNITOLO DIACO

Do not take MANNITOLO DIACO

• If you are allergic to mannitol or to any of the other ingredients of this medicine (listed in section 6).
• If you have absence of urine production (anuria) due to severe kidney impairment.
• If you suffer from pulmonary congestion or pulmonary edema (fluid accumulation in the lungs).
• If you have active cerebral or intracranial hemorrhage.
• If you are severely dehydrated.

During blood transfusions, it is recommended not to administer the medicine through the same infusion catheter as whole blood due to the possible risk of pseudo-agglutination.
It is recommended not to use this medicine as a vehicle for other drugs.
Warnings and precautions
Talk to your doctor or pharmacist before taking MANNITOLO DIACO.
This medicine must be administered to you with great caution

• if you suffer from severe heart problems (congestive heart failure)
• if you suffer from severe renal failure and clinical conditions associated with edema and fluid and salt retention. In cases of severe renal failure, a first and second dose should be used to test patient tolerance
• if you are being treated with corticosteroid or corticotropin medicines.

This medicine must not be administered to you:

• simultaneously with blood transfusion in the same intravenous infusion, due to the risk of pseudo-agglutination. If administration of the medicine is necessary at the same time as a blood transfusion, add 20 mEq of sodium chloride to the medicine for each liter of mannitol solution.

During mannitol administration, monitoring is recommended for:

• fluid balance, electrolytes, and plasma osmolarity (balance of fluids and salt concentration in the blood);
• kidney function to prevent irreversible osmotic nephrosis (kidney cell damage);
• diuresis to avoid accumulation of mannitol, which could lead to heart failure;
• cerebral perfusion pressure, which must always be maintained above 70 mmHg.

Use immediately after opening the container. The container is intended for single and uninterrupted administration, and any remaining solution must not be used.
The solution should be clear, colorless or almost colorless, and free from visible particles. Do not infuse if crystals are present; any precipitate present may be dissolved by brief exposure to a temperature of 40–70°C (using a water bath), then allow to cool before use.
Children
In children, the safety and efficacy of mannitol have not been established.
Other medicines and MANNITOLO DIACO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Mannitol enhances the toxic effects of aminoglycosides.
Mannitol may increase the toxic effects of curare agents and may increase the risk of digoxin toxicity in case hypokalemia occurs.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine must not be used during pregnancy or breastfeeding unless absolutely necessary and under strict medical supervision.
Driving and use of machinery
It does not affect the ability to drive vehicles or operate machinery.
“For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.”

3. How to take MANNITOL DIACO

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
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 should not be used unless specifically prescribed.
The dose depends on the patient's age, weight, and clinical condition.

Adults
Treatment of oliguric renal failure (reduced urinary excretion)
After possible correction of plasma volume, administer a test dose of approximately 200 mg/kg body weight by infusion over 3–5 minutes to induce a diuresis of 30–50 ml/hour for the following 2–3 hours.
A second test dose may be administered if the response is inadequate.
Usual doses of mannitol range from 50 to 100 g, with infusion rates adjusted to achieve a urinary flow of 30–50 ml/hour.

Reduction of intracranial pressure or intraocular pressure
Administer 0.5–2 g of mannitol/kg body weight over 30–60 minutes.

Increase in renal excretion of toxic substances
Administer 5% mannitol solution at an infusion rate sufficient to maintain a urinary flow of 150–500 ml/hour.
In debilitated patients, 500 mg of mannitol/kg body weight may be sufficient.

Incompatibilities with Mannitol DIACO
Avoid adding corticotropin hormones, barbiturates, noradrenaline, metaraminol, suxamethonium, etoposide, aztreonam, or filgrastim to the mannitol solution.
Use immediately after opening the container. The container is intended for single, uninterrupted administration; any remaining solution must not be used.
Shake well before administration. Do not use the medicine if the solution is not clear, colorless or almost colorless, or if it contains particles (see section “Warnings and precautions”).
Observe all standard precautions to maintain sterility before and during intravenous infusion.

Use in children
In children, the safety and efficacy of mannitol have not been established.
Treatment of oliguric renal failure
Administer 0.25–2 g of mannitol/kg body weight or 60 g/m² of body surface area over 2–6 hours.

Reduction of intracranial pressure or intraocular pressure
Administer 1–2 g of mannitol/kg body weight or 30–60 g/m² of body surface area.

If you take more MANNITOL DIACO than you should
In case of accidental overdose by infusion, discontinue treatment immediately and keep the patient under observation for signs and symptoms related to the administered drug, providing appropriate symptomatic and supportive measures as necessary.
In case of accidental ingestion or overdose of Mannitol DIACO, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of Mannitol DIACO, consult your doctor or pharmacist.

If you stop treatment with MANNITOL DIACO
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are the side effects of Mannitol DIACO. There are insufficient data available to establish the frequency of the individual listed effects.

• Hypersensitivity reactions (allergy)
• Urticaria (itching)
• Headache
• Seizures
• Feeling faint
• Blurred vision
• Congestive heart failure
• Tachycardia (rapid heartbeat)
• Anginal pain (chest pain)
• Nausea
• Vomiting
• Diarrhea
• Urinary retention
• Hypotension (low blood pressure)
• Pulmonary edema (fluid in the lungs)
• Electrolyte and acid-base imbalances (imbalance of fluids, salts, and blood acidity)
• Hypernatremia (increased sodium levels in the blood)
• Dehydration (lack of fluids)
• Febrile reactions
• Chills
• Pain and infection at the infusion site
• Venous thrombosis (blood clot formation)
• Phlebitis extending from the infusion site (vein inflammation)
• Tissue necrosis (tissue death)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
http://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 MANNITOL DIACO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the product in its original, unopened packaging, properly stored.
.
Store the medicine in its original packaging and in a tightly closed container.
Do not refrigerate or freeze.
Do not use this medicine if you notice that the solution is not clear, colourless or almost colourless, or if it contains particles (see section "Warnings and precautions").
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MANNITOLO DIACO contains
Mannitolo DIACO 5%

• The active substance is mannitol. 1000 ml contain 50 g of mannitol.
• The other components are: water for injectable preparations. mMol/litre: mannitol 274 Theoretical osmolarity (mOsm/litre) 274 pH: 4.5 - 7.0

Mannitolo DIACO 10%

• The active substance is mannitol. 1000 ml contain 100 g of mannitol.
• The other components are: water for injectable preparations. mMol/litre: mannitol 549 Theoretical osmolarity (mOsm/litre) 549 pH: 4.5 - 7.0

Mannitolo DIACO 18%

• The active substance is mannitol. 1000 ml contain 180 g of mannitol.
• The other components are: water for injectable preparations. mMol/litre: mannitol 988 Theoretical osmolarity (mOsm/litre) 988 pH: 4.5 - 7.0

Description of the appearance of MANNITOLO DIACO and package contents
Infusion solution, sterile and pyrogen-free
Mannitolo DIACO 5%
50 ml vial
100 ml vial
250 ml vial
500 ml vial
1000 ml vial
Mannitolo DIACO 10%
50 ml vial
100 ml vial
250 ml vial
500 ml vial
1000 ml vial
Mannitolo DIACO 18%
50 ml vial
100 ml vial
250 ml vial
500 ml vial
1000 ml vial
Marketing Authorization Holder and Manufacturer
DIACO BIOFARMACEUTICI S.R.L.
Via Flavia n.124 - 34147 - Trieste (Italy)
Manufacturer
S.M. FARMACEUTICI S.R.L.
Via Flavia n.124 - 34147 - Trieste (Italy)