Osmofundina 10% solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Osmofundina 10% infusion solution

Mannitol

Contents of the leaflet:

What Osmofundina 10% is and what it is used for

What you need to know before using Osmofundina 10%

How to use Osmofundina 10%

Possible side effects

Storage of Osmofundina 10%

Contents of the package and other information

1. What Osmofundina 10% is and what it is used for

Osmofundina is an infusion solution (administered intravenously via a drip) containing mannitol.

It is used mainly:

• to protect the kidneys by maintaining or increasing urine flow.
• to reduce pressure or fluid volume within the skull.
• to increase urine output in cases of poisoning, to facilitate the elimination of toxic substances.
• as a solution used in the treatment of acute glaucoma attacks.

2. What you need to know before using Osmofundina 10%

Do not use Osmofundina:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you have abnormally low urine output.
• if you have severe heart failure.
• if you have fluid accumulation (edema) in the lungs or brain.
• if you have loss or lack of water in the body tissues (dehydration).
• if you have abnormally high levels of electrolytes in body tissues or fluids (hyperosmolarity).
• if you have bleeding in the brain (intracranial hemorrhage).
• if you have difficulty in passing urine (urinary obstruction).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Osmofundina.

Take special care with Osmofundina if you have:

• a blood or fluid transfusion causing an increase in blood volume (hypervolemia).
• abnormally low or no urine output. In such cases, your doctor will perform a perfusion test before treatment.
• exposure to low temperatures, as the mannitol solution may crystallize (see information intended for healthcare professionals).

Your doctor:

• will administer this solution only with caution if you have heart problems.
• will monitor your heart and circulatory condition before and during treatment. They will ensure you have adequate hydration before treatment.
• will monitor levels of mineral salts (electrolytes), water, and acid-base balance. Kidney and heart function will also be monitored.
• will also monitor blood pressure and urine output.

Use of Osmofundina with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In general, concomitant administration of Osmofundina with any medicine that may cause kidney toxicity should be avoided, as it may lead to fluid and electrolyte retention.

It is important that you inform your doctor if you are taking any of the following medicines:

• Cyclosporine, a medicine used to suppress unwanted immune reactions.
• Medicines for the heart such as digoxin.
• Lithium, a medicine used to treat a mental illness.
• Other medicines that increase urine production.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is unknown whether this medicine is excreted in breast milk. Therefore, your doctor will administer this medicine only with special caution.

3. How to use Osmofundina 10%

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

This medicine is administered directly into the bloodstream via intravenous infusion (drip into a vein).

Dosage

Adults and elderly

Your doctor will determine the correct amount of medicine, which will depend on your age, weight, and clinical condition.

As a general guideline, 25 to 100 g/day of mannitol will be administered. Your doctor may administer amounts exceeding 200 g/day if considered necessary.

Children

Your doctor will determine the appropriate dose.

If you use more Osmofundina than you should

It is unlikely that this will occur, as your doctor will ensure you receive the correct amount, and administration will be under medical or nursing supervision.

However, if you were to receive more than the intended amount, this could cause disturbances in the body fluid composition, requiring corrective measures. In severe cases, symptoms such as high blood pressure, heart failure, drowsiness, confusion, decreased level of consciousness, nausea, vomiting, seizures, low blood pressure, increased heart rate, fluid accumulation in the legs, swelling, and kidney function problems may occur. If your blood has a very low pH (acidosis), very high doses of mannitol may cause brain damage.

Corrective measures will be determined by your doctor. The first step will be to immediately stop the infusion. Other measures may include administration of electrolyte-containing fluids (such as sodium, calcium, chlorides, etc.). In severe cases, artificial kidney treatment (hemodialysis) may be necessary.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects depend on the dose received, the clinical condition, and the body's water and electrolyte balance.

The frequency of adverse effects is classified into the following categories:

Frequency not known ( cannot be estimated from the available data):

• Unexpected severe chest pain.
• Seizures.
• Muscle stiffness.
• Excessive blood acidity.
• Very low sodium levels.
• Very high potassium levels.
• Excessive water in the body.
• Anaphylactic shock.
• Very high sodium levels, very low potassium levels, and very low blood water levels due to the production of abnormally high urine output (polyuria).
• Fluid accumulation in the body (overload).
• Difficulty in passing urine (urinary retention, oliguria).
• Skin damage.
• Pain in arms, back pain.
• Tremors.
• Dizziness.
• High urine volume (polyuria).
• Nausea, vomiting.
• Stomach pain.
• Pain or tenderness at injection site.
• Dry mouth or thirst.
• Fever.
• Headache.
• Watery eyes.
• Local allergic reactions which may include red or rashy skin, runny nose or fever, swelling, breathing difficulty, slow heartbeat, or low blood pressure.

This medicine may alter blood pressure and the body's fluid balance.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Osmofundina 10%

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Do not use this medicine if the solution is not clear, if you see particles at the bottom, or if the container shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers. Doing so helps protect the environment.

6. Contents of the container and additional information

Composition of Osmofundin:

• The active substance is mannitol. 100 ml of solution contains 10 g of mannitol.
• The other component is water for injections.

Appearance of the product and contents of the container

Osmofundina is a clear, colourless infusion solution supplied in plastic bottles (Ecoflac Plus) of 250 and 500 ml.

Marketing Authorization Holder and Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona)

This leaflet was last approved in: January 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended exclusively for healthcare professionals:

Single-use containers. Any unused residual contents should be discarded after completion of the infusion.

The infusion solution should be inspected visually before use. The solution must be clear, free from precipitates, and the container must be intact. Do not administer if these conditions are not met.

If crystals appear, immerse the bottle in a water bath at 50 °C until the crystals have redissolved. Infuse the solution only if it is perfectly clear and free from sediments.

The solution should only be used if the container closure is undamaged and the solution is clear.

Use an aseptic technique when administering the solution and when adding medications, if necessary.

Before mixing this solution with other medicinal products, potential incompatibilities must be considered.

Special attention should be paid to the patient's clinical condition and laboratory parameters (electrolytes, fluid and acid-base balance) during the use of this solution.