Osmofundina 20% concentrated solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Osmofundina 20% concentrate for infusion solution

Mannitol

Package leaflet contents:

1. What Osmofundina 20% concentrate is and what it is used for
2. What you need to know before using Osmofundina 20% concentrate
3. How to use Osmofundina 20% concentrate
4. Possible side effects
5. Storage of Osmofundina 20% concentrate
6. Contents of the pack and other information

1. What Osmofundina 20% concentrated is and what it is used for

Osmofundina concentrated is an infusion solution (administered intravenously via an infusion set) containing mannitol.

It is mainly used:

• 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 intoxication, to facilitate the elimination of toxic substances.
• as a solution for administering treatment during an acute attack of glaucoma.

2. What you need to know before starting to use Osmofundina 20% concentrated

Do not use Osmofundina concentrated:

• 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 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 passing urine (urinary obstruction).

Warnings and precautions

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

Take special care with Osmofundina concentrated if you have:

• a blood transfusion or infusion of fluids causing an increase in blood volume (hypervolemia).
• abnormally low or absent 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 physicians or healthcare professionals).

Your doctor:

• will administer this solution only with caution if you have heart problems.
• will monitor your heart and circulatory status before and during treatment. They will ensure you are adequately hydrated 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 concentrated 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 concentrated with any medicine that may cause kidney toxicity should be avoided, as it may lead to fluid and electrolyte retention.

It is important to 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 20% concentrate

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 blood through an intravenous infusion (venous drip).

Dosage

Adults and elderly

Your doctor will decide the correct dose of the 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 doses exceeding 200 g/day if considered necessary.

Children

Your doctor will determine the appropriate dose.

If you use more Osmofundina concentrate than you should

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

However, if you receive more than you should, this could cause disturbances in the composition of your body fluids, which would require correction. 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 damage the brain.

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, indicating 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 available data):

• Unexpected, severe chest pain.
• Seizures.
• Muscle stiffness.
• Excessive acidity in the blood.
• 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 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.
• Increased urine volume (polyuria).
• Nausea, vomiting.
• Stomach pain.
• Pain or tenderness at the 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 difficulties, 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 concentrate 20%

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 refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Osmofundina concentrate:

• The active substance is mannitol. 100 ml of solution contains 20 g of mannitol.
• The other components are water for injections.

Appearance of the product and contents of the container

Osmofundina concentrate 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 summary of product characteristics was approved in: February 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency of 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 visually inspected before use. The solution must be transparent, free from precipitates, and the container must be intact. Do not administer if these conditions are not met.

Due to its hypertonic nature, this solution must be administered intravenously only, as otherwise it may cause tissue irritation. The administration of hyperosmotic solutions, such as 20% mannitol, should be carried out via large peripheral or central veins. Possible signs of inflammation or infection at the infusion site should be monitored daily.

If crystals appear, immerse the bottle in a water bath at 50 °C until the crystals redissolve. Infuse the solution only if it is perfectly clear and free of 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. Use an infusion system with a filter.

Before mixing this solution with other medicinal products, potential incompatibilities must be taken into account.

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