OSMOFUNDINE CONCENTRATED 20% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Osmofundina Concentrated 20% Solution for Infusion

Mannitol

Contents of the pack:

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

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

Osmofundina Concentrated is a solution for infusion (which is administered intravenously through a drip) that contains mannitol.

It is used mainly:

• to protect the kidneys by maintaining or increasing urine flow.
• to reduce pressure or fluid volume in the skull.
• to increase urine flow in case of poisoning to facilitate the elimination of toxic substances.
• as a solution for administering treatment in case of an acute glaucoma attack.

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

Do not use OsmofundinaConcentrated:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have abnormally low urine excretion.
• if you have severe heart failure.
• if you have fluid accumulation (edema) in the lungs or brain.
• if you have water loss or scarcity 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 eliminating urine (urinary obstruction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Osmofundina Concentrated.

Be particularly careful with Osmofundina Concentrated if you:

• have a blood transfusion or fluid that produces an increase in blood volume (hypervolemia).
• have abnormally low or no urine elimination. In this case, your doctor will perform a perfusion test before treatment.
• are exposed to low temperatures, the mannitol solution may crystallize (see information for healthcare professionals).

Your doctor:

• will give you this solution with caution if you have heart problems.
• will monitor your heart and circulatory conditions before and during treatment. He will make sure you have enough water before treatment.
• will check the levels of mineral salts (electrolytes), water, and acid-base balance. He will monitor kidney and heart function.
• will also check blood pressure and urine production.

Using Osmofundina Concentrated with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

• Cyclosporine, a medicine used to suppress unwanted immune reactions.
• Heart medicines 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

It is not known whether it is excreted in breast milk. Therefore, your doctor will only administer this medicine with special caution.

3. How to use Osmofundina Concentrated 20%

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

This medicine is administered directly into the blood, through a drip in a vein (infusion).

Dose

Adults and elderly

Your doctor will decide the correct amount of medicine, and this will depend on your age, weight, and clinical situation.

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

Children

Your doctor will decide the dose that can be administered.

If you use more Osmofundina Concentrated than you should

It is unlikely that this will happen, as your doctor will ensure that you receive the correct amount and administration will be under medical or nurse control.

However, if you receive more than you should, this could cause an alteration in the composition of body fluids, which would require correction. In severe cases, symptoms such as high blood pressure, heart failure, drowsiness, confusion, decreased consciousness, nausea, vomiting, convulsions, decreased blood pressure, increased heart rate, fluid accumulation in the legs, swelling, and kidney problems may appear. If your blood has a very low pH (acidosis), high doses of mannitol may damage the brain.

The corrective measures will be determined by your doctor. The first will be to interrupt immediately. Other measures may include administering fluids with electrolytes (such as sodium, calcium, chlorides...). If the disorder is severe, it may be necessary to resort to artificial kidney (hemodialysis)

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects depend on the dose received, the clinical situation, and the balance of water and salts.

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

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

• Sudden severe chest pain.
• Convulsions.
• Muscle stiffness.
• Too much acid in the blood.
• Very low sodium levels.
• Very high potassium levels.
• Too much water in the body.
• Anaphylactic shock.
• Very high sodium levels, very low potassium levels, and very low water level in the blood due to abnormally high urine production (polyuria).
• Fluid accumulation in the body (overload).
• Difficulty eliminating urine (urinary retention, oliguria).
• Skin damage.
• Pain in arms, back pain.
• Tremors.
• Dizziness.
• High urine volumes (polyuria).
• Nausea, vomiting.
• Abdominal pain.
• Pain or sensitivity at the injection site.
• Dry mouth or thirst.
• Fever.
• Headache.
• Watery eyes.
• Local allergic reactions that may include red skin or rash, runny nose or fever, swelling, difficulty breathing, slow heartbeat, or low blood pressure.

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Osmofundina Concentrated 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 which is stated on the carton. The expiry date is the last day of the month stated.

Do not use this medicine if the solution is not clear, if you notice particles at the bottom or if the container is visibly damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Osmofundina Concentrated:

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

Appearance and pack contents

Osmofundina Concentrated is a clear and colorless solution for infusion, which comes in plastic bottles (Ecoflac Plus) of 250 and 500 ml.

Marketing authorisation holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona)

This leaflet was approved in: February 2020

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

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This information is intended only for healthcare professionals:

Single-use containers. Discard any unused contents after completing the infusion.

The infusion solution should be visually inspected before use. The solution must be transparent, not contain precipitates, and the container must be intact. Do not administer otherwise.

Due to its hypertonic nature, it will only be infused intravenously; otherwise, it could cause tissue irritation. The administration of hyperosmotic solutions, such as 20% mannitol, should be performed in large peripheral or central veins. Possible signs of inflammation or infection at the infusion site should be checked daily.

In case of crystal formation, immerse the bottle in a water bath at 50 ºC to redisolve the crystals. Infuse the solution only if it is perfectly clear and does not present sediment.

The solution should only be used if the container closure is not damaged and the solution is clear.

Use an aseptic procedure to administer the solution and the addition of medicines if necessary. Use an infusion system with a filter.

Before mixing the solution with other medicines, possible incompatibilities should be considered.

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