Leaflet: information for the user

Osmofundina concentrated 20% solution for perfusion

Manitol

Osmofundina Concentrada is a perfusion solution (administered intravenously via a drip) that contains mannitol.

It is mainly used:

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

Do not use Osmofundina concentrated:

• if you are allergic to the active ingredient or any of the other components of this medication (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 tissues or bodily fluids (hyperosmolality).
• if you have bleeding in the brain (intracranial hemorrhage).
• if you have difficulty urinating (urinary obstruction).

Warnings and precautions

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

Be especially careful with Osmofundina concentrated if you have:

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

Your doctor:

• will give you this solution only with caution if you have heart problems.
• will monitor your heart and circulatory conditions before and during treatment. They will ensure you have enough water before treatment.
• will control your electrolyte levels, water balance, and acid-base balance. They will monitor kidney and heart function.
• will also monitor your blood pressure and urine production.

Using Osmofundina concentrated with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Generally, co-administration of Osmofundina concentrated with any medication that may cause kidney toxicity should be avoided, as it may cause fluid and electrolyte retention.

It is essential to inform your doctor if you use any of the following medications:

-Ciclosporina, a medication used to suppress unwanted immune reactions.

-Heart medications such as digoxin.

-Lithium, a medication used to treat a mental disorder.

-Other medications that increase urine production.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The excretion of this medication in breast milk is unknown. Therefore, your doctor will only administer this medication with special caution.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This medication is administered directly into the blood, via intravenous infusion.

Dosage

Adults and elderly

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

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 on the dose that can be administered.

If you use more Osmofundina Concentrate than you should

This is unlikely to happen, as your doctor will ensure that you receive the correct amount and administration will be done under the doctor's or nurse's supervision.

However, if you receive more than the intended amount, this could cause an alteration 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 consciousness, nausea, vomiting, seizures, decreased blood pressure, increased heart rate, fluid accumulation in the legs, swelling, and kidney function problems may appear. If your blood has a very low pH (acidosis), high doses of mannitol may damage the brain.

Your doctor will determine the corrective measures. The first step will be to stop immediately. Other measures may include administering fluids with electrolytes (such as sodium, calcium, and chloride). If the condition is severe, it may be necessary to use artificial kidney treatment (hemodialysis).

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

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

Like all medications, this medication may produce adverse effects, although not everyone may experience them.

Adverse effects depend on the dose received, the clinical situation, and the balance of water and electrolytes.

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

Unknown frequency (cannot be estimated from available data):

• Intense 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 water levels in the blood due to the formation of abnormally high urine levels (polyuria).
• Fluid accumulation in the body (overload).
• Difficulty in urination (urinary retention, oliguria).
• Skin damage.
• Arm pain, 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.
• Runny eyes.
• Local allergic reactions that may include, red skin or rash, runny nose or fever, swelling, difficulty breathing, slow heart rate, or low blood pressure.

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

If you consider any of the adverse effects you are experiencing to be severe or appreciate any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Reporting

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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Osmofundina Concentrate:

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

Appearance of the product and contents of the package

Osmofundina Concentrate is a clear and colorless solution for perfusion that is presented in plastic flasks (Ecoflac Plus) of 250 and 500 ml.

Holder of the marketing authorization and responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 Rubí (Barcelona)

This leaflet was approved in: February 2020

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for medical professionals or healthcare professionals:

Single-use containers. Dispose of any unused content after completing the perfusion.

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

Due to its hypertonic nature, it should only be infused intravenously,otherwise it could cause irritation to tissues. Administration of hypertonic solutions, such as mannitol 20%, should be performed in peripheral or central large veins. Daily monitoring of possible signs of inflammation or infection at the perfusion site is recommended.

In case crystals appear, submerge the flask in a water bath at 50 °C to redisolve the crystals. Infuse the solution only if it is perfectly clear and does not present sediments.

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 add medications if necessary. Use a perfusion system with a filter.

Before mixing the solution with other medications, consider possible incompatibilities.

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