Mannitol 20% Fresenius

Patient Information Leaflet: User Information

MANNITOL 20% FRESENIUS, 200 mg/ml, Solution for Infusion

Mannitol

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is MANNITOL 20% FRESENIUS and what is it used for
• 2. Important information before using MANNITOL 20% FRESENIUS
• 3. How to use MANNITOL 20% FRESENIUS
• 4. Possible side effects
• 5. How to store MANNITOL 20% FRESENIUS
• 6. Contents of the pack and other information

1. What is MANNITOL 20% FRESENIUS and what is it used for

MANNITOL 20% FRESENIUS is a medicine that increases the amount of urine excreted and moves water from tissues to the vascular space. The medicine reduces intracranial and intraocular pressure. It is administered intravenously.

• Indications for use:
• increased diuresis (increased urine excretion) in the prevention and treatment of oliguria (reduced urine production) in acute renal failure;
• reduction of intracranial pressure and reduction of brain edema;
• reduction of elevated intraocular pressure when it cannot be reduced by other means;
• increased excretion of toxic substances by the urinary system (so-called forced diuresis).

2. Important information before using MANNITOL 20% FRESENIUS

When not to use MANNITOL 20% FRESENIUS:

• if the patient is allergic to mannitol;
• if the patient has advanced renal failure with anuria;
• if the patient has symptoms of pulmonary congestion or pulmonary edema;
• if the patient has intracranial hemorrhage, except for hemorrhages during craniotomy (surgical opening of the skull);
• if the patient is severely dehydrated;
• if the patient develops progressive renal failure with increasing oliguria (significant reduction in urine output) and azotemia (excess nitrogen in the blood) after starting mannitol administration;
• if the patient's heart failure worsens or symptoms of pulmonary congestion increase after starting mannitol administration.

Warnings and precautions

In patients with significant renal function disorders before starting MANNITOL 20% FRESENIUS, the doctor will administer a test dose to check the body's reaction to the medicine.

• During MANNITOL 20% FRESENIUS administration, the doctor will monitor:
• sodium and potassium levels in the blood (whether there is a disturbance in fluid and electrolyte balance);
• hourly diuresis (amount of urine excreted per hour);
• whether hypovolemia (too little blood in the blood vessels) worsens;
• whether congestive heart failure (heart dysfunction characterized by edema in the legs and pulmonary edema) worsens;
• renal function.

The medicine must not be administered intramuscularly or subcutaneously, and not in combination with blood.

MANNITOL 20% FRESENIUS and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

• Caution should be exercised when using the following medicines in combination with MANNITOL 20% FRESENIUS:
• neomycin (an antibiotic used to treat fungal infections) due to the increased risk of hearing loss and kidney damage;
• kanamycin (an antibiotic used to treat infections) due to the risk of hearing loss;
• digitalis glycosides (medicines used to treat heart failure) due to the risk of digitalis toxicity, especially if the patient has low potassium levels in the blood;
• diuretic medicines, as mannitol enhances their effect;
• other diuretic medicines, including carbonic anhydrase inhibitors, as they may enhance the effect of reducing intraocular pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

MANNITOL 20% FRESENIUS has no or negligible influence on the ability to drive and use machines.

3. How to use MANNITOL 20% FRESENIUS

This medicine is administered only by medical personnel. The medicine must not be used by yourself. In case of doubts, consult a doctor.

Using a higher dose of MANNITOL 20% FRESENIUS than recommended

In case of using a higher dose of the medicine, inform your doctor or nurse immediately.

• Rapid administration of a large amount of mannitol may cause:
• excessive increase in fluid volume in the blood vessels;
• heart failure;
• pulmonary edema.

Using higher doses of the medicine than recommended may cause excessive loss of electrolytes, especially sodium, potassium, and chlorides. Low levels of these electrolytes may cause:

• orthostatic hypotension (decrease in blood pressure when changing position from lying to standing);
• tachycardia (rapid, abnormal heart rhythm);
• decrease in central venous pressure (due to too little blood in the blood vessels);
• disorders of nerve conduction and muscle function (muscle paralysis);
• atrophy of the gastrointestinal tract (lack of muscle contraction in the gastrointestinal tract).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

• pulmonary congestion (characteristic crackling in the lungs);
• disturbances in fluid and electrolyte balance;
• acidosis (accumulation of excessive amounts of acidic substances in the blood);
• dry mouth, increased thirst;
• excessive diuresis (excretion of large amounts of urine), urinary retention;
• edema;
• headache, dizziness;
• blurred vision;
• seizures;
• nausea, vomiting, diarrhea;
• rhinitis;
• arm pain;
• skin necrosis;
• thrombophlebitis (formation of inflammation and small blood clots, characterized by palpable hardening of the vein, redness around it, pain, and tenderness);
• chills;
• urticaria (bright red, itchy blisters on the skin);
• dehydration (excessive loss of fluid from the body);
• decrease in blood pressure;
• tachycardia (rapid, abnormal heart rhythm);
• fever;
• chest pain similar to angina (severe pain behind the sternum, radiating to the arms, jaw);
• congestive heart failure (heart dysfunction characterized by edema in the legs and pulmonary edema);
• vein pain and irritation caused by too rapid administration of the medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store MANNITOL 20% FRESENIUS

Store the medicine out of sight and reach of children.

• Store in a temperature below 25°C. Do not freeze.
• The packaging should not be stored and used again after opening. Unused medicine should not be used.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
• Do not use this medicine if you notice contamination, color change, or if the packaging is 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 protect the environment.

6. Contents of the pack and other information

What MANNITOL 20% FRESENIUS contains

• The active substance is mannitol. 1 ml of solution contains 200 mg of mannitol. 1000 ml of solution contains 200 g of mannitol.
• The other ingredient is water for injections.

The osmolality of the solution is 1098 mOsmol/l.

What MANNITOL 20% FRESENIUS looks like and contents of the pack

The medicine is a clear and colorless liquid.

• glass bottle: 100 ml, 250 ml, or 500 ml, and
• glass bottle: 20 x 100 ml, 12 x 250 ml, and 12 x 500 ml, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Manufacturer

Fresenius Kabi Italia S.r.l., Via Camagre 41, 37063 Isola della Scala - Verona, Italy