Mannitol 25 % Injection

The active ingredient, mannitol, belongs to a group of medicines called osmotic diuretics which works by preventing reabsorption of water and sodium.

Mannitol works in the kidneys by enhancing the excretion of sodium, potassium and chloride salts into the urine. These salts draw excess water from the blood into the urine.

MANNITOL 25 % INJECTION FRESENIUS may, for example, be used to:

• Prevent and treat a low output of urine, associated with kidney failure.
• Determine if you have acute oliguria (low urine volume) and to help with glomerular filtration (flow of filtered fluid through the kidney) in low blood pressure.
• Reduce pressure in the brain due to too much fluid retention (cerebral oedema) and in the eyes (intra - ocular oedema).

You should not be given MANNITOL 25 % INJECTION FRESENIUS if you:

• are hypersensitive (allergic) to mannitol
• have kidney disease with established anuria (inability to produce urine), oliguria (reduced urine production) or azotaemia (kidney disease)
• have kidney failure, with no response to a test dose of MANNITOL 25 % INJECTION FRESENIUS
• have swelling and congested lungs (fluid accumulates in the lungs, see section 4)
• have bleeding in the brain, except during craniotomy (the surgical removal of part of the bone from the skull to expose the brain)
• have abnormal weakness of extremely thin blood vessels
• are severely dehydrated (excessive loss of body water)
• have congestive heart failure (heart problems which can cause shortness of breath or ankle swelling)
• also receive whole blood
• have pre-existing plasma hyperosmolarity, a condition in which the blood has high concentrations of salt, sugar and other substances
• have a disturbance of the blood-brain barrier (the network of blood vessels and tissue that helps keep harmful substances from reaching the brain).

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if:

• you have heart, lung and kidney problems (see “You should not be given MANNITOL 25 % INJECTION FRESENIUS if you”)
• you have kidney dysfunction, heart failure or lung congestion (fluid accumulates in the lungs) that is worsening
• you are dehydrated causing high levels of salt and an increase in red blood cells in your blood
• you recently had an operation
• you have excessive fluid intake due to a mental condition (known as psychogenic polydipsia)
• you have high or low levels of potassium in the blood
• you have an acid-base imbalance in the body
• you have a fever (increased body temperature).

The risk for developing low levels of salt in the blood (hyponatraemia) is increased in children, women and elderly people. The risk for developing damage or diseases that affects the brain (encephalopathy) due to low levels of salt in the blood (hyponatraemia) is increased in children, women and patients with low oxygen levels in the blood (hypoxaemia) and diseases of the nervous system.

Other medicines and MANNITOL 25 % INJECTION FRESENIUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your healthcare provider if you are taking any of the following medicines, as they may interact with MANNITOL 25 % INJECTION FRESENIUS:

• Water tablets (diuretics) used for swelling.
• A medicine used to stabilise your mood known as lithium.
• Antibiotics used to treat infections (such as aminoglycosides).
• A medicine used to suppress your immune system known as ciclosporin.
• Heart medicines (such as digoxin).
• Blood thinning medicines used to keep your blood from clotting.

Your doctor will tell you how long your treatment with MANNITOL 25 % INJECTION FRESENIUS will last. If you have the impression that the effect of MANNITOL 25 % INJECTION FRESENIUS is too strong or too weak, tell your doctor or pharmacist. You will not be expected to give yourself MANNITOL 25 % INJECTION FRESENIUS. It will be given to you by a person who is qualified to do so.

MANNITOL 25 % INJECTION FRESENIUS will be injected slowly into a vein. MANNITOL 25 % INJECTION FRESENIUS has to be warmed before use to dissolve crystals. Your doctor will use a filter type administration set for large volumes.

The usual dose to increase output of urine is 50 to 200 g over a 24 hour period of infusion. Your doctor will adjust your dose according to the quantity of urine you produce. Your doctor will use different doses and infusion rates for different types of disorders.

If you receive more MANNITOL 25 % INJECTION FRESENIUS than you should Since a healthcare provider will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of MANNITOL 25 % INJECTION FRESENIUS Since a healthcare provider will administer MANNITOL 25 % INJECTION FRESENIUS, it is unlikely that a dose will be missed.

MANNITOL 25 % INJECTION FRESENIUS can have side effects. Not all side effects reported for MANNITOL 25 % INJECTION FRESENIUS are included in this leaflet. Should your general health worsen or you experience any untoward effects while receiving MANNITOL 25 % INJECTION FRESENIUS, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop administration of MANNITOL 25 % INJECTION FRESENIUS immediately:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to MANNITOL 25 % INJECTION FRESENIUS. You may need urgent medical attention.

Tell your doctor immediately if the following happens:

• If you have difficulty breathing and coughing, as you may have congested lungs (fluid accumulates in the lungs).
• If you have severe headache, nausea and vomiting which may be signs of increased pressure in the brain.
• Changes in the way your heart beats, for example if your heart beats very fast, irregular, slower than usual or if you can feel your heart beating (palpitations) and if you have angina-like chest pains.
• If you produce more or less urine than is normal for you, or if there is traces of blood in your urine.

Tell your doctor if you notice any of the following:

Side effects with unknown frequency

• Fluid and electrolyte imbalance and acidosis (increased acidity in the blood and body tissues). Signs may be dehydration of tissues (excessive loss of body water), rapid breathing, muscle spasms, twitching, convulsions, irregular heartbeat, blood pressure changes, nausea (feeling sick), dry mouth or throat.
• Acute water toxicity if your renal flow is not adequate. Signs may be headache, changes in behaviour, confusion, irritability and drowsiness, shortness of breath and heart failure.
• Reactions at the area of injection: pain, redness, necrosis (dead skin) and thrombophlebitis (swelling and inflammation of a vein caused by a blood clot).
• Dizziness, blurred vision.
• Runny nose, sneezing.
• Dry mouth, thirst, nausea and vomiting.
• Arm pain and cramps.
• Chills and fever.
• Weakness, tiredness and feeling unwell.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects Healthcare providers are asked to report any suspected adverse drug reactions to the Holder of the Certificate of Registration at the following email address: [email protected] and to the relevant medicine’s regulatory authority in the country where the product is marketed. If you get side effects, talk to doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MANNITOL 25 % INJECTION FRESENIUS.

• Store at or below 25 °C.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date stated on the bag.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).