Mannitol 10% Solution for Infusion BP

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Mannitol 10% Infusion is and what it is used for.
2. What do you need to know before you are given Mannitol 10% Infusion.
3. How you will be given Mannitol 10% Infusion.
4. Possible side effects.
5. How to store Mannitol 10% Infusion.
6. Contents of the pack and other information.

• Allergy to mannitol (which is found naturally in some fruit and vegetables and may be added to some cosmetics, food-stuffs and medicines, during manufacturing). You may have developed sensitivity to this substance, without having received intravenous treatment with mannitol. If you are unsure about this, ask your doctor.
• If you have a high concentration of solutes in your blood (hyperosmolarity).
• Failure of the kidneys to produce urine. If you are receiving medicines which may be harmful to your kidneys (for example, certain antibiotics or anticancer medicines).
• If you are severely dehydrated (a loss of water from the body, e.g. due to vomiting or diarrhoea, profuse sweating or certain medications). Symptoms will include dry mouth and dizziness.
• If you have severe heart disease (heart failure).
• If you have a build up of fluid in the lungs (pulmonary oedema), associated with heart failure.
• If you have bleeding inside the skull (active intracranial bleeding) or if you have some types of recent, severe head injury.

Please tell your doctor if you have, or have had, any of the following medical conditions:

• Kidney disease or poor kidney function.
• If you are receiving medicines which may be harmful to your kidneys (for example, certain antibiotics or anticancer medicines).
• If you are severely dehydrated (a loss of water from the body, e.g. due to vomiting, diarrhoea, profuse sweating or certain medications). Symptoms will include dry mouth and dizziness.
• A low level of sodium (salt) in your blood (hyponatremia).

When monitoring is required, your doctor may want to carry out tests to ensure that your dose is sufficient.

These tests may include:

• How well your heart, lungs and kidneys are working.
• The amount of liquid you are receiving.
• The amount of urine you are producing.
• The blood pressure in the veins returning blood to your heart (central venous pressure).
• The amount of chemicals, such as sodium and potassium, in your blood and urine (electrolytes).
• The acidity of your blood and urine (your acid-base balance).

This solution should not be given through the same needle as a blood transfusion. This can damage the red blood cells or cause them to clump together.

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

The following medicines are known to affect or be affected by Mannitol 10% Infusion. Please tell your doctor if you are taking any of these medicines:

• Diuretics (water tablets, to increase the amount of urine you produce).
• Ciclosporin (used to prevent rejection of a transplant).
• Lithium (used for mental disorders).
• Aminoglycosides (a type of antibiotic).
• Depolarising neuromuscular blocking drugs (drug used during anaesthesia to cause muscle paralysis). These will be controlled by your anaesthetist.
• Oral anticoagulants (medicines to thin the blood, for example warfarin).
• Digoxin (a heart medicine).

You should ask your doctor about what you can eat or drink.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

It is not known whether mannitol could affect your unborn baby or your pregnancy. It is also not known whether mannitol could reach your baby through your breast milk. Your doctor will therefore only give you Mannitol 10% Infusion, during pregnancy or breast-feeding, if it is essential.

Ask your doctor or nurse for advice before driving or using machines.

If you are given too much Mannitol 10% Infusion (over-infusion) or if it is given too fast, this may lead to the following symptoms:

• Too much blood in the blood vessels (hypervolaemia). The symptoms include swelling in the arms and legs (peripheral oedema), difficulty breathing (pulmonary oedema and dyspnea), fluid in the abdomen (ascites), imbalances of the chemicals in your body (electrolytes imbalance) and your blood may become too acid (acidosis).
• Headache.
• Feeling sick (nausea).
• Shivering.
• Confusion.
• Tiredness.
• Fits (seizures) reduced consciousness (stupor) and unconsciousness (coma).
• Kidney failure (acute renal failure).

If you develop any of these symptoms, you must inform your doctor immediately. Your infusion will be stopped and you will be given treatment, depending on the symptoms.

If a medication has been added to Mannitol 10%, you should read the Package Leaflet of the added medicine for a list of possible symptoms.

Your doctor will decide when to stop giving you this infusion.

These may be signs of a very severe or even fatal allergic reaction called anaphylactic shock:

• Difficulty breathing.
• A low blood pressure.
• Swelling of the skin of the face and throat.
• Hives.
• Skin rash.

• An increase in pressure within the skull, causing headaches, feeling sick, being sick, back pain, blurred vision and other changes to your sight, such as difficulty moving your eyes.
• Coma, convulsions, confusion or tiredness (lethargy) due to damage of the central nervous system.
• Heart failure
  • Excess fluid on the lungs, causing shortness of breath,
  • Swelling of ankles, fingers or face, due to build up of fluid in the body,
  • Fatigue and weakness.
• Damage to the kidneys, which might cause difficulty with passing water or a decreased or increased amount of urine being passed.
• Other hypersensitivity infusion reactions include high blood pressure, chills, fever, sweating, cough, painful or stiff muscles, itchy skin, nausea, vomiting, and headache.

You will be given treatment depending on the symptoms.

Other side effects, which you may experience, include:

• Dehydration.
• Dryness of the mouth.
• Thirst.
• Nausea, feeling sick.
• Feeling numbness or tingling.
• Headache.
• Dizziness.
• A rapid or irregular heartbeat.
• Chest pain.
• Bloating, constipation.
• Cramps.
• Blurred vision.
• Runny nose.
• Hives.
• Pain.
• Skin coloration (redness).
• Swelling or fluid accumulation.
• Blisters (may be filled with clear fluid or blood).
• Skin turns dark red, purple, or black.
• Abnormal sensation (tingling, prickling, burning, etc.).
• Numbness or loss of sensation.
• Vomiting.
• Fever.
• Chills.
• The reactions due to administration technique may include swelling, pain, itching, rash or redness at the infusion site or along the path of the vein.
• Escape of the infusion solution into the tissues around the vein. This might cause swelling and pain at the injection site. In severe cases, blood flow will be decreased and the surrounding tissue will be injured.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

The active substance is mannitol.

The only other ingredient is water for injections.

Each 1000 ml of solution contains 100 grams of mannitol.

Mannitol 10% Infusion is a clear solution, free from visible particles. It is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is wrapped in a sealed, protective, outer plastic overpouch.

The bag sizes are:

• 250 ml
• 500 ml

The bags are supplied in cartons. Each carton contains one of the following quantities:

• 30 bags of 250 ml
• 20 bags of 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder :

United Kingdom:

Republic of Ireland:

Manufacturers for Great Britain:

Manufacturers for Ireland: