Hyfuta 20 mg/2 ml Solution

The active substance is furosemide. HYFUTA belongs to a group of medicines called diuretics. It works in your kidneys to increase the amount of urine produced. HYFUTA may be used to treat swelling of the ankles, feet, legs, brain, heart or lungs.

HYFUTA should not be administered to you:

• If you are hypersensitive or (allergic) to HYFUTA or any of the other ingredients of HYFUTA (listed in section 6).
• if you have increased uraemia (high levels of waste products, normally excreted in the urine) and oliguria (urinate less than usual) during treatment of severe progressive kidney disease
• if your kidneys are failing or have stopped working due to liver coma
• if you have low levels of potassium or sodium salts or an imbalance of chemicals in your blood (shown in a blood test)
• if your blood volume is low (you may feel dizzy or faint or have pale skin) or if you are dehydrated
• if you have low blood pressure (dizziness or light - headedness)
• if you are unable to pass urine (anuria)
• if you previously received certain medicines that have damaged your kidneys or liver
• if you have severe liver problems (cirrhosis), affecting your consciousness
• if you have Addison’s disease (a hormonal disorder causing you not to make enough cortisol and other hormones in your adrenal glands)
• if you have too much calcium in your blood
• if you are breastfeeding your baby (see section 4.6).

Warnings and precautions

Special care should be taken with HYFUTA. Tell your doctor or healthcare provider:

• if you have kidney problems or difficulty passing urine (for example caused by a large prostate gland)
• if you have low blood pressure (hypotension)
• if you have liver problems
• if you have diabetes
• if you have gout
• if you have adrenal disease
• if you have heart failure
• if you are elderly you may be more liable to electrolyte deficiency. Your sodium and potassium levels must be regularly monitored and corrected if necessary by supplements and a potassium rich diet. Calcium and magnesium levels should also be monitored.
• if you are dehydrated
• if you are taking medicines such as cardiac glycosides or steroids
• if you are an elderly person who also takes risperidone
• if you are on a low sodium diet, as you may lose too much water and get low blood pressure.
• if you experience ringing in the ears or hearing loss

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself HYFUTA. It will be given to you by a person who is qualified to do so. Your doctor will work out your dose of HYFUTA to be given and how many times the dose must be repeated.

HYFUTA is normally given into a vein (intravenously) or into a muscle (intramuscularly).

If you receive more HYFUTA than you should

Since your health care provider will administer HYFUTA, he/she will control the dosage. However, in the event of an overdosage your doctor will manage the overdosage.

HYFUTA can have side effects. Not all side effects reported for HYFUTA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving HYFUTA, please consult your health care provider for advice.

If any of the following happens, stop taking HYFUTA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• ‘swelling of the ankles or legs, face, lip, tongue, or throat, 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 HYFUTA. You may need urgent medical attention or hospitalization.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• yellowing of the eyes or skin, stomach pain, nausea; dark coloured urine; these may be signs of jaundice or inflammation of the pancreas
• pain on the kidneys, blood in the urine and fever
• change in the way your heart beats, for example, if it starts beating faster or slower
• severe skin conditions such as bullous lesion, acute generalised exanthematous pustulosis
• acute generalised exanthematous pustulosis (AGEP) and drug rash with eosinophilia syndrome (characterised by severe allergic reaction, accompanied by fever and blisters on the skin, peeling of the skin and tiny spots from bleeding in the skin).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• lack of energy, drowsiness, weakness, muscle cramps, restlessness, dehydration, dry mouth and thirst – these may be signs of a disturbance in the balance of electrolytes (salts) in your blood
• metabolic acidosis (characterised by chest pain, irregular heartbeat, nausea, vomiting or unusual weakness/tiredness).

Less frequent side effects:

• elevated quantity of cholesterol in your blood
• insomnia (difficulty sleeping)
• heart complaints e.g., irregular heartbeat and heart failure
• headache, dizziness
• cough
• constipation
• low blood pressure
• vomiting
• abnormal functioning of your kidney
• rash
• itching
• back pain

• Store in a refrigerator (2 °C to 8 °C). Do not freeze the reconstituted and diluted solution.

• Store all medicines out of reach of children.

• Protect from light.

• Keep the vial in the outer carton until required for use.

• The reconstituted final medicines solution is stable for 24 hours at ambient room temperature at or below 25 °C (77 °F), must be refrigerated at 2 °C to 8 °C (36 °F to 46 °F).

• Do not store in a bathroom.

• Do not use after the expiry date stated on the label / carton / vial.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

For single use only. Discard any unused contents.