Frusemide 20 mg/2 ml

The active ingredient, furosemide, belongs to a group of medicines called diuretics. It works in your kidneys to increase the amount of urine produced. FRUSEMIDE 20 mg/2 ml FRESENIUS may be used to treat swelling of the ankles, feet, legs, brain, heart or lungs.

You should not be administered FRUSEMIDE 20 mg/2 ml FRESENIUS:

• if you are hypersensitive (allergic) to furosemide, sulphonamides or any of the other ingredients of FRUSEMIDE 20 mg/2 ml FRESENIUS (see 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).

You will not be expected to give yourself FRUSEMIDE 20 mg/2 ml FRESENIUS. It will be given to you by a person who is qualified to do so. FRUSEMIDE 20 mg/2 ml FRESENIUS is normally administered in hospital, by a doctor or healthcare provider. Your doctor will tell you how long your treatment with FRUSEMIDE 20 mg/2 ml FRESENIUS will last. Your doctor will decide what dose you should be given and how many times the dose must be repeated. FRUSEMIDE 20 mg/2 ml FRESENIUS is normally given into a vein (intravenously) or into a muscle (intramuscularly).

FRUSEMIDE 20 mg/2 ml FRESENIUS can have side effects. Not all side effects reported for FRUSEMIDE 20 mg/2 ml FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while being given FRUSEMIDE 20 mg/2 ml FRESENIUS, please consult your doctor, pharmacist or other healthcare provider for advice. If any of the following happens, stop receiving FRUSEMIDE 20 mg/2 ml FRESENIUS and tell your doctor immediately:

• swelling of the hands, feet, ankles, face, lips and 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 FRUSEMIDE 20 mg/2 ml FRESENIUS. You may need urgent medical attention. Tell your doctor immediately if you notice 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 (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).

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:

• skin rash and sensitivity to light (photosensitivity)
• gout attacks (aching or swollen joints), an abnormally high level of uric acid in the blood (hyperuricaemia)
• headache, paraesthesia (feeling of tingling, burning or numbness of the skin with no apparent reason), fainting
• high blood sugar
• high levels of sugar in your urine (glycosuria) which is characterised by extreme hunger, extreme thirst or dehydration, accidental urination or more frequent urination
• passing urine more often than normal (leading to an excessive depletion of body fluids and calcium)
• hypovolaemia (when the liquid portion of your blood (plasma) is too low, caused by vomiting, diarrhoea or excessive bleeding), dehydration (especially if your are elderly, characterised by increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or joint pains or weakness, cramps or spasms, stomach upsets or uneven heartbeats)
• dizziness, headache, paraesthesia (an abnormal sensation, typically tingling or prickling), syncope (loss of consciousness caused by a fall in blood pressure)
• low blood pressure which may cause dizziness when standing up
• bone marrow depression (a decrease in bone marrow activity, resulting in reduced production of blood cells)
• serious blood problems (characterised by bruising more easily or bleeding, getting more infections (e.g. sore throat, mouth ulcers, fever), feeling weak or tired more than usually).

Frequency not known:

• blurred or yellow vision
• hearing problems, such as deafness or ringing in the ears
• muscle pain and cramps or spasms
• nausea (feeling sick), vomiting, diarrhoea
• tiredness, irritated skin, pain at the injection site and fever
• stomach pain, nausea and vomiting (pancreatitis)
• a heart defect in premature babies found in the days or weeks after birth (patent ductus arteriosus)
• inflammation of blood vessels (vasculitis)
• difficulty urinating and completely emptying your bladder (if you have a bladder emptying disorder, an enlarged prostate gland or restricted urinary flow)
• low levels of thiamine (vitamin B1) (characterised by loss of appetite, weakness, pain in the limbs, shortness of breath and swollen feet or legs)
• high levels of cholesterol or triglycerides (fats) in your blood.

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

Reporting of side effects: Health care 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 your doctor, pharmacist or nurse. You can also report side effects via the 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 FRUSEMIDE 20 mg/2 ml FRESENIUS.

• Store all medicines out of reach of children.
• Store in the original outer packaging at or below 30 °C, protected from light.