Siserup 20 mg/40 mg Tablets

The active ingredient in SISERUP is furosemide. SISERUP is one of a group of medicines called diuretics (water tablets). Your doctor has prescribed SISERUP to treat a condition called oedema where there is too much water in your body. This could be due to problems with your heart, lungs, kidneys, liver, blood vessels or high blood pressure. Furosemide helps your kidneys to get rid of the extra water that is not needed in your body.

Do not take SISERUP

• if you are hypersensitive (allergic) to furosemide, sulphonamides or any of the other ingredients of SISERUP (listed in section 6).
• if you have severe kidney damage which has stopped them working properly and producing urine
• if you are pregnant or may think you are pregnant or planning to get pregnant
• if you are breastfeeding
• if you have very low levels of potassium, sodium or other electrolytes in your blood or low blood volume (your doctor will be able to advise you)
• if you are dehydrated
• if you have low blood pressure
• if you take potassium supplements or potassium sparing diuretics for high blood pressure (e.g. amiloride or spironolactone)
• if you have liver cirrhosis (tiredness, weakness, water retention, feeling or being sick, loss of weight or appetite, yellowing skin or eyes, itch) or liver encephalopathy (confusion, altered levels of consciousness and coma as a result of liver failure)
• if you have Addison’s disease (low levels of corticosteroid hormones secreted)
• if you have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow, fast or irregular heartbeats).

Warnings and precautions

Take special care with SISERUP

Talk to your doctor or pharmacist before taking SISERUP

• if you have low blood volume (hypovolaemia) or are at risk of developing low blood pressure
• if you have low levels of protein in the blood (hypoproteinaemia) as a result of kidney damage
• if you suffer from liver congestion (slowed blood flow through the vessels) or other liver problems
• if you have kidney problems or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage
• if you are elderly, if you are on other medications which can cause the drop of blood pressure and if you have other medical conditions that are risks for the drop of blood pressure
• if you are having prostate trouble or difficulty passing urine or if have had gout
• if you have an abnormal blood condition
• if you are about to undergo any blood or urine tests.

Do not share medicines prescribed for you with any other person. Always take SISERUP exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. The usual starting dose for excess fluid is 20 mg (1 tablet of SISERUP 20 mg) to 80 mg (4 tablets of SISERUP 20 mg or 2 tablets of SISERUP 40 mg) in the morning. Your doctor may decide to increase your dose further if necessary. Six hours after a 40 mg dose (1 tablet of SISERUP 40 mg or 2 tablets of SISERUP 20 mg), 80 mg (2 tablets of SISERUP 40 mg or 4 tablets of SISERUP 20 mg) may be taken and, if necessary, after another six hours, 120 mg (3 tablets of SISERUP 40 mg). After the oedema (e.g., swelling of limbs due to much water in your body) is controlled, maintenance therapy is continued at 20 mg (1 tablet of SISERUP 20 mg) to 40 mg (1 tablet of SISERUP 40 mg) daily. For doses exceeding 120 mg per day (more than 3 tablets of SISERUP 40 mg), it should be taken as 2 or 3 separate doses during the day. The usual dose for the treatment of high blood pressure is 40 mg to 80 mg daily (1 – 2 tablets of SISERUP 40 mg). Your doctor may prescribe another medicine for high blood pressure, to be taken together with SISERUP 40 mg tablet. Forced diuresis (increased excretion of urine e.g., used in management of barbiturate poisoning) 20 mg to 40 mg SISERUP (1 – 2 tablets of SISERUP 20 mg) is given in addition to infusion of electrolyte solution. Further treatment depends on the elimination of urine and must include substitution of the fluid and electrolyte losses. In poisoning with acid or basic substances the elimination rate can be further increased by alkalisation or acidification of the urine, respectively. This treatment will be managed by your doctor. Infants and children under 15 years Children generally receive an oral dose of 2 mg/kg body mass per day in divided doses. This may be titrated to a maximum of 6 mg/kg.

Method of administration

• SISERUP should be taken with a sufficient quantity of liquid (e.g. one glass of water)
• SISERUP should be taken at the same time every day, with or without food.

If you take more SISERUP than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of an overdose include dehydration and changes in the levels of certain chemicals in the blood.

If you forget to take SISERUP

Do not take a double dose to make up for forgotten individual doses.

SISERUP can have side effects. Not all side effects reported for SISERUP are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SISERUP, please consult your health care provider for advice. If any of the following happens, stop taking SISERUP and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe allergic reaction which may include a skin rash, itching, dermatitis, peeling skin, sensitivity to sunlight or sun lamps or fever, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever could be a condition called Stevens-Johnson syndrome.
• Inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have a fever, feel drowsy, or notice swelling e.g. of the ankles.
• Blood clot (causing pain, swelling or tenderness in the legs) These are very serious side effects. If you have them, you may have had a serious reaction to SISERUP You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Dehydration, altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth, weakness, tiredness or drowsiness, restlessness, fits, muscle pain, fatigue or cramps, low blood pressure causing loss of concentration and slowed reactions, difficulty passing water, fast or irregular heart rate and feeling and being sick.
• Low blood volume (hypovolaemia)
• Increased creatinine and blood urea (seen in blood tests)

Less frequent side effects:

• Anaemia causing tiredness, breathlessness, unusual bleeding or bruising
• Changes in the body seen in tests such as levels of cholesterol, glucose, uric acid
• Gout
• Changes in vision including blurred or yellow vision
• Light-headedness, sensations of pressure in the head, headache, drowsiness, weakness, changes in vision, dry mouth, dizziness when standing.
• Irregular heartbeat
• Muscle cramps or weakness
• Changes in the amount or need to urinate
• Tiredness
• Dry mouth, thirst, feeling or being sick, changes in bowel movements including diarrhoea and constipation
• Deafness (sometimes irreversible)
• Changes in blood cells such as amount of white blood cells, reduction of platelets causing a rash fever, sweating, tiredness, and weight loss. Your doctor will perform regular blood tests to ensure no changes have occurred.
• Psychiatric disorder NOC causing delusions, hallucinations, disorganized speech
• Feeling ‘pins and needles’ or tingling sensation
• Confusion, headache, tiredness, generally feeling unwell, fever
• ‘Ringing’ in the ears, loss of hearing usually reversible
• Symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin
• Inflammation of the pancreas causing pains in your abdomen or back and nausea
• Changes in the liver causing yellowing of the skin or whites of the eyes
• Skin rashes
• Involuntary movements of the muscle
• Inflammation or failure of the kidney which may cause back pain or changes in the amount or need to urinate

Side effects with frequency unknown:

• Worsening of conditions where there is already balances of fluid or chemicals in the body
• Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)
• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
• Decreased levels of potassium in the body

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

Reporting of side effects

If you get side effects, talk to your doctor or 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 SISERUP.

Store all medicines out of reach of children. Store at or below 25 °C. Keep blister packs in carton until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).