Furobe 40 mg Tablets

FUROBE 40 mg TABLET belongs to a group of medicines called diuretics (water tablets). FUROBE 40 mg TABLET is used to get rid of excess fluid from the body, and in the treatment of high blood pressure. Excess fluid can build up in certain conditions which affect the heart, lungs, kidneys or liver. FUROBE 40 mg TABLET is used to remove that fluid by making you pass more water.

Do not take FUROBE 40 mg TABLET:

• If you are hypersensitive (allergic) to furosemide or any of the other ingredients of LASIX (listed in section 6).
• If you are hypersensitive (allergic) to sulfonamides, such as sulfadiazine or co-trimoxazole.
• If your doctor has told you that you have a low blood volume, low blood pressure or are dehydrated.
• If you have been told by a doctor that you have kidney failure. In some types of kidney failure, it is still acceptable to take LASIX. Your doctor will be able to decide.
• If you have severe liver problems.
• If you are not passing any water (urine).
• If you have low potassium or sodium levels in your blood (determined by a blood test).
• If you are breastfeeding (see “Pregnancy and breastfeeding”).

Do not use FUROBE 40 MG TABLET if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking FUROBE 40 MG TABLET.

Warnings and precautions

Take special care with FUROBE 40 MG TABLET if:

• You have difficulty in passing water (urine).
• You are 65 years of age or older.
• You have liver or kidney problems.
• You have diabetes (high blood sugar).
• You have low blood pressure or feel dizzy when you stand up.
• You are male and you have prostate problems.
• You have gout.
• You feel dizzy or feel dehydrated. This can happen if you have lost a lot of water through being sick, having diarrhoea or passing water very often. It can also happen if you are having trouble drinking or eating, or are sweating excessively, such as during strenuous exercise.
• You are going to have a glucose test.
• You have a condition called lupus erythematosus.

It is recommended to undergo regular monitoring of blood levels for sodium, potassium, kidney function (creatinine levels) while taking FUROBE 40 MG TABLET. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking FUROBE 40 MG TABLET.

Other medicines and FUROBE 40 mg TABLET

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).

The following medicines can affect the way LASIX works and increase the chance of you getting side effects:

• Medicines such as ramipril, enalapril, perindopril (called angiotensin-converting enzyme [ACE] inhibitors) or losartan, candesartan, irbesartan (called angiotensin II receptor antagonists), used to treat high blood pressure. Your doctor may need to change the dose of your medicine or ask you to stop taking it.
• Medicines for high blood pressure or heart problems. Your doctor may need to change the dose of these medicines.
• Medicines used as a general anaesthetic for relaxing your muscles during surgery.
• Medicines for diabetes. These may not work as well when you are taking FUROBE 40 MG TABLET.
• Theophylline (used for wheezing, cough or difficulty in breathing).
• Cisplatin (used to treat some cancers).
• Digoxin (used to treat heart problems). Your doctor may need to change the dose of digoxin.
• Phenytoin (used to treat epilepsy and seizures [fits]).
• Ciclosporin (used to prevent the rejection of organs after a transplant).
• Corticosteroids, such as prednisone (used to treat inflammation).
• Medicines used as injections for x-ray examinations.
• Medicines used for constipation (laxatives) if used for a long time, such as bisacodyl or senna.
• Other water tablets (diuretics) such as hydrochlorothiazide. Your doctor may need to change the dose of your FUROBE 40 MG TABLET.
• Chloral hydrate (used as a sedative and for insomnia).
• Risperidone (used to treat schizophrenia and bipolar disease).
• Medicines that have a poisonous effect on the kidneys.
• Liquorice, often used in cough medicines if taken in large amounts.
• Probenecid (used to treat gout), as it may reduce the effect of FUROBE 40 MG TABLET.
• Levothyroxine (used to treat an underactive thyroid gland).
• Aliskiren (used to treat high blood pressure).
• Methotrexate (used to treat autoimmune diseases, rheumatoid arthritis and some cancers).

Do not share medicines prescribed for you with any other person. Always take FUROBE 40 mg TABLET exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure.

The usual starting dose for excess fluid is 40 mg in the morning, but this may be reduced to 20 mg daily for maintenance. Your doctor may decide to increase your dose further if necessary. For doses exceeding 120 mg per day, 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. Your doctor may prescribe another medicine for high blood pressure, to be taken together with FUROBE 40 mg TABLET.

Children's dosages are usually in 1 to 3 mg per kg body weight. A maximum dose of 120 mg should not be exceeded.

Taking FUROBE 40 mg TABLET with food and drink: FUROBE 40 mg TABLET should be taken in the morning with or without food. Your doctor will tell you how long your treatment with FUROBE 40 mg TABLET will last.

If you have the impression that the effect of FUROBE 40 mg TABLET is too strong or too weak, talk to your doctor or pharmacist.

If you take more FUROBE 40 mg TABLET than you should: If you take an overdose, fluid, electrolyte depletion and dehydration are the most common symptoms. The treatment for overdose is water and electrolyte replacement in accordance with urine output. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control center.

If you forget to take FUROBE 40 mg TABLET: If you forget to take a dose, take another as soon as you remember. Then take your next dose at the normal time. Do not take a double dose to make up for forgotten individual doses.

FUROBE 40 mg TABLET can have side effects. Not all side effects reported for FUROBE 40 mg TABLET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FUROBE 40 mg TABLET, please consult your health care provider for advice.

If any of the following happen, you should stop taking FUROBE 40 mg TABLET and tell your doctor immediately or go to the casualty department at your nearest hospital:

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

These are very serious side effects. If you have them, you may have had a serious allergic reaction or other type of reaction to FUROBE 40 mg TABLET. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Severe pain in your stomach area radiating to your back. This could be a sign of pancreatitis.
• Severe skin and mucous membrane reactions, for example with blisters or skin detachment (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis [AGEP] [acute febrile drug eruption], drug eruption with eosinophilia and systemic symptoms); lichenoid reactions that manifest as small, itchy, reddish-purple, uneven changes to the skin, genitals or in the mouth.
• Unexplained bleeding, bruising more easily, frequent infections (including fever, severe chills, sore throat), or feeling weaker or more tired than usual. LASIX can affect the number of blood cells, causing serious blood problems.
• Increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or joint pains or weakness, cramps or spasms, stomach upset or uneven heartbeats. These could be signs of dehydration or changes in your normal body chemicals. Severe dehydration can lead to blood clots or gout.
• Yellowing of your skin or eyes, or your urine becomes darker in colour. These could be signs of a liver problem. In patients who already have liver problems, a more serious liver problem known as liver encephalopathy may occur. Symptoms include forgetfulness, fits, mood changes and coma.
• Kidney failure (drowsiness, shortness of breath, fatigue, confusion, nausea, fits, passing less urine than is normal for you).
• Embolism (difficulty breathing, chest pains, light-headedness, dizziness, numbness, confusion, difficulty walking or talking, fast heartbeat, sweating, feeling anxious, coughing up blood or pink, foamy mucus).
• Kidney problems and difficulty passing urine.

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:
• Too low levels of sodium in your blood (shortness of breath, headache, dizziness, confusion, coma).
• Too low levels of potassium in your blood (abnormal or slow heart rate, low blood pressure, cramps, weakness).
• LASIX can decrease the levels of chloride in your blood.
• LASIX can increase the levels of creatinine in your blood.
• Feeling dizzy or light-headed when standing up quickly from a lying or sitting position. This could be due to low blood pressure.
• An increase in the volume of urine you produce.
• Increased uric acid levels, which may cause gout attacks (warmth, pain swelling in a joint, usually the big toe).
• Less frequent side effects:
• If you have diabetes, you may be less able to control the levels of glucose in your blood.
• Dry mouth.
• Tingling or numbness of your hands and feet (pins and needles).
• Problems hearing or ringing in your ears (tinnitus). This especially affects people who already have problems with their kidneys.
• Deafness, which could be permanent.
• Feeling sick (nausea), being sick (vomiting) and diarrhoea.
• Erythema multiforme (red, often itchy spots, which starts on the limbs and sometimes spreads to the face and the rest of the body, the spots may blister or may progress to form raised, red, pale-centred marks, other symptoms include fever, sore throat, headache and/or diarrhoea).
• Purple spots on your skin caused by bleeding from small blood vessels.
• Increased sensitivity of your skin to the sun.
• Fever.
• Vasculitis (inflammation of your blood vessels, causing fever, general aches and pains, night sweats, headache, fatigue and weight loss).
• Frequency unknown side effects:
• Blood clotting problems (pain, swelling and tenderness in one of your legs, warm skin in the area of the clot, red skin).
• Worsening of systemic lupus erythematosus.
• Decreased levels of calcium or magnesium in your blood (muscle weakness, muscle tightness, tremors, or twitches, irritability or insomnia, numbness and tingling, severe drowsiness, fatigue, and confusion, fast or irregular heart rate, seizures).
• Unusual muscle movements, such as jerking, twitching or muscle spasm, muscle cramps.
• Muscle injury resulting in muscle pain in your shoulders, thighs, or lower back.
• Vertigo (spinning sensation or loss of balance), visual impairment, feeling pressure in your head.
• People with bladder and prostate problems may notice urine retention (your bladder does not empty all the way).
• Headache, dizziness and fainting.

Blood tests: LASIX can change the levels of liver enzymes or body fats known as cholesterol and triglycerides. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of suspected adverse reactions: If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who umc.org) found on SAHPRA website. Suspected adverse reactions can also be reported directly to the HCR via email: [email protected] or tel: +27(0) 12 643 2000. By reporting side effects, you can help provide more information on the safety of Furobe 40 Tablets.

Store in a cool place at or below 25 ºC. Protect from light. Store all medicines out of reach of children. Do not store in bathrooms in order to protect from light. Do not take the medicine after the expiry date stated on the Label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).