Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

• Keep this leaflet. You may need to read it again before, during or after use of this medicine. 
• If you have any further questions, ask your health care provider. 
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm  them, even if their symptoms are the same as yours. 
• If any of the side effects become serious, or if you notice any side effects not listed in this  leaflet, please inform your health care provider. 

In this leaflet: 

1. What Frusemide Tablet is and what it is used for 
2. What you need to know before you use Frusemide Tablet 
3. How to use Frusemide Tablet 
4. Possible side effects 
5. How to store Frusemide Tablet 
6. Contents of the pack and other information 

WHAT FRUSEMIDE TABLET IS AND WHAT IT IS USED FOR 

Frusemide is one of a group of medicines called diuretics (‘water tablets’). Your doctor  has prescribed Frusemide Tablets 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. Frusemide is also used to treat high blood  pressure. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FRUSEMIDE TABLET  Do not take Frusemide Tablet:  

• If you are allergic to Frusemide, other diuretics or any of the other ingredients of this  medicine.  
• If you are allergic to sulphonamides (drugs used to treat infections, e.g.  Sulphamethoxazole) 
• If you are dehydrated or have lost a lot of blood 
• If you have kidney failure or you are not passing any urine 
• If you have very low levels of potassium in your blood which will make your muscles feel  weak or you may suffer paralysis 
• If you have very low levels of sodium in your blood which may be caused by excessive  sweating, vomiting or reaction to another drug 
• If you are breast feeding 
• If you have liver disease causing symptoms that affect your central nervous system  such as changes in mood, confusion or drowsiness.

Warnings and precautions 

Talk to your doctor or pharmacist before taking Frusemide tablets:  • If you are pregnant or planning to become pregnant 

• If you suffer from prostate trouble  
• If you have difficulty in passing urine 
• If you have diabetes 
• If you have gout 
• If you have low blood pressure or feel dizzy when you stand up 
• If you suffer from porphyria (a genetic or inherited disorder of the red blood pigment haemoglobin). Symptoms include severe stomach, back or thigh pain. Nausea, vomiting  or constipation may also be present along with muscle weakness in arms and legs • If you have kidney problems as a result of liver disease 
• If you are the parent or carer of a premature baby, as your doctor will need to monitor  your child’s kidney function. This is due to the possible formation of kidney stones • If you are elderly, you may be more sensitive to the effects of Frusemide tablets • If you have ever suffered from cramps (electrolyte deficiency, salt imbalance) • If you have low levels of protein in your blood (hypoproteinaemia). This will show in  blood tests 
• If you feel dizzy or dehydrated 
• If you are going to have a glucose test 
• If you are elderly, if you are on other medications which can cause the drop in blood  pressure and if you have other medical conditions that are risks for the drop of blood  pressure. 
• If you have or have ever had systemic lupus erythematosus (sle), a disease of the  immune system which affects skin, bones, joints and internal organs. 

Your doctor will want to monitor you and may take blood for testing while you are taking  this medicine. 

Other medicines and Frusemide Tablets  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any  other medicines.  

• Digoxin used to treat heart failure or an irregular heartbeat; your doctor may need to  change your dose.  
• Drugs to lower blood pressure such as ACE inhibitors, beta-blockers, calcium  channel blockers, alpha-blockers or vasodilators: when taken with Frusemide may  cause your blood pressure to fall too low or affect your heart. Your doctor may need to  change your dose of Frusemide.  
• Antibiotics for infections such as cephalosporins: some antibiotics can affect your  kidneys and Frusemide can make this effect worse.  
• Carbenoxolone, liquorice and sucralfate for stomach ulcers. Your salt balance may  be altered causing your muscles to feel weak while taking carbenoxolone and liquorice. 

Do not take Frusemide within two hours of taking sucralfate as Frusemide will not work  as well.  

• Lithium for depression or mania: as the effect of lithium may be increased. Your doctor  will check your lithium levels and may change your dose.  
• Aspirin and Indometacin non steroidal anti-inflammatory medicines used to relieve  pain and inflammation: Frusemide may increase the side effects of aspirin. Indometacin  (used for treating rheumatism) can reduce the effect of Frusemide.  
• Medicines to control diabetes or high blood pressure: these medicines may not  work as well when taken with Frusemide.  
• Aminoglycosides e.g. gentamycin for serious infections: the risk of side effects from  gentamycin or Frusemide is greater. Your doctor will only give you Frusemide if it is  essential.  
• Aminoglutethimide and Cisplatin to treat cancer: Aminoglutethimide may cause a  decrease of sodium in your blood. Frusemide may increase the side effects of cisplatin;  your doctor may change your dose of Frusemide.  
• Phenytoin to control epilepsy (fits): Frusemide may not work as well.  • Carbamazepine to control epilepsy: it may increase the side effects of Frusemide if  taken together.  
• Corticosteroids used to treat allergic reactions and reduce inflammation (e.g.  hydrocortisone): your salt balance may be altered causing your muscles to feel weak.  • Reboxetine for depression: your salt balance may be altered causing your muscles to  feel weak. 
• Amphotericin for fungal infections: your salt balance may be altered causing your  muscles to feel weak.  
• Laxatives used over a long period of time: your salt balance may be altered causing  your muscles to feel weak.  
• The effects of curare-type muscle relaxants (medicine that is used to relax muscles  during surgery or other procedures) may be increased.  
• Theophylline (to help against breathing difficulties): the effects may be increased.  • Certain treatments for asthma e.g. salmeterol, salbutamol, terbutaline (B2- sympathomimetics) when taken in large amounts: your salt balance may be altered  causing your muscles to feel weak.  
• Probenecid for gout: Frusemide will not work as well or the effect of probenecid may be  increased.  
• Methotrexate for rheumatism or psoriasis: Frusemide will not work as well or the effect  of methotrexate may be increased.  
• Corticotrophin a drug used to treat rheumatoid arthritis.  
• Ciclosporin a drug used following organ transplant to suppress the immune system:  can cause an increased risk of gouty arthritis (painful inflammation of the joints)  • Radiocontrast agents used in x-ray examinations: patients may experience  deterioration in renal function.  
• Metolazone (another diuretic): when taken together with Frusemide can increase the amount of urine you pass which, in turn, could lead to dehydration.

• Other diuretics e.g. amiloride; when taken together with Frusemide your salt balance  may be altered causing your muscles to feel weak.  
• Risperidone: when taken with Frusemide, you may have an increased risk of stroke or  death in elderly people with dementia. 

Pregnancy, breast-feeding and fertility  

Do not take Frusemide if you are pregnant. If you are pregnant or breast feeding, think  you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for  advice before taking this medicine. If you become pregnant while taking Frusemide,  speak to your doctor as they will need to check the growth of your baby. Do not take  Frusemide tablets if you are breast-feeding.  

Driving and using machines  

Do not drive or operate machinery if you feel drowsy, dizzy or have blurred vision after  taking Frusemide.  

Frusemide Tablets contain lactose.  

If you have been told by your doctor that you have an intolerance to some sugars,  contact your doctor before taking this medicinal product. 

3. HOW TO USE FRUSEMIDE TABLET 

Always take Frusemide tablets exactly as your doctor or pharmacist has told you. Check  with your doctor or pharmacist if you are not sure. 

Adults 

• The recommended starting dose is 40 mg of Frusemide once a day or on alternate  days.  
• Your doctor may adjust your dose gradually until you respond. You should NOT adjust  the dose unless instructed to do so by your doctor. 
• In very serious cases your doctor may ask you to take up to a maximum 1,500 mg per  day. 

Elderly 

Your doctor may start you on a lower dose and gradually increase this dose. 

Use in children 

• Your doctor will tell you the exact dose for your child based on your child’s weight. • The recommended dose is between 1–3 mg per kg of your child’s weight. • The maximum dose for children is 40 mg daily. 

Method of administration 

Frusemide tablets are for oral use. 

Swallow the tablets with a drink of water.

If you take more Frusemide Tablets than you should  

If you take more medicine than your doctor has told you to, contact a doctor or your  nearest hospital casualty department immediately and take your Frusemide tablets with  you. Taking too many Frusemide tablets may make you feel confused, unable to focus,  show a lack of emotion or interest in anything. You may also have dizziness, light  headedness, fainting (due to low blood pressure), uneven heartbeat, muscle weakness  or cramps and blood clots (signs include pain and swelling at the part of the body that is affected). You may also have problems with your kidneys or blood.  

If you forget to take Frusemide Tablets  

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 double the amount to make up for a forgotten  dose.  

If you stop taking Frusemide Tablets  

Speak to your doctor before you stop taking Frusemide tablets.  

Blood Tests  

Your doctor may carry out blood tests to check that the levels of some salts in the blood  are at the correct levels.  

If you have any further questions on the use of this medicine, ask your doctor or  pharmacist. 

4. POSSIBLE SIDE EFFECTS 

Like all medicines, this medicine can cause side effects, although not everybody gets  them. These effects are normally mild or moderate and often disappear after a short  time. 

If you have any of the following side effects while taking your medicine tell your  doctor immediately or go to hospital straight away:  

• Severe allergic reaction which may include inflammation of the kidney (nephritis), a red  and lumpy skin rash, severe blistering of the skin, difficulty breathing, swelling of face,  mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the  swelling affects your throat and makes breathing and swallowing difficult, go to hospital  straight away.  
• Purple spotting or unexpected bruising of the skin  
• Increased sensitivity to touch, skin prickling, skin is sensitive to sunlight  • Spasms, muscle twitching and cramps  
• Inflammation of the pancreas which may cause severe pains in your abdomen or back,  nausea, vomiting and fever  
• You notice yellowing of your skin or eyes and 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.

• Swollen kidneys. 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. If symptoms become worse you may start to feel confused or go into a coma.  • Kidney stones in premature babies  
• Inflammation of blood vessels, often with skin rash (vasculitis) 
• You find it hard to urinate. This could be a symptom of acute urinary retention.  • Blood in your urine or pain in your abdomen or groin. This could be a disorder in which  there is excess calcium deposited in the kidneys (nephrocalcinosis).  
• Increased thirst, headache, feeling dizzy or light-headed, fainting, confusion, muscle or  joint pains or weakness, cramps or spasms, stomach upsets 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’.  
• Acute generalised exanthemateous pustulosis “(AGEP)” (acute febrile drug eruption)  (frequency not known)  
• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)  (frequency not known)  
• Deafness (sometimes irreversible) (frequency uncommon)  
• Frusemide can occasionally cause changes in your blood; your doctor will perform  regular blood tests to ensure no changes have occurred. The symptoms of these  changes include anaemia, leading to tiredness or lethargy, unusual bleeding or bruising,  blood slow to clot, ulcers in your throat, mouth or on your skin. Changes in the blood  can make you more likely to catch infections. 

Other effects which may occur: 

• If you have diabetes, this may not be as well controlled 
• Low blood pressure causing light-headedness, headache, dizziness, drowsiness,  weakness, dry mouth or problems with your eyesight 
• If this medicine is used in premature babies during the first weeks of life, it may cause  persistence of a blood channel that normally closes at or around birth (PDA – patent  ductus arteriosus). This may cause heart failure, failure to grow, shortness of breath,  rapid breathing and rapid pulse. 
• Skin reactions such as itching, marks on the skin, flaky or scaly skin • Gout causing pain normally in the joints of your legs 
• Hearing problems or ringing in your ears (tinnitus) 
• Blood clots in the elderly 
• If you have problems urinating Frusemide may make this worse 
• Sickness, vomiting, diarrhoea, or generally feeling unwell. 
• Changes in natural body blood chemicals (sodium, chloride, potassium, calcium,  magnesium, creatinine, urea, uric acid, water, cholesterol, triglycerides, liver enzymes  such as transaminases and reduced glucose tolerance)
• Blood may become more alkaline (metabolic alkalosis) 
• Inform your doctor if you have bone weakness (osteoporosis) 

5. HOW TO STORE FRUSEMIDE TABLET 

• Keep this medicine out of the sight and reach of children. 
• Store below 30°C 
• Do not use Frusemide Tablet after the expiry date which is stated on the carton and label after ‘EXP’. The expiry date refers to the last day of that month. 

6. FURTHER INFORMATION. 

Each Frusemide 20 Tablet contains: Frusemide 20mg 

Each Frusemide 40 Tablet contains: Frusemide 40mg 

What FRUSEMIDE TABLET looks like and contents of the pack 

Frusemide 20mg: 10 x 10 tablets packed in blisters and placed in inner carton with  insert.  

Frusemide 40mg: 10 x 10 tablets packed in blisters and placed in inner carton with  insert.