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Package Leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Furosemide belongs to a group of drugs called diuretics. Water, sodium, potassium and waste products are filtered out of the bloodstream in the kidney. Most of the water and filtered salts are subsequently reabsorbed by the bloodstream. Furosemide blocks the movement of sodium back into the bloodstream, thereby preventing the re-absorption of water, causing you to pass more urine than you usually do.

Furosemide is used to treat oedema (fluid retention) caused by heart failure, and certain liver and kidney disorders. It is also used to manage a condition called oliguria, where the body produces abnormally small amount of urine, due to kidney disease.

Do not take Furosemide if you:

•    Are allergic to or have ever suffered an allergic reaction to furosemide, other diuretics or sulphonamide related drugs (e.g. sulphamethoxazole)

•    Have severe kidney damage which has stopped them working properly or producing urine

•    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)

•    Are dehydrated

•    Have low blood pressure

•    Are taking potassium supplements or potassium sparing diuretics for high blood pressure (e.g. amiloride or spironolactone)

•    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).

•    Have digitalis poisoning

•    Have Addison’s disease (a condition where low levels of corticosteroids are secreted)

•    Are breast-feeding

•    Are allergic to any of the other ingredients listed in section 6, Contents of pack and other Information.

Warnings and precautions

Talk to you doctor or pharmacist before taking Furosemide if you:

•    have low blood pressure or low blood volume (hypovolemia)

•    suffer from prostate trouble, have an enlarged prostate or have difficulty in passing urine

•    suffer from gout or diabetes (if you are taking insulin your doctor may need to adjust your insulin dosage)

•    are an elderly patient

•    have liver congestion (slowed blood flow through the vessels) or other liver or kidney problems

•    have an abnormal blood condition

•    have low levels of protein in the blood (hypoproteinaemia). The signs of this may include swelling, feeling sick (nausea) or being sick (vomiting), diarrhoea and stomach pain.

•    have brain disorders affecting your nervous system, or a condition called porphyria. This is a disorder that can cause skin blisters, pain in and around the stomach area (abdomen)

•    are about to undergo any blood or urine tests

You should visit your doctor regularly while you are taking this medicine, as he/she may

wish to carry out some tests.

Other medicines and Furosemide:

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

medicines, including medicines obtained without a prescription. Especially:

•    Medicines used to treat high blood pressure, such as ACE inhibitors, alpha blockers (e.g. Prazosin), beta blockers, calcium channel blockers, angiotensin II receptor blockers, diuretics and rennin inhibitors (e.g. aliskiren).

•    Medicines used to treat an irregular heartbeat, such as amiodarone, disopyramide, flecainide, sotalol, lidocaine, tocainide, mexiletine and digoxin.

•    Other diuretics including metolazone, acetazolamide and thiazide diuretics

•    Colestyramine or colestipol for high cholesterol can cause reduced absorption of furosemide and should be administered 2 to 3 hours apart from furosemide.

•    Antibiotic medicines for infections that affect your ears or kidneys (e.g. cefaclor, colistin, gentamicin, vancomycin, lymecycline, cefaloridine)

•    Moxisylte for Raynaud’s syndrome or other vasodilators such as hydralazine

•    Drugs used to treat other mental illness such as lithium, amisulpride, sertindole and pimozide

•    Carbamazepine, phenobarbital and phenytoin, drugs used to treat epilepsy

•    Baclofen or tizanidine, used to treat muscle spasm

•    Nitrates for angina

•    Tacrolimus, used to reduce the risk of organ rejection after an organ transplant

•    Drugs used to treat attention deficit hyperactivity disorder (ADHD)

•    Anti-anxiety medications and hypnotics such as choral hydrate and triclofos which can be used to treat insomnia

•    ACTH/Corticosteroids, used to reduce inflammation (e.g. hydrocortisone)

•    Antihistamines, used to treat allergic reactions

•    Medicines used to treat diabetes (anti-diabetics) e.g. insulin, metformin and sulphonylureas

•    Oral contraceptives (both oestrogen and progesterone containing contraceptives)

•    Non steroidal anti-inflammatory medicines used to relieve pain and inflammation (e.g. ibuprofen, naproxen, indometacin and ketorolac)

•    Salicylates such as aspirin for pain

•    Theophylline, salbultamol, bambuterol, salmeterol, terbutaline and other inhalers used to treat asthma

•    Cisplatin, or other drugs used to treat cancer

•    Levodopa, for Parkinson’s disease

•    Alprostadil for erectile dysfunction

•    Methotrexate, used to treat cancer and also for psoriasis and rheumatoid arthritis

•    Probenecid, a treatment for gout

•    Carbenoxolone, used to treat stomach ulcers

•    Laxatives

•    Medicines or food containing liquorice

•    Some drugs used to treat viral infection, such as nelfinavir, ritonavir or saquinavir

•    Amphotericin B, a medicine used to treat fungal infections

•    If you are about to undergo a procedure where curariform muscle relaxants (e.g. vercuronium) or anaesthetics may be used, tell your anaesthetist/dentist or healthcare professional

•    Aldesleukin, a drug used to treat kidney cancer.

•    Sucralfate, a drug used to treat ulcers and other stomach problems can cause reduced absorption of furosemide and should be administered at least 2 hours apart from furosemide. Antidepressants e.g. Monoamine oxidase inhibitors (MAOIs) such as phenelzine, Tricyclic antidepressants such as amitriptyline, clomipramine, imipramine and nortriptyline. Selective noradrenaline re-uptake inhibitors like reboxetine

Please tell your doctor or pharmacist if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription.

Furosemide with alcohol

Taking furosemide with alcohol may cause low blood pressure.

Pregnancy and breast-feeding

DO NOT take this medicine if you are pregnant or likely to become pregnant, or if you are breast-feeding.

Driving and using machines

As this medicine may reduce mental alertness and cause dizziness, you should not drive or operate machinery until you know how the drug affects you.

Important information about one of the ingredients in your medicine

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

Always take your medicine as directed by your doctor. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.

Adults and children over 12 years

Water retention: The usual starting dose is 40mg in the morning, then 20mg daily or 40mg on alternate days. Up to 80mg a day may be given.

High blood pressure: 20-40mg twice a day.

Elderly: You may be given a lower dose to start.

If necessary, your doctor may adjust the dose to suit your individual requirements.

You should NOT adjust the dose unless instructed to do so by your doctor.

Children under 12 years

Your doctor will tell you the exact dose for your child based on your child’s weight.

The usual dose is between 1 to 3 mg per kilogram of your child’s body weight.

The maximum dose for children is 40mg daily.

Dose adjustment may be required

Your doctor may adjust your dosage if you have a low level of protein in the blood (hypoproteinaemia) or problems with your liver.

How to take your tablets

You should take your tablets in the morning, unless instructed otherwise by your doctor.

Swallow the tablets with a drink of water.

If you forget to take Furosemide

If you forget to take a dose, take it as soon as you remember unless it is nearly time to take the next dose. Never take a double dose to make up for the one you have missed.

If you take more Furosemide than you should

If you or anybody else has taken too many tablets you should contact your nearest hospital casualty department or your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Furosemide tablets can cause side effects, although not everybody gets them.

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 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

•    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)

• Aplastic anaemia- shortage of one or more types of blood cells (Symptoms include fatigue, shortness of breath with exertion, rapid or irregular heart rate, pale skin, frequent or prolonged infections, unexplained or easy bruising, nosebleeds and bleeding gums, prolonged bleeding from cuts)

• Bone marrow depression (Symptoms of bone marrow suppression depend on the type(s) of blood cell shortage. Reduced red blood cells (RBC) produce anemia symptoms (fatigue, pale skin, lips, and nail beds, increased heart rate, tiring easily with exertion, dizziness, shortness of breath. Reduced white blood cells (WBC) produce symptoms of a weak immune system (fever and chills, rash, diarrhea, signs of infection (swelling, redness, areas that are painful or warm to the touch). Reduced platelets produce classic excess bleeding symptoms (easy bruising, bleeding: nose bleeds, or bleeding gums or mouth, blood in the urine, dark or black bowel movements)

Tell your doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

•    Dehydration

•    Altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth, thirst, weakness, tiredness or drowsiness, restlessness, fits, headache, confusion, muscle pain fatigue or cramps, low blood pressure, difficulty passing water, fast or irregular heart rate and stomach problems including feeling and being sick

Common: may affect up to 1 in 10 people

•    Low blood volume (hypovolaemia)

•    Increased creatinine and blood urea (seen in blood tests)

Uncommon: may affect up to 1 in 100 people

•    Anaemia causing tiredness, breathlessness, unusual bleeding or bruising

•    Changes in the body seen in tests such as levels of cholesterol, glucose, uric acid

•    Gout (symptoms include red, tender, hot, stiff and swollen joints)

•    Changes in vision including blurred or yellow vision

•    Low blood pressure causing loss of concentration and slowed reactions, light-headedness, sensations of pressure in the head, headache, dizziness, 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

•    High blood sugar (Hyperglycaemia)

•    Involuntary leakage of urine (Urinary incontinence)

•    Blockage of the flow of urine out of the body (urinary obstruction)

Rare: may affect up to 1 in 1,000 people

•    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 causing delusions, hallucinations, disorganized speech

•    Feeling ‘pins and needles’ or tingling sensation

•    Confusion

•    Headache, dizziness

•    “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

•    Inflammation or failure of the kidney which may cause back pain or changes in the amount or need to urinate

•    Tiredness, generally feeling unwell

•    Fever

•    Increase in liver transaminase

Very rare: may affect up to 1 in 10,000 people

•    Involuntary movements of the muscle

Not known: frequency cannot be estimated from the available data

•    Worsening of conditions where there is already balances of fluid or chemicals in the body

•    Increased levels of glucose in the body

Additional side effects in children

•    Increased risk or persistence of patent ductus arteriosus in premature infants

•    Kidney stones in premature babies

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

Do not store above 25°C. Keep the container tightly closed.

Store in the original container and protect from light and moisture.

Do not use after the expiry date shown on the label.

Return any leftover tablets to your pharmacist. Only keep them if your doctor tells you to. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

What Furosemide contains

Furosemide tablets contain the active ingredient Furosemide.

The tablets also contain the inactive ingredients: lactose monohydrate, magnesium stearate, sodium starch glycollate and maize starch.

What do your tablets look like and contents of the pack

Furosemide 20mg tablets: White, circular, flat tablets with a breakline on one side. Each tablet contains Furosemide 20mg.

Pack sizes: 20mg tablets- 28, 56,100, 250, 500 and 1000 tablets.

Who has made your tablets

Strada Production Ireland Ltd, Waterford Road, Clonmel, Co.Tipperary. Product Licence Holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, WA8 0RP, UK. Distributed by

Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K. PL 20395/0107

This Leaflet was last revised in: July 2014