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PATIENT INFORMATION LEAFLET FUROSEMIDE 40mg/5ml Oral Solution Furosemide 40mg

Read all of this leaflet carefully before you start taking this medicine.

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

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

This medicine has been prescribed for you. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

t. What Furosemide is and what it is used for

2.    Before you take Furosemide

3.    Flow to take Furosemide

4.    Possible side effects

5.    Flow to store Furosemide 3. Further information

t. WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR

⁼urosemide belongs to a group of medicines called diuretics which reduce excess water (fluid retention) in the body by increasing urine production. Water can accumulate if you have a condition affecting your heart, lungs, kidney, liver or blood vessels. Furosemide 40mg/5ml Oral Solution is particularly useful for patients who cannot take tablets.

2. BEFORE YOU TAKE FUROSEMIDE

DO NOT take Furosemide if you:

are allergic (hypersensitive) to furosemide, sulphonamides, or any of the other ingredients of Furosemide 40mg/5ml Oral Solution (see Section 6 and end of Section 2). have low blood volume (dehydration) or have lost a lot of blood e.g. after a severe injury have very low blood salt levels, have liver problems such as cirrhosis.

have kidney failure and/or you cannot pass urine even after taking Furosemide. have kidney failure due to drug toxicity affecting your kidneys or liver, have precoma associated with advanced liver disease, are breast-feeding.

Warnings and precautions:

Falk to your doctor or pharmacist before taking Furosemide if you have

•    enlarged prostate or any obstruction of urine flow

•    low blood pressure, or risk of sudden drop in blood pressure

•    diabetes or if you are pre-disposed to diabetes e.g. if there is a family history of diabetes

•    gout (symptoms including sudden severe joint pain)

•    acute kidney failure due to disease or damage to the liver and kidneys

•    'nephritic syndrome' (signs of kidney disorders, e.g. protein or blood in the urine)

•    if you are pregnant

•    low levels of protein in the blood

•    if you are elderly, or if you are on other medications which can cause a drop in blood pressure and if you have other medical conditions that can cause blood pressure to drop.

Careful monitoring will be needed if Furosemide is used to treat premature babies. While you are taking this medicine, your doctor may give you regular blood tests to monitor levels of salts and minerals in your blood to ensure that your kidneys are working properly.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The dosage of your other medicines may need to be altered while using Furosemide. In particular, tell your doctor if you are taking:

•    Glycosides for heart conditions e.g. digoxin, digitoxin, which are used to treat heart failure and unusual heart rhythms, heartbeat regulators e.g. lidocaine and mexiletine

•    Medication for high blood pressure known as ACE inhibitors or angiotensin - II receptor antagonists e.g. captopril and losartan, beta-blockers e.g. atenolol.

•    Alpha-blockers e.g. prazosin, used to treat high blood pressure or prostate problems

•    Sucralfate (for peptic ulcer). Furosemide and sucralfate must not be taken within 2 hours of each other.

•    Lithium containing medicines (to treat mental illness).

•    Non-steroidal anti-inflammatory agents (NSAIDs) e.g. indomethacin, aspirin and other salicylates. These may affect your kidneys if taken with Furosemide.

•    Antidiabetic drugs.

•    Muscle relaxants e.g. theophylline and curare-type drugs, hydralazine, baclofen or general anaesthetics

•    Cisplatin (a treatment for cancer). If taken with Furosemide, it can cause hearing, balance or kidney problems.

•    Carbamazepine or Phenytoin (an antiepileptic) may stop Furosemide working if taken together.

•    Aminoglutethimide used to treat cancer

•    Corticosteroids used to treat inflammation e.g. hydrocortisone

•    Carbenoxolone used to treat mouth ulcers

•    Extended use of laxatives may cause altered blood salt levels

•    Probenecid used to treat gout

•    Amphotericin used to treat infections caused by fungus

•    Amisulpride, Sertindole or Reboxetine for depression or chlorpromazine for mental problems called 'psychoses'

•    Ciclosporin used after transplants

•    Ritonavir used to treat viral infections

•    Atomoxetine used to treat ADHD

•    Potassium salts to treat low potassium levels in the blood

•    Warfarin to prevent stroke

•    Theophylline or Salbutamol used to treat asthma. These medicines also treat Chronic Obstructive Pulmonary disease

•    Clofibrate used to treat high cholesterol

•    Nitrate medication to treat chest pain or heart disease

•    Alprostadil used to treat male impotence

•    Medicines used to treat unusual heart beats, such as amiodarone or disopyramide

•    Medicines used to treat infections caused by bacteria, such as vancomycin

•    Medicines used to treat high blood pressure and other medicines used to remove water from the body known as diuretics, such as acetazolamide and metolazone

•    Anything that contains large amounts of liquorice

•    Antihistamines e.g. cetirizine

•    Alcohol, as can cause low blood pressure when taking Furosemide treatment

•    Medicines causing specific changes to your ECG (heart trace) (prolongation of the QT interval)

•    Aliskiren used to treat high blood pressure

•    Medicines used to treat anxiety e.g. diazepam

•    Contraceptives such as oestrogens and progestagens

Pregnancy and breast-feeding

⁼urosemide must not be given during pregnancy unless advised by your doctor, in which case your unborn baby's growth should be monitored. Furosemide must not be used while /ou are breast-feeding.

□riving and using machines

This medicine has the potential to cause dizziness, drowsiness and visual problems. If affected, do not drive or operate machinery, mportant information about some of the ingredients of Furosemide

⁼urosemide contains:

ethanol (alcohol) up to 442mg per 5ml dose, (equivalent to 10.6ml of beer or 4.4ml of wine). To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as alcoholics and patients with liver disease, or epilepsy.

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VENDOR CODE TO BE PRINTED AT THE BOTTOM RIGHT HAND CORNER OF FRONT AND BACK PAGE PRINT FREE AREA

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" liquid maltitol (nyarogenatea glucose syrup). IT you nave an intolerance to some sugars, contact your doctor Before taking tms medicine.

3. HOW TO TAKE FUROSEMIDE

Always take Furosemide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Only take Furosemide by mouth.

•    It is best to take this medicine in the morning, or according to a schedule which will least affect your activities and sleep. The usual dose is :

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f you take more Furosemide than you should:

If you take more Furosemide than you should, your body will lose blood salts and water. Contact your doctor or local hospital accident and emergency department immediately and ake this leaflet or the medication with you.

If you forget to take Furosemide:

If you have forgotten to take your medicine, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose in one morning to make up for a orgotten individual dose.

1. POSSIBLE SIDE EFFECTS

Jke all medicines, Furosemide can cause side effects, although not everybody gets them. If any of these side effects occur, you may need medical attention, so tell your doctor.

You should STOP using Furosemide and seek advice from your doctor if you experience:

•    a rare allergic reaction (signs include skin rashes and increased sensitivity to light)

•    inflammation of the blood vessels (vasculitis, which may cause rash, fever and muscle or joint pain)

•    inflammation of the pancreas (indicated by stomach and/or back pain)

•    severe joint pain

•    fever or shock

•    skin and mucous membrane reactions (Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome. In a more severe form of the condition called Toxic Epidermal Necrolysis, layers of the skin may peel off to leave large areas of raw exposed skin all over the body)

⁼urosemide may occasionally cause changes in the chemical or cellular composition of your blood, and therefore your doctor may want to perform blood tests.

⁼urosemide is intended to cause fluid loss from the body, and therefore your salts and water balance might be disturbed. You may get an • increased thirst, • headache, • a fall in blood pressure, • confusion, • muscle cramps, • weakness or paralysis, • irregular heartbeat and • stomach upset. Existing conditions e.g. cirrhosis of the liver, causing salt imbalance, may te aggravated by Furosemide.

In elderly patients, dehydration due to loss of fluid may occur and blood clots (thromboses) may develop.

If you already have difficulty passing urine, you may find that your existing symptoms worsen or become painful, due to the extra volume of urine produced.

Uncommon side effects include:

Deafness (sometimes irreversible)

Rare side effects include:

•    increase or decrease in your red or white blood cells or platelets, or bone marrow effects. You may notice tiredness, an infection or easy bruising.

•    a tickling, burning sensation in the skin (paraesthesia).

•    hearing loss or 'ringing' in the ears, problems with your sight, feeling dizzy, light headed or sleepy, confusion, slower reactions.

•    if you have diabetes you may be less able to control the levels of glucose in your blood

•    feeling sick (nausea) or a general feeling of being unwell. Diarrhoea and being sick (vomiting)

•    gout, signs may include sudden severe joint pain.

Yery rare side effects include:

•    muscular tremors or spasms (tetany).

•    calcium deposits in the kidneys of premature infants or, if given in their first few weeks, affects on the circulation of blood to the heart.

•    Furosemide can change the levels of liver enzymes or body fats known as cholesterol - these can be detected through blood tests.

Frequency not known side effects include:

Acute generalised exanthematous pustolusis (AGEP)(acute febrile drug eruption) dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)

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 efects 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.

5. HOW TO STORE FUROSEMIDE

<eep out of the sight and reach of children. Do not store above 25°C. Do not use Furosemide after the expiry date stated on the label. Do not use Furosemide after the bottle has been opened for more than three months. Take any unused medicine to your pharmacist for disposal.

5. FURTHER INFORMATION

What Furosemide contains

the active Ingredient is Furosemide 40mg/5ml.

the other ingredients are liquid maltitol (E965), ethanol, disodium hydrogen phosphate dodecahydrate, sodium hydroxide, citric acid monohydrate, cherry flavour (containing propylene glycol) and purified water. See end of Section 2.

What Furosemide looks like and contents of the pack

⁼urosemide 40mg/5ml Oral Solution is a clear cherry flavoured liquid and is available in 150ml amber glass bottles.

Marketing Authorisation Holder and Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL 04917/0073 Revision Date: December 2015.

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