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FUROSEMIDE 50MG/ML ORAL SOLUTION
PATIENT INFORMATION LEAFLET
FUROSEMIDE 50mg/5ml Oral Solution
Usual starting dose is 4mls daily. Your doctor will adjust the dose to suit you, and will advise whether to take daily or on alternate days. Take exactly what is
prescribed for you by your doctor. The maximum daily dose is 150ml.
Your doctor will advise you on the correct dose. The maximum daily dose is 4ml per day.
Your doctor will advise you on the correct dose.
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
take this leaflet or the medication with you.
Furosemide 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 50mg/5ml Oral Solution is particularly useful for patients who cannot take tablets.
If you forget to take Furosemide:
BEFORE YOU 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
forgotten individual dose.
DO NOT take Furosemide if you:
are allergic (hypersensitive) to furosemide, sulphonamides, or any of the other ingredients of Furosemide 50mg/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.
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)
Talk 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.
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. Iidocaine 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 progestogens
Pregnancy and breast-feeding
Furosemide 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
you are breast-feeding.
Furosemide may occasionally cause changes in the chemical or cellular composition of your blood, and therefore your doctor may want to perform blood tests.
Furosemide 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
be 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.
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.
POSSIBLE SIDE EFFECTS
Like 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.
Warnings and precautions:
If you take more Furosemide than you should:
WHAT FUROSEMIDE IS AND WHAT IT IS USED FOR
HOW TO TAKE FUROSEMIDE
The usual dose is :
In this leaflet:
1. What Furosemide is and what it is used for
2. Before you take Furosemide
3. How to take Furosemide
4. Possible side effects
5. How to store Furosemide
6. Further information
liquid maltitol (hydrogenated glucose syrup). If you have an intolerance to some sugars, contact your doctor before taking this medicine.
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.
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.
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.
Very 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.
HOW TO STORE FUROSEMIDE
Keep 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.
What Furosemide contains
the active ingredient is Furosemide 50mg/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
Furosemide 50mg/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 04917/0074
Revision Date: December 2015.
Driving and using machines
This medicine has the potential to cause dizziness, drowsiness and visual problems. If affected, do not drive or operate machinery.
Important information about some of the ingredients of Furosemide
• 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.
VENDOR CODE TO BE PRINTED AT THE BOTTOM RIGHT HAND CORNER OF FRONT AND BACK PAGE
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.