Furosemide 40mg Tablets

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Document: leaflet MAH GENERIC_PL 04077-0005 change

Package Leaflet: Information for the user.

FUROSEMIDE 40MG TABLETS

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.

• Ask your doctor or pharmacist if you need more information or advice.

• 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 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.

What is in this leaflet

1. What Furosemide is and what is it used for

2. What you need to know before you take Furosemide Tablets

3. How to take Furosemide Tablets

4. Possible side effects

5. How to store Furosemide Tablets

6. Contents of the pack and other information

1. WHAT FUROSEMIDE IS AND WHAT IS IT USED FOR

Furosemide belongs to a group of medicines known as diuretics, these work on your kidneys to remove excess water from the body. Furosemide tablets are used for the treatment of water retention (oedema) caused by heart failure, cirrhosis of the liver or certain kidney diseases. They may also be used to treat water retention due to mild to moderate high blood pressure and in the management of reduced urine production due to kidney failure.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FUROSEMIDE TABLETS

Do NOT take this medicine if you:

• are allergic (hypersensitive) to furosemide, other sulphonamide related drugs or any of the other ingredients in Furosemide tablets (see section 6)

• have severe kidney damage which has stopped them working properly and 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

• take 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 Addison’s disease (low levels of corticosteroid hormones secreted)

• have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow, fast or irregular heart beats).

• are breast-feeding

Warnings and precautions

Check with your doctor or pharmacist before taking Furosemide tablets if you have:

• low blood volume (hypovolaemia) or are at risk of developing low blood pressure

• low levels of protein in the blood (hypoproteinaemia) as a result of kidney damage

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

• kidney problems

• or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage

• are elderly, if you are on other medications which can cause the drop of blood pressure and if you have other medical conditions that are risks for the drop of blood pressure

• prostate trouble or difficulty passing urine

• or have had gout

• have an abnormal blood condition

• are about to undergo any blood or urine tests

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

Other medicines and Furosemide Tablets Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• drugs to lower blood pressure, such as ACE inhibitors, renin

inhibitors, alpha blockers, calcium channel blockers, diuretics, phenothiazines

• drugs to treat mental illness (eg. pimozide, amisulpride,sertindole)

• drugs for arrhythmias (e.g. sotalol, amiodarone, flecanide)

• digoxin for your heart

• moxisylte for Raynaud’s syndrome

• nitrates (for angina)

• lithium for depression or mania

• sucralfate for stomach ulcers

• colestyramine or colestipol for high cholesterol

• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen or naproxen

• aspirin for pain

• antibiotics for infections that affect your kidneys or ears (e.g. cefaclor, colistin, gentamicin, vancomycin)

• amphoterecin (to treat fungal infections)

• chloral hydrate (to treat insomnia)

• antidepressants (e.g. monoamine oxidase inhibitors (MAOIs))

• medicines to control diabetes such as insulin or tablets

• antiepileptics e.g. phenytoin or carbamazepine

• corticosteroids or antihistamines (to treat allergic reactions)

• drugs for ADHD

• drugs treating cancer e.g. aldesleukin

• levodopa (for Parkinson’s disease)

• oral contraceptives

• alprostadil for erectile dysfunction

• certain treatments for asthma such as theophylline

or salbutamol _H|aB|B

• probenecid to prevent gout

• laxatives used over a long period of time

• medicines or foods containing liquorice

• 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

Furosemide and alcohol

You should avoid drinking alcohol while taking Furosemide tablets as this may lower your blood pressure further.

Pregnancy and breast-feeding

Speak to your doctor before you take Furosemide tablets if you are pregnant, thinking of getting pregnant, or breast-feeding

Driving and using machines

Do not drive or operate machinery if you feel less alert after taking Furosemide tablets.

Important information about some of the ingredients in Furosemide tablets

Your medicine contains lactose; do not take Furosemide tablets if you have been told by your doctor that you have an intolerance to a sugar called lactose.

3. HOW TO TAKE FUROSEMIDE TABLETS

Always take Furosemide tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with a glass of water.

Doses:

• Adults and children over 12 years:

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

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

• Elderly: may be reduced in this age group.

• Children under 12 years: a more suitable dosage form is used in this age group.

Dosage adjustment may be necessary in patients with:

• hypoproteinaemia

• liver congestion/dysfunction

If you take more than you should

If you (or someone else) accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor immediately. Take this leaflet and any remaining tablets and the container with you.

If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next dose. Do not take a double dose to make up for a forgotten dose.

Multi

Ul Packaging ^ Solutions

VERSION G

Customer	M&A Pharmachem	Drawing	L00000502			View/Backup	Title	HEAD to HEAD
Description	FUROSEMIDE 40MG TABLETS	Flat Size	296.3 _:	x 165	mm	Colours FRONT (or cover)
	FUROSEMIDE 40MG TABLETS	Fold Size/Lip	296.3 _:	x 165	mm / 0	Colours FRONT (or cover)	Black
Item Code	PP2480	Material	050 gsm Uncoated			Colours
PPN/2nd Code	163078	Pharmacode/ 2D Code	246		111111	(or inner)	Black
Operatoi	Yarnold, Paul	Type/Pages	Reel		2 pp	History \|	G on 20/10/2016 09:32:32	\| Submitted

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)

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, weakness, tiredness or drowsiness, restlessness, fits, muscle pain fatigue or cramps, low blood pressure causing loss of concentration and slowed reactions, difficulty passing water, fast or irregular heart rate and 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

• Changes in vision including blurred or yellow vision

• Light-headedness, sensations of pressure in the head, headache, 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

• Deafness (sometimes irreversible)

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 NOC causing delusions, hallucinations, disorganized speech

• Feeling ‘pins and needles’ or tingling sensation

• Confusion

• Headache

• ‘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

• Tiredness, generally feeling unwell

• Fever

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

• Involuntary movements of the muscle

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

• Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)

• Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)

• Decreased levels of potassium in the body

Additional side effects in children

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

• Kidney stones in infants

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.

5. HOW TO STORE FUROSDEMIDE TABLETS

Keep this medicine out of the sight and reach of children.

Do not store above 25°C and the protect from light.

Store in a cool dry place, in the original container.

Do not use the tablets after the expiry date shown on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What these tablets contain:

The active ingredient in each tablet is furosemide 40mg.

The other ingredients are lactose, maize starch, magnesium stearate and povidone.

What these tablets look like and contents of the pack:

Furosemide 40mg tablets are flat, roiund and white with “M&A” logo on one side and a breakline on the reverse. They are available in blister packs of 28, 30 and 100 tablets and in plastic tubs of 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

M & A Pharmachem Ltd, Bolton, BL5 2AL, UK.

This leaflet was last revised 10/2016

PP2480

Not known: frequency cannot be estimated from the available data

• Worsening of conditions where there is already balances of fluid

Multi

Ul Packaging ^ Solutions

VERSION G

Customer	M&A Pharmachem	Drawing	L00000502			View/Backup	Title	HEAD to HEAD
Description	FUROSEMIDE 40MG TABLETS	Flat Size	296.3 _:	x 165	mm	Colours FRONT (or cover)
	FUROSEMIDE 40MG TABLETS	Fold Size/Lip	296.3 _:	x 165	mm / 0	Colours FRONT (or cover)	Black
Item Code	PP2480	Material	050 gsm Uncoated			Colours
PPN/2nd Code	163078	Pharmacode/ 2D Code	246		111111	(or inner)	Black
Operatoi	Yarnold, Paul	Type/Pages	Reel		2 pp	History \|	G on 20/10/2016 09:32:32	\| Submitted

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