PACKAGE LEAFLET: INFORMATION FOR THE USER

FUROSEMIDE 40 mg TABLETS

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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What Furosemide is for

2.    Before you take Furosemide

3.    How to take Furosemide

4.    Possible side effects

5.    How to store Furosemide

6.    Further information

1. WHAT FUROSEMIDE IS FOR

Furosemide is one of a group of medicines called diuretics (water tablets).

Your doctor has prescribed Furosemide to treat a condition called oedema where there is too much water in your body. This could be due to problems with your heart, kidneys, liver, blood vessels or high blood pressure.

Furosemide helps your kidneys to get rid of the extra water that is not needed in your body.

2. BEFORE YOU TAKE FUROSEMIDE

Do not take Furosemide and tell your

doctor if you

•    are allergic to Furosemide or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    are allergic to sulphonamides such as sulfadiazine or co-trimoxazole (drugs used to treat infections)

•    are dehydrated or have lost a lot of blood

•    have kidney failure

•    have severe liver problems

•    are not passing any urine

•    have very low levels of potassium in your blood, which will make your muscles feel weak or you may suffer paralysis

•    have very low levels of sodium in your blood, which may be caused by excessive sweating, vomiting or reaction to another drug

•    are breast-feeding.

Take special care with Furosemide

Tell your doctor before you take this medicine if you

•    are pregnant or are planning a pregnancy

•    have difficulty passing urine, especially in men with an enlarged prostate gland

•    have low blood pressure

•    have diabetes

•    have gout (pain and swelling of the joints)

•    have liver or kidney problems

•    suffer from porphyria (an inherited iron disorder)

•    have a history of electrolyte (e.g. calcium, potassium or sodium) deficiency

•    are the parent or carer of a premature baby, as your doctor will need to monitor your child's kidney function.

Your doctor will want to monitor you, and

may take blood for testing while you are

taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Furosemide tablets work:

•    Other diuretics such as Amiloride or Metolazone

•    Medicines for your heart such as Digoxin, Digitoxin, Disopyramide, Flecanide, Lidocaine or Sotalol. Your doctor may need to change your dose

•    Medicines to treat high blood pressure such as Captopril, Candesartan, Clonidine, Guanethidine, Doxazosin, Atenolol,

Amlodipine or Sodium Nitroprusside. Your doctor may need to change your dose

•    Medicines to treat chest pain such as Glyceryl Trinitrate

•    Medicines to treat diabetes such as Metformin

•    Medicines for depression such as Lithium, Reboxetine, Amitriptyline or Moclobemide

•    Medicines for mental health problems such as Amisulpride, Pimozide, Sertindole or Prochlorperazine

•    Medicines for sleeping problems and anxiety such as Diazepam or Temazepam

•    Carbamazepine or Phenytoin to control epilepsy

•    Medicines to treat infections such as Gentamicin, Vancomycin or some antibiotics

•    Amphotericin to treat fungal infections

•    Ciclosporin to stop the rejection of organs after transplants

•    Aldesleukin, Aminoglutethimide or Cisplatin to treat cancer

•    Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as Aspirin, Ibuprofen, Indometacin or Ketorolac for pain and swelling

•    Probenecid to treat gout

•    Methotrexate to treat cancers of the skin, joint or bowel diseases

•    Muscle relaxants such as Baclofen or Tizanidine

•    Carbenoxolone or Sucralfate to treat ulcers

•    Medicines for constipation (laxatives) if used over a long period of time

•    Medicines for asthma such as Theophylline

•    Cough or cold remedies bought over the counter

•    Steroids such as Hydrocortisone or Prednisolone to treat inflammation and allergies

•    Oestrogens for contraception or hormone replacement therapy.

If you need an operation tell your doctor you are taking Furosemide, as when anaesthetics are given with Furosemide your blood pressure may be lowered.

Taking Furosemide with alcohol

Seek advice from your doctor about drinking alcohol while taking Furosemide.

Pregnancy and breast-feeding

Speak to your doctor before you take Furosemide if you are pregnant or are planning a pregnancy. Do not take Furosemide if you are breast-feeding.

Driving and using machines

Furosemide may make you feel less alert. If affected do not drive or operate machinery.

Important information about some of the ingredients of Furosemide

Your medicine contains lactose. If you know you have an intolerance to some sugars, contact your doctor before taking Furosemide.

3. HOW TO TAKE FUROSEMIDE

Always take Furosemide tablets exactly as your doctor has told you. Take this medicine by mouth.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Adults including elderly:

The usual starting dose is 40 mg once a day.

Your doctor may adjust your dose gradually until you respond. If you are elderly you may be given a lower dose.

Children:

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

If you take more Furosemide than you should

Contact your doctor or go to a hospital immediately. Take the package or container with you.

If you forget to take Furosemide

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

If you stop taking Furosemide

Speak to your doctor before you stop taking Furosemide.

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

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 taken by premature babies in the first weeks of life Furosemide may affect growth and cause shortness of breath and rapid breathing

•    skin reactions such as itching, marks on the skin, flaky or scaly skin

•    thirst, headache, confusion, muscle cramps, muscle weakness, irregular heartbeat

•    dehydration

•    gout causing pain normally in the joints of your legs

•    numbness or tingling

•    hearing problems or ringing in your ears (tinnitus)

•    blood tests which show changes in the levels of liver enzymes or body fats such as cholesterol

•    if you have problems urinating Furosemide may make this worse

•    nausea, vomiting, diarrhoea or generally feeling unwell.

If any of the side effects become serious, or

if you notice any side effects not listed in this

leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE FUROSEMIDE

4. POSSIBLE SIDE EFFECTS

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

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

•    severe allergic reaction, which may include a red and lumpy skin rash, difficulty breathing, swelling of the 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

•    sensitivity to sunlight

•    spasms, muscle twitching and cramps

•    inflammation of the pancreas, which may cause severe pain in the abdomen and back

•    liver problems, which may cause yellowing of the skin or whites of the eyes (jaundice) or dark urine. In patients who already have liver problems, a more serious liver problem known as hepatic encephalopathy may occur. Symptoms include forgetfulness, fits, mood changes or coma

•    swollen kidneys, which may change the number of times you pass urine or may cause blood in your urine or swelling of the ankles

•    kidney stones in premature babies.

Furosemide 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 and lethargy; unusual bleeding or bruising, blood slow to clot; ulcers in your throat, mouth or on your skin.

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What Furosemide tablets contain

The active ingredient in Furosemide 40 mg tablets is furosemide. The other ingredients are lactose, maize starch, potato starch, colloidal anhydrous silica and magnesium stearate.

What Furosemide tablets look like and contents of the pack

Furosemide 40 mg tablets are round white tablets with the marking MP22 on one side and a break line engraved on the other.

The tablets come in blister packs and containers of 28, 30, 56, 60, 84, 100, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Genethics Europe Limited,

41 - 43 Klimentos, Klimentos Tower,

Nicosia 1061, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last approved in 03/2016

GE0016/O/PIL/GE1