TEVA UK Ref: 231-30-61263-Z LEA SPIRONOLACTONE A/S TABS TUK <DEB Version: 2    12 February 2016

SPIRONOLACTONE 25 mg, 50 mg AND 100 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

WHAT IS IN THIS LEAFLET:

1. What Spironolactone is and what it is used for

2. What you need to know before you take Spironolactone

3. How to take Spironolactone

4. Possible side effects

5. How to store Spironolactone

6. Contents of the pack and other information

OWHAT SPIRONOLACTONE IS AND WHAT IT IS USED FOR

Spironolactone is a type of medicine called a diuretic, which increases the amount of water (urine) passed. Spironolactone is used to stimulate your kidneys to pass more urine, to get rid of excess water and salt which may be causing problems.

Spironolactone Tablets are used for:

• treating build-up of fluid in the body (oedema) which may be caused by congestive heart failure, liver cirrhosis, the kidney condition nephrotic syndrome (kidney damage which results in large amounts of protein in the urine) or ascites, a condition in which fluid collects in the abdomen • diagnosis and treatment of hyperaldosteronism (overproduction of the hormone aldosterone).

OWHAT YOU NEED TO KNOW BEFORE YOU TAKE SPIRONOLACTONE

Do NOT take Spironolactone and talk to your

doctor if you:

•    are allergic (hypersensitive) to spironolactone or any of the other ingredients of this medicine

•    suffer from kidney failure, or significant deterioration of kidney function

•    have a high level of potassium in your blood (hyperkalaemia)

•    suffer from Addison's disease (an underactive adrenal gland)

•    are sometimes completely unable to pass urine

•    are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Spironolactone if you:

•    suffer from or have a family history of liver disease.

•    suffer from kidney problems.

Concomitant administration of Spironolactone with certain medicines, potassium supplements and food rich in potassium may lead to severe hyperkalaemia (increased potassium blood level). The symptoms of severe hyperkalaemia might include muscle cramps, irregular heart rhythm, diarrhoea, nausea, dizziness or headache.

Other important information you should

remember while taking Spironolactone

•    If you see another doctor or go into hospital, let him or the staff know what medicines you are taking.

•    Inform your doctor or dentist if you are taking Spironolactone before undergoing surgery.

•    Spironolactone may also cause problems if you have a local or a general anaesthetic.

Other medicines and Spironolactone

Talk to your doctor if you are taking any of the

following:

•    diuretics ('water tablets')

•    potassium supplements

•    ACE inhibitors (such as captopril or enalapril maleate)

•    antihypertensives (tablets for high blood pressure)

•    carbenoxolone (medicine used for treatment of mouth and stomach ulcers)

•    noradrenaline (medicine used to treat depression and hyperactivity)

•    aspirin, indometacin (non-steroidal anti-inflammatory drugs)

•    digoxin (medicine used to treat various heart conditions)

•    trimethoprim and and trimethoprim-sulfamethoxazole

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not take Spironolactone if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Spironolactone may cause drowsiness and dizziness. If affected do not drive or operate machinery.

Important information about some of the ingredients of Spironolactone

Patients who are intolerant to lactose should note that spironolactone tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

HOW TO TAKE SPIRONOLACTONE

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

The spironolactone tablets should be swallowed preferably with a glass of water and they should be taken with food. The usual dose is:

Adults

The usual starting dose is 100 mg once daily. This may then be adjusted by your doctor according to your condition, up to a maximum of 200 - 400 mg per day.

If spironolactone is being used by your doctor to help in diagnosing your illness, a dose of 400 mg per day for up to four weeks may be used. It may then be reduced, as appropriate.

Children

Your doctor will decide the correct dose for your child based on their weight. This will be given in divided doses and may be adjusted if necessary. If a child has difficulty taking the tablets they may be crushed and taken with food or drink.

The Elderly

Your doctor may begin your treatment with a low dose, and then adjust it as appropriate, particularly if you suffer from liver or kidney problems.

If you take more Spironolactone than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, mental confusion, nausea, vomiting, dizziness, or diarrhoea. Weakness or muscle spasm may occur. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

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

If you stop taking Spironolactone

You should continue to take these tablets for as long as your doctor tells you to.

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

^ POSSIBLE SIDE EFFECTS

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or nettle rash).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Common (affects less than 1 in 10 people)

The following common side effects have been reported:

•    nausea and vomiting

•    abdominal pain, diarrhoea or constipation

•    drowsiness and lethargy

•    headache

•    mental confusion

•    loss of co-ordination

•    fever

•    rashes

•    breast soreness

•    irregularities with your periods

•    temporary impotence

•    mild masculinisation effects (e.g. a deepening of the voice in women)

•    elevated levels of potassium in blood (hyperkalaemia)

•    liver problems (hepatotoxicity).

Rare (may affect up to 1 in 1,000 people)

•    breast enlargement in men may occur, but this is usually reversible on stopping treatment.

Not known (frequency cannot be estimated from the available data)

•    change in sex drive for both men and women (libido)

•    disturbances in body electrolytes

•    reduced number of cells that fight infection -white cells (leukopenia), reduced number of cells that help with clotting (thrombocytopenia)

•    excessive growth of breast tissue in men (gynaecomastia)

•    skin rash, generalised itchiness

•    skin allergy with development of itchiness and weals (urticaria), excessive hair growth (hypertrichosis)

•    hair loss

•    general weakness, muscle cramps

•    sudden kidney failure

•    pemphigoid (condition presenting with fluid-filled blisters on the skin)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

HOW TO STORE SPIRONOLACTONE

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

These tablets should be stored below 25°C, protected from light, in the package or container supplied. Do not transfer them to another container. Do not use spironolactone Tablets after the expiry date that is stated on the outer packaging. 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.

O CONTENTS OF THE PACK AND OTHER INFORMATION

What Spironolactone Tablets contain:

•    The active ingredient is spironolactone 25 mg, 50 mg or 100 mg.

•    The other ingredients are colloidal anhydrous silica, sodium laurilsulfate, lactose monohydrate, microcrystalline cellulose (E460), rice starch, povidone (E1201), peppermint oil, magnesium stearate, hypromellose (E464), polyethylene glycol and the colours titanium dioxide (E171) and iron oxide (E172).

In addition to these ingredients the 25 mg tablets contain agar (E460) and talc (E553b), the 50 mg tablets contain agar (E460), and the 100 mg tablets contain sodium starch glycolate, menthol and talc (E553b)

What Spironolactone looks like and contents of the pack:

•    The 25 mg tablet is a buff coloured biconvex film-coated tablet marked "APS" or plain on one side and "25 0705" on the reverse.

•    The 50 mg tablet is a buff coloured biconvex film-coated tablet marked "APS" or plain on one side and "50 0707" on the reverse.

•    The 100 mg tablet is a buff coloured biconvex film-coated tablet marked "APS” or plain on one side and "100 0706" on the reverse.

The product is available in pack sizes of 7, 10,

14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,

150, 160 and 168 tablets. The 25 mg and 50 mg strength tablets are also available in a pack size of 500 tablets. See outer packaging or the pharmacy label for contents i.e. the number of tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG This leaflet was last revised: January 2016

PL 00289/0071-72, PL00289/0136

^ET7W71