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Package leaflet: Information for the user

SPIRONOLACTONE 25MG TABLETS _SPIRONOLACTONE 100MG 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.

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

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 Spironolactone tablets are and what they are used for

2.    What you need to know before you take Spironolactone tablets

3.    How to take Spironolactone tablets

4.    Possible side effects

5.    How to store Spironolactone tablets

6.    Contents of the pack and other information

1. What Spironolactone tablets are and what they are used for

•    The active ingredient is Spironolactone.

•    Spironolactone belongs to a class of drugs known as "diuretics"- you may know these as 'water' tablets. Diuretics help to get rid of excess water in the body. Your medicine can be used to treat liver problems (i.e. cirrhosis with ascites and oedema, malignant ascites), Hyperaldosteronism (high levels of aldosterone in the body), Kidney problems (i.e. nephritic problems) and Heart Failure (i.e.congestive cardiac failure).

•    Spironolactone can also be used to test for hyperaldosteronism.

You must talk to a doctor if you do not feel better or if you feel worse.

Children should only be treated under guidance of a paediatric specialist.

2. What you need to know before you take Spironolactone tablets

Do not take Spironolactone tablets if you:

•    are allergic to Spironolactone or any of the other ingredients (listed in section 6) signs of an allergic reaction include a rash, itching, difficulty breathing or swelling of the lips, face, throat or tongue

•    suffer from anuria (absence of urine production)

•    suffer from severe kidney disease

•    have addison's disease (inadequate functioning of adrenal gland), a hormone deficiency characterised by extreme weakness, loss of weight and low blood pressure

•    have high potassium levels in the blood (hyperkalaemia)

•    have diabetes mellitus with or without kidney problems

•    are taking eplerenone (a medicine for high blood pressure)

Children with moderate to severe kidney disease must not take spironolactone.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spironolactone tablets if you:

•    suffer from disturbances of blood chemicals e.g. potassium, calcium, chloride and urea (detected in blood tests)

•    are a woman who has irregular periods

•    have swollen breasts

•    have too little sodium in the blood (hyponatraemia)

•    suffer from porphyria - a generic disorder of red blood cell pigment (symptoms include stomach pain, seizures, vomiting, hallucinations, fast heart rate)

•    you suffer from kidney disease especially children with hypertension or liver disease. Your doctor will routinely assess you.

•    suffer from serious respiratory disorders

•    suffer from diarrhoea

•    have recently had surgery or you are seriously ill

•    are elderly

•    are pregnant

•    are taking any other water tablets (diuretics) in combination with spironolactone which may cause low sodium levels (hyponatraemia) in the blood

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.

Long-term use of Spironolactone Tablets is not advised in young patients. Your doctor will decide whether this medicine is suitable for you.

If you experience reduced kidney function or kidney failure you may have severe increases in the levels of potassium in your blood. This can affect the way your

heart functions and in extreme cases can be fatal.

If any of the above apply to you, talk to your doctor or pharmacist before taking Spironolactone Tablets.

Tests

Tell your doctor or nurse that you are taking Spironolactone Tablets if you are going to have a blood test. This is because this medicine can affect the results of some blood tests, such as liver tests or tests to measure blood levels of certain other drugs e.g. digoxin.

Other medicines and Spironolactone tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

•    other diuretic drugs (water tablets), e.g. furosemide

•    medicines or supplements containing potassium, e.g. Lo-salt

•    cardiac glycosides e.g. digoxin (used to treat heart conditions)

•    ciclosporin or tacrolimus (drugs used to prevent organ transplant rejection, treat rheumatoid arthritis, eczema or psoriasis)

•    corticosteroids (used to treat Addison's disease, e.g. fludrocortisone)

•    medicines used to treat high blood pressure (e.g. ACE inhibitors, angiotensin II receptor antagonists, diuretics, calcium channel blockers and other blood pressure lowering drugs)

•    anti-diabetics (used to treat diabetes, e.g. chlorpropamide)

•    anti-coagulants (drugs used to thin the blood, e.g. warfarin, Heparin, low molecular weight heparin)

•    lithium (used to treat mental illness, e.g. mania and bipolar disorders)

•    mitotane (a drug used to treat cancer of the adrenal gland)

•    carbenoxolone (used to treat stomach ulcers)

•    colestyramine (used to treat high cholesterol)

•    the contraceptive pill

•    non-steroidal anti-inflammatory drugs (NSAIDs) (used to relieve pain, inflammation and stiffness, e.g. indometacin, mefenamic acid ibuprofen and diclofenac)

•    trimethoprim and trimethoprim-sulfamethoxazole

•    aspirin

•    antipyrine

•    noradrenaline

•    medicines known to cause hyperkalaemia (raised blood potassium levels)

If you are going to have an operation where you will be given an anaesthetic, tell the doctor in charge that you are taking Spironolactone.

Pregnancy, breast-feeding and fertility Pregnancy

Always talk to your doctor before taking any medicine if you are pregnant, planning to become pregnant.

You should discuss the use of spironolactone with your doctor, who will advise you to consider an alternative method of feeding your baby while you are taking this medicine.

Breast-feeding

Breast-feeding is not recommended while taking Spironolactone Tablets. Always check with your doctor if you are not sure.

Driving and using machines

Take care if you drive or operate machinery.

Spironolactone tablets can cause drowsiness and dizziness. Patients should make sure they are not affected when driving or operating machinery.

Spironlactone tablets contain Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Spironolactone tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The number of tablets you need to take depends on your illness.

Taking this medicine

•    Take this medicine by mouth.

•    Swallow these tablets with water and preferably with food.

ADULTS

Congestive heart failure

The usual dose for adults is 100mg daily. To control the condition the usual dose is 25mg-200mg daily. The maximum daily dose is up to 400mg daily.

Nephrotic syndrome

The usual dose for adults is 100mg-200mg daily.

Liver cirrhosis (liver disease)

The usual dose for adults is 100mg-400mg daily depending on your condition. Swollen abdomen

The usual dose for adults is 100mg-200mg daily. The maximum daily dose is up to 400mg daily.

Diagnosis of primary aldosteronism

Long test: the usual daily dose is 400mg for 3-4 weeks.

Short test: the usual daily dose is 400mg for 4 days.

Treatment of primary aldosteronism

The usual adult dose is 100mg-400mg in preparation for surgery. If surgery is not suitable your doctor will decide a suitable dose to control the condition.

ELDERLY

Your doctor may prescribe a different dose to those above, depending on your liver or kidney function and response to treatment.

CHILDREN

The number of tablets you give your child will depend on your child's weight and response to treatment. The usual dose is 3mg per kg of body weight daily in divided doses. Tablets may be crushed and dispersed in food or drink if necessary. Speak to your doctor before giving this medicine to your child.

Always follow your doctor's advice about when and how to take your medicine and always read the label. Your pharmacist may be able to help if you are not sure.

If you forget to take Spironolactone tablets

If you forget to take a dose at the correct time, take your Spironolactone tablets as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose

If you take more of your spironolactone than you should

If you (or somebody else) accidentally take too much medicine, contact your nearest hospital casualty department, doctor or pharmacist immediately.

Symptoms of an overdose include drowsiness, confusion, nausea, vomiting, dizziness or diarrhoea.

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse.

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

4. Possible side effects

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

Stop taking Spironolactone and contact your doctor at once if you develop high blood levels of potassium (muscle twitching or weakness, irregular heart beat, unusual tiredness or weakness, paralysis with or without loss of muscle tone, circulatory failure), especially if you have impaired kidney function or a diet high in potassium.

Contact your doctor immediately if you experience the following:

•    an allergic reaction (hypersensitivity) such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, shock, collapse, skin rash or itching.

•    a severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)

•    a severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis)

•    a severe form of allergic reaction called DRESS syndrome which may show up with the following symptoms: fever, skin rash, joint pain, swelling of glands, abnormalities of blood including increase in blood cells called eosinophils, abnormalities of kidney and liver function.

Tell your doctor or pharmacist if you notice any of the following side effects, they get worse or if you notice anything not listed.

•    Increase in blood levels of nitrogen or urea especially in those with impaired kidney function, altered numbers and types of blood cells.

•    If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want you to have a blood test. This may be due to reduced number of cells that fight infection- white cells (leukopenia), reduced number of cells that help with clotting (thrombocytopenia)

•    Low blood levels of sodium, changes in the levels of chemicals in the body.

•    Lack of muscle control or coordination, drowsiness, nausea, dizziness, headache, clumsiness, tiredness, mental confusion, fever.

•    Yellow skin and eyes (jaundice), spironolactone can cause impairment of liver function; Hepatoxicity (a poisonous effect on the liver)

•    Inflammation of the stomach lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps, diarrhoea, being sick, stomach upset

•    Skin rashes including pale or red irregular raised patches with severe itching (hives), hair loss.

•    Bone softening due to vitamin D deficiency, leg cramps.

•    Acute kidney failure particularly in those who already have impaired kidney function.

•    Enlarged breasts in men, changes in voice pitch, reduced sexual potency in men, decreased sexual ability.

•    Mild androgenic effects like breast tenderness, breast lumps, increased hair growth in females, change in sex drive in women, irregular periods, sweating, Menstrual disorders, breast pain.

•    Irregular heartbeat, tingling sensation, paralysis or difficulty in breathing, which may be symptoms of raised potassium levels in your blood. Your doctor will conduct regular blood tests to monitor potassium levels in your blood. Your doctor will conduct regular blood tests to monitor potassium and other electrolyte levels. He or she may stop you treatment if necessary.

•    general discomfort and illness

•    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.

5. How to store Spironolactone tablets

•    Keep out of the sight and reach of children.

•    Do not use this medicine after expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not store above 25⁰C. Store in the original package in order to protect from light and moisture.

•    Do not throw away any medicines via waste water 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 Spironolactone Tablets contain:

•    The active substance is Spironolactone.

•    The other ingredients are: colloidal anhydrous silica, sodium lauryl sulfate, rice starch, lactose monohydrate, micro-crystalline cellulose, povidone, peppermint oil, magnesium stearate, methyl-hydroxy propylcellulose, polyethylene glycol, opaspray (E171, E464, E172), talc. The 25mg tablets also contain agar.

What Spironolactone Tablets look like and contents of the pack:

•    Spironolactone 25mg tablets are buff coloured, biconvex, film coated tablets marked '25' on one side and 'BL' on the reverse.

•    Spironolactone 100mg tablets are buff coloured, biconvex, film coated tablets marked '100' on one side and 'BL' on the reverse.

•    Spironolactone tablets are available in bottle packs of 21, 28, 100, 250,

500, 1000 tablets and blister pack of 28 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address:

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Spironolactone 25mg Tablets; PL 17907/0330 Spironolactone 100mg Tablets; PL 17907/0331

This leaflet was last revised in March 2016

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

V7 01-03-16 D0    g

SAME SIZE ARTWOK 420 x 160 mm Back

420 mm