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PACKAGE LEAFLET: INFORMATION FOR THE USER

SPIRONOLACTONE 25 mg & 100 mg TABLETS

(Spironolactone)

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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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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

1. What Spironolactone is and what it is used for

The active ingredient of the tablets is Spironolactone. Spironolactone belongs to a group of medicines called diuretics (water tablets) or aldosterone antagonists, which inhibit the action of the hormone aldosterone. One of the functions of aldosterone is to ensure that the body retains sodium. It forms part of a system that regulates the balance of fluids and salts in the body ('RAAS', renin angiotensin aldosterone system). Spironolactone promotes the excretion of urine in patients in whom there is an accumulation of fluid in the tissues (oedema) or in the abdominal cavity (ascites) by increasing the amount of sodium (salt) excreted in the urine. Potassium loss as a possible consequence of using certain diuretics is reduced. The antihypertensive effect relies on the excretion of water and salt.

Spironolactone may be prescribed by your doctor for:

•    treatment of accumulation of fluid in the tissues as a result of heart disorders;

•    treatment of severe heart failure (NYHA III-IV);

•    raised blood pressure as an adjunct to a salt-free diet and diuretics;

•    certain kidney disorders;

•    accumulation of fluid in the tissues in the abdominal cavity;

•    to be used during medical investigations (diagnostics) to confirm the presence of disorders due to high amounts of aldosterone produced in the adrenal cortex (Conn's disease) and its treatment.

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

2. What you need to know before you take Spironolactone

Do not take Spironolactone and tell your doctor if you

•    are allergic to Spironolactone or any of the other ingredients in the tablets (listed in section 6);

•    suffer from severely impaired kidney function or from a sudden or rapidly deteriorating kidney disease, including cases in which no urine, or very little urine, is being produced;

•    have high blood levels of potassium (hyperkalaemia) or any other conditions associated with hyperkalaemia;

•    have low blood levels of sodium (hyponatraemia);

•    are taking potassium-sparing diuretics (including eplerenone) or potassium supplements, or dual-RAAS blockade with the combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB).

Children

Children with moderate to severe kidney disease must not

take Spironolactone.

Take special care with Spironolactone

Tell your doctor before you take this medicine if you

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Spironolactone

•    if you need to use Spironolactone for a long time; your doctor should perform regular follow-up checks (for example on the levels of potassium and sodium in your blood), especially if you are elderly;

•    if you have a liver disorder; your doctor should exercise caution when treating you;

•    if you have a kidney disorder; your doctor should exercise caution when treating you;

•    if you have a raised level of potassium in the blood or impaired kidney function; administration of Spironolactone is not advised (see also "Do not take Spironolactone”);

•    if you have severe renal dysfunction which is being simultaneously treated with potassium supplements, since severe hyperkalaemia can occur which can result in cardiac arrest (sometimes fatal);

•    if you use certain diuretics, called potassium-sparing diuretics (such as amiloride and triamterene); concomitant use with Spironolactone is contra-indicated, because the risk of excessively high levels of potassium in the blood (hyperkalaemia) is increased;

•    in the case of long-term treatment of young patients with Spironolactone, your doctor should weigh the advantages carefully against the long-term disadvantages.

Tell your doctor if one of the above warnings applies to you, or has done so in the past.

Other medicines and Spironolactone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, your doctor may wish to alter your dose of Spironolactone if you are taking any of the following:

•    medicines for high blood pressure including ACE inhibitors, ganglion-blocking drugs;

•    other diuretics;

•    non-steroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen;

•    potassium supplements;

•    heparin or low molecular weight heparin (medicines used to prevent blood clots);

•    drugs that inhibit blood coagulation (anticoagulants,

'blood thinners'), noradrenaline (an agent with a stimulant effect on a particular part of the nervous system (sympathomimetic));

•    lithium (used to treat depression);

•    digoxin (used in the treatment of various heart conditions);

•    alcohol, barbiturates or narcotics;

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

•    cholestyramine (used for reducing cholesterol levels in the blood);

•    corticosteroids, ACTH (prescribed for different epileptic conditions);

•    ammonium chloride (e.g. in liquorice);

•    ciclosporin.

Spironolactone with food

The action of spironolactone is not affected by food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Spironolactone should not be used during pregnancy. Spironolactone should only be used during breast-feeding if clearly needed.

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. Spironolactone may induce impotence and menstrual irregularities.

Driving and using machines

Side effects such as dizziness, headache and confusion can sometimes occur while you are using Spironolactone. In this case, do not drive a vehicle or use machines.

3. How to take Spironolactone

Always take Spironolactone tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults

The recommended dosage is 100 mg daily, administered as one or several doses. The adult dose varies from 25 mg to 400 mg spironolactone a day. If you are not sure how much to take, ask your doctor or pharmacist.

You should take the tablets with meals. If the total dose is more than 100 mg per day, the dose must be administered in divided doses spread throughout the day.

Use in children

The recommended dose is 3 mg per kg body weight daily, in several divided doses. In order to make it easier for children to take, the tablets may first be ground or crushed and then suspended in a glass of water by stirring.

The elderly

It is recommended that elderly patients should be started on the lowest possible dose and gradually increase the dosage as needed to obtain the desired effect. Caution and regular medical checks are advised, especially in the event of renal impairment.

Remember to take your medicine. Taking your tablets at the same time each day gives the best effect. It also helps you remember when you should take the tablets.

If you take more Spironolactone than you should

If you have taken too much Spironolactone, contact your doctor or pharmacist immediately. Keep the pack so that the doctor can see what medicine you have taken. Symptoms of an overdose may include nausea and vomiting, and (more rarely) drowsiness, confusion, skin rash or diarrhoea. Disturbance of the fluid and salt balance and dehydration may occur.

If you forget to take Spironolactone

If you have forgotten to take a dose, take it as soon as possible unless it is almost time to take the next dose, in which case you should not take the forgotten dose, but continue according to the schedule prescribed. Do not take a double dose to make up for the one you have missed. Ask your doctor or pharmacist if you are not sure.

If you stop taking Spironolactone

If you stop using Spironolactone, the original symptoms may return. Always contact your doctor if you want to stop using the medicine.

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

4. Possible side effects

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

The side effects depend on the dose and the duration of treatment.

The most common side effects are hyperkalaemia, reproductive system and breast disorders, including gynaecomastia. Gynaecomastia appears to be related to both dosage level and duration of therapy and is usually reversible as soon as the treatment is discontinued. Other very common undesirable side effects are headache, digestive disturbances, diarrhoea, fatigue and drowsiness.

Very common: may affect more than 1 in 10 people

•    High blood levels of potassium (hyperkalaemia), in patients with severe renal dysfunction who are receiving concomitant treatment with potassium supplements;

•    Headache;

•    Indigestion, diarrhoea;

•    Men: reduced libido, erectile dysfunction, impotence, enlargement of the mammary glands (gynaecomastia);

•    Women: breast disorders, tenderness of the breasts, menstrual disorders, deepening of the voice (in many cases irreversible);

•    Fatigue, drowsiness.

Common: may affect up to 1 in 10 people

•    Hyponatraemia (low blood levels of sodium, in particular during combined intensive therapy with thiazide diuretics), hyperkalaemia in (1) patients with severe renal dysfunction, (2) patients receiving treatment with ACE inhibitors or potassium chloride, (3) the elderly, and

(4) diabetic patients;

•    Nausea and vomiting;

•    Women: changes in vaginal secretions, reduced libido, absence of periods (amenorrhoea), post-menopausal bleeding;

•    Weakness, somnolence (lethargy) in patients with cirrhosis, sensations of tickling, itching or tingling for which there is no cause (paraesthesia);

•    General weakness.

Uncommon: may affect up to 1 in 100 people

•    Acidity of the blood (acidosis) in patients with liver problems;

•    Confusion;

•    Skin rash, urticaria, erythema, chloasma, generalised itchiness;

•    Muscle spasms;

•    Leg cramps;

•    Elevated serum creatinine levels.

Rare: may affect up to 1 in 1,000 people

•    Very severe blood abnormalities (deficiency of white blood cells) accompanied by sudden high fever, severe throat pain and mouth ulcers (agranulocytosis), blood abnormality (platelet deficiency) accompanied by bruises and tendency to bleed (thrombocytopenia);

•    Allergic reactions;

•    Insufficient fluid in the tissues (dehydration), porphyria, temporary increase in nitrogen levels in the blood and urine, elevated uric acid levels in the blood (hyperuricemia), This can in susceptible patients lead to gout attacks;

•    Paralysis, weakness and stiffness of the leg muscles (paraplegia) due to hyperkalaemia.

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

•    Breast cancer;

•    Inflammation of the vessel walls (vasculitis);

•    Gastric inflammation, gastric ulcers, gastrointestinal haemorrhage, cramps;

•    Hepatitis;

•    Hair loss (alopecia), skin problems (eczema, erythema annulare centrifugum (EAC));

•    Systemic lupus erythematosus (SLE);

•    Acute renal failure;

•    Excessive hair growth (hypertrichosis);

•    Bone softening (osteomalacia).

Not known: frequency cannot be estimated from the available data

•    Slight androgenic effects, including hirsutism;

•    Reversible hyperchloraemic metabolic acidosis - usually accompanied by hyperkalaemia - has been reported in some patients with decompensated hepatic cirrhosis, even where renal function was normal;

•    Dizziness, ataxia;

•    Mild hypotension;

•    Itchiness and blistering of the skin around the lips and the rest of the body (Stevens-Johnson syndrome);

•    Detachment of the top layer of skin from the lower layers of skin, all over the body (toxic epidermal necrolysis);

•    Skin rash, fever and swelling (which could be symptoms of something more serious, drug rash and eosinophilia and systemic symptoms).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via yellow card scheme website: 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

Keep out of the sight and reach 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.

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 Spironolactone tablets contain

The active ingredient in Spironolactone 25 mg and 100 mg tablets is spironolactone. The other ingredients are calcium sulphate dihydrate, maize starch, crospovidone, povidone, pregelatinised starch, magnesium stearate, peppermint flavour (peppermint oil and starch) and quinoline yellow (E104).

What Spironolactone tablets look like and contents of the pack

The 25 mg tablets are pale yellow tablets with the marking MP28 on one side.

The 100 mg tablets are pale yellow tablets with the marking MP29 on one side.

Both strengths have a peppermint odour.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 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

Haupt Pharma Berlin GmbH,

Moosrosenstrasse 7, 12347 Berlin, Germany

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

This leaflet was last revised in 04/2016

GE0019-0020/0/PIL1/GE1