What ALDACTONE is used for?

ALDACTONE is used to treat,

Congestive heart failure

Nephrotic syndrome (a kidney disorder)

Liver cirrhosis with fluid retention (oedema) and swelling of the abdomen (ascites)

A cancerous disease with swelling of the abdomen (malignant ascites)

Or diagnose primary aldosteronism (a condition where excess hormone is produced)

Warning And Precautions

Talk to your doctor before taking this medicine, if you:

Are allergic to spironolactone or any of the other ingredients in this medicine

Have diabetes

Have Addison’s disease (weakness, loss of energy, low blood pressure and dark pigmentation of the skin)

Have kidney problems which may be severe or worsening

Have high blood levels of potassium

Have a diet high in potassium

Have low blood levels of sodium

Have liver cirrhosis

Have been passing small amounts of urine

Have an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and nervous system disorders (porphyria)

Have abnormal periods or swollen breasts

ALDACTONE should not be taken if you are breast-feeding

If you are pregnant or planning to become pregnant, speak to your doctor before taking this medicine

ALDACTONE may cause dizziness or drowsiness. Make sure you are not affected before you drive or operate machinery

Interactions

Tell your doctor if you are taking,

Blood pressure lowering medicines such as captopril or enalapril, valsartan or losartan

Chlorpropamide (used in diabetes)

Digoxin (used in some heart conditions)

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

Fludrocortisone (a corticosteroid)

Warfarin (used to thin the blood)

Other potassium-sparing diuretics

Lithium (used for some mental illnesses)

Indomethacin and mefenamic acid used for pain

Potassium supplements (potassium salts)

Noradrenaline (norepinephrine) (used for low blood pressure or heart problems)

An anaesthetic

Carbenoxolone (an ulcer healing drug)

Trimethoprim and trimethoprim-sulfamethoxazole used as antibiotic

Always take this medicine exactly as your doctor has told you

Swallow the tablet with water

Directions and For Use

Adults

Congestive heart failure – 100mg a day. The maintenance dose is 25-200mg a day. In difficult or severe cases, up to a maximum of 400mg a day may be taken

Nephrotic syndrome – 100-200mg a day

Liver cirrhosis with fluid retention and swelling of the abdomen – 100-400mg a day. Your doctor will decide on the best maintenance dose for you

A cancerous disease with swelling of the abdomen – 100-200mg a day. In severe cases, up to a maximum of 400mg a day may be taken

Primary aldosteronism diagnosis – Long test: 400mg a day for 3-4 weeks. Short test: 400mg a day for 4 days

Primary aldosteronism treatment – 100-400mg a day in preparation for surgery

What is ALDACTONE?

ALDACTONE contains Spironolactone which belongs to a group of medicines called potassium-sparing diuretics (water tablets), which help you lose excess fluid from your body

Congestive heart failure – 100mg a day. The maintenance dose is 25-200mg a day. In difficult or severe cases, up to a maximum of 400mg a day may be taken

Nephrotic syndrome – 100-200mg a day

Liver cirrhosis with fluid retention and swelling of the abdomen – 100-400mg a day. Your doctor will decide on the best maintenance dose for you

A cancerous disease with swelling of the abdomen – 100-200mg a day. In severe cases, up to a maximum of 400mg a day may be taken

Primary aldosteronism diagnosis – Long test: 400mg a day for 3-4 weeks. Short test: 400mg a day for 4 days

Primary aldosteronism treatment – 100-400mg a day in preparation for surgery

Children

Usual starting dose is 3mg per kg of body weight a day, to be taken in divided doses. Your doctor will adjust the dose depending on the response to treatment

If you take more ALDACTONE

If you take more ALDACTONE at the same time, contact your nearest hospital casualty department or tell your doctor immediately

Symptoms of an overdose include drowsiness, mental confusion, dizziness, diarrhoea, decreased blood levels of sodium, increased blood levels of potassium (symptoms include ‘pins and needles’ or tingling, unusual tiredness or weakness, muscular weakness, paralysis with a loss of muscle tone, muscle spasm)

If you forget to take ALDACTONE

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the right time

Do not take a double dose to make up for a forgotten dose

If you stop taking ALDACTONE

Consult your doctor before you stop taking ALDACTONE

Side Effects

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

High blood levels of potassium (muscle twitching or weakness, irregular heartbeat, 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

An allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, shock, collapse, skin rash or itching

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

Increased bruising, nosebleeds, sore throats or infections

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

Lack of muscle control or coordination, drowsiness, dizziness, headache, clumsiness tiredness, confusion

Impaired liver function, a poisonous effect on the liver

Stomach upset, inflammation of the stomach lining, bleeding in the stomach, stomach or intestinal ulcers, stomach cramps, diarrhea

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/drive, breast tenderness, breast lumps and increased hair growth in females, irregular periods, sweating

Storage

Store at room temperature (15-25ºC)

Keep this medicine out of reach of children

Do not use this medicine after the expiry date