Spirolon

Spirolon 25 tablets 25 mg: Yellow, round, film-coated tablets, scored with Remedica's logo on one side and embossed with "SP 25" on the other side.
Each film-coated tablet contains spironolactone 25 mg.
Spirolon 100 tablets 100 mg: Yellow, round, film-coated tablets, scored on one side and embossed with "SP 100" on the other side.
Each film-coated tablet contains spironolactone 100 mg.
The active substance is spironolactone.
Excipients/Inactive Ingredients: Core: Pregelatinised starch, microcrystalline cellulose, macrogol 6000, polysorbate 80, sodium starch glycolate (type A), sodium laurilsulfate, colloidal anhydrous silica, menthol, magnesium stearate, (lactose monohydrate, maize starch and povidone - for 25 mg only).
Coating: Hypromellose, macrogol 400, titanium dioxide, talc and quinoline yellow aluminium lake E104.

Spirolon contains the active substance spironolactone. Spirolon belongs to a group of medicines called 'diuretics' or 'water' tablets.
The patient may have gone to the doctor because of swollen ankles or were short of breath. This can happen when the heart's pumping action has become weak because of too much fluid in the body. This is called 'congestive heart failure'. Pushing extra fluid around the body means the heart has to work harder. The doctor has given the patient Spirolon to help lose the extra fluid from the body.
This will mean the heart has to do less work. The patient will lose the extra fluid as urine, so they may need to go to the toilet more often while talking Spirolon.
The patient can also take Spirolon for the following illnesses: 'Nephrotic syndrome' - a kidney disorder that causes too much fluid in the body.
'Ascites' - too much fluid in the abdomen and 'Oedema' - accumulation of fluid beneath skin or in one or more cavities of the body that produces swelling, for example caused by cirrhosis of the liver.
'Malignant ascites' - fluid containing cancer cells that collect in the abdomen.
'Primary aldosteronism' - extra fluid in the body caused by too much of a hormone called 'aldosterone'.
If the patient has these illnesses, Spirolon will help the body to get rid of the extra fluid.
Patients must be advised to talk to a doctor if they do not feel better or if they feel worse.
Children should only be treated under guidance of a paediatric specialist.

Always take this medicine exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
The pharmacist's label on the pack also gives this information.
The number of tablets needed to be taken depends on the illness.
Recommended dose: This medicine should be taken once a day with food.
Adults: The adult dose varies from 25 mg to 400 mg spironolactone a day, depending on the condition being treated. If the patient is not sure how much to take, they must be advised to ask the doctor or pharmacist.
Elderly: The patient will be started on a low starting dose and gradually increase the dosage as needed to obtain the desired effect.
Use in children and adolescents: If Spirolon is given to a child, the number of tablets to be given will depend on the child's weight. The doctor will work out the number of tablets that should be given.
Spirolon 25 tablets 25 mg: The score line is only there to help in breaking the tablet if the patient is having difficulty swallowing it whole.
Spirolon 100 tablets 100 mg: The tablet can be divided into equal doses.
Forgotten intake of Spirolon: If the patient forgets to take the tablet, they may take it as soon as they remember, unless it is almost time for the next dose. A double dose should not be taken to make up for a missed dose.
Stopping intake of Spirolon: Patients must be advised that it is important to keep taking Spirolon until the doctor tells them to stop, even if they start to feel better. If the patient stops taking the tablets too soon, the condition may get worse.
If the patient has any further questions on the use of this medicine, they must be advised to ask the doctor.

If the patient accidentally takes too many tablets, they must be advised to contact the doctor or go to the nearest hospital accident and emergency department immediately. The symptoms of an overdose are feeling drowsy, dizzy, feeling dehydrated and the patient may feel confused. The patient may also feel or be sick, suffer from diarrhoea and may have skin rashes that will appear as flat red areas of skin with overlapping small raised bumps. Changes in the blood sodium and potassium levels may leave the patient feeling weak and suffering from tingling, prickling or numbness of the skin and/or muscle spasms but these symptoms are unlikely to be associated with severe overdosage.

Spirolon should not be taken: if the patient is allergic to spironolactone or any of the other ingredients of this medicine (listed in Description); if the patient cannot pass urine; if the patient has severe kidney disease; if the patient has hyperkalaemia (raised blood potassiun levels); if the patient has Addison's disease (a hormone deficiency characterised by extreme weakness, loss of weight and low blood pressure); if the patient is breast-feeding; if the patient is taking water tablets (potassium-sparing diuretics) or any potassium supplements; if the patient is taking eplerenone (a medicine for high blood pressure).
Children with moderate to severe kidney disease must not take Spirolon.

Patients must be advised to talk to the doctor or pharmacist before taking Spirolon: if the patient is pregnant; if the patient suffers from kidney disease especially children with hypertension or liver disease (the patient will be routinely assessed particularly if elderly); if the patient has difficulty passing urine; if the patient has a disease that can result in electrolyte balance disturbance in blood such as potassium or sodium; if the patient has severe heart failure.
If the patient experiences reduced kidney function or kidney failure, the patient may have severe increases in the levels of potassium in the blood. This can affect the way heart functions and in extreme cases this can be fatal.
Concomitant administration of Spirolon 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.
Excipients: Spirolon 25 tablets 25 mg contain lactose.
If the patient has been told by the doctor that they have an intolerance to some sugars, they must be advised to contact the doctor before taking this medicinal product.
Spirolon tablets contain less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Driving and using machines: Patients must be advised to take care if they drive or operate machinery. Drowsiness and dizziness have been associated with spironolactone treatment and may affect the ability to drive or operate machinery safely.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she must be advised by the doctor or pharmacist before taking this medicine.
Spirolon should not be used if the patient is breast-feeding. She must be advised to discuss the use of Spirolon with her doctor, who will advise her to consider an alternative method of feeding the baby while taking this medicine.

Like all medicines this medicine can cause side effects, although not everybody gets them.
Patients must be advised to inform the doctor immediately if they experience any of the following symptoms after taking this medicine. Although they are very rare, the symptoms can be severe: itchiness and blistering of the skin around the lips and the rest of the body, red or purple rash spreading and forming blisters (Stevens-Johnson syndrome); detachment of the top layer of skin from the lower layers of skin, all over the body (toxic epidermal necrolysis - TEN); skin rash, fever and swelling [which could be symptoms of something more serious, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)]; yellow skin and eyes (jaundice); Spirolon can cause impairment of liver function; irregular heartbeat that can be fatal, tingling sensation, paralysis (loss of muscle function) or difficulty in breathing (which may be symptoms of raised potassium levels in the blood) (regular blood tests will be conducted to monitor potassium and other electrolyte levels and treatment may be stopped if necessary.).
List of other side effects of Spirolon by frequency: Very common (may affect more than 1 in 10 people): Raised potassium in the blood.
Common (may affect up to 1 in 10 people): Confusion; Dizziness; Vomiting and feeling sick; Rash; Itching of the skin; Muscle or leg cramps; Kidney failure or abnormal function; Breast enlargement in men; Breast pain (in men); Feeling generally unwell.
Uncommon (may affect up to 1 in 100 people): Changes in the breast such as breast lumps; Disturbances in body electrolytes such as high blood calcium; Abnormal functioning of the liver; Skin allergy with development of itchiness and hives, nettle-like rash; Breast pain (in women); Menstrual problems in women.
Not known (frequency cannot be estimated from the available data): Lowered white blood cell count in blood; Reduced number of cells that fight infection - white blood cells which make infections more likely; Reduced number of cells that help with clotting which increases risk of bleeding or bruising; Change in sex drive for both men and women; Digestion problems, stomach upset; Skin condition presenting with fluid-filled blisters (pemphigoid); Excessive hair growth; Hair loss.

Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines. The dose of Spirolon may be altered if they are taking any of the following: digoxin or carbenoxolone; medicines for high blood pressure including angiotensin-converting enzyme (ACE) inhibitors; other diuretics; non-steroidal anti-inflammatory drugs (NSAID) such as aspirin, indomethacin, mefenamic acid or ibuprofen; potassium supplements; antipyrine; heparin or low molecular weight heparin (medicines used to prevent blood clots); medicines known to cause hyperkalaemia (raised blood potassium levels); trimethoprim and trimethoprim-sulfamethoxazole.
Spirolon reduces the patient's responsiveness to noradrenaline. If the patient is going to have an operation where they will be given an anesthetic, they must be advised to inform the doctor in charge that they are taking Spirolon. Patients must be advised to inform the doctor if they are using abiraterone for the treatment of prostate cancer.
Spirolon with food, drink and alcohol: See Dosage & Administration.

Store below 25°C. Protect from light and moisture.

Diuretics

C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.

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