Spironol 100

Patient Information Leaflet

Spironol 100, 100 mg, coated tablets
Spironolactonum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Spironol 100 is and what it is used for
2. What you need to know before taking Spironol 100
3. How to take Spironol 100
4. Possible side effects
5. How to store Spironol 100
6. Contents of the pack and other information

1. What Spironol 100 is and what it is used for

Spironol 100 contains the active substance spironolactone. Spironol 100 belongs to a group of medicines called diuretics, also known as water tablets.
You may have visited your doctor due to swollen ankles or breathlessness. These symptoms may occur when the heart's ability to pump blood weakens due to excess fluid in the body. This is known as congestive heart failure. The need to pump excess fluid throughout the body means the heart must work harder. Your doctor has prescribed Spironol 100 to help remove excess fluid from your body. As a result, the heart will be able to work less intensively. The excess fluid is removed through the urine, so you may need to pass urine more frequently while taking Spironol 100.
Spironol 100 may also be used in the following conditions:

• Nephrotic syndrome – a kidney disorder caused by excess fluid in the body.
• Ascites – excess fluid in the abdominal cavity, and oedema – fluid accumulation under the skin or in at least one body cavity (causing swelling), for example, due to liver cirrhosis.
• Malignancy-related ascites – excess fluid due to accumulation of cancer cells in the abdominal cavity.
• Primary hyperaldosteronism – excess fluid in the body caused by abnormally high levels of a hormone called aldosterone.
• Hypertension – as an add-on therapy in patients who do not respond adequately to other antihypertensive medicines.

If you have any of the conditions listed above, Spironol 100 will help eliminate excess fluid from your body.
If you do not feel better or feel worse after taking Spironol 100, consult your doctor.
Children should only be treated under the supervision of a paediatrician.

2. Important information before using Spironol 100

When not to take Spironol 100:

• if the patient is allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6);
• if the patient has Addison's disease (a deficiency of certain hormones, characterized by extreme weakness, weight loss, and low blood pressure);
• if the patient has hyperkalaemia (increased potassium levels in the blood);
• if the patient is unable to pass urine (anuria);
• if the patient has severe kidney disease;
• if the patient is breastfeeding;
• if the patient is taking potassium-sparing diuretics (diuretic medicines that preserve potassium) or any other medicines to correct potassium deficiency;
• if the patient is taking eplerenone (a medicine used to treat high blood pressure).

Spironolactone is contraindicated in children and adolescents with moderate or severe kidney impairment.

Warnings and precautions

Before starting to take Spironol 100, discuss this with your doctor or pharmacist.

• if the patient has kidney disease, especially children with hypertension, or liver disease. The doctor will assess the patient's condition during routine visits;
• if the patient has difficulty passing urine;
• if the patient has a condition associated with disturbances in blood electrolyte levels, such as potassium or sodium;
• if the patient has severe heart failure;
• if the patient is pregnant.

Concomitant use of Spironol 100 with certain medicines, potassium supplements, or potassium-rich food products may lead to severe hyperkalaemia (increased potassium levels in the blood). Symptoms of severe hyperkalaemia may include muscle cramps, heart rhythm disturbances, diarrhoea, nausea, dizziness, or headache.

In case of impaired kidney function or kidney failure, the patient may develop a dangerous increase in blood potassium levels. This may affect heart function and, in extreme cases, may lead to death.

Spironol 100 and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

If the patient is taking abiraterone for the treatment of prostate cancer, they should inform their doctor.

Tell the doctor if the patient is taking mitotane for the treatment of malignant adrenal tumours. This medicine should not be used simultaneously with mitotane.

The doctor may adjust the dose of Spironol 100 if the patient is taking any of the following medicines:

• digoxin or carbenoxolone,
• medicines used to treat high blood pressure, including ACE inhibitors,
• other diuretic medicines,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, indomethacin, mefenamic acid, or ibuprofen,
• potassium supplements,
• heparin or low-molecular-weight heparin (medicines used to prevent blood clots),
• antipyrine,
• medicines that may cause hyperkalaemia (increased potassium levels in the blood),
• trimethoprim and trimethoprim with sulfamethoxazole.

Spironol 100 reduces the response to noradrenaline.

If the patient is due to undergo surgery under anaesthesia, inform the attending doctor about the use of Spironol 100.

Spironol 100 with food and drink

This medicine should be taken during a meal (see section 3 "How to take Spironol 100").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

There is limited data on the use of Spironol 100 in pregnant women. The doctor will prescribe Spironol 100 only if the potential benefits outweigh the potential risks.

Breastfeeding

Spironol 100 should not be used in breastfeeding mothers. The patient should speak with her doctor, who may advise an alternative method of feeding the baby during treatment with this medicine.

Driving and operating machinery

Exercise caution when driving and operating machinery.

Drowsiness and dizziness may occur with the use of Spironol 100, which may affect the ability to drive and operate machinery.

Spironol 100 contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicinal product.

Spironol coated tablets contain sodium lauryl sulphate

This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Spironol 100

This medicine should always be taken as directed by the physician. In case of doubts, consult a doctor or pharmacist.
The number of tablets taken depends on the severity of the disease. This medicine should be taken once daily during a meal.
Adults
The dose for adults is 25 mg to 400 mg of spironolactone per day, depending on the condition being treated.
In case of doubts, consult a doctor or pharmacist.
Elderly patients
The physician will start treatment with a low initial dose and then gradually increase the dose if necessary, until the desired effect is achieved.
Children and adolescents
If Spironol 100 is taken by children, the number of tablets depends on the child's body weight. The dose is determined individually by the physician.
Taking more than the recommended dose of Spironol 100
If too many tablets are accidentally taken, contact a doctor immediately or go to the emergency department of the nearest hospital. Symptoms of overdose include drowsiness, dizziness, nausea, vomiting, diarrhoea, feeling of dehydration, confusion. A rash may appear in the form of flat red areas on the skin with small raised bumps.
Very large overdose may lead to changes in blood sodium and potassium levels, causing weakness, tingling, pricking, or numbness of the skin and (or) muscle cramps.
Missed dose of Spironol 100
If a patient forgets to take a tablet of Spironol 100, they should take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Spironol 100
Spironol 100 should be taken for as long as directed by the physician. Do not stop taking this medicine without consulting a doctor, even if the patient feels better. Stopping treatment too early may cause the patient's condition to worsen.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately inform your doctor if any of the following symptoms occur after taking the medicine. Although these symptoms are very rare, they may be severe.

• Itching and blisters on the skin around the lips and other parts of the body (Stevens-Johnson syndrome),
• Separation of the outer layer of skin from the underlying layers over the entire body surface (toxic epidermal necrolysis, TEN),
• Skin rash, fever, and swelling (which may be signs of more serious disorders, such as drug reaction with eosinophilia and systemic symptoms, DRESS),
• Yellowing of the skin and eyes (jaundice); Spironol 100 may cause liver function disorders,
• Irregular heartbeat, which may lead to death, tingling sensations, paralysis (loss of muscle function), or breathing difficulties. These may be symptoms of increased potassium levels in the blood. Your doctor will recommend regular blood tests to monitor potassium and other electrolyte levels. If necessary, your doctor may decide to discontinue treatment.

List of other adverse reactions by frequency of occurrence:
Very common: may affect more than 1 in 10 people

• Increased potassium levels in the blood.

Common: may affect up to 1 in 10 people

• Confusion.
• Dizziness.
• Nausea.
• Itching of the skin.
• Rash.
• Muscle cramps, including in the legs.
• Kidney failure or impaired kidney function.
• Breast enlargement in men.
• Breast pain (in men).
• General malaise.

Uncommon: may affect up to 1 in 100 people

• Breast changes, such as benign breast tumors (in men).
• Electrolyte imbalances, such as high calcium levels in the blood.
• Liver function disorders.
• Skin allergy with itching and blisters, rash resembling hives.
• Menstrual disorders in women.
• Breast pain (in women).

Frequency not known: cannot be estimated from the available data

• Decreased number of white blood cells in the blood.
• Decreased number of white blood cells involved in fighting infections, making it easier to contract infections.
• Decreased number of cells involved in blood clotting, increasing the risk of bleeding or bruising.
• Changes in sex drive (libido) in both women and men.
• Digestive disorders, gastritis.
• A condition in which fluid-filled blisters appear on the skin (pemphigoid).
• Excessive hair loss.
• Excessive hair growth.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Spironol 100

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Spironol 100 contains

• The active substance is spironolactone. One tablet contains 100 mg of spironolactone.
• Other ingredients are: rice starch, monohydrate lactose, sodium lauryl sulfate, talc, magnesium stearate, sodium carboxymethylstarch (type A), hypromellose, Macrogol 20 000.

What Spironol 100 looks like and contents of the pack
Film-coated tablets, almost white to cream in colour, biconvex, round, with a score line on one side allowing for division of the tablet. The tablet can be divided into equal doses.
Spironol 100 is packed in blisters made of Aluminium/PVC foil, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: (22) 755 50 81

For further information about this medicinal product, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]
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