SPIRONOL 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Spironol, 50 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Spironol and what is it used for
4. Important information before taking Spironol
   1. When not to take Spironol:
   2. Warnings and precautions
   3. Spironol and other medicines
   4. Spironol with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Spironol contains lactose
   8. Spironol film-coated tablets contain sodium lauryl sulfate
5. How to take Spironol
   1. Adults
   2. Elderly patients
   3. Children and adolescents
   4. Taking a higher dose of Spironol than recommended
   5. Missing a dose of Spironol
   6. Stopping treatment with Spironol
6. Possible side effects
   1. List of other side effects by frequency:
   2. Reporting side effects
7. How to store Spironol
8. Contents of the pack and other information
   1. What Spironol contains
   2. What Spironol looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet: May 2025

Package Leaflet: Information for the User

Spironol, 50 mg, Film-Coated Tablets

Spironolactone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Spironol and what is it used for

Spironol contains the active substance spironolactone. Spironol belongs to a group of medicines called diuretics, also known as water tablets.
The reason for the patient's visit to the doctor may be swelling of the ankles or shortness of breath. These symptoms may occur if the heart's pumping function is weakened due to too much fluid in the body. This is called congestive heart failure.
The need to pump excess fluid throughout the body means that the heart has to work harder. The doctor prescribes Spironol to the patient in order to get rid of excess fluid from the body. As a result, the heart will be able to work less intensely.
Excess fluid is removed in the urine, so during treatment with Spironol, it may be necessary to use the toilet more often.
Spironol may also be used in the following conditions:

• Nephrotic syndrome - a kidney disorder that causes excess fluid in the body.
• Ascites - excess fluid in the abdominal cavity and edema - fluid accumulation under the skin or in at least one body cavity (causing swelling), for example, due to liver cirrhosis.
• Ascites caused by malignant tumors - excess fluid due to the accumulation of cancer cells in the abdominal cavity.
• Primary hyperaldosteronism - excess fluid in the body caused by too high a concentration of a hormone called aldosterone.
• Hypertension - as an additional medicine in patients who do not respond sufficiently to other antihypertensive medicines.

If the patient has the above conditions, Spironol will help get rid of excess fluid from the body.
If, after taking Spironol, the patient does not feel better or feels worse, they should consult a doctor.
Children should only be treated under the supervision of a pediatrician.

2. Important information before taking Spironol

When not to take Spironol:

• 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 hyperkalemia (elevated potassium levels in the blood);
• if the patient is unable to urinate (anuria);
• if the patient has severe kidney disease;
• if the patient is breastfeeding;
• if the patient is taking potassium-sparing diuretics (potassium-sparing diuretics) or any other medicines to supplement potassium levels;
• 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 renal impairment.

Warnings and precautions

Before starting treatment with Spironol, the patient should discuss it with their doctor or pharmacist:

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

Taking Spironol with certain medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, heart rhythm disturbances, diarrhea, nausea, dizziness, or headache.
In the event of kidney dysfunction or failure, the patient may experience a dangerous increase in potassium levels in the blood. This can affect heart function and, in extreme cases, lead to death.

Spironol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking abiraterone for the treatment of prostate cancer, they should inform their doctor.
The patient should inform their doctor if they are taking mitotane for the treatment of adrenal gland cancer. This medicine should not be taken at the same time as mitotane.
The doctor may change the dose of Spironol if the patient is taking any of the following medicines:

• digoxin or carbenoxolone;
• medicines used to treat high blood pressure, including ACE inhibitors;
• other diuretics;
• 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);
• antipyretics;
• medicines that may cause hyperkalemia (elevated potassium levels in the blood);
• trimethoprim and trimethoprim with sulfamethoxazole.

Spironol reduces the response to noradrenaline.
If the patient is to undergo surgery with anesthesia, they should inform their doctor about taking Spironol.

Spironol with food and drink

This medicine should be taken with food (see section 3: "How to take Spironol").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There is limited data on the use of Spironol in pregnant women. The doctor will only prescribe Spironol if the potential benefits outweigh the potential risks.
Breastfeeding
Spironol should not be taken by breastfeeding mothers. The patient should discuss with their doctor, who may advise an alternative method of feeding the baby during treatment with this medicine.

Driving and using machines

The patient should be cautious while driving or operating machinery.
Drowsiness and dizziness associated with taking Spironol may affect the ability to drive or operate machinery.

Spironol contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicinal product.

Spironol film-coated tablets contain sodium lauryl sulfate

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

3. How to take Spironol

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
The amount of tablets taken depends on the severity of the disease. This medicine should be taken once a day, with food.

Adults

The dose for adults is 25 mg to 400 mg of spironolactone per day, depending on the disease being treated.
If the patient is unsure, they should ask their doctor or pharmacist.

Elderly patients

The doctor will start treatment with a low initial dose and then gradually increase it as necessary until the desired effect is achieved.

Children and adolescents

If Spironol is taken by children, the number of tablets depends on the child's body weight.
The doctor will determine the dose individually.

Taking a higher dose of Spironol than recommended

If the patient has taken too many tablets by mistake, they should contact their doctor or go to the emergency department of the nearest hospital immediately.
Symptoms of overdose include drowsiness, dizziness, nausea, vomiting, diarrhea, feeling dehydrated, confusion. A rash may appear in the form of flat red surfaces on the skin with small bumps. A very large overdose can lead to changes in sodium and potassium levels in the blood, with weakness, tingling, or numbness of the skin, and (or) muscle cramps.

Missing a dose of Spironol

If the patient forgets to take a tablet, they should take it as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Spironol

Spironol should be taken for as long as the doctor has prescribed. The patient should not stop taking the medicine without consulting their doctor, even if they feel better. If the patient stops taking the medicine too quickly, their condition may worsen.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Spironol can cause side effects, although not everybody gets them.
The patient should immediately inform their doctorif they experience any of the following symptoms after taking the medicine. Although these symptoms are very rare, they can be serious:

• itching and blisters on the skin around the lips and on other parts of the body (Stevens-Johnson syndrome),
• the top layer of the skin peeling off from the lower layers of the skin on the entire surface of the body (toxic epidermal necrolysis, TEN),
• skin rash, fever, and swelling (which may be symptoms of a more serious disorder, drug reaction with eosinophilia and systemic symptoms, DRESS),
• yellowing of the skin and eyes (jaundice); Spironol may cause liver function disorders,
• irregular heartbeat, which can lead to death, feeling of tingling, paralysis (loss of muscle function), or difficulty breathing. These may be symptoms of elevated potassium levels in the blood. The doctor will recommend regular blood tests to monitor potassium and other electrolyte levels. If necessary, the doctor may decide to stop treatment.

List of other side effects by frequency:

Very common: may affect more than 1 in 10 people

• Elevated potassium levels in the blood.

Common: may affect up to 1 in 10 people

• Disorientation.
• Dizziness.
• Nausea.
• Itching of the skin.
• Rash.
• Muscle cramps, including leg cramps.
• Kidney failure or dysfunction.
• Breast enlargement in men.
• Chest pain (in men).
• General feeling of being unwell.

Uncommon: may affect up to 1 in 100 people

• Changes in the breasts, such as benign breast tumors (in men).
• Electrolyte disturbances, such as high calcium levels in the blood.
• Liver function disorders.
• Skin allergy with itching and blisters, urticaria-like rash.
• Menstrual disorders in women.
• Chest pain (in women).

Frequency not known: cannot be estimated from the available data

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

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Spironol

The medicine should be stored out of 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 month stated.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Spironol contains

The active substance of the medicine is spironolactone. One tablet contains 50 mg of spironolactone.

• Other ingredients are: rice starch, lactose monohydrate, sodium lauryl sulfate, croscarmellose sodium, talc, magnesium stearate, hypromellose (HPMC 606), macrogol 20,000.
• Macrogol 20,000.

What Spironol looks like and contents of the pack

Tablets are film-coated with a transparent coating, almost white to creamy in color, biconvex, round with a "50" engraving on one side of the tablet and a horizontal score line on the other side. Diameter approximately 9 mm.
Spironol is packaged in PVC/Aluminum blisters placed in a cardboard box. The box contains 30, 60, or 90 tablets and a patient information leaflet.

Marketing authorization 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
In order to obtain more detailed information about the medicine, the patient should 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]

Date of last revision of the leaflet: May 2025

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