Verospiron

Leaflet accompanying the packaging: information for the user

Verospiron, 25 mg, tablets

Spironolactone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Verospiron and what is it used for

Verospiron belongs to a group of medicines called diuretics, also known as water tablets. The reason for your doctor visit may have been 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. Your doctor prescribes Verospiron to get rid of excess fluid from the body. This will allow the heart to work less hard. Excess fluid is removed in the urine, so you may need to use the toilet more often while taking Verospiron. Verospiron can also be used for the following conditions:

• Hypertension, in combination with other medicines, when previous treatment with other antihypertensive medicines has been insufficient.
• Ascites - excess fluid in the abdominal cavity, for example, due to liver cirrhosis or cancer.
• Edema in nephrotic syndrome - kidney dysfunction caused by excess fluid in the body.
• Primary hyperaldosteronism - excess fluid in the body caused by too high a level of a hormone called aldosterone.

Children should only be treated under the supervision of a pediatrician. If you have these conditions, Verospiron will help get rid of excess fluid from the body.

2. Important information before taking Verospiron

When not to take Verospiron:

• if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6);
• if you have Addison's disease (a deficiency of certain hormones, characterized by extreme weakness, weight loss, and low blood pressure);
• if you have hyperkalemia (high potassium levels in the blood);
• if you have difficulty urinating;
• if you have acute kidney failure - a severe kidney disease;
• if you are taking potassium-sparing diuretics or any other medicines to supplement potassium;
• if you are taking eplerenone (a medicine used to treat high blood pressure);
• if you are breastfeeding.

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

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Verospiron.

• if you have kidney or liver disease;
• if you have diabetes with kidney problems or without them;
• if you are taking other diuretics (diuretics) at the same time as Verospiron, as this may lead to a decrease in sodium levels in the blood (hyponatremia);
• if you are taking any other medicines that affect potassium levels in the blood;
• if you are on a potassium-rich diet or using salt substitutes containing potassium;
• if you are elderly.

Taking Verospiron with certain other medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (high potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, heart rhythm disturbances, diarrhea, nausea, dizziness, or headache. In such cases, your doctor will regularly order blood tests. In the event of kidney dysfunction or failure, you may experience a dangerous increase in potassium levels in the blood. This can affect the heart's function and, in extreme cases, lead to death.

• if you have porphyria, a specific disorder related to the production of a chemical that contains iron and gives blood its red color;
• if you are pregnant.

Unless necessary, you should not take this medicine for a long time.

Verospiron and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. If you are taking abiraterone for prostate cancer, you should tell your doctor. You should tell your doctor if you are taking mitotan for adrenal gland cancer. This medicine should not be taken at the same time as mitotan. Your doctor may change the dose of Verospiron if you are taking any of the following medicines:

• digoxin (used for certain heart disorders),
• medicines used to treat stomach ulcers (such as carbenoxolone),
• medicines used to treat high blood pressure, including ACE inhibitors, angiotensin II receptor antagonists, diuretics, calcium antagonists, beta blockers,
• nitrates (e.g., nitroglycerin) may cause additional lowering of blood pressure caused by Verospiron,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, acetylsalicylic acid, indomethacin, and mefenamic acid,
• potassium supplements,
• medicines known to cause hyperkalemia (high potassium levels in the blood),
• heparin or low molecular weight heparin (medicines used to prevent blood clots),
• medicines containing ammonium chloride (expectorant medicines),
• antipyretics, used to lower fever,
• antipsychotic medicines, tricyclic antidepressants (used for mental disorders),
• lithium used to treat mental illnesses (e.g., mania, bipolar disorder),
• sedatives (e.g., barbiturates) or anesthetics, painkillers,
• norepinephrine,
• immunosuppressive medicines (medicines used to prevent rejection of a transplanted organ, such as cyclosporine and tacrolimus),
• corticosteroids and antihistamines (medicines used to treat rheumatoid arthritis, eczema, psoriasis, or allergic reactions), terfenadine,
• medicines used to treat epilepsy (such as carbamazepine),
• medicines that prevent blood clotting, known as anticoagulants (coumarin derivatives),
• agonists of certain hormones that act on the pituitary gland, such as luteinizing hormone-releasing hormone (LHRH) agonists,
• medicines used to treat high cholesterol (e.g., cholestyramine),
• trimethoprim and trimethoprim in combination with sulfamethoxazole.

If you are to undergo surgery with anesthesia, you should inform your doctor about taking Verospiron.

Verospiron with food, drink, and alcohol

This medicine should be taken during a meal (see section 3 "How to take Verospiron"). Drinking alcohol is contraindicated while taking Verospiron.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy There are limited data on the use of Verospiron in pregnant women. Your doctor will prescribe Verospiron only if the potential benefits outweigh the potential risks. Breastfeeding You should not breastfeed while taking Verospiron. You should talk to your doctor, who will advise on an alternative method of feeding your baby while taking this medicine.

Driving and using machines

You should be careful when driving or operating machinery. Drowsiness and dizziness associated with taking Verospiron may affect your ability to drive or operate machinery. Verospiron contains lactose.If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Verospiron

This medicine should always be taken as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist. The amount of tablets to take depends on the severity of the disease. It is recommended to take once a day, during a meal. While taking Verospiron, your doctor may order a blood test to check potassium and creatinine levels.

Use in adults

The dose for adults is 25 mg to 200 mg of spironolactone per day. If you are unsure about the dose, you should ask your doctor or pharmacist.

Use in the elderly

Your doctor will start treatment with the smallest initial dose and then gradually increase the dose as needed until the desired effect is achieved.

Use in children and adolescents

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

Taking a higher dose of Verospiron than recommended

If you accidentally take too many tablets, you should contact your doctor or the nearest hospital emergency department. Symptoms of overdose may include drowsiness, dizziness, nausea, vomiting, diarrhea, and disorientation. Changes in sodium and potassium levels in the blood may cause weakness and tingling, pricking, or numbness of the skin and (or) muscle cramps.

Missing a dose of Verospiron

If you forget to take a tablet of Verospiron, you should take it as soon as possible, unless it is almost time for the next dose. You should not take a double dose to make up for the missed dose.

Stopping treatment with Verospiron

Verospiron should be taken for as long as your doctor has prescribed. You should not stop taking the medicine without consulting your doctor, even if you feel better. If you stop taking the medicine too quickly, your condition may worsen. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Verospiron can cause side effects, although not everybody gets them. You should tell your doctor immediatelyif you experience any of the following symptoms after taking the medicine. Although these symptoms are very rare or of unknown frequency, they can be serious.

• Severe skin reactions with fever, severe skin rash, urticaria, redness, itching, blistering, peeling, swelling, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) (unknown frequency).
• Drug rash with eosinophilia and systemic symptoms (DRESS). DRESS syndrome starts with flu-like symptoms with a rash on the face, followed by widespread skin rash, high fever, swollen lymph nodes, elevated liver enzyme activity in blood tests, and an increased number of a type of white blood cell (eosinophilia).

Eosinophilia can cause a rash on the skin, and an increased number of a type of white blood cell (eosinophilia) can cause an increased risk of bleeding or bruising or purpura (purple spots on the skin).

• Jaundice (yellowing of the skin and eyes) - Verospiron may cause liver dysfunction (uncommon) and hepatitis (rare).
• Irrregular heartbeat (very common in patients with kidney failure and in patients taking potassium-containing products) - these may be symptoms of high potassium levels in the blood. Your doctor will order regular blood tests to monitor potassium and other electrolyte levels. If necessary, your doctor may decide to stop treatment.

Other side effects:

Very common side effects (may affect at least 1 in 10 people):

• high potassium levels in the blood (in patients with kidney failure and in patients taking potassium-containing products),
• heart rate or rhythm problems,
• decreased sex drive (libido) in both men and women,
• menstrual disorders, breast tenderness, and breast enlargement in women,
• erectile dysfunction, gynecomastia, and breast pain in men.

Common side effects (may affect up to 1 in 10 people):

• high potassium levels in the blood (in elderly patients, with diabetes, and taking ACE inhibitors),
• disorientation,
• dizziness,
• nausea, vomiting,
• skin rash, itching,
• muscle cramps,
• acute kidney failure,
• infertility (with high doses - 450 mg per day),
• malaise.

Uncommon side effects (may affect up to 1 in 100 people):

• breast tumors (men),
• electrolyte disturbances,
• liver dysfunction,
• urticaria (hives),
• drowsiness (in patients with liver cirrhosis),
• headache,
• fatigue.

Rare side effects (may affect up to 1 in 1,000 people):

• allergic reactions,
• gastritis, stomach ulcers, stomach bleeding, stomach pain, diarrhea,
• low sodium levels in the blood, dehydration,
• porphyria (disorders of red blood cell pigment synthesis, causing abdominal pain, muscle pain, urine discoloration, seizures, and mental disorders).

Very rare side effects (may affect up to 1 in 10,000 people):

• decreased white blood cell count (leukopenia, agranulocytosis), decreased platelet count (thrombocytopenia), or increased eosinophil count in the blood (eosinophilia),
• weak androgen effect, including hirsutism and voice changes,
• vasculitis,
• hepatitis,
• hair loss,
• eczema, erythema multiforme,
• lupus-like symptoms,
• osteomalacia (softening of the bones),
• changes in laboratory test results for kidney function (increased urea and creatinine levels in the blood),
• inability to move due to muscle weakness (flaccid paralysis due to high potassium levels in the blood, paralysis of both upper or lower limbs).

Frequency not known (frequency cannot be estimated from the available data):

• decreased red blood cell count (anemia),
• decreased platelet count or increased eosinophil count in the blood (eosinophilia), which increases the risk of bleeding or bruising or purpura (purple spots on the skin),
• acidosis (acidification of the blood),
• general weakness or lethargy and coordination problems (ataxia),
• lethargy,
• low blood pressure,
• itching all over the body,
• excessive hair growth,
• leg cramps,
• drug fever,
• pemphigoid (a disease that causes blisters on the skin),
• changes in laboratory test results (increased hemoglobin A1c).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can report side effects directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration 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 You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Verospiron

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. This medicine does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Verospiron contains

• -The active substance of the medicine is spironolactone. One tablet contains 25 mg of spironolactone.
• -The other ingredients are: colloidal anhydrous silica, magnesium stearate, talc, cornstarch, lactose monohydrate.

What Verospiron looks like and contents of the packaging

Almost white, round tablets, 9 mm in diameter, flat, with beveled edges, with the inscription "VEROSPIRON" on one side. Verospiron tablets are packaged in aluminum/PVC blisters. The blisters are packaged in a cardboard box containing a patient leaflet. The packaging contains 20 or 100 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary

Manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o. ul. Ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Poland Gedeon Richter Plc. Gyömrői út 19-21 1103 Budapest Hungary For more information about the medicine, you should contact: GEDEON RICHTER POLSKA Sp. z o.o. ul. Ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Tel. +48 (22) 755 96 48 lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: May 2025