Verospiron

Package Leaflet: Information for the User

Verospiron, 50 mg, hard capsules

Verospiron, 100 mg, hard capsules

Spironolactone

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

• Keep this 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 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 pack 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 has prescribed Verospiron to get rid of excess fluid from your body. This will allow your heart to work less hard. Excess fluid is removed in the urine, so you may need to urinate more often when 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 the presence of a tumor.
• Edema in nephrotic syndrome - kidney dysfunction caused by excess fluid in the body.
• Primary hyperaldosteronism - excess fluid in the body due to too high a level of a hormone called aldosterone.

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

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 renal failure - severe kidney disease;
• if you are taking potassium-sparing diuretics or any other medicines to supplement potassium levels;
• 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 renal impairment.

Warnings and precautions

Before taking Verospiron, discuss it with your doctor or pharmacist.

• if you have kidney or liver disease;
• if you have diabetes with kidney problems or without kidney problems;
• if you are taking other diuretics (at the same time as Verospiron), as this may lead to low sodium levels in the blood (hyponatremia);
• if you are taking 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 to check potassium and other electrolyte levels. If you have kidney dysfunction or renal failure, you may experience a dangerous increase in potassium levels in the blood. This can affect heart function and, in severe cases, lead to death.

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

Unless necessary, this medicine should not be used for a long time.

Verospiron and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

If you are taking abiraterone for prostate cancer, tell your doctor. You should not take Verospiron with mitotan, used to treat adrenal gland cancer. Your doctor may change the dose of Verospiron if you are taking any of the following medicines:

• digoxin (used for certain heart conditions),
• 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 blood pressure lowering 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 (used to prevent rejection of a transplanted organ, such as cyclosporine and tacrolimus),
• corticosteroids and antihistamines (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 going to have surgery with anesthesia, inform your doctor that you are taking Verospiron.

Verospiron with food, drink, and alcohol

This medicine should be taken with food (see section 3 "How to take Verospiron"). Drinking alcohol is not recommended while taking Verospiron.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy There is limited data on the use of Verospiron in pregnant women. Your doctor will only prescribe Verospiron if the potential benefits outweigh the potential risks. Breastfeeding You should not breastfeed while taking Verospiron. You should discuss with your doctor an alternative method of feeding your child during treatment with this medicine.

Driving and using machines

Be careful when driving or operating machinery. Drowsiness and dizziness caused by Verospiron may affect your ability to drive or operate machinery.

Verospiron 100 mg contains the colorant - orange yellow (E110).

Orange yellow may cause allergic reactions. Verospiron capsules contain lactose.If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. Verospiron capsules contain sodium lauryl sulfate.The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Verospiron

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The number of capsules to take depends on the severity of your condition. It is recommended to take once a day, with food. During Verospiron treatment, your doctor may order blood tests to monitor potassium and creatinine levels.

Adult dose

The dose for adults is from 25 mg to 400 mg of spironolactone per day. If you have any doubts about the dose, ask your doctor or pharmacist.

Dose in elderly patients

Your doctor will start treatment with the lowest initial dose and gradually increase it as necessary until the desired effect is achieved.

Dose in children and adolescents

Children should not be treated with Verospiron 50 mg, hard capsules, and Verospiron 100 mg, hard capsules. Instead, Verospiron 25 mg, tablets may be used in an appropriate dose based on the child's body weight. The doctor will determine the dose individually.

Taking a higher dose of Verospiron than recommended

If you have taken too many capsules, 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, numbness, or muscle cramps.

Missing a dose of Verospiron

If you forget to take a capsule, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping Verospiron treatment

Verospiron should be taken for as long as your doctor has prescribed. Do 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, ask your doctor or pharmacist.

4. Possible side effects

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

• Severe skin reactions with fever, severe skin rash, urticaria, redness, itching, blistering, peeling, swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) (unknown frequency).
• Drug rash with eosinophilia and systemic symptoms (DRESS). DRESS starts with flu-like symptoms and a rash on the face, followed by widespread skin rash, high fever, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
• Jaundice (yellowing of the skin and eyes) - Verospiron may cause liver dysfunction (not very common) and hepatitis (rare).
• Skin rash, fever, and swelling (which may be symptoms of more serious disorders, drug rash, and eosinophilia with systemic symptoms).
• Irregular heartbeat (very common in patients with renal failure and in patients taking potassium-containing products) - 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 renal failure and in patients taking potassium-containing products),
• heart rhythm or pulse 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 renal 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,
• breast pain in women,
• fatigue.

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

• allergic reactions,
• low sodium levels in the blood, dehydration,
• gastritis, stomach ulcers, stomach bleeding, stomach pain, diarrhea,
• 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,
• inability to move due to muscle weakness (flaccid paralysis due to high potassium levels in the blood, paralysis of both upper or lower limbs),
• vasculitis,
• hepatitis,
• hair loss,
• eczema, erythema multiforme,
• lupus-like symptoms,
• osteomalacia (softening of the bones),
• changes in laboratory test results for kidney function (elevated 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 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 causes purpura (purple spots on the skin),
• acidosis (acidification of the blood),
• general weakness or lethargy and coordination problems (ataxia),
• lethargy,
• low blood pressure,
• excessive hair growth,
• pemphigoid (a disease that causes blistering of the skin),
• leg cramps,
• drug fever,
• changes in laboratory test results (elevated glycosylated hemoglobin levels).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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

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 month. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Verospiron contains

• -The active substance is spironolactone.
• Each Verospiron 50 mg capsule contains 50 mg of spironolactone.
• Other ingredients are: sodium lauryl sulfate, magnesium stearate, cornstarch, lactose monohydrate, quinoline yellow (E 104), titanium dioxide (E 171), gelatin.
• Each Verospiron 100 mg capsule contains 100 mg of spironolactone.
• -Other ingredients are: sodium lauryl sulfate, magnesium stearate, cornstarch, lactose monohydrate, orange yellow (E 110), titanium dioxide (E 171), quinoline yellow (E 104), gelatin.

What Verospiron looks like and contents of the pack

Verospiron 50 mg - hard capsules, yellow-white in color. The granules in the capsule are white. Verospiron 100 mg - hard capsules, orange-yellow in color. The granules in the capsule are white. Verospiron capsules are packaged in aluminum/PVC blisters. The blisters are packaged in a cardboard box containing a patient leaflet. The pack contains 30 hard capsules.

Marketing authorization holder and manufacturer

Gedeon Richter Plc., Gyömrői út 19-21, 1103 Budapest, Hungary. For more information about this medicine, 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