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 any not listed in this leaflet, please 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 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 extra 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. The 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 cancer.
• 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 remove 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:

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.

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 be performed.

In the event of kidney dysfunction or renal failure, you may experience a dangerous increase in potassium levels in the blood. This can affect heart function and, in extreme cases, lead to death.

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 now or have recently taken, as well as any medicines you plan to take.

If you are taking abiraterone for the treatment of prostate cancer, tell your doctor.

Tell your doctor if you are taking mitotane for the treatment of adrenal gland cancer. This medicine should not be taken at the same time as mitotane.

Your doctor may change the dose of Verospiron if you are taking any of the following medicines:

• digoxin (used in 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-adrenergic 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 in case of mental disorders),
• lithium used in the treatment of mental illnesses (e.g., mania, bipolar disorder),
• sleeping pills (e.g., barbiturates) or anesthetics, painkillers,
• norepinephrine,
• immunosuppressive medicines (medicines used to prevent the 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 acting on the pituitary gland, e.g., 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, inform your doctor about 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 plan to have a child, 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

Do 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 associated with taking Verospiron may affect your ability to drive or operate machinery.

Verospiron 100 mg contains the dye - 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 the medicine is considered "sodium-free".

3. How to take Verospiron

Always take this medicine 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 the disease. It is recommended to take once a day, with food.

During treatment with Verospiron, your doctor may order blood tests to monitor potassium and creatinine levels.

Use in adults

The dose for adults is 25 mg to 400 mg of spironolactone per day.

If you have any doubts about the dose, ask your doctor or pharmacist.

Use in the elderly

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

Use in children and adolescents

Children should not be treated with Verospiron 50 mg and Verospiron 100 mg hard capsules. Instead, Verospiron 25 mg tablets may be used in an appropriate dose, depending 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, disorientation. Changes in sodium and potassium levels in the blood can 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 possible, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Verospiron

Take Verospiron for as long as your doctor has prescribed. Do not stop treatment 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.

Tell your doctor immediatelyif you experience any of the following symptoms after taking the medicine. Although these symptoms are 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) (frequency unknown).
• 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 the number of a type of white blood cell (eosinophilia).
• Jaundice (yellowing of the skin and eyes) - Verospiron may cause liver dysfunction (uncommon) and hepatitis (rare).
• Skin rash, fever, and swelling (which can be symptoms of more serious disorders, drug rash, and eosinophilia and systemic symptoms).
• Irrregular heartbeat (very common in patients with renal impairment 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 discontinue 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 impairment 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, excessive breast tissue growth (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):

• benign breast tumors (men),
• electrolyte disturbances,
• liver dysfunction,
• urticaria (formation of itchy hives on the skin),
• 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 androgenic effects, 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,
• softening of the bones (osteomalacia),
• 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 unknown (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 purple spots on the skin (purpura),
• acidosis of the blood (acidosis),
• general weakness or lethargy and coordination problems (ataxia),
• lethargy,
• low blood pressure,
• excessive hair growth,
• pemphigoid (a disease that causes blisters on 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 any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Adverse Reaction Monitoring, 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 which is stated on the packaging after "EXP".

The expiry date refers to the last day of that month.

There are no special storage precautions for this medicine.

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.
• The 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.
• -The 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