Verospiron

Patient Information Leaflet

Verospiron, 50 mg, hard capsules
Verospiron, 100 mg, hard capsules
Spironolactonum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Verospiron is and what it is 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 Verospiron is and what it is used for

Verospiron 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 is weakened 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 Verospiron to help remove this excess fluid from your body. As a result, the heart can work less strenuously. The excess fluid is eliminated through the urine, which may mean you need to pass water more frequently while taking Verospiron.

Verospiron may also be used in 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 tumour.
• Oedema in nephrotic syndrome – a kidney disorder caused by excess fluid in the body.
• Primary hyperaldosteronism – excess fluid in the body caused by high levels of a hormone called aldosterone.

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

2. Important information before taking Verospiron

When not to take Verospiron:

• 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 (increased potassium levels in the blood);
• if the patient has difficulty passing urine;
• if the patient has acute renal failure – severe kidney disease;
• if the patient is taking diuretics known as potassium-sparing diuretics or any other medicines to correct potassium deficiency;
• if the patient is taking eplerenone (a medicine used to treat high blood pressure);
• if the patient is breastfeeding.

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

Warnings and precautions

Before starting Verospiron, discuss this with your doctor or pharmacist if:

• the patient has kidney or liver disease;
• the patient has diabetes with or without kidney function disorders;
• the patient is taking any other diuretic (water tablets) together with Verospiron, as this may lead to reduced sodium levels in the blood (hyponatremia);
• the patient is taking any other medicines affecting blood potassium levels;
• the patient is on a potassium-rich diet or using salt substitutes containing potassium;
• the patient is elderly.

Concurrent use of Verospiron with certain medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (elevated blood potassium levels). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
In such cases, the doctor will regularly order laboratory tests.
In patients with impaired kidney function or kidney failure, dangerous increases in blood potassium levels may occur. This may affect heart function and, in extreme cases, may lead to death.

• if the patient has porphyria, a specific disorder affecting the production of a chemical compound containing iron that gives blood its red color;
• if the patient is pregnant.

This medicine should not be used long-term unless necessary.

Verospiron 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 your doctor if the patient is taking mitotane for the treatment of malignant adrenal tumors. This medicine should not be used together with mitotane.

The doctor may adjust the dose of Verospiron if the patient is 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 channel blockers, beta-blockers, nitrates (e.g. nitroglycerin) – these may cause additional blood pressure lowering effects due to Verospiron,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, acetylsalicylic acid, indomethacin, and mefenamic acid,
• potassium supplements,
• medicines known to cause hyperkalemia (increased blood potassium levels),
• heparin or low molecular weight heparin (medicines used to prevent blood clots),
• medicines containing ammonium chloride (expectorant medicines),
• antipyrines, used to reduce fever,
• antipsychotics, tricyclic antidepressants (used in psychiatric disorders),
• lithium used in the treatment of psychiatric disorders (e.g. mania, bipolar disorder),
• sleeping pills (e.g. barbiturates), anaesthetics, or painkillers,
• noradrenaline,
• immunosuppressive medicines (medicines used to prevent organ transplant rejection, such as cyclosporine and tacrolimus),
• corticosteroids and antihistamines (medicines used to treat rheumatoid arthritis (a chronic joint disease), 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 pituitary hormones, e.g. luteinizing hormone-releasing hormone (LHRH) agonists,
• medicines used to treat high blood cholesterol levels (e.g. cholestyramine),
• trimethoprim and trimethoprim in combination with sulfamethoxazole.

If the patient is scheduled for surgery under anaesthesia, inform the attending doctor about the use of 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 during treatment with Verospiron.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Breastfeeding is not recommended during treatment with Verospiron. The patient should discuss alternative feeding methods with her doctor while taking this medicine.

Driving and using machines

Exercise caution when driving or operating machinery.

Drowsiness and dizziness may occur during treatment with Verospiron, which may affect the ability to drive or operate machinery.

Verospiron 100 mg tablets contain a colouring agent – Sunset Yellow (E110).
Sunset Yellow may cause allergic reactions.

Verospiron capsules contain lactose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Verospiron capsules contain sodium lauryl sulfate. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Verospiron

This medicine should always be taken according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
The number of capsules to take depends on the severity of the disease. It is recommended to take the medicine once
daily, during a meal.
While taking Verospiron, your doctor may recommend blood tests to monitor potassium and creatinine levels.
Use in adults
The dose for adults ranges from 25 mg to 400 mg of spironolactone per day.
If you have any doubts about the dose, consult your doctor or pharmacist.
Use in elderly patients
The treating doctor will start treatment with the lowest initial dose and then gradually increase the dose if necessary, until the desired effect is achieved.
Use 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 at an appropriate dose depending on the child's body weight. The doctor will determine the dose individually.
Taking more Verospiron than recommended
If too many capsules are accidentally taken, contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include: drowsiness, dizziness, nausea, vomiting, diarrhoea, and feeling disoriented. Changes in blood sodium and potassium levels may cause weakness, as well as tingling, pricking, or numbness of the skin and (or) muscle cramps.
Missing a dose of Verospiron
If a patient forgets to take a Verospiron capsule, 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 Verospiron treatment
Verospiron should be taken for as long as your doctor has instructed. Do not stop taking the medicine without consulting your doctor, even if you feel better. Stopping treatment too early may cause your condition to worsen.
If you have any further questions about the use of this medicine, consult your 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 in the patient after taking the medicine. Although these symptoms usually occur very rarely or at an unknown frequency, they may be severe.

• Severe skin reactions with fever, severe skin rash, urticaria, redness, itching, blistering, skin peeling, swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) (frequency unknown).
• Drug rash with eosinophilia and systemic symptoms (DRESS). The DRESS syndrome begins with influenza-like symptoms and a rash on the face, followed by widespread skin rashes, high fever, swollen lymph nodes, increased liver enzyme activity in blood tests, and an increased number of a type of white blood cells (called eosinophilia).
• Jaundice (yellowing of the skin and eyes) – Verospiron may cause disturbances in liver function (not uncommon) and hepatitis (very rare).
• Skin rash, fever, and swelling (which may be signs of more serious disorders, such as drug rash, eosinophilia, and systemic symptoms).
• Irregular heart function (very common in patients with kidney failure and in patients who are simultaneously taking potassium-containing products) – these may be symptoms of increased blood potassium levels. Your doctor will recommend regular blood tests to monitor potassium and other electrolyte levels. If necessary, your doctor may decide to discontinue treatment.

Other adverse reactions:
Very common adverse reactions (may affect at least 1 in 10 patients):

• increased blood potassium levels (in patients with kidney failure and in patients simultaneously taking potassium-containing products),
• problems with heart rate or rhythm,
• reduced sexual drive (libido) in both sexes,
• menstrual disorders, breast tenderness and enlargement in women,
• erectile dysfunction, excessive growth of breast tissue (gynecomastia), and breast pain in men.

Common adverse reactions (may affect up to 1 in 10 patients):

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

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• benign breast tumors (men),
• disturbances in electrolyte concentrations,
• disturbances in liver function,
• urticaria (formation of itchy skin wheals),
• somnolence (in patients with liver cirrhosis),
• headache,
• breast pain in women,
• fatigue.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• allergic reactions,
• low blood sodium levels, inadequate tissue hydration (dehydration),
• gastric mucosal inflammation, gastric ulcers, gastrointestinal bleeding, stomach pain, diarrhea,
• porphyria (disorders of red blood pigment synthesis causing abdominal pain, muscle pain, red or brown discoloration of urine, seizures, and psychiatric disturbances).

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• decreased number of white blood cells (leukopenia, agranulocytosis), decreased number of platelets (thrombocytopenia), or increased number of blood eosinophils (eosinophilia),
• weak androgenic effects, including hirsutism and voice changes,
• inability to perform movements due to loss of muscle function (flaccid paralysis due to increased blood potassium levels, paralysis of both upper or lower limbs),
• vasculitis,
• hepatitis,
• hair loss,
• rash, erythema annulare,
• lupus-like symptoms,
• softening of the bones (osteomalacia),
• changes in laboratory test results related to kidney function (increased blood urea and creatinine levels),
• inability to perform movements due to loss of muscle function (flaccid paralysis due to increased blood potassium levels, paralysis of both upper or lower limbs).

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

• reduced number of oxygen-carrying cells (anaemia),
• reduced number of cells involved in blood clotting or increased number of eosinophils in blood (eosinophilia), increasing the risk of bleeding or bruising, or causing purpuric skin spots (purpura),
• blood acidification (acidosis),
• general weakness or lethargy and problems with muscle coordination (ataxia),
• lethargy,
• low blood pressure,
• excessive hair growth,
• pemphigoid (a disease causing blisters on the skin),
• leg muscle cramps,
• drug-induced fever,
• changes in laboratory test results (increased glycated hemoglobin levels).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the 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 following "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, corn starch, 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, corn starch, lactose monohydrate, sunset 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 colour. Granulate inside the capsule is white.
Verospiron 100 mg – hard capsules, orange-yellow in colour. Granulate inside the capsule is white.
Verospiron capsules are packed in aluminium/PVC blisters. The blisters are placed in a cardboard box containing the patient leaflet. The pack contains 30 hard capsules.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

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
Poland
Tel. +48 (22) 755 96 48
[email protected]