Verospiron

Package leaflet: Information for the user

Verospiron, 25 mg, tablets
Spironolactonum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell 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 pills.
You may have visited your doctor due to swollen ankles or shortness of breath.
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 excess fluid from the body.
As a result, the heart will be able to work less strenuously.
The excess fluid is eliminated through urine, so you may need to urinate 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 – kidney dysfunction caused by excess fluid in the body.
• Primary hyperaldosteronism – excess fluid in the body due to abnormally high levels of a hormone called aldosterone.

Children should only be treated under the supervision of a paediatrician.
If you have any of the conditions listed above, Verospiron will help eliminate excess fluid from the body.

2. Important information before using 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 supplement potassium;
• 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 complications;
• the patient is taking any other diuretics (water tablets) together with Verospiron, as this may lead to decreased sodium levels in the blood (hyponatremia);
• the patient is taking any other medicines affecting potassium levels in the blood;
• the patient is on a potassium-rich diet or using potassium-containing salt substitutes;
• the patient is elderly.

Concomitant use of Verospiron with certain medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (increased potassium levels in the blood). 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 absolutely necessary.

Verospiron and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

If the patient is taking abiraterone for the treatment of prostate cancer, they should inform their doctor.

Tell the doctor if the patient is taking mitotane for the treatment of adrenal gland cancers. This medicine should not be used together with mitotane.

The doctor may need to 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), which may cause additional blood pressure lowering effects when used with 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 potassium levels in the blood);
• heparin or low-molecular-weight heparin (medicines used to prevent blood clots);
• ammonium chloride-containing medicines (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), anesthetics, or painkillers;
• noradrenaline;
• immunosuppressive medicines (medicines used to prevent rejection of transplanted organs, 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 hormones acting on the pituitary gland, e.g. luteinizing hormone-releasing hormone (LHRH) agonists;
• medicines used to treat high cholesterol levels in the blood (e.g. cholestyramine);
• trimethoprim and trimethoprim in combination with sulfamethoxazole.

If the patient is scheduled for surgery under anesthesia, inform the attending physician 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 plans 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 must not be undertaken during treatment with Verospiron. The patient should discuss alternative feeding methods with her doctor while taking this medicine.

Driving and operating machinery

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

3. How to use Verospiron

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The number of tablets 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 usual dose for adults is 25 mg to 200 mg of spironolactone per day.
If in doubt about the dose, consult your doctor or pharmacist.
Use in elderly patients
The treating physician 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
If Verospiron is taken by children, the number of tablets depends on the child's body weight. The doctor will determine the dose individually.
Taking more Verospiron than prescribed
If too many tablets are accidentally taken, contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include: drowsiness, dizziness, nausea, vomiting, diarrhea, and feeling confused. Changes in blood sodium and potassium levels may cause weakness, tingling, pricking, or numbness of the skin, and (or) muscle cramps.
Missing a dose of Verospiron
If a patient forgets to take a tablet of Verospiron, 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 should 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 with unknown frequency, they may be severe.

• Severe skin reactions with fever, severe skin rash, urticaria, redness, itching, blistering, peeling of the skin, swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) (frequency not known).

• Drug rash with eosinophilia and systemic symptoms (DRESS). The DRESS syndrome begins with flu-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 liver function disorders (not uncommon) and hepatitis (very rare).

• Irregular heart function (very common in patients with kidney impairment and in patients who are simultaneously taking potassium-containing products) – these may be symptoms of increased potassium levels in the blood. 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 occur in at least 1 in 10 patients):

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

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

• increased potassium levels in the blood (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 occur in up to 1 in 100 patients):

• benign breast tumours (in men),
• disturbances in electrolyte levels,
• liver function disorders,
• urticaria (itchy skin welts),
• drowsiness (in patients with liver cirrhosis),
• headache,
• fatigue.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

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

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

• decreased number of white blood cells (leukopenia, agranulocytosis), decreased number of platelets (thrombocytopenia), or increased number of eosinophilic granulocytes in the blood (eosinophilia),
• weak androgenic effects, including hirsutism and voice changes,
• vasculitis (inflammation of blood vessels),
• hepatitis,
• hair loss,
• rash, annular erythema,
• 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 move due to loss of muscle function (flaccid paralysis due to increased potassium levels in the blood, paralysis of both upper or lower limbs).

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

• reduced number of oxygen-carrying cells (anaemia),
• reduced number of cells involved in blood clotting or increased number of eosinophils in the 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,
• generalized itching,
• excessive hair growth,
• leg muscle cramps,
• drug-induced fever,
• pemphigoid (a disease causing blisters on the skin),
• 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, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Verospiron

Keep this medicine 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 stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Verospiron contains

• The active substance is spironolactone. One tablet contains 25 mg of spironolactone.
• Other ingredients are: colloidal anhydrous silica, magnesium stearate, talc, maize starch, lactose monohydrate.

What Verospiron looks like and contents of the pack
Almost white, round tablets, 9 mm in diameter, flat with bevelled edges, marked with
"VEROSPIRON" on one side.
Verospiron tablets are packed in aluminium/PVC blisters. The blisters are placed in a
cardboard box containing the patient leaflet. The pack contains 20 or 100 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 further information about this medicine, 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]