UraCtone

Patient Information Leaflet

URACTONE 100 mg tablets

Spironolactone
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What URACTONE is and what it is used for
2. What you need to know before taking URACTONE
3. How to take URACTONE
4. Possible side effects
5. How to store URACTONE
6. Contents of the pack and other information

1. What URACTONE is and what it is used for

URACTONE contains the active substance spironolactone, which belongs to a group of medicines
called potassium-sparing diuretics, used to promote urine elimination and to
prevent excessive loss of potassium in the urine.
This medicine is indicated for:

• the treatment of a condition in which levels of the hormone aldosterone are elevated (primary hyperaldosteronism);
• the treatment of fluid accumulation in the body due to increased production of the hormone aldosterone (secondary hyperaldosteronism), which occurs in diseases of the heart (congestive heart failure), liver (hepatic cirrhosis with ascites), and kidneys (nephrotic syndrome);
• the treatment of high blood pressure (essential arterial hypertension) when therapies with other medicines are ineffective or not tolerated.

2. What you need to know before taking URACTONE

Do not take URACTONE

• if you are allergic to spironolactone or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (impaired renal function and creatinine clearance below 30 mL/min per 1.73 m² body surface area, acute renal failure);
• if you have problems passing urine (anuria);
• if you have high levels of potassium in your blood (hyperkalemia);
• if you have a disease of the adrenal gland (Addison's disease) or other conditions associated with high blood potassium levels (hyperkalemia);
• if you have very low levels of sodium in your blood (severe hyponatremia);
• if you have reduced blood volume (hypovolemia) or are in a condition characterized by excessive fluid loss (dehydration).

Warnings and precautions
Talk to your doctor or pharmacist before taking URACTONE.
Always take this medicine under medical supervision.
URACTONE may cause an increase in potassium levels in the blood (hyperkalemia).
Concomitant administration of URACTONE with certain medicines, potassium supplements, and potassium-rich foods may lead to increased potassium levels in the blood (severe hyperkalemia).
Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, and headache.
Stop treatment with URACTONE and inform your doctor immediately if, during therapy, you experience any of the following symptoms of elevated potassium levels in the blood (hyperkalemia):

• altered sensation in arms and legs (paresthesia);
• muscle weakness, fatigue;
• loss of voluntary movement and reduced muscle tone in arms and legs (flaccid paralysis of extremities);
• slowed heart rate (bradycardia);
• severe circulatory problems (shock).

Take this medicine under close medical supervision and with caution if you are in any of the following conditions:

• if you have very low blood pressure (severe hypotension);
• if you have kidney problems (reduced renal function and creatinine clearance below 60 mL/min per 1.73 m² body surface area);
• if you have liver problems;
• if you are taking other medicines that may increase potassium levels in the blood (hyperkalemia) (see section “Other medicines and URACTONE”);
• if you have severe heart problems, as increased potassium levels in the blood may lead to death.

During treatment with URACTONE, your doctor will monitor possible changes in body water and salt levels (electrolyte imbalance). Therefore, you will need periodic blood tests to monitor:

• blood glucose levels (glycemia);
• sodium and potassium levels;
• creatinine levels to assess kidney function, especially if you are elderly or have kidney or liver problems (renal or hepatic impairment).

Inform your doctor if, during treatment with this medicine, you develop any of the following symptoms:

• excessive thirst, dry mouth, general weakness, drowsiness, restlessness, muscle pain or cramps, low blood pressure (hypotension), difficulty urinating (oliguria), excessively rapid heartbeat, gastrointestinal disturbances. These are symptoms of low sodium levels in the blood (hyponatremia);
• increased blood nitrogen levels (azotemia), especially if you have kidney problems (renal failure);
• increased blood acidity due to elevated chloride levels (hyperchloremic acidosis), often associated with increased potassium levels (hyperkalemia), particularly if you have severe liver problems (decompensated hepatic cirrhosis), even if your kidneys are functioning properly;
• development of breast tissue in men (gynecomastia), which may depend on the dose taken and duration of treatment and which usually resolves after stopping treatment. Rarely, it may persist even after discontinuation of therapy;
• voice changes. Therefore, if your profession involves heavy use of the voice (e.g. actor, singer, teacher), your doctor will evaluate with you whether starting URACTONE treatment is appropriate.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and URACTONE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take URACTONE if you are taking the following medicines, as this increases the risk of a marked increase in potassium levels in the blood (severe hyperkalemia) (see section “Warnings and precautions”):

• medicines that increase urine elimination, such as other potassium-sparing diuretics and aldosterone blockers;
• potassium salts, used to correct potassium deficiency;
• medicines that reduce potassium excretion;
• non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation;
• medicines used to treat cardiovascular diseases, such as ACE inhibitors and angiotensin II receptor antagonists (valsartan, losartan);
• medicines used to control blood clotting (heparin, low molecular weight heparin);
• medicines used after organ transplantation or to treat immune system disorders (tacrolimus, cyclosporine);
• medicines used to treat infections (trimethoprim and trimethoprim-sulfamethoxazole).

Inform your doctor if you are taking abiraterone for prostate cancer treatment.
Inform your doctor if you are taking mitotane for the treatment of malignant adrenal gland tumors. This medicine must not be used concomitantly with mitotane.
Take URACTONE with caution and inform your doctor if you are taking the following medicines:

• lithium salts, used to treat certain mood disorders;
• noradrenaline (norepinephrine), a medicine used to increase blood pressure;
• carbenoxolone, used to treat stomach ulcers;
• digoxin, used to treat certain heart conditions;
• colestyramine, a medicine used to lower blood cholesterol levels;
• medicines used to lower blood pressure (antihypertensives).

URACTONE with food and alcohol
Take this medicine with food.
During treatment with this medicine, avoid consuming excessive amounts of liquorice, as it may interfere with the effect of URACTONE.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, take URACTONE only when strictly necessary and under direct medical supervision.
Do not breastfeed while taking URACTONE, as canrenone, a substance formed in the body from spironolactone, passes into breast milk.
Driving and using machines
URACTONE may affect your ability to drive or operate machinery, especially at the beginning of treatment or after consuming alcohol. If you experience drowsiness or dizziness, avoid driving or operating machinery.

3. How to take URACTONE

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Swallow the tablet during meals with water.
Your doctor will determine the dose based on your response to treatment and your tolerance to the medicine.

Treatment of elevated aldosterone levels (primary and secondary hyperaldosteronism)
The recommended dose is 2 tablets of 100 mg per day.

Treatment of high blood pressure (hypertensive states)
The recommended dose is 1–2 tablets (100–200 mg) per day.
If you are taking other medicines that lower blood pressure (antihypertensives), your doctor will need to reduce the dose of the antihypertensive medicine, as URACTONE enhances its effects (synergistic effects) (see section “Other medicines and URACTONE”).

Use in children
Your doctor will reduce the dose according to your child's body weight. Generally, the recommended dose is 3 mg per kg of body weight.
A dose of 25 mg cannot be achieved with this medicine.

If you take more URACTONE than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
After taking an excessive dose of this medicine, disturbances in the body's water and electrolyte balance may occur, along with symptoms such as drowsiness and confusion. Your doctor will determine the appropriate treatment based on your symptoms.

If you forget to take URACTONE
Do not take a double dose to make up for the missed tablet. Take only the next tablet at the scheduled time.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (the frequency of adverse reactions cannot be determined from the available data)

• increased levels of potassium in the blood (hyperkalaemia), especially if you have kidney problems (impaired renal function). This effect may manifest with symptoms such as irregular heartbeat (arrhythmia), fatigue, muscle weakness, for example in the legs;
• reduced levels of sodium in the blood (hyponatraemia), particularly if you consume large amounts of fluids;
• reduction in blood volume (hypovolaemia);
• excessive fluid loss (dehydration);
• onset or worsening of increased blood acidity caused by elevated chloride levels in the blood (hyperchloraemic metabolic acidosis);
• dizziness;
• leg cramps;
• disturbances in the levels of salts in the body (electrolyte imbalance), which may be related to concomitant diseases, concomitant use of other medicines, and dietary habits. In such cases, your doctor should correct these imbalances, especially if they are severe;
• voice changes (dysphonia), such as lowering of voice pitch in women and raising of voice pitch in men. These effects may persist even after discontinuation of treatment;
• stomach bleeding (gastric bleeding);
• stomach damage (ulcer), inflammation of the stomach (gastritis);
• diarrhoea, cramp-like pains, nausea and vomiting;
• kidney problems (acute renal failure, impaired renal function);
• breast pain;
• breast development in men. This effect depends on the dose and duration of treatment; it usually resolves after treatment is stopped (reversible effect), but sometimes may persist even after therapy has been discontinued;
• menstrual irregularities dependent on the dose of medicine taken (dose-dependent), absence of menstruation, bleeding during menopause (post-menopausal bleeding);
• sexual problems (erectile dysfunction) in men and sexual disorders (changes in libido);
• benign breast tumour (neoplasm);
• reduced number of white blood cells in the blood (leucopenia), reduced number of platelets in the blood (thrombocytopenia);
• dizziness, somnolence, loss of coordination of movements (ataxia);
• headache (cephalalgia), mental confusion;
• feeling of tiredness (lethargy);
• inflammation of the liver (hepatitis), increased levels of certain liver enzymes;
• hair loss (alopecia);
• itching, skin irritation (rash, urticaria);
• condition characterised by fluid-filled blisters on the skin (bullous pemphigoid);
• abnormal growth of body hair in women (hirsutism);
• severe skin allergic reactions (Stevens-Johnson syndrome SJS, toxic epidermal necrolysis TEN, drug reaction with eosinophilia and systemic symptoms DRESS);
• malaise.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store URACTONE

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What URACTONE contains

• The active substance is spironolactone. Each tablet contains 100 mg of spironolactone.
• The other components are: starch, polyvinylpyrrolidone, magnesium stearate, calcium sulfate, peppermint flavor.

Description of the appearance of URACTONE and package contents
Carton pack containing 10 white tablets in blister.
Marketing Authorization Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 – 20143 Milan – Italy.
Manufacturer
DOPPEL Farmaceutici S.r.l. – Plant at Via Volturno, 48 – 20089 Quinto De' Stampi – Rozzano (MI), Italy