URACTONE 100 mg Tablets

Зміст інструкції

1. URACTONE 100 mg tablets
   1. What is URACTONE and what is it 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

URACTONE 100 mg tablets

Spironolattone

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is URACTONE and what is it used for

URACTONE contains the active ingredient spironolactone, which belongs to a group of medicines
called potassium-sparing diuretics, used to promote urine elimination and to
prevent excessive potassium loss with 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 an increase in the production of the hormone aldosterone (secondary hyperaldosteronism), which occurs in heart disease (congestive heart failure), liver disease (hepatic cirrhosis in the ascites stage) and kidney disease (nephrotic syndrome);
• the treatment of high blood pressure (essential arterial hypertension) when therapies with other medicines are not effective or are not tolerated.

2. What you need to know before taking URACTONE

Do not take URACTONE

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

Warnings and precautions
Talk to your doctor or pharmacist before taking URACTONE.
Take this medicine always under the control of your doctor.
URACTONE may cause an increase in potassium levels in the blood (hyperkalaemia).
The concomitant administration of URACTONE with certain medicines, potassium supplements and foods
rich in potassium may cause an increase in potassium levels in the blood (severe hyperkalaemia). The
symptoms of severe hyperkalaemia may include muscle cramps, irregular heartbeat,
diarrhoea, nausea, dizziness and headache.

Stop treatmentwith URACTONE and tell your doctor immediatelyif, during
therapy, you experience the following symptoms of increased potassium levels in the blood (hyperkalaemia):

• alteration of sensitivity in the arms and legs (paresthesia);
• muscle weakness, fatigue;
• loss of voluntary movement and decrease in the tone of the muscles of the arms and legs (flaccid paralysis of the extremities);
• slowing of the heartbeat (bradycardia);
• severe problem with blood circulation (shock).

Take this medicine under strict medical supervision, with caution,if you are in one of the
following conditions:

• if you suffer from very low blood pressure (severe hypotension);
• if you have kidney problems (reduced renal function and creatinine clearance less than 60 mL/min per 1.73 m of body surface area);
• if you have liver problems;
• if you are taking other medicines that may promote increased potassium levels in the blood (hyperkalaemia) (See section “Other medicines and URACTONE”);
• if you have severe heart problems, as increased potassium levels in the blood can lead to death.

During treatment with URACTONE, your doctor will need to assess any changes in the
amount of water and salts present in the body (electrolyte imbalance). Therefore, they will perform
periodic blood tests to monitor:

• blood sugar levels (glycaemia);
• sodium and potassium levels;
• creatinine levels to assess your kidney function, especially if you are elderly and suffer from kidney and liver problems (renal or hepatic alterations).

Tell your doctor if you experience symptoms such as:

• excessive thirst, dry mouth, general weakness, drowsiness, agitation, muscle pain or cramps, decreased blood pressure (hypotension), difficulty urinating (oliguria), excessively fast heartbeat, stomach and intestinal disorders. These are the symptoms of a decrease in sodium in the blood (hyponatraemia);
• increased levels of nitrogen in the blood (azotaemia), especially if you have kidney problems (renal failure);
• increased acidity of the blood due to increased levels of chlorine in the blood (hyperchloraemic acidosis), often associated with increased levels of potassium in the blood (hyperkalaemia), especially if you have severe liver problems (decompensated cirrhosis), even if your kidneys are functioning properly;
• development of breasts in men (gynaecomastia), which may depend on the dose taken and the duration of treatment and which, generally, disappears when treatment is stopped. It may rarely persist even after discontinuation of therapy;
• changes in voice. Therefore, if you work in a profession where your voice is important (actor, singer, teacher), your doctor will assess with you the opportunity to start treatment with URACTONE.

For those who engage in sports: the use of the medicine without therapeutic need constitutes doping
and may still result in positive doping tests.

Other medicines and URACTONE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Do not takeURACTONE if you are taking the following medicines, because there is a greater risk of a
marked increase in potassium levels in the blood (severe hyperkalaemia) (See section
“Warnings and precautions):

• medicines that promote urine excretion, such as other potassium-sparing diuretics and aldosterone blockers;
• potassium salts, used to supplement potassium deficiencies;
• medicines that reduce potassium excretion;
• non-steroidal anti-inflammatory drugs, used to relieve pain and inflammation;
• medicines used for the treatment of cardiovascular diseases, such as ACE inhibitors and angiotensin II receptor antagonists (valsartan, losartan);
• medicines used to control blood coagulation (heparin, low molecular weight heparin);
• medicines used after a transplant or for the treatment of immune system disorders (tacrolimus, cyclosporine);
• medicines used in infections (trimethoprim and trimethoprim-sulfamethoxazole).

Tell your doctor if you are using abiraterone for the treatment of prostate cancer.
Tell your doctor if you are taking mitotane for the treatment of malignant tumors of the adrenal glands. This medicine should not be used in conjunction with mitotane.
Take URACTONE with cautionand tell 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 for the treatment of lesions (ulcers) in the stomach;
• digoxin, used for the treatment of certain heart disorders;
• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• 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 compromise the effect of URACTONE.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, take URACTONE only when absolutely necessary and under the direct
control of your doctor.

Do not breastfeedif you are taking URACTONE because canrenone, a substance that derives from the
transformation of spironolactone in the body, passes into breast milk.

Driving and operating machinery
URACTONE may impair your ability to drive vehicles or operate machinery, especially at the beginning
of therapy or after consuming alcohol. If you experience drowsiness or dizziness, avoid driving vehicles or
operating machinery.

3. How to take URACTONE

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Swallow the tablet during meals and with water.
The doctor will establish the dose based on your response to treatment and your tolerability 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 increases its effects (synergistic effects) (See the section “Other medicines and URACTONE”).

Use in children
The doctor will reduce the dose based on your child's body weight. In general, the recommended dose
is 3 mg per Kg of body weight.
You cannot obtain a dose of 25 mg with this medicine.

If you take more URACTONE than you should
In case of accidental intake/ingestion of an excessive dose of URACTONE, immediately inform your doctor or go to the nearest hospital.
Following the intake of an excessive dose of this medicine, an alteration may occur
in the amount of water and salts present in the body (electrolyte balance) and symptoms such as
drowsiness and confusion. The doctor will establish the appropriate therapy for you based on your symptoms.

If you forget to take URACTONE
Do not take a double dose to compensate for forgetting the tablet. Take only the
next tablet, at the scheduled time.
If you have any doubts 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 gets them.
The following side effects may occur:

Frequency not known(the frequency of side effects cannot be estimated from the available data)

• increased potassium levels in the blood (hyperkalaemia), especially if you have kidney problems (impaired renal function). This effect can manifest with symptoms such as

heartbeat rhythm disturbances (irregular heart rate), fatigue, muscle weakness, for example in the legs;

• decreased sodium levels in the blood (hyponatraemia), especially if you take large amounts of fluids;
• decreased blood volume (hypovolaemia);
• excessive fluid loss (dehydration);
• appearance or worsening of increased blood acidity caused by increased chloride levels in the blood (hyperchloraemic metabolic acidosis);
• dizziness;
• leg cramps;
• changes in the amount of salts present in the body (electrolyte imbalance), which may be related to concomitant diseases, simultaneous use of other medicines and diet. In this case, the doctor will need to correct these alterations, especially if they are pronounced;
• changes in voice (hoarseness) such as lowering of the voice tone in women and increase in tone in men. These effects may persist even after stopping treatment;
• stomach bleeding (gastric bleeding);
• stomach injury (ulcer), stomach inflammation (gastritis);
• diarrhoea, cramp-like pains, nausea and vomiting;
• kidney problems (acute renal failure, impaired renal function);
• breast pain;
• development of breast tissue in men. This effect depends on the dose and duration of therapy, generally disappears after stopping treatment (reversible effect), but may sometimes persist even after discontinuation of therapy;
• irregular menstrual cycle depending on the dose of medicine taken (dose-dependent), absence of menstrual cycle, bleeding during menopause (post-menopause);
• sexual problems (erectile dysfunction) in men and sexual disorders (changes in libido);
• benign breast tumor (neoplasia);
• decreased number of white blood cells in the blood (leukopenia), decreased number of platelets in the blood (thrombocytopenia);
• vertigo, drowsiness, loss of coordination (ataxia);
• headache, mental confusion;
• feeling of tiredness (lethargy);
• liver inflammation (hepatitis), increase in certain liver enzymes;
• hair loss (alopecia);
• itching, skin irritation (rash, urticaria);
• condition characterized by blisters filled with fluid on the skin (pemphigoid);
• abnormal hair growth in women (hirsutism);
• severe allergic skin reactions (Stevens-Johnson syndrome SJS, toxic epidermal necrolysis TEN, drug reaction with eosinophilia and systemic symptoms DRESS);
• malaise.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What URACTONE contains

• The active ingredient is spironolactone. Each tablet contains 100 mg of spironolactone.
• The other ingredients are: starch, polyvinylpyrrolidone, magnesium stearate, calcium sulfate, peppermint essence.

Description of the appearance of URACTONE and contents of the pack
Pack of 10 white tablets in blisters.

Marketing Authorisation Holder
SPA – Società Prodotti Antibiotici S.p.A. – Via Biella, 8 – 20143 Milan – Italy.

Manufacturer
DOPPEL Farmaceutici S.r.l. – Manufacturing facility at Via Volturno, 48 – 20089 Quinto De' Stampi – Rozzano (MI)

• Italy