ALDACTONE 25 мг Капсулы твердые

Содержание инструкции

1. Aldactone 25 mg hard capsules, 100 mg coated tablets
   1. What is Aldactone and what is it used for
   2. What you need to know before taking Aldactone
   3. How to take Aldactone
   4. Possible side effects
   5. How to store Aldactone
   6. Contents of the pack and other information

Aldactone 25 mg hard capsules, 100 mg coated tablets

spironolattone

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Aldactone is and what it is used for
• 2. What you need to know before you take Aldactone
• 3. How to take Aldactone
• 4. Possible side effects
• 5. How to store Aldactone
• 6. Contents of the pack and other information

1. What is Aldactone and what is it used for

Aldactone contains the active ingredient spironolactone, a substance that belongs to a
group of drugs called “diuretics”, which help to produce more urine, thus contributing
to relieving discomfort caused by an excessive accumulation of fluids in the body ( edema).
Aldactone is used to treat a disease caused by an increase in the production
of the hormone aldosterone, which manifests with a decrease in potassium in the blood and
high blood pressure ( primary and secondary hyperaldosteronism) and states ofhigh blood pressure
of unknown cause ( essential hypertension), when other drugs have not
proven effective or tolerated.

2. What you need to know before taking Aldactone

Do not take Aldactone

• if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6);
• if your kidneys are not working well (acute renal failure and decreased creatinine clearance);
• if you do not urinate (anuria);
• if the potassium in your blood is higher than normal (hyperkalemia) and you suffer from a disease called Addison's disease;
• if the sodium in your blood is lower than normal (hyponatremia);
• if the volume of your blood decreases (hypovolemia);
• if you are dehydrated;
• during pregnancy and breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Aldactone.
Pay particular attention and ask your doctor for advice before taking Aldactone if:

• you suffer from very low blood pressure (severe hypotension);
• your kidneys are not working well, as the risk of increased potassium in the blood is higher (hyperkalemia);
• your voice is important in your life and work (e.g. actors, teachers, singers), as spironolactone can cause changes in voice.

During treatment with this medicine, the following conditions may occur:

• dry mouth, thirst, loss of strength, drowsiness, agitation, muscle cramps, decreased blood pressure, decreased urine production, changes in heartbeat and gastrointestinal disturbances, if the sodium in your blood becomes too low (hyponatremia); this condition may occur especially if the medicine is combined with other diuretics and if you suffer from edema (excess fluid accumulation in the body);
• increased potassium in your blood (hyperkalemia) with changes in your heartbeat, fatigue or weakness in your legs and increased acidity in your blood due to excessive loss of sodium bicarbonate (hyperchloremic acidosis), conditions that may occur especially if your liver function is severely impaired (decompensated hepatic cirrhosis) and you have normal kidney function;
• increased nitrogen in your blood, especially if your kidney function is impaired;
• dehydration and hypovolemia (severe decrease in your blood) may occur;
• For some patients with castration-resistant prostate cancer, tumor progression has been observed during treatment with spironolactone. Spironolactone may increase the value of PSA (prostate-specific antigen, a marker for prostate cancer).

Tell your doctor if you experience any of the above conditions or if you do not feel well during treatment with this medicine.
During treatment with spironolactone, to keep your health under control and
monitor your response to the drug, your doctor will perform regular blood tests to
check sodium, potassium, creatinine and sugar (glucose).
In particular if:

• you are an elderly patient or have impaired kidney or liver function;
• you are taking other medications that cause an increase in potassium, which your doctor will inform you about if you are taking them.

The concomitant administration of Aldactone with some potassium supplements and
potassium-rich foods may cause severe hyperkalemia (increased levels of potassium in the
blood), with symptoms such as muscle cramps, irregular heartbeat, diarrhea, nausea,
dizziness and headache.
During therapy with Aldactone it is therefore important to avoidthe intake of potassium, and
drugs such as potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists,
aldosterone blockers, heparin, low molecular weight heparin, and drugs that
induce an increase in potassium in the blood, unless you are simultaneously practicing
treatment with corticosteroid-based drugs (see paragraph
“Other medicines and Aldactone”).

Other medicines and Aldactone
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Your doctor will assess whether to prescribe Aldactone if you are already taking any of the following
drugs:

• potassium-sparing diuretics or aldosterone blockers;
• potassium saltsused to restore an imbalance of minerals;
• drugs that reduce potassium excretion, your doctor will tell you if any of these are among the medicines you usually take;
• non-steroidal anti-inflammatory drugs(NSAIDs), which may reduce the effectiveness of Aldactone;
• ACE inhibitors,angiotensin II receptor antagonists (valsartan, losartan)used to treat high blood pressure;
• heparinsused to thin the blood;
• trimethoprim and trimethoprim- sulfamethoxazole(drugs used for bacterial infections) .These medicines, if taken with spironolactone, may excessively increase potassium in your blood (even severe hyperkalemia). In addition, the simultaneous use of other drugs used to treat high blood pressure can lead to a more pronounced drop in blood pressure. Non-steroidal anti-inflammatory drugs, on the other hand, may reduce the effect of Aldactone.

Pay attention to the simultaneous intake of Aldactone with:

• carbenoxolone(used for the treatment of stomach ulcers) as the simultaneous intake of this medicine and spironolactone compromises the pharmacological action of both drugs;
• licoriceas the simultaneous intake of licorice in large quantities may compromise the action of the medicine;
• lithium salts(used to treat mental disorders) as spironolactone reduces the elimination of these drugs, increasing their toxicity;
• norepinephrine(used as a potent vasoconstrictor during surgery under local or general anesthesia), as if you are being treated with spironolactone you may not respond to the therapeutic action of this drug;
• tacrolimus and cyclosporine(used to prevent organ rejection after a transplant): the simultaneous intake of one of these two medicines and spironolactone may excessively increase potassium levels in the blood;
• digoxin(used in the treatment of heart function alterations): Aldactone increases digoxin in the blood;
• drugs used to lower blood pressure: the simultaneous intake with spironolactone potentiates the blood pressure lowering effect;
• non-steroidal anti-inflammatory drugs(NSAIDs): the simultaneous intake of these drugs may compromise the action of Aldactone;
• cholestyramine(used to reduce cholesterol levels in the blood): the simultaneous intake of Aldactone may induce hyperchloremic acidosis (increased amount of acids in your blood due to excessive loss of sodium bicarbonate) with increased potassium in the blood (hyperkalemia).

Aldactone with food and alcohol
The absorption of this medicine is favored if you have a full stomach.
The intake of alcohol during treatment with Aldactone may impair your
ability to drive vehicles and operate machinery (see section “Driving and using
machinery”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy

You must not take Aldactone during pregnancy. Studies confirm toxic effects of
the drug on fetuses (antiandrogenic effects).
Breastfeeding

Do not take this medicine if you are breastfeeding.
Driving and using machinery
This medicine may impair your ability to drive vehicles and operate machinery due to
side effects that may occur during treatment with Aldactone.
Keep in mind that these disorders may occur more frequently at the beginning of
therapy with spironolactone or if you consume alcohol during treatment.

Aldactone 25 mg hard capsules contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e.
essentially ‘sodium-free’.

Aldactone 100 mg coated tablets contains sucrose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

For those who play sports
The use of the drug without therapeutic need constitutes doping and may still result in
positive doping tests.

3. How to take Aldactone

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
This medicine must always be taken under strict medical supervision.

Treatment of primary and secondary hyperaldosteronism
The recommended dose may vary from 100 mg to 300 mg divided throughout the day.
The doctor may decrease or increase the dosage you need to take depending on your
response to the medicine.

Treatment of essential hypertension
The recommended dose may vary from 200 mg to 400 mg divided throughout the day, for the
first 2 - 3 weeks of treatment. This will be followed by maintenance therapy, defined by the
doctor based on your response to the medicine, which generally ranges from 25 mg to 100 mg per day.

Use in children and adolescents

Treatment of primary and secondary hyperaldosteronism
The doctor will define a reduced dose, compared to that for adults, based on the child's body weight

Method of administration
It is recommended to take the medicine on a full stomach in the morning during breakfast.
Both tablets and capsules must be swallowed whole without being chewed, with
a good amount of liquid (about ½ glass of water).
Caution should be exercised in elderly patients and patients with severe liver and kidney failure as the activity and elimination of the medicine may be altered.

If you take more Aldactone than you should
In case of taking a dose higher than that prescribed, stop taking it and

immediately inform your doctor or go to the nearest hospital. In case of
administration of an excessive dose of this medicine, disorders such as
drowsiness, confusion and severe alterations of mineral salts in your blood may occur, for example
increased potassium (hyperkalemia).

If you forget to take Aldactone
Do not take a double dose to make up for a missed dose.

If you stop taking Aldactone
Ask your doctor for advice if you intend to stop treatment.
If you have any doubts about the use of this medicine, ask 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 can occur with frequency not known (frequency cannot be estimated from available data of studies on the active substance):

• increase or severe reduction in the number of white blood cells (eosinophilia or agranulocytosis);
• reduction in the number of platelets in the blood (thrombocytopenia);
• dizziness and leg cramps that may be due to: increased potassium levels in the blood (hyperkalemia), decreased sodium levels in the blood (hyponatremia), reduced blood volume (hypovolemia) or dehydration;
• alteration of your heartbeat, fatigue or weakness of the legs, caused by possible increased potassium levels in the blood (hyperkalemia), more likely in patients with kidney disorders;
• appearance or worsening of a condition that causes an increase in the amount of acid in your blood due to excessive loss of sodium bicarbonate (hyperchloremic metabolic acidosis);
• alteration of mineral salt levels (your health status, diet and taking other medicines can influence the development of this condition);
• alteration of the voice manifesting with difficulty in producing vocal sounds (hoarseness) and lowering of the tone of voice in women and increase in tone in men, which may persist even after stopping the medicine;
• nausea, vomiting or diarrhea;
• liver inflammation (hepatitis) and increased liver function test values;
• lesion of the stomach wall, sometimes with bleeding (gastric ulcer);
• inflammation of the stomach lining (gastritis);
• stomach cramps;
• skin reactions including urticaria and itching;
• a condition characterized by blisters filled with fluid on the skin (bullous pemphigoid);
• abnormal hair growth (hirsutism);
• alopecia;
• increased urine production and consequent worsening of disorders in patients with urinary flow obstruction;
• severe impairment of kidney function (acute renal failure);
• increased sensitivity of the nipples to the touch, breast pain (mastodynia) and breast enlargement (gynecomastia) in both men and women, the latter effect in men disappears with discontinuation of the medicine;
• irregular menstrual cycle (amenorrhea or postmenopausal bleeding);
• erectile dysfunction;
• progression of castration-resistant prostate cancer;
• vertigo;
• drowsiness;
• loss of muscle coordination (ataxia);
• headache;
• continuous sleepiness (lethargy);
• skin disorders, such as itching, rashes, urticaria, formation of red papules or widespread blisters and scaling, especially on legs, arms, hands and feet, which may also extend to the face and lips, occasionally accompanied by fever. These may be disorders of severe skin diseases such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell 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 Aldactone

Keep this medicine out of the sight and reach of children.

Aldactone 25 mg hard capsules: do not store at a temperature above 30°C.

Aldactone 100 mg coated tablets: this medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 Aldactone contains
Aldactone 25 mg hard capsules

• The active ingredient is spironolactone. Each hard capsule contains 25 mg of spironolactone.
• The other ingredients are: macrogol, talc, corn starch, erythrosine (E127), indigotine (E132), titanium dioxide (E171), gelatin.

Aldactone 100 mg coated tablets

• The active ingredient is spironolactone. Each coated tablet contains 100 mg of spironolactone.
• The other ingredients are: magnesium stearate, corn starch, sodium carboxymethylcellulose, gelatin, macrogol, light magnesium carbonate, heavy kaolin, talc, sodium docusate, titanium dioxide (E171), sucrose.

Description of the appearance of Aldactone and contents of the pack

Aldactone 25 mg hard capsules:is presented in a box containing 16 capsules in blisters.

Aldactone 100 mg coated tablets:is presented in a box containing 10 tablets
in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24, 17489 - Greifswald (Germany).

Manufacturers
Aldactone 25 mg hard capsules
Sanofi-Aventis S.A. Ctra. C-35 (La Batllòria-Hostalric) km 63.09 - 17404 Riells i Viabrea
(Girona) - Spain
DELPHARM REIMS, 10 rue Colonel Charbonneaux, Reims - 51100 (France)
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 23-24, 17489 - Greifswald (Germany)
Aldactone 100 mg coated tablets
Sanofi S.r.l. - Strada Statale 17, Km 22 - 67019 Scoppito (AQ)