Aldactone

Leaflet attached to the packaging: information for the user

Warning!

The leaflet should be kept. Information on the immediate packaging in a foreign language.

Aldactone (Aldactone 10 ml Canrenoate)

20 mg/ml solution for injection
Potassium canrenoate
Aldactone and Aldactone 10 ml Canrenoate are different trade names for the same drug

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Aldactone and what is it used for
• 2. Important information before using Aldactone
• 3. How to use Aldactone
• 4. Possible side effects
• 5. How to store Aldactone
• 6. Package contents and other information

1. What is Aldactone and what is it used for

Aldactone is an aldosterone antagonist, which blocks the binding of aldosterone to its receptor, thereby preventing the reabsorption of sodium and the excretion of potassium ions.
Potassium canrenoate exhibits its properties only in the presence of aldosterone, and its action may be inhibited by increasing aldosterone concentrations. It inhibits aldosterone biosynthesis only at very high doses.
Potassium canrenoate increases the excretion of sodium and chlorides, slightly increases the excretion of calcium, inhibits the excretion of ammonium, magnesium, and potassium ions, and causes alkalization of the urine.
Potassium canrenoate has too weak a diuretic effect to be used as a regular diuretic. The diuretic effect can only be increased by concurrent administration with loop or thiazide diuretics.
By reducing glomerular filtration, potassium canrenoate may increase blood urea levels.
Depending on the severity of hyperaldosteronism, the diuretic effect becomes apparent within 3 to 6 hours after intravenous administration and may last up to 72 hours. Stabilized diuretic effect occurs after 2 weeks of treatment.
Indications:

• primary hyperaldosteronism;
• secondary hyperaldosteronism in severe, chronic liver diseases, accompanied by edema and ascites;
• secondary hyperaldosteronism in chronic heart failure with edema;
• in cases where oral administration of aldosterone antagonists is not possible and the action of other diuretics is insufficient. Page 1 7

2. Important information before using Aldactone

When not to use Aldactone

If:

• the patient is allergic to the active substance, spironolactone, or to any of the other ingredients of this drug (listed in section 6),
• hyperkalemia (elevated potassium ion levels in the blood) or hyponatremia (reduced sodium ion levels in the blood) occur,
• renal function disorders with serum creatinine levels above 1.8 mg/dl and creatinine clearance below 30 ml/min,
• acute renal failure and anuria (lack of urine production in the kidneys or absence of urine in the bladder due to ureteral obstruction) occur. Do not use during pregnancy and breastfeeding.

Warnings and precautions

Before starting treatment with Aldactone, you should discuss it with your doctor, pharmacist, or nurse.
Close medical supervision is particularly required in the following cases:

• renal function disorders (serum creatinine levels between 1.2 mg/dl and 1.8 mg/dl or creatinine clearance between 60 ml/min and 30 ml/min),
• patients prone to acidosis and/or hyperkalemia due to their underlying disease (e.g., diabetes),
• arterial hypotension,
• hypovolemia.

Fluid and electrolyte balance: The fluid and electrolyte status should be regularly monitored, especially in the elderly with renal and hepatic disorders.
Hyperkalemia may occur in patients with impaired renal function or after excessive potassium intake and may cause irregular heart rhythm, which can lead to death.
If hyperkalemia develops, treatment with Aldactone should be discontinued, and if necessary, active measures should be taken to reduce potassium levels to normal values.
Hyponatremia may occur, especially if Aldactone is administered in combination with other diuretics.
Reversible hyperchloremic metabolic acidosis, usually in combination with hyperkalemia, occurred in a few patients with decompensated liver cirrhosis, even if renal function was normal.
Urea: Reversible increases in blood urea levels occurred during Aldactone therapy, mainly in patients with impaired renal function.
Caution should be exercised when using Aldactone in patients who are at risk of acidosis and hyperkalemia (e.g., in diabetes).
Close monitoring of serum potassium levels is required in patients with impaired renal function with serum creatinine levels between 1.2 and 1.8 mg/dl or creatinine clearance below 60 ml/min per 1.73 m² body surface area, as well as when using Aldactone in combination with other drugs that may increase potassium levels (see "Aldactone and other drugs").
The results of radioimmunological tests used to determine digoxin levels in the blood may be falsely elevated in patients treated with Aldactone. It is suspected that this may be due to the use of insufficiently specific antibodies.
Aldactone may falsely elevate the results of cortisol determination by the Mattingly method.
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In animal studies, carcinogenic effects were found with long-term administration, so treatment with Aldactone should be carried out for as short a period as possible and always considering the need for further administration.
The use of Aldactone may lead to positive results in doping tests.
The use of Aldactone as a doping agent can endanger health.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor before using this drug.
Use during pregnancy and breastfeeding is contraindicated.
There is no available information on the effect of Aldactone on human fertility.

Driving and using machines

Aldactone, even when used as recommended, may alter the patient's reaction time to the extent that it impairs their ability to drive vehicles and operate machinery. This applies especially to the initial treatment period, to situations where previously used drugs have been replaced with others, when additional drugs have been started, and in cases of concurrent alcohol consumption.

Aldactone and other drugs

You should tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
Concomitant administration of Aldactone and:

• diuretics may enhance their effect,
• carbenoxolone may reduce the effect of the latter,
• non-steroidal anti-inflammatory drugs may increase the risk of hyperkalemia,
• other potassium-sparing diuretics (triamterene, amiloride), potassium supplements, or angiotensin-converting enzyme (ACE) inhibitors may lead to life-threatening increases in blood potassium levels,
• angiotensin-converting enzyme (ACE) inhibitors may cause increased serum creatinine levels,
• concomitant use of furosemide and ACE inhibitors may cause acute renal failure,
• acetylsalicylic acid, indomethacin, and other prostaglandin synthesis inhibitors may reduce the effect of potassium canrenoate,
• digoxin may lead to increased digoxin levels in the blood,
• epinephrine or norepinephrine may reduce the effect of these drugs on the cardiovascular system.

Potassium canrenoate may modify the results of radioimmunological tests used to determine digoxin levels in the blood.

Aldactone contains sodium and potassium

The drug contains 37.1 mg of sodium (the main component of table salt) in one ampoule. This corresponds to 1.9% of the maximum recommended daily sodium intake in the diet for adults.
The drug contains less than 1 mmol (39 mg) of potassium per dose, which means the drug is considered "potassium-free".
The drug may cause pain at the injection site.

3. How to use Aldactone

This drug should always be used as recommended by your doctor. If you have any doubts, you should consult your doctor.
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The recommended dose is 200 mg to 400 mg (1-2 ampoules) per day, depending on the severity of hyperaldosteronism. In exceptional cases, the dose can be increased to 800 mg (4 ampoules) per day. Usually, a single dose of 200 mg (one ampoule) is administered.

Use in children and adolescents

Newborns, infants, and children should receive the daily dose in an amount of solution suitable for their age and condition, divided into three separate doses administered by slow, short intravenous infusion, at hourly intervals.
The recommended dosage is usually:

• children with a body weight up to 50 kg - initial dose up to 4-5 mg/kg/day, and then up to 2-3 mg/kg/day.
• infants - maximum initial dose 2-3 mg/kg/day, then up to 1.5-2 mg/kg/day.

The drug should be injected intravenously at a rate not exceeding 1 ampoule (10 ml) per 2-3 minutes to avoid local vein irritation and nausea. The drug should not be injected into thin veins.
In patients receiving high doses of Aldactone or when it is necessary to improve the patient's tolerance to the drug, potassium canrenoate can be administered in divided doses or by intravenous infusion lasting about 30 minutes.
In patients with impaired renal function with serum creatinine levels between 1.2 mg/dl and 1.8 mg/dl, and creatinine clearance below 60 ml/min, treatment with Aldactone may be carried out under the condition of frequent monitoring of serum potassium levels.
The ampoule should be opened immediately before injection. Longer storage of an opened ampoule may lead to clouding of the solution. Any remaining solution in the ampoule cannot be reused.
Slight opalescence of the solution does not affect the tolerance of the drug. If the solution is clearly cloudy, which may be due to improper storage, the solution should not be administered. Only a clear solution without visible impurities can be used.
Accidental intravenous injection of the drug may be harmful, so before starting administration, it should be ensured that the needle is in the vein.

Use of a higher than recommended dose of Aldactone

Overdose of potassium canrenoate may lead to drowsiness, impaired consciousness, and electrolyte disturbances.
No specific antidote is known.
Drowsiness and impaired consciousness usually resolve after reducing the dose or discontinuing the drug.

4. Possible side effects

Like all drugs, this drug may cause side effects, although they do not occur in everyone.
Possible side effects are listed below according to the classification of systems and organs. The frequency of occurrence is defined as follows: very common (≥ 1/10); common (≥ 1/100 to <1>Common(may occur in up to 1 in 10 people)

• headache, excessive drowsiness (lethargy), ataxia

Uncommon(may occur in up to 1 in 100 people)

• hyperkalemia
• In women - breast tenderness, menstrual disorders (amenorrhea or intermenstrual bleeding), postmenopausal bleeding
• In men - sensitivity of the nipples and gynecomastia. Erectile dysfunction and decreased libido may occur

Rare(may occur in up to 1 in 1000 people)

• hyperchloremic metabolic acidosis, hyponatremia, increased uric acid levels in the blood, electrolyte imbalance may cause the following symptoms: cardiac arrhythmias, fatigue, muscle weakness, muscle cramps, dizziness.
• hypotension
• bone demineralization, osteomalacia
• hirsutism
• voice disorders (hoarseness) or deepening of the voice. In some cases, both in men and women, voice disorders may not resolve despite discontinuation of treatment. Therefore, in people for whom voice is particularly important (e.g., actors or teachers), the therapeutic benefits should be carefully weighed against the risk of treatment
• nausea, vomiting, diarrhea, abdominal cramps, stomach or intestinal ulcers, with possible bleeding
• thrombocytopenia, eosinophilia in patients with liver cirrhosis
• dizziness
• transient confusion syndrome, which resolves after reducing the dose or temporary discontinuation of treatment
• pain at the injection site

Unknown(frequency cannot be determined based on available data)

• vasculitis
• redness, urticaria, exfoliation, vasculitis, erythema multiforme, pseudo-lupus-like and lichen planus-like changes, alopecia, alopecia areata
• agranulocytosis
• liver damage, hepatitis

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Aldactone

The drug should be stored out of sight and reach of children.
Do not store above 25°C. Store the ampoules in the outer packaging to protect them from light.
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Do not use this drug after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Drugs should not be disposed of in the sewage system or in household waste containers. You should ask your pharmacist what to do with unused drugs. This will help protect the environment.

6. Package contents and other information

What Aldactone contains

• The active substance is potassium canrenoate (1 ampoule of 10 ml contains 200 mg of potassium canrenoate).
• The other ingredients are: sodium carbonate, sodium chloride, potassium hydroxide, water for injections.

What Aldactone looks like and what the package contains

A 10 ml glass ampoule.
10 ampoules in a cardboard box.
A clear, colorless to slightly yellowish solution in a glass ampoule.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
Germany

Manufacturer:

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
Germany
Cenexi SAS
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 6618119.00.00

Parallel import authorization number: 174/14

Date of leaflet approval: 14.05.2024

[Information about the trademark]
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