Package Leaflet: Information for the User

Aldoleo 50 mg/50 mg Tablets

clortalidona/espironolactona

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Aldoleo and what it is used for

2.What you need to know before you start taking Aldoleo

3.How to take Aldoleo

4.Possible side effects

5Storage of Aldoleo

6.Contents of the pack and additional information

Aldoleo contains two active principles: clortalidona and espironolactona. Clortalidona and espironolactona belong to the group of medications called diuretics.They are medications that increase the elimination of liquids from the body.

Aldoleo is used to reduce swelling caused by the accumulation of liquids (edema) due to certain kidney, liver, or heart diseases and to reduce high blood pressure (hypertension).

Children should only be treated under the supervision of a pediatrician.

Do not take Aldoleo:

• If you are allergic to spironolactone or chlorthalidone or any of the other components of this medication (listed in section 6).
• If you are allergic to a group of medications called thiazides or other sulfonamide-derived drugs.
• If you have a condition called Addison's disease that causes damage to the adrenal cortex resulting in hormonal deficiency.
• If you have high levels of potassium in your blood (hyperkalemia).
• If you are taking potassium supplements or other medications used to treat high blood pressure or heart problems (cardiac insufficiency): potassium-retaining diuretics (including eplerenone) or the combination of an angiotensin-converting enzyme (ACE) inhibitor and an angiotensin receptor antagonist (ARA).
• If you have high levels of calcium in your blood (hypercalcemia).
• If your kidneys have significant problems functioning (severe renal insufficiency or acute renal failure with absence of urine production (anuria)).
• If you are a child with moderate to severe kidney disease (renal insufficiency).
• If your liver has significant problems functioning (hepatic insufficiency).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Aldoleo.

Inform your doctor if you experience any of the following situations:

• If you have any liver or kidney problems,
• If you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur within a few hours to a week after taking Aldoleo,
• If you have a condition called lupus erythematosus,
• If you are diabetic,
• If you are about to undergo surgery,
• If you are taking other diuretics,
• If you have high levels of uric acid (gout),
• If you have high levels of cholesterol and triglycerides,
• If you have had allergies or bronchial asthma.

The concomitant administration of Aldoleo with certain medications, potassium supplements, and foods rich in potassium may cause severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heart rhythm, diarrhea, nausea, dizziness, or headache.

Children and adolescents

It is recommended that they not take this medication.

Taking Aldoleo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You may need to adjust the dose or discontinue treatment with any of the following medications:

• Medications that can alter potassium levels in the blood (e.g., potassium-sparing diuretics, potassium supplements, trimethoprim, and trimethoprim/sulfamethoxazole (cotrimoxazole)).
• Other medications for treating high blood pressure (anti-hypertensives).
• Medications that can alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine, trimethoprim/sulfamethoxazole (cotrimoxazole)).
• Certain anti-ulcer medications (e.g., carbenoxolone).
• Non-steroidal anti-inflammatory medications for pain and fever (e.g., acetylsalicylic acid, antipyrine, indomethacin, mefenamic acid).
• Glucocorticoids.
• Barbiturates and narcotics.
• Muscle relaxants (e.g., tubocurarine).
• Medications used in emergency situations to raise blood pressure (e.g., norepinephrine (noradrenaline)).
• Digoxin (used to treat various heart diseases).
• Anticoagulants.
• Lithium (used to treat certain types of depression).
• Medications used in adrenal cortex hypofunction (e.g., corticotropin (ACTH)).

Inform your doctor if you are taking abiraterone for the treatment of prostate cancer.

Taking Aldoleo with food and drinks

Avoid consuming "regimen salts" as it may cause an increase in plasma potassium levels (hyperkalemia), which can lead to severe intoxication.

Avoid drinking alcohol as it may further decrease blood pressure.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is recommended not to take Aldoleo if you are pregnant, think you may be pregnant, or are trying to become pregnant.

It is recommended that women who are breastfeeding not take Aldoleo as it passes into breast milk.

Driving and operating machinery

Observe your response to the medication, as in some cases, drowsiness and dizziness have been reported, especially at the beginning of treatment. If this occurs, do not drive or operate hazardous machinery.

Interference with diagnostic tests

Aldoleo may interfere with the results of diagnostic tests. If you are to undergo any analytical tests to assess digoxin levels, inform your doctor that you are taking Aldoleo, as it may alter the results.

If you are to undergo a diagnostic test to assess parathyroid function, inform your doctor, as it may interrupt your treatment before the test.

Use in the elderly

Elderly patients may be more sensitive to the effects of this medication.

Use in athletes

This medication contains a component that may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose must be adjusted individually, so your doctor will establish the appropriate dose for you and make any necessary adjustments.Do not interrupt treatment with Aldoleo without informing your doctor.

The usual initial recommended dose is 1 tablet daily in the morning until the pathology is controlled.

The recommended maintenance dose is 1 tablet daily or every other day. In many cases, 2 tablets per week is sufficient.

It is not recommended that the dose of clortalidona administered be greater than 50 mg/day (1 tablet daily).

The tablets will be administered orally.

If you take more Aldoleo than you should

If you take more Aldoleo than recommended, you may feeldrowsiness, mental confusion, very low blood pressure, and cardiac rhythm disturbances, nausea, vomiting, diarrhea, or skin rash with redness or skin lesions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Aldoleo

If you forget to take a dose, simply take your normal dose when it is time to take the next one. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Aldoleo

Do not interrupt your treatment with Aldoleo without first asking your doctor, as it could worsen your condition. If you need to stop taking this medication, your doctor will tell you how to do it.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The frequency of adverse reactions depends on the daily dose and the duration of treatment.

The following side effects are important and if you experience one of them, you will need immediate action:

In some cases, patients have presented alterations in blood electrolytes. Very rarely, this has led to a serious disease consisting of an increase in blood potassium levels (hyperkalemia). If you have heart rhythm disturbances, a tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Aldoleo and inform your doctor immediately.

Frequent side effects (can affect up to 1 in 10 people)

• Discomfort, fatigue.
• Diarrhea, nausea.
• Headache, drowsiness.
• Excessive development of breasts in men (gynecomastia), which is the most frequent side effect, especially during long-term treatments (2-7 months). This effect is usually reversible upon suspension of treatment.
• Irregular menstruation, (amenorrhea, postmenopausal bleeding).
• Impotence.

Less frequent side effects (can affect up to 1 in 100 people)

• Electrolyte disturbances, including increased potassium in the blood (hyperkalemia) and decreased sodium in the blood (hyponatremia).
• Cramps, tingling sensation (paresthesia).
• Confusion.
• Rash on the skin, redness, urticaria, itching.
• Elevation of creatinine concentration in the blood.

Rare side effects (can affect up to 1 in 1,000 people)

• Decreased white blood cell count in the blood (leucopenia).
• Dizziness.
• Acute renal insufficiency.

Very rare side effects (can affect up to 1 in 10,000 people)

-Chest pain.

-Liver function impairment.

-Coordination disorder (ataxia).

-Changes in sexual desire.

-Benign breast tumors.

-Excessive hair growth (hirsutism), hair loss (alopecia).

Side effects of unknown frequency (cannot be estimated from available data)

• Fever.
• Benign breast tumor.
• Abdominal pain, vomiting, gastrointestinal disturbances, pancreatitis.
• Yellowing of the skin and/or mucous membranes, due to obstruction of the bile ducts (cholestasis).
• Allergic reaction.
• Systemic lupus erythematosus activation.
• Leg cramps.
• Psychogenic impotence.
• Mastalgia.
• Dermatitis, light sensitivity, rashes, angioedema
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

When using Aldoleo with other diuretics, it may also cause: decreased sodium in the blood (hyponatremia) characterized by vomiting, digestive difficulties, dry mouth, thirst, fatigue, and discomfort, due to increased diuretic effect. To avoid hyponatremia, the dosage should be reduced below the normal dose.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE collection pointat the pharmacy.In case of doubtask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Aldoleo

• The active principles are:clortalidona 50 mg,espironolactona 50 mg.

-The other components are:microcrystalline cellulose, calcium hydrogen phosphate, talc, magnesium stearate, sodium carboxymethylcellulose (type A) (from potato), povidone K-30.

Appearance of the product and content of the packaging

Round, convex tablets of white color.

Packaging of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Teofarma S.r.l

Via F.lli Cervi, 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Last review date of thisleaflet: June 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.