Aldoleo 50 mg/50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aldoleo 50 mg/50 mg tablets

chlorthalidone/spironolactone

Read the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aldoleo is and what it is used for

Aldoleo contains two active substances: chlortalidone and spironolactone. Chlortalidone and spironolactone belong to a group of medicines called diuretics. These are medicines that increase the removal of fluids from the body.

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

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

2. What you need to know before taking Aldoleo

Do not take Aldoleo:

• If you are allergic to spironolactone or chlorthalidone, or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to a group of medicines called thiazides or to other drugs derived from sulfonamides.
• If you have a condition called Addison's disease, which causes damage to the adrenal cortex leading to hormonal deficiency.
• If you have high levels of potassium in your blood (hyperkalaemia).
• If you are taking potassium supplements or other medicines used to treat high blood pressure or heart problems (heart failure): potassium-sparing diuretics (including eplerenone), or a combination of an angiotensin-converting enzyme inhibitor (ACE inhibitor) and an angiotensin receptor antagonist (ARA).
• If you have high levels of calcium in your blood (hypercalcaemia).
• If your kidneys have significant functional problems (severe renal failure or acute renal failure with absence of urine production (anuria)).
• If you are a child with moderate to severe kidney disease (renal failure).
• If your liver has significant functional problems (hepatic failure).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Aldoleo.

Inform your doctor if you have any of the following conditions:

• if you have 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 effusion) or increased eye pressure, and may occur within hours to a week after taking Aldoleo,
• if you have a condition called systemic lupus erythematosus,
• if you are diabetic,
• if you are scheduled for surgery,
• if you are taking other diuretics,
• if you have high levels of uric acid (gout),
• if you have high cholesterol and triglyceride levels,
• if you have had allergies or bronchial asthma.

Concomitant administration of Aldoleo with certain medicines, potassium supplements, or potassium-rich foods may cause severe hyperkalaemia (increased potassium levels in the blood). Symptoms of severe hyperkalaemia may include muscle cramps, irregular heartbeat, diarrhoea, nausea, dizziness, or headache.

Children and adolescents

It is recommended that children and adolescents do not take this medicine.

Taking Aldoleo with other medicines

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

It may be necessary to adjust the dose or discontinue treatment with any of the following medicines:

• Medicines that may alter potassium levels in the blood (e.g., potassium-sparing diuretics, potassium supplements, trimethoprim, and trimethoprim/sulfamethoxazole (cotrimoxazole)).
• Other medicines used to treat high blood pressure (antihypertensives).
• Medicines that may alter the body's electrolyte balance (e.g., ammonium chloride, cholestyramine, trimethoprim/sulfamethoxazole (cotrimoxazole)).
• Certain anti-ulcer medicines (e.g., carbenoxolone).
• Non-steroidal anti-inflammatory drugs for pain and fever (e.g., acetylsalicylic acid, antipyrine, indomethacin, mefenamic acid).
• Steroidal anti-inflammatory medicines (corticosteroids).
• Barbiturates and narcotics.
• Muscle relaxants (e.g., tubocurarine).
• Medicines used in emergency situations to raise blood pressure (e.g., norepinephrine (noradrenaline)).
• Digoxin (used to treat various heart conditions).
• Medicines that reduce blood clotting ability (anticoagulants).
• Lithium (used in the treatment of certain types of depression).
• Medicines used for adrenal cortex underfunction (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 so-called "dietary salt substitutes" as they may increase plasma potassium levels (hyperkalaemia), which could lead to serious poisoning.

Avoid alcohol consumption, as it may further lower blood pressure.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding women are advised not to take Aldoleo, as it passes into breast milk.

Driving and using machines

Be aware of how this medicine affects you, as drowsiness and dizziness may occur, especially at the beginning of treatment. If this happens, do not drive or operate dangerous machinery.

Interference with diagnostic tests

Aldoleo may interfere with the results of diagnostic tests. If you are undergoing blood tests to assess digoxin levels, inform your doctor that you are being treated with Aldoleo, as it may affect test results.

If you are undergoing a diagnostic test to evaluate parathyroid function, inform your doctor, as treatment may need to be interrupted before the test.

Use in elderly patients

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

Use in athletes

This medicine contains a component that may result in a positive doping test.

3. How to take Aldoleo

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dose should always be individually adjusted, so your doctor will determine the appropriate dose for you and make any adjustments considered necessary. Do not stop treatment with Aldoleo without informing your doctor.

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

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

It is not recommended that the administered dose of chlorthalidone exceed 50 mg/day (1 tablet daily).

The tablets are to be taken orally.

If you take more Aldoleo than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Aldoleo

If you forget to take a dose, simply take your next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Aldoleo

Do not stop treatment with Aldoleo without first consulting your doctor, as your condition could worsen. If you need to discontinue this medicine, your doctor will advise you on how to do so.

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

4. Possible adverse effects

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

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

The following adverse effects are important and, if you experience any of them, immediate action will be required:

In some cases, patients have experienced disturbances in blood electrolytes. Very rarely, this has led to a serious condition involving increased levels of potassium in the blood (hyperkalemia). If you experience irregular heartbeat, tingling sensation, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Aldoleo and contact your doctor immediately.

Frequent adverse effects (may affect up to 1 in 10 people)

• Malaise, fatigue.
• Diarrhea, nausea.
• Headache, drowsiness.
• Excessive breast development in men (gynecomastia), which is the most common adverse reaction, especially during long-term treatment (2–7 months). This effect is usually reversible upon discontinuation of treatment.
• Irregular menstruation (amenorrhea, postmenopausal bleeding).
• Impotence.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Electrolyte disturbances, including increased potassium in blood (hyperkalemia) and decreased sodium in blood (hyponatremia).
• Cramps, tingling sensation (paresthesia).
• Confusion.
• Skin rash, redness, urticaria, itching.
• Increased blood creatinine concentration.

Rare adverse effects (may affect up to 1 in 1,000 people)

• Decreased number of white blood cells in blood (leukopenia).
• Dizziness.
• Acute renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Chest pain.
• Impaired liver function.
• Lack of coordination of movements (ataxia).
• Changes in sexual desire.
• Benign breast cysts.
• Hair loss (alopecia), excessive hair growth (hypertrichosis).

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

• Fever.
• Benign breast tumor.
• Abdominal pain, vomiting, gastrointestinal disturbances, inflammation of the pancreas (pancreatitis).
• Yellowish discoloration of the skin and/or mucous membranes due to obstruction of the bile ducts (cholestatic jaundice).
• Allergic reaction.
• Activation of systemic lupus erythematosus.
• Muscle cramps in the lower limbs.
• Psychogenic impotence.
• Breast pain.
• Dermatitis, photosensitivity, rashes, pemphigoid.
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

When Aldoleo is used together with other diuretics, decreased sodium in blood (hyponatremia) may also occur, characterized by vomiting, digestive disturbances, dry mouth, thirst, fatigue, and malaise, due to an enhanced diuretic effect. To prevent hyponatremia, the dosage should be reduced below the normal dose.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aldoleo

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Aldoleo

• The active substances are: chlorthalidone 50 mg, spironolactone 50 mg.

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

Appearance of the product and contents of the pack

Round convex white tablets.

Pack containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Teofarma S.r.l

Via F.lli Cervi, 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Date of the most recent revision of the leaflet: June 2023

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Care Products (AEMPS) http://www.aemps.gob.es/.