ALDOLEO 50 MG/50 MG TABLETS

Introduction

Package Leaflet: Information for the User

Aldoleo 50 mg/50 mg Tablets

Chlorthalidone/Spironolactone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Aldoleo and what is it used for
2. What you need to know before you take Aldoleo
3. How to take Aldoleo
4. Possible side effects

5 Conservation of Aldoleo

1. Contents of the pack and further information

1. What is Aldoleo and what is it used for

Aldoleo contains two active substances: chlorthalidone and spironolactone. Chlorthalidone and spironolactone belong to a group of medicines called diuretics. They are medicines that increase the elimination of fluids from the body.

Aldoleo is used to reduce swelling caused by fluid accumulation (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.

2. What you need to know before you take Aldoleo

Do not take Aldoleo:

• If you are allergic to spironolactone or chlorthalidone or 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 sulphonamide-derived drugs.
• If you have a disease called Addison's disease, which causes damage to the adrenal cortex, leading to a hormonal deficiency.
• If you have high potassium levels in your blood (hyperkalemia).
• 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) and an angiotensin receptor antagonist (ARA).
• If you have high calcium levels in your blood (hypercalcemia).
• If your kidneys have severe problems functioning (severe renal insufficiency or acute renal failure with no urine production (anuria)).
• If you are a child suffering from moderate to severe kidney disease (renal insufficiency).
• If your liver has severe problems functioning (liver insufficiency).

Warnings and precautions

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

Inform your doctor if you suffer from any of the following conditions:

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

The concomitant administration of Aldoleo with certain medicines, potassium supplements, and foods rich in potassium can cause severe hyperkalemia (increased potassium levels in the blood). The symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

Children and adolescents

It is recommended that they do not take this medicine.

Taking Aldoleo with other medicines

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

It may be necessary to change the dose or interrupt treatment with any of the following medicines:

• Medicines that can alter potassium levels in the blood (e.g., potassium-sparing diuretics, potassium supplements, trimethoprim, and trimethoprim/sulfamethoxazole (co-trimoxazole)).
• Other medicines for treating high blood pressure (antihypertensives).
• Medicines that can alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine, trimethoprim/sulfamethoxazole (co-trimoxazole)).
• Certain anti-ulcer medicines (e.g., carbenoxolone).
• Non-steroidal anti-inflammatory medicines for pain and fever (e.g., acetylsalicylic acid, antipyrine, indomethacin, mefenamic acid).
• Corticosteroid anti-inflammatory medicines.
• Barbiturates and narcotics.
• Muscle relaxants (e.g., tubocurarine).
• Medicines used in emergency situations to increase blood pressure (e.g., norepinephrine (noradrenaline)).
• Digoxin (used to treat various heart diseases).
• Medicines that decrease blood coagulation (anticoagulants).
• Lithium (used to treat certain types of depression).
• Medicines 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 "regime salts" as it may cause an increase in potassium levels in the blood (hyperkalemia), which can lead to severe poisoning.

Avoid drinking alcohol as it may further decrease blood pressure.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 breastfeeding women do not take Aldoleo as it passes into breast milk.

Driving and using machines

Observe your response to the medication because in some cases, drowsiness and dizziness have occurred, especially at the start of treatment. If this happens, do not drive or operate hazardous machinery.

Interference with diagnostic tests

Aldoleo may interfere with the results of diagnostic tests. If you are going to have any blood tests to check digoxin levels, inform your doctor that you are being treated with Aldoleo, as it may alter the results.

If you are going to have a diagnostic test to check parathyroid function, inform your doctor, as they may need to interrupt treatment before the test.

Use in older people

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

Use in athletes

This medicine contains a component that can produce a positive result in doping tests.

3. How to take Aldoleo

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

The recommended maintenance dose is 1 tablet per day or every other day. Often, 2 tablets per week are sufficient.

It is not recommended to administer a dose of chlorthalidone greater than 50 mg/day (1 tablet per day).

Tablets should be taken orally.

If you take more Aldoleo than you should

If you take more Aldoleo than recommended, you may feel drowsy, confused, have very low blood pressure, and heart rhythm disturbances, nausea, vomiting, diarrhea, or skin rash with redness or lesions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and the leaflet of the medicine 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 for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Aldoleo

Do not stop taking Aldoleo without asking your doctor first, as it may worsen your condition. If you need to stop taking this medicine, your doctor will tell you how to do it.

If you have any further questions on 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 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 to take immediate action:

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

Common side effects (may affect up to 1 in 10 people)

• Discomfort, fatigue.
• Diarrhea, nausea.
• Headache, drowsiness.
• Excessive breast development in men (gynecomastia), is the most frequent adverse reaction, especially during long-term treatments (2-7 months). This effect is usually reversible with treatment withdrawal.
• Irregular menstruation, (amenorrhea, postmenopausal bleeding).
• Impotence.

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

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

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

• Decreased white blood cell count (leukopenia).
• Dizziness.
• Acute renal failure.

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

• Chest pain.
• Liver function disorders.
• Loss of coordination (ataxia).
• Changes in sexual desire.
• Benign breast cysts.
• Hair loss (alopecia), excessive hair growth (hypertrichosis).

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

• Fever.
• Benign breast tumor.
• Abdominal pain, vomiting, gastrointestinal disorders, pancreatitis (inflammation of the pancreas).
• Yellowing 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.
• Psychological impotence.
• Breast pain.
• Dermatitis, sensitivity to light, eruptions, pemphigoid
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

With the combined use of Aldoleo with other diuretics, the following may also occur: decreased sodium levels in the blood (hyponatremia) characterized by vomiting, digestive difficulties, dry mouth, thirst, fatigue, and discomfort, due to an increased diuretic effect. To avoid hyponatremia, the dosage should be reduced below the normal dose.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation 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 which is stated on the packaging after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Aldoleo

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

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

Appearance of the product and contents of the pack

White, round, convex tablets.

Package of 20 tablets.

Marketing authorization holder and manufacturer

Teofarma S.r.l

Via F.lli Cervi, 8

27010 VALLE SALIMBENE (Pavia)

ITALY

Date of last revision of this leaflet: June 2023

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