Package Leaflet: Information for the User

Aldactacine 25 mg/15 mg Tablets

espironolactona/altizida

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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1.What is Aldactacine and what it is used for

2.What you need to know before taking Aldactacine

3.How to take Aldactacine

4.Possible side effects

5.Storage of Aldactacine

6. Contents of the pack and additional information

Aldactacine is composed of two active principles,spironolactone and chlorthalidone.Spironolactone and chlorthalidone belong to a group of medications called diuretics. They are the medications that increase the elimination of liquids from the body.

Aldactacine is used to reduce high blood pressure (hypertension) and swelling caused by the accumulation of liquids (edemas) that are caused by certain kidney, liver, or heart diseases.

Do not take Aldactacine:

• if you are allergic to the active ingredients (spironolactone and altizide) or to any of the other components of this medication(listed in section 6).
• if you have a history of autoimmune diseases such as lupus erythematosus
• if you have certain kidney function disorders (acute renal insufficiency, severely impaired renal function, urinary retention, or anuria)
• if you have elevated levels of potassium or calcium in your blood
• if you have a condition called Addison's disease that causes damage to the adrenal cortex leading to hormonal deficiency
• if you are using eplerenone (a medication to reduce high blood pressure).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Aldactacine if:

• you have severe liver problems, including cirrhosis
• you are diabetic
• you have kidney, liver, or are elderly, the use of spironolactone and altizide may alter your blood levels of some electrolytes, so your doctor will perform regular monitoring
• you are about to undergo surgery, as altizide may alter your response to some medications used during operations
• you have gout
• you are taking other medications that may reduce potassium levels in your blood
• you should not use spironolactone with potassium supplements, as it may cause a severe potassium overdose

The concomitant administration of Aldactacine 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.

Consult your doctor as soon as possible if during treatment you experience a decrease in vision or eye pain, as these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within a few hours to several weeks after taking Aldactacine.

Your doctor may perform regular tests to monitor your blood levels of salt, cholesterol, and triglycerides during treatment with Aldactacine to predict the risk of adverse effects.

Other medications and Aldactacine

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.There are some medications that may interact with Aldactacine:

• Medications that may alter potassium levels in the blood (e.g., potassium-sparing diuretics)
• The concomitant administration of Aldactacine with medications that are known to increase potassium levels in the blood may lead to a severe increase in potassium levels.
• Pain and fever medications (e.g., aspirin, antipyrine)
• Certain antiulcer medications (e.g., carbenoxolone)
• Nonsteroidal anti-inflammatory medications (aspirin, indomethacin, mefenamic acid)
• Medications that may alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine)
• Muscle relaxants (e.g., tubocurarine)
• Certain anti-inflammatory medications (corticosteroids)
• Other medications that lower blood pressure (antihypertensives)
• Alcohol, barbiturates, narcotics
• Medications used in emergency situations to raise blood pressure (e.g., norepinephrine)
• Medications to regulate heart rhythm (e.g., digoxin)
• Lithium
• Certain medications to lower cholesterol levels (cholestyramine and colestipol)
• Medications to treat diabetes (oral hypoglycemic agents and insulin)
• Medications to treat gout (e.g., allopurinol, uricosuric agents, xanthine oxidase inhibitors)
• Trimethoprim and trimethoprim-sulfamethoxazole.

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

Inform your doctor if you are using mitotane for the treatment of malignant tumors of the adrenal glands.This medication should not be used with mitotane.

Interference with diagnostic tests

Aldactacine may interfere with the results of certain diagnostic tests. If you need to undergo a test to evaluate your digoxin levels, inform your doctor that you are taking Aldactacine, as it may alter the results.

Aldactacine may also alter the results of parathyroid function tests, so you should stop taking the medication before undergoing these tests.

Use in children

Aldactacine is not recommended for use in children or adolescents under 18 years old.

Taking Aldactacine with food, drinks, and alcohol

Alcohol

Avoid drinking excessive amounts of alcohol while taking this medication, as it may potentiate the hypotensive effect of Aldactacine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

There is limited data on the use of Aldactacine in pregnant women. Your doctor will only prescribe Aldactacine if the potential benefits outweigh the potential risks.

Breastfeeding

Aldactacine should not be used if you are breastfeeding your child.You should discuss the use of Aldactacine with your doctor, who will recommend an alternative method of feeding your baby while taking this medication.

Fertility

Women of childbearing age should take adequate contraceptive measures.

Consult your doctor or pharmacist before taking any medication.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result for doping control.

Driving and operating machinery

Aldactacine may cause drowsiness and dizziness, especially at the beginning of treatment. If you experience these effects, consult your doctor before engaging in these activities.

Do not operate tools or machinery if your ability to do so is impaired by this medication.

Aldactacine contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

The recommended initial dose of Aldactacine is1 to2 tablets per day. Your doctor may increase or decrease it as needed to reach the dose you need. Your doctor will adjust the dose at intervals of 2 weeks or more. The maximum dose of Aldactacine is 8 tablets per day.

Aldactacine tablets can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Aldactacine.

Ask your doctor if you think the effect of Aldactacine is too strong or too weak.

If you take more Aldactacine than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Aldactacine

If you forgot to take a dose, take the next scheduled dose at the correct time.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Aldactacine

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. If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

• In some cases, patients have presented alterations in blood electrolytes, and very rarely this has led to a potentially life-threatening serious disease (called hyperkalemia). If you have irregular heart rhythm, numbness, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Aldactacine and inform your doctor immediately.

Very common side effects (can affect more than 1 in 10 patients):

• Increased potassium in the blood (hyperkalemia)

Common side effects (can affect up to 1 in 10 patients):

• Confusion
• Dizziness, headache, drowsiness
• Diarrhea, vomiting, nausea, abdominal pain
• Itching, skin rash
• Leg cramps
• Acute kidney injury
• Excessive development of breasts in men (gynecomastia), breast pain in men, breast enlargement, menstrual irregularities, postmenopausal bleeding, impotence
• Fever, fatigue, malaise

Rare side effects (can affect up to 1 in 100 patients):

• Benign tumors in the breast in men
• Alterations in blood electrolytes, decreased sodium
• Numbness (paresthesia), cramps
• Pancreatitis
• Jaundice, liver function alterations
• Sensitivity to light, eczema, urticaria, redness
• Elevation of creatinine in the blood
• Breast pain in women

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

• Decreased number of neutrophils in the blood (agranulocytosis), decreased number of white blood cells in the blood (leucopenia), decreased number of platelets in the blood (thrombocytopenia)
• Acute kidney failure

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

• Allergic reaction, activation of autoimmune processes (lupus erythematosus)
• Non-physical impotence
• Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma], blurred vision for distant objects (acute myopia)
• Gastrointestinal disorders
• Severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug-induced rash with eosinophilia and systemic symptoms), pemphigoid (disease that produces blisters filled with fluid on the skin)
• Lupus

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. Do not store at a temperature above 25°C.

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

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aldactacine

• The active principles are spironolactone and chlorthalidone. Each tablet contains 25 mg of spironolactone and 15 mg of chlorthalidone.

• The other components (excipients) are: lactose monohydrate, rice starch, sodium lauryl sulfate, potassium polymethacrylate and magnesium stearate E 470b.

Appearance of the product and contents of the packaging

Aldactacine tablets are white, lenticular in shape and scored.

Aldactacine is presented in boxes with blisters containing 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

2333 CW

Leiden

Netherlands

Last review date of this leaflet: 02/2025

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