ALDACTACINE 25 mg/15 mg TABLETS

2. What you need to know before you take Aldactacine

Do not take Aldactacine:

• if you are allergic to the active substances (spironolactone and altizide) or to any of the other ingredients of this medicine (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 failure, severely altered renal function, lack of urine arrival in the bladder, or anuria)
• if you have high levels of potassium or calcium in the blood
• if you suffer from a disease called Addison's disease that causes damage to the adrenal cortex, leading to a hormonal deficiency
• if you are using eplerenone (a medicine 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 liver cirrhosis
• you are diabetic
• you have kidney, liver, or heart problems, or if you are elderly, the use of spironolactone and altizide may alter your blood levels of certain electrolytes, so your doctor will perform periodic checks
• you are going to undergo surgery, as altizide may alter the response to certain medicines used during operations
• you have gout
• you take other medicines that may reduce potassium levels in the blood
• it is not recommended to use spironolactone with salt substitutes, as severe poisoning can occur

The concomitant administration of Aldactacine with certain medicines, potassium supplements, and foods rich in potassium may cause severe hyperkalemia (increase in blood potassium concentration). The symptoms of severe hyperkalemia could include muscle cramps, irregular heartbeat, 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 they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within a few hours or weeks after taking Aldactacine.

During treatment with Aldactacine, your doctor may perform periodic tests to check your blood levels of salt, cholesterol, and triglycerides and predict the risk of side effects.

Other medicines and Aldactacine

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. There are some medicines that can interact with Aldactacine:

• Medicines that can alter potassium levels in the blood (e.g., potassium-sparing diuretics)
• The concomitant administration of Aldactacine with medicines known to increase potassium levels in the blood may lead to a serious increase in potassium levels in the blood.
• Pain and fever medicines (e.g., aspirin, antipyretics)
• Certain anti-ulcer medicines (e.g., carbenoxolone)
• Non-steroidal anti-inflammatory medicines (aspirin, indomethacin, mefenamic acid)
• Medicines that can alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine)
• Muscle relaxants (e.g., tubocurarine)
• Certain anti-inflammatory medicines (corticosteroids)
• Other medicines that lower blood pressure (antihypertensives)
• Alcohol, barbiturates, narcotics
• Medicines used in emergency situations to increase blood pressure (e.g., norepinephrine)
• Medicines to regulate heart rhythm (e.g., digoxin)
• Lithium
• Certain medicines to reduce cholesterol levels (cholestyramine and colestipol)
• Medicines to treat diabetes (oral hypoglycemics and insulin)
• Medicines for gout (e.g., allopurinol, uricosurics, xanthine oxidase inhibitors)
• Trimethoprim and trimethoprim-sulfamethoxazole.

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

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

Interference with diagnostic tests

Aldactacine may interfere with the results of some diagnostic tests. If you are to undergo any diagnostic tests to assess digoxin levels, inform your doctor that you are being treated with Aldactacine, as it may alter the results.

Aldactacine may also alter the results of parathyroid function tests, so treatment should be discontinued before performing these tests.

Use in children

The use of Aldactacine is not recommended in children or adolescents under 18 years of age.

Taking Aldactacine with food, drinks, and alcohol

Alcohol

Avoid drinking too much alcohol while taking this medicine, as it may enhance the hypotensive effect of Aldactacine.

Pregnancy, breastfeeding, and fertility

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.

Pregnancy

There are limited data on the use of Aldactacine in pregnant women. Your doctor will only prescribe Aldactacine if the potential benefit outweighs the potential risk.

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 that you consider an alternative method for feeding your baby while taking this medicine.

Fertility

Women of childbearing age should take adequate contraceptive measures.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Driving and using machines

Aldactacine may cause, especially at the start of treatment, drowsiness and dizziness. If you experience these effects, you should consult your doctor before performing these activities.

Do not operate tools or machines if your ability to use them is affected by this medicine.

Aldactacine contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to Take Aldactacine

The recommended initial dose of Aldactacine is 1 to 2 tablets per day. Your doctor may increase or decrease it if necessary until you 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 at the same time every day.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 Toxicology Information Service, phone 91 562 04 20.

If you forget to take Aldactacine

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Aldactacine

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. If you experience any of the side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Very common side effects (may affect more than 1 in 10 people):

• Increased potassium in the blood (hyperkalemia)

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

• Confusion
• Dizziness, headache, drowsiness
• Diarrhea, vomiting, nausea, abdominal pain
• Itching, skin rash
• Leg cramps
• Acute kidney injury
• Excessive breast development in men (gynecomastia), breast pain in men, increased breast size, menstrual irregularities (irregularities, amenorrhea, post-menopausal bleeding), impotence
• Fever, fatigue, malaise

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

• Benign breast tumors in men
• Electrolyte disturbances in the blood, decreased sodium
• Tingling sensation (paresthesia), cramps
• Pancreatitis
• Jaundice, liver function disorders
• Photosensitivity, eczema, urticaria, redness
• Increased creatinine levels in the blood
• Breast pain in women

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

• Decreased neutrophil count in the blood (agranulocytosis), decreased white blood cell count in the blood (leukopenia), decreased platelet count in the blood (thrombocytopenia)
• Acute kidney failure

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

• Benign breast tumors
• Changes in libido
• Loss of coordination (ataxia)
• Hair loss (alopecia), excessive hair growth (hypertrichosis)
• Chest pain

Side effects with frequency not known (cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aldactacine

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

Do not use this medicine if you notice visible signs of deterioration.

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 Aldactacine

• The active substances are spironolactone and altizide. Each tablet contains 25 mg of spironolactone and 15 mg of altizide.

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

Appearance of the product and pack contents

Aldactacine tablets are white, lenticular, and scored.

Aldactacine is available in cartons with blister packs containing 40 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Spain

Manufacturer

Piramal Pharma Solutions (Dutch) B.V.

Bargelaan 200

2333 CW

Leiden

Netherlands

Date of last revision of this leaflet: 02/2025

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