Espironolactona alter 100 mg comprimidos recubiertos con pelicula efg
Introduction
Package Insert: Information for the Patient
Espironolactona Alter 100 mg Film-Coated Tablets
Read this package insert carefully before starting to take this medication, as it contains important information for you.
- Keep this package insert, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.
1. What is Espironolactona Alter 100 mg and what is it used for
This medication contains spironolactone which belongs to a group of medicines called diuretics. These are medicines that increase the elimination of liquids from the body.
Spironolactone is used to reduce high blood pressure (hypertension), swelling caused by accumulation of liquids (edemas) due to certain kidney, liver or heart diseases and in the treatment of heart failure in combination with other medicines used.
It is also used in the diagnosis and treatment of diseases caused by an abnormally high production of a natural hormone (aldosterone).
Children should only be treated under the supervision of a pediatrician.
2. What you need to know before starting to take Espironolactone Alter 100 mg
Children with severe kidney failure should not take spironolactone.
Do not take Espironolactona Alter
- If you are allergic to spironolactone or any of the other components of this medication (including those listed in section 6) or to any other similar medication.
- If you have certain kidney function disorders (acute kidney failure, severely impaired kidney function, inability to urinate, or anuria)
- If you have high levels of potassium in your blood
- If you have a disease called Addison's disease that causes damage to the adrenal cortex resulting in hormonal deficiency
- If you are being treated with eplerenone (a medication used to help prevent the worsening of heart failure after a heart attack)
Warnings and precautions
Consult your doctor or pharmacist before starting to take Espironolactona Alter 100 mg.
- If you have severe liver problems, including cirrhosis
- If you are diabetic
- If you have kidney, liver, severe heart failure, or if you are an elderly patient, the use of spironolactone may alter your blood levels of certain electrolytes, so your doctor will perform regular monitoring
- If you are being treated with other medications used to treat high blood pressure or heart failure (diuretics that retain potassium, ACE inhibitors, angiotensin II antagonists, aldosterone blockers) or with medications to prevent blood clotting (heparins), as the concurrent use of these medications with Espironolactona Alter may lead to an increase in your blood potassium levels that can cause serious problems
- If you are being treated with anti-inflammatory non-steroidal medications (for pain and inflammation) or with beta-blockers (for the treatment of high blood pressure and other heart problems), as the concurrent use of Espironolactona Alter with these medications may lead to an increase in your blood potassium levels
- Do not recommend the use of spironolactone with salt substitutes (potassium-containing salt substitutes), with high-potassium diets, or with potassium supplements, as this may lead to a severe potassium intoxication by increasing your blood potassium levels
- If you have mild or moderate heart failure, as this medication may increase your blood potassium levels
- If you are over 80 years old, your doctor will assess how well your kidneys are functioning.
- The concurrent administration of Espironolactona Alter 100 mg with certain medications, potassium supplements, and high-potassium foods may cause severe hyperkalemia (elevated potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.
During treatment with Espironolactona Alter, your doctor may perform regular blood tests to monitor your electrolyte levels and predict the risk of adverse effects. If you have severe heart failure, your doctor will closely monitor your potassium and creatinine levels in the blood.
Taking Espironolactona Alter 100 mg with other medications
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 Espironolactona Alter 100 mg:
- Medications that may alter potassium levels in the blood (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, and potassium supplements)
- The concurrent administration of spironolactone with medications known to increase potassium levels in the blood may lead to a severe increase in potassium levels in the blood.
- Anti-inflammatory non-steroidal medications (e.g., aspirin, phenazone, indomethacin, mefenamic acid) for pain and fever
- Carbenoxolone (for the treatment of stomach or intestinal ulcers)
- Medications that may alter the balance of electrolytes in the body (e.g., ammonium chloride, cholestyramine)
- Certain anti-inflammatory medications (corticosteroids)
- Other medications that lower blood pressure (anti-hypertensives)
- Alcohol, barbiturates, narcotics
- Norepinephrine (noradrenaline), a medication used in emergency situations to raise blood pressure
- Digoxin (a medication to regulate heart rhythm)
- Medications that decrease blood clotting (dicumarinics)
- Lithium
- 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
Espironolactona Alter 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 Espironolactona Alter, as it may alter the results.
Taking Espironolactona Alter 100 mg with food, drinks, and alcohol
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medication, as it may potentiate the hypotensive effect of Espironolactona Alter.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.
Pregnancy
Do not take Espironolactona Alter if you are pregnant, think you may be pregnant, or if you are trying to become pregnant.
Breastfeeding
Do not take Espironolactona Alter if you are breastfeeding your child.
Fertility
Women of childbearing age should take adequate contraceptive measures.
Use in athletes
This medication contains spironolactone, which may produce a positive result in doping control tests.
Driving and operating machinery
Espironolactona Alter 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.
Espironolactona Alter contains lactose.If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.
Espironolactona Alter contains sodium.This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to Take Espironolactona Alter 100 mg
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose of spironolactone for the treatment of high blood pressure is 50 to 100 mg per day. Your doctor will adjust the dose at intervals of 2 weeks or more, and may increase it up to 200 mg per day.
In the case of heart failure, the usual initial dose is 25 mg per day. Your doctor may increase or decrease it as needed to reach the dose you need. The dose should not exceed 50 mg per day.
The maximum dose of spironolactone is 400 mg per day.
Use in children
In children, the dose can be administered as long as the child is able to swallow the tablets.
Spironolactone 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.
Your doctor will decide the duration of treatment with this medication.
Ask your doctor if you think the effect of spironolactone is too strong or too weak.
If you take more Espironolactona Alter than you should
A spironolactone overdose may cause drowsiness, mental confusion, low blood pressure, irregular heart rhythm, nausea, vomiting, diarrhea, skin rash, dehydration, and electrolyte imbalance.
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 ingested.
If you forgot to take Espironolactona Alter
If you forgot to take a dose, take the next scheduled dose at the correct time.
Do not take a double dose to make up for the missed doses.
If you stop taking Espironolactona Alter
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, Espironolactona Alter may cause side effects, although not everyone will experience them.
The following side effects are serious and require immediate action if you experience one of them:
- In some cases, patients have presented alterations in blood electrolytes, and very rarely this has led to a potentially life-threatening situation (called hyperkalemia). If you have irregular heart rhythm, numbness, muscle weakness, flaccid paralysis, or muscle spasms, stop taking Espironolactona Alter and inform your doctor immediately.
Very common side effects (may affect more than 1 in 10 patients):
- Increased potassium in the blood (hyperkalemia)
Common side effects (may affect up to 1 in 10 patients):
- Confusion
- Discomfort, fatigue, dizziness, headache, drowsiness
- Itching, skin rash, redness
- Excessive breast development in men (gynecomastia), menstrual irregularities (amenorrhea, postmenopausal bleeding), impotence, breast pain in men
- Diarrhea, nausea
- Acute kidney injury
Rare side effects (may affect up to 1 in 100 patients):
- Benign tumors in the breast in men
- Itching
- Alterations in blood electrolytes (decreased sodium)
- Numbness (paresthesia)
- Liver function alterations
- Urticaria
- Elevated creatinine levels in the blood
- Breast pain in women
Rare side effects (may affect up to 1 in 1,000 patients)
- Acute kidney failure
- Agranulocytosis (decreased neutrophil count in the blood), leucopenia (decreased white blood cell count in the blood), thrombocytopenia (decreased platelet count in the blood)
- Liver function alterations
Very rare side effects (may affect up to 1 in 10,000 patients):
- Benign tumors in the chest
- Hair loss (alopecia), excessive hair growth (hypertrichosis)
- Coordination disorder (ataxia)
- Changes in libido
Side effects of unknown frequency (cannot be estimated from available data):
- Gastrointestinal disorders
- Pemphigoid (a disease that produces blisters filled with fluid on the skin)
- Severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms)
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 listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttp://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Spironolactone Alter 100 mg
Keep this medication out of the sight and reach of children.
This medication does not require special conditions for conservation.
Do not use Spironolactone Alter after the expiration date that appears on the packaging after the abbreviation 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. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.
6. Contents of the packaging and additional information
The active principle is spironolactone. Each tablet contains 100 mg of spironolactone.
The other components (excipients) are: lactose, carboxymethylcellulose sodium, magnesium stearate, hypromellose (E464), povidone, titanium dioxide (E171), and hydroxypropylcellulose.
Appearance of the product and contents of the packaging
The film-coated tablets are white, biconvex, and scored on one of their faces.
They are presented in packaging of 20 and 30 film-coated tablets.
Holder of the marketing authorization and responsible for manufacturing
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
or
Laboratorios Alter, S.A
C/ Zeus 6
Polígono Industrial R2
28880 Meco (Madrid)
Spain
Last review date of this leaflet:February 2025
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.
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