ESPIRONOLACTONA ORION 50 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Espironolactona Orion 50 mg Tablets EFG

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 Package Leaflet

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

1. What is Espironolactona Orion and what is it used for

The active substance of this medicine, spironolactone, reduces excess fluid in the body by increasing urinary secretion. It differs from many other diuretics in that potassium is not lost in the urine.

This medicine is used for the treatment of:

• high blood pressure or heart failure, as additional treatment in patients who do not respond adequately to other treatments
• inflammations related to kidney, liver, or other diseases, when other treatments have not been effective
• primary aldosteronism (overactivity of the aldosterone hormone secretion in the adrenal glands).

It is possible that a doctor has prescribed this medicine for the treatment of a disease other than the one mentioned in this leaflet.

2. What you need to know before you take Espironolactona Orion

Do not takeEspironolactona Orion

• if you are allergic (hypersensitive) to spironolactone or any of the other components of this medicine (listed in section 6)
• if you have acute or chronic kidney failure
• if your urine secretion has stopped
• if it has been determined that your blood potassium level is too high
• if you have low sodium levels in the blood
• if it has been determined that you suffer from acute adrenal cortical failure (Addison's disease)
• if you have a hereditary disorder of hemoglobin, the red blood cell pigment, which causes blisters on the skin, abdominal pain, and nervous system disorders (porphyria).
• Espironolactona Orion should not be used in children with moderate or severe kidney failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take spironolactone

• if you have liver or kidney failure
• if you have diabetes and also kidney failure
• if you have stomach or duodenal ulcers.

Taking spironolactone with certain medicines, potassium supplements, and foods rich in potassium can cause severe hyperkalemia (elevated blood potassium levels). Symptoms of severe hyperkalemia can include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

Also, inform your doctor if you have other diseases or allergies.

If you need surgery

If you need surgical treatment while using this medicine, inform the treating doctor that you are using this medicine.

Children

Espironolactona Orion should be used with caution in children with high blood pressure who have mild kidney failure, as there is a risk of hyperkalemia (elevated blood potassium levels).

Espironolactona Orion should not be used in children with moderate or severe kidney failure (see section “Do not take Espironolactona Orion”).

Other medicines and Espironolactona Orion

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. The concurrent use of certain medicines can affect their efficacy or the efficacy of spironolactone or cause adverse reactions.

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.

It is very important that the treating doctor knows if you are using any of the following medicines:

• medicines used to treat high blood pressure, heart failure, and kidney diseases, especially ACE inhibitors (such as enalapril, captopril, lisinopril, perindopril, or ramipril) and angiotensin II receptor blockers (such as irbesartan, candesartan, losartan, telmisartan, or valsartan)
• digoxin for the treatment of heart failure
• other potassium-sparing diuretics (amiloride or triamterene)
• aldosterone blockers
• heparin or low molecular weight heparin (medicines used to prevent blood clot formation)
• concomitant potassium supplement
• warfarin for blood coagulation inhibition
• tacrolimus for rejection suppression after transplant surgery
• non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid, ibuprofen, or ketoprofen) for regular and long-term use
• lithium for the treatment of mood disorders
• noradrenaline
• certain anesthetics
• trimethoprim and trimethoprim-sulfamethoxazole
• abiraterone for the treatment of prostate cancer.

Taking Espironolactona Orion with food and drinks

A diet rich in potassium is not recommended due to the risk of hyperkalemia.

Pregnancy, breast-feeding, and fertility

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

Use in athletes

This medicine contains spironolactone, which can produce a positive result in doping tests.

Driving and using machines

Dizziness, fatigue, or other adverse effects (see section 4) may occur, especially when starting treatment or adjusting the dose. These effects can affect your ability to drive or use machines. Avoid driving and using machines at the beginning of this treatment and after a dose increase until you know how this medicine affects you.

Espironolactona Orion contains lactose

The 50 mg tablets contain 114 mg of lactose (as monohydrate). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Espironolactona Orion

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

The daily dose can be taken as a single dose or divided into two doses. Drink a glass of water or some other liquid with the tablet.

The tablets should be taken with food. Note that the medicine is better absorbed when taken with food.

Always take the medicine at the same time to maintain a constant effect of the drug. This is also the best way to remember to take the medicine.

The dosage of spironolactone is individual, depending on your disease and general state of health. The doses mentioned below are the usual recommended doses.

Your doctor will periodically check the levels of different chemicals (e.g., serum electrolytes and creatinine concentrations) in your body during treatment.

Adults:

Severe heart failure:The initial dose is usually 25 mg per day. The doctor may decide to increase the dose to 50 mg per day or reduce it to 25 mg every two days, if necessary.

Hypertension and inflammation:The usual dose is 25 to 100 mg per day.

Severe inflammation:200 to 400 mg per day for a short period.

Treatment of excessive aldosterone secretion (a hormone secreted by the adrenal gland):100 to 400 mg per day before surgery. The doctor determines an individual dose for each patient so that the lowest effective dose is used if surgical treatment is not suitable.

Use in elderly people:

Normally, it is not necessary to adjust the dose unless you have kidney or liver failure.

Use in children:

The doctor prescribes the dose based on the child's weight and disease.

The tablet can be divided into equal doses.

Kidney failure:

The doctor takes into account kidney failure when determining the dose and during treatment follow-up.

Do not use this medicine if your doctor has told you that you have severe kidney failure.

If you takemore Espironolactona Orion than you should

Immediately contact your doctor or hospital if you or someone else, for example, a child, takes too much of the medicine. Symptoms of overdose include fatigue, confusion, instability, vomiting, dizziness, skin rash, and diarrhea.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Bring this package of tablets with you if you go to a doctor's appointment or hospital.

If you forget to takeEspironolactona Orion

Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose. Never take a double dose or two doses in a row. Before going on vacation or traveling, make sure you have enough medication available.

If you have any other questions about 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.

It is more likely that side effects occur in patients with poor health and multiple diseases. Neurological side effects, such as confusion, headache, and lack of enthusiasm (apathy), occur mainly in patients with liver dysfunction due to long-term damage (liver cirrhosis).

Side effects are listed below by frequency:

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

• headache
• gastrointestinal disorders
• nausea
• diarrhea
• vomiting
• dry skin
• drowsiness
• breast growth in men
• breast tenderness
• menstrual disorders
• impotence.

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

• high blood potassium levels or low blood sodium levels
• confusion
• abnormal sensations
• skin rash
• itching
• hives
• leg cramps
• changes in blood creatinine or renin levels.

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

• dehydration
• apathy (lack of response, loss of initiative)
• changes in sexual desire
• dizziness
• kidney failure
• decrease in white blood cell or platelet count.

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

• liver dysfunction
• hair loss
• increased body hair
• benign breast tumors.

Frequency not known (cannot be estimated from the available data):

• toxic epidermal necrolysis (TEN)
• Stevens-Johnson syndrome
• drug reaction with eosinophilia and systemic symptoms (DRESS)
• bullous pemphigoid (a condition characterized by fluid-filled blisters on the skin).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Espironolactona Orion

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

Do not use Espironolactona Orion after the expiry date stated on the package. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Espironolactona Orion

• The active substance is spironolactone. Each tablet contains 50 mg of spironolactone.
• The other components are lactose monohydrate, cornstarch, povidone, polysorbate 80, peppermint essential oil, anhydrous colloidal silica, magnesium stearate.

Appearance of Espironolactona Orion and contents of the pack

White or almost white, round, flat, beveled-edged, scored tablet, 9 mm in diameter, code ORN213.

The tablet can be divided into equal doses.

The tablets are packaged in HDPE plastic bottles with a closure.

Package sizes:

30, 50, 100 tablets

PVC/Al blisters

30 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:July 2025

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