Spironolactone Orion 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Espironolactone Orion 100 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

This medicine is used to treat:

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

Your doctor may have prescribed this medicine to treat a condition other than those listed in this leaflet.

2. What you need to know before taking Espironolactone Orion

Do not take Espironolactone Orion

• if you are allergic (hypersensitive) to spironolactone or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute or chronic renal failure
• if your urine output has ceased
• if you have been diagnosed with high blood potassium levels
• if you have low sodium levels in the blood
• if you have been diagnosed with acute adrenal cortical insufficiency (Addison's disease)
• if you have a hereditary disorder of hemoglobin, the red pigment in the blood, causing skin blisters, abdominal pain, and nervous system disorders (porphyria).
• Espironolactone Orion must not be used in children with moderate or severe renal impairment.

Warnings and precautions

Talk to your doctor or pharmacist before starting spironolactone

• if you have hepatic or renal impairment
• if you have diabetes and also renal impairment
• if you have a stomach or duodenal ulcer
• if you are pregnant.

Concomitant administration of spironolactone with certain medicines, potassium supplements, and potassium-rich foods may cause severe hyperkalemia (increased potassium levels in blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

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

If you need surgical treatment

If you require surgical treatment while taking this medicine, inform your treating physician that you are using this medicine.

Children

Espironolactone Orion should be used with caution in children with high blood pressure who have mild renal impairment, as there is a risk of hyperkalemia (increased blood potassium levels).

Espironolactone Orion must not be used in children with moderate or severe renal impairment (see section "Do not take Espironolactone Orion").

Other medicines and Espironolactone Orion

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Concomitant use of certain medicines may affect their efficacy or the efficacy of spironolactone, or may cause adverse reactions.

Inform your doctor if you are taking mitotane for the treatment of malignant adrenal gland tumors. This medicine should not be used together with mitotane.

It is very important that your treating physician knows if you are taking 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 supplements
• warfarin for blood clotting inhibition
• tacrolimus for suppression of transplant rejection after transplant surgery
• anti-inflammatory analgesics (e.g., acetylsalicylic acid, ibuprofen, or ketoprofen) used regularly and long-term
• lithium for the treatment of mood disorders
• noradrenaline
• certain anesthetics
• trimethoprim and trimethoprim-sulfamethoxazole
• abiraterone for the treatment of prostate cancer.

Taking Espironolactone Orion with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Limited data are available on the use of spironolactone in pregnant women. Your doctor will prescribe Espironolactone Orion only if the potential benefit outweighs the potential risk.

Breastfeeding

You must not use Espironolactone Orion while breastfeeding. Discuss the use of Espironolactone Orion with your doctor, who will advise you to consider an alternative method of feeding your baby while taking this medicine.

Use in athletes

This medicine contains spironolactone, which may result in a positive doping test.

Driving and using machines

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

Espironolactone Orion contains lactose

The 100 mg tablets contain 228 mg of lactose (as monohydrate). If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Espironolactone Orion

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

The daily dose may be taken as a single dose or divided into two doses. Drink a glass of water or another 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 each day to maintain a constant effect of the drug. This is also the best way to remember to take your medicine.

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

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

Adults:

Severe heart failure: The usual starting dose is 25 mg per day. Your doctor may decide to increase the dose to 50 mg per day or reduce it to 25 mg every other day, if necessary.

High blood pressure and edema: The usual dose is 25 to 100 mg per day.

Severe edema: 200 to 400 mg per day for a short period of time.

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

Use in elderly patients:

Dosage adjustment is generally not necessary unless you have renal or hepatic impairment.

Use in children:

The doctor will prescribe the dose based on the child's body weight and medical condition.

The tablet may be divided into equal doses.

Renal impairment:

The doctor will take renal impairment into account when determining the dose and monitoring treatment.

Do not use this medicine if your doctor has told you that you have severe renal impairment.

If you take more Espironolactone Orion than you should

Contact your doctor or go to the hospital immediately if you or someone else, for example a child, takes too high a dose of this medicine. Symptoms of overdose include fatigue, confusion, unsteadiness, vomiting, dizziness, skin rash, and diarrhea.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone 91 562 04 20, stating the name of the medicine and the amount ingested.

Take this tablet packaging with you if you go to a medical consultation or to the hospital.

If you forget to take Espironolactone Orion

Take the missed dose as soon as possible. If it is almost time for your next dose, do not take the missed dose. Never take a double dose or two doses in succession. Before going on holiday or travelling, make sure you have enough medicine available.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are more likely to occur in patients with poor health status and multiple medical conditions. Neurological adverse effects, such as confusion, headache, and lack of enthusiasm (apathy), occur mainly in patients with hepatic dysfunction due to long-term liver damage (hepatic cirrhosis).

The adverse effects are listed below by frequency:

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

• headache
• gastrointestinal disorders
• nausea
• diarrhoea
• vomiting
• dry skin
• somnolence
• breast tissue growth in men
• breast tenderness
• menstrual disorders
• impotence

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

• too high a concentration of potassium in the blood or too low a concentration of sodium in the blood
• confusion
• abnormal sensations
• skin rashes
• itching
• urticaria
• leg cramps
• changes in blood concentrations of creatinine or renin

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

• dehydration
• apathy (lack of responsiveness, loss of initiative)
• changes in sexual drive
• dizziness
• renal failure
• decrease in the number of white blood cells or blood platelets

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

• hepatic dysfunction
• hair loss
• increased body hair
• benign breast tumours

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Spironolactone Orion

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

Do not use Spironolactone Orion after the expiry date shown on the container. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Espironolactone Orion

• The active substance is spironolactone. Each tablet contains 100 mg of spironolactone.
• The other components are monohydrate lactose, corn starch, povidone, polysorbate 80, peppermint essential oil, anhydrous colloidal silica, magnesium stearate.

Appearance of Espironolactone Orion and contents of the pack

White or almost white, round, flat tablet with bevelled edges, scored, 11 mm in diameter, code ORN352.

The tablet can be divided into equal doses.

The tablets are packed in HDPE plastic bottles with child-resistant caps.

Pack sizes:

30, 50, 100 tablets

PVC/Al blisters

30 tablets

Only some pack sizes may be commercially available.

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

August 2025

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