Package Insert: Information for the Patient

Espironolactona Orion 100 mg Tablets EFG

Read this package insert carefully before taking this medicine, 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 medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of this medication, spironolactone, reduces excess fluid in the body by increasing urine production. It differs from many other diuretics in that it does not lose potassium in the urine.

This medication 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 (primary hyperactivity of aldosterone hormone secretion in the adrenal glands).

Your doctor may have prescribed this medication for the treatment of some other disease not mentioned in this prospectus.

Do not takeOrion Espironolactona

• if you are allergic (hypersensitive) to spironolactone or any of the other components of this medication (listed in section 6)
• if you have acute or chronic renal insufficiency
• 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 your blood
• if it has been determined that you have acute adrenal cortical failure (also known as Addison's disease)
• if you have a hereditary disorder of hemoglobin, the red pigment of the blood, that causes blisters on the skin, abdominal pain, and nervous system disorders (porphyria).
• Orion Espironolactona should not be used in children with moderate or severe renal insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to takespironolactone

• if you have liver or renal insufficiency
• if you have diabetes and also renal insufficiency
• if you have a stomach or duodenal ulcer.

The concomitant administration ofspironolactonewith 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.

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

If you need surgery

If you need surgery while using this medication, inform your doctor that you are using this medication.

Children

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

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

Other medications and Orion Espironolactona

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. The concomitant use of certain medications may affect the efficacy of spironolactone or cause adverse reactions.

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

• medications used to treat high blood pressure, heart failure, and kidney disease, especially those called 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 (medications used to prevent blood clotting)
• potassium supplements
• warfarin for the inhibition of blood coagulation
• tacrolimus for the suppression of rejection after organ transplantation
• long-term and regular use of nonsteroidal anti-inflammatory drugs (such as aspirin, ibuprofen, or ketoprofen)
• lithium for the treatment of mood disorders
• noradrenaline
• certain anesthetics
• mitotane for the treatment of cancer
• trimethoprim and trimethoprim-sulfamethoxazole
• abiraterone for the treatment of prostate cancer.

Taking Orion Espironolactona with food and drinksandbeverages

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

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.

Use in athletes

This medication contains spironolactone, which may produce a positive result in doping control tests.

Driving and operating machinery

Dizziness, fatigue, or other adverse effects (see section 4) may occur, especially when starting treatment or adjusting the dose. These effects may affect your ability to drive or operate machinery. Avoid driving and operating machinery at the beginning of treatment and after increasing the dose until you know how this medication affects you.

Orion Espironolactona contains lactose

The 100mg tablets contain 228mg of lactose (as monohydrate). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 another liquid with the tablet.

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

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

The dosing of spironolactone is individual, depending on your disease and overall health status. 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 initial dose is usually 25mg per day. The doctor may decide to increase the dose to 50mg per day or reduce it to 25mg every two days, if necessary.

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

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

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

Use in elderly people:

Generally, no dose adjustment is necessary unless you have renal or hepatic insufficiency.

Use in children:

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

The tablet can be divided into equal doses.

Renal insufficiency:

The doctor takes into account renal insufficiency when determining the dose and monitoring treatment.

Do not use this medication if your doctor has told you that you have severe renal insufficiency.

If you takemore Espironolactona Orion than you should

Get in touch with your doctor or the hospital immediately if you or another person, for example a child, takes too much of the medication. Symptoms of overdose include fatigue, confusion, instability, vomiting, dizziness, skin rash, and diarrhea.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Carry this packaging of tablets with you when you visit your doctor or a hospital.

If you forgot to takeEspironolactona Orion

Take the missed dose as soon as possible. If it is almost time to take the next dose, do not take the missed dose. Never take a double dose or two consecutive doses. Make sure you have enough medication available before going on vacation or traveling.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

It is more likely that side effects will occur in patients with poor health conditions 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 (cirrhosis).

Side effects are listed below by frequency:

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

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

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

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

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

• dehydration
• apathy (lack of response, loss of initiative)
• changes in sexual drive
• dizziness
• renal insufficiency
• decrease in white blood cell or platelet count.

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

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

Frequency unknown(the frequencycannot be estimated from available data):

• toxic epidermal necrolysis (TEN)
• Stevens-Johnson syndrome
• drug reaction with eosinophilia and systemic symptoms (DRESS)
• erythema multiforme (skin condition characterized by blisters filled with fluid).

Reporting of side effects

If you experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Espironolactona Orion after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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. 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 Espironolactona Orion

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

Appearance of Espironolactona Orion and contents of the packaging

White or off-white, round, flat, beveled-edge, scored, 11 mm in diameter, code ORN352.

The tablet can be divided into equal doses.

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

Packaging sizes:

30, 50, 100 tablets

PVC/Al blisters

30 tablets

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Responsible manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

July 2024

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )