FINOSPIR 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Finospir, 25 mg, 50 mg and 100 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents:
3. What is Finospir and what is it used for
4. Important information before taking Finospir
   1. When not to take Finospir
   2. Warnings and precautions
   3. Children
   4. Finospir and other medicines
   5. Finospir with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Finospir contains lactose
5. How to take Finospir
   1. Adults:
   2. Use in the elderly:
   3. Use in children:
   4. Kidney failure:
   5. Overdose of Finospir
   6. Missed dose of Finospir
6. Possible side effects
   1. Reporting side effects
7. How to store Finospir
8. Package contents and other information
   1. What Finospir contains
   2. What Finospir looks like and contents of the package
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the Patient

Finospir, 25 mg, 50 mg and 100 mg, tablets

Spironolactone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Finospir and what is it used for
• 2. Important information before taking Finospir
• 3. How to take Finospir
• 4. Possible side effects
• 5. How to store Finospir
• 6. Package contents and other information

1. What is Finospir and what is it used for

The active substance of the medicine, spironolactone, reduces excess fluid in the body by increasing urine production. Spironolactone differs from other diuretic medicines in that it does not cause potassium loss in the urine. The medicine is used to treat:

• high blood pressure or heart failure as an additional medicine in patients who do not respond sufficiently to other medicines
• swelling associated with kidney, liver, or other diseases, when other treatment methods have been ineffective
• primary aldosteronism (excessive aldosterone production by the adrenal glands).

Your doctor may have prescribed this medicine for a condition other than those listed in this package leaflet. Children should only be treated under the supervision of a pediatrician.

2. Important information before taking Finospir

When not to take Finospir

• if you are allergic (hypersensitive) to spironolactone or any of the other ingredients of this medicine (listed in section 6)
• if you have acute or chronic kidney failure
• if you have anuria (no urine production)
• if you have excessively high potassium levels in the blood
• if you have low sodium levels in the blood
• if you have acute adrenal failure (adrenal crisis)
• if you have congenital hemoglobin disorders (porphyria). This disease causes blisters on the skin, abdominal pain, and nervous system disorders
• Finospir should not be used in children with moderate or severe kidney failure.

Warnings and precautions

Before starting to take Finospir, discuss it with your doctor or pharmacist.

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

Taking Finospir with certain medicines, potassium supplements, or potassium-rich foods may lead to severe hyperkalemia (high potassium levels in the blood). Symptoms of severe hyperkalemia may include muscle cramps, heart rhythm disorders, diarrhea, nausea, dizziness, or headache. You should also inform your doctor about all other diseases and allergies. If surgical treatment is required, if surgical treatment is required, you should inform your doctor about the medicine you are taking.

Children

Finospir should be used with caution in children with high blood pressure, who have mild kidney failure, due to the risk of hyperkalemia (high potassium levels in the blood). Finospir should not be used in children with moderate or severe kidney failure (see "When not to take Finospir").

Finospir and other medicines

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Taking certain medicines at the same time may affect their effectiveness, the effectiveness of Finospir, or cause side effects. Inform your doctor if you are taking mitotane for the treatment of adrenal gland cancer. This medicine should not be taken at the same time as mitotane. It is very important to inform your doctor about taking any of the following medicines:

• medicines used to treat high blood pressure, heart failure, and kidney disease, in particular ACE inhibitors (enalapril, captopril, lisinopril, perindopril, or ramipril) and angiotensin II receptor antagonists (e.g., irbesartan, candesartan, losartan, telmisartan, or valsartan)
• digoxin, used to treat heart failure
• potassium-sparing diuretics (amiloride or triamterene)
• aldosterone antagonists
• heparin or low molecular weight heparin (medicines used to prevent blood clots)
• potassium supplements
• warfarin, a medicine that prevents blood clotting
• tacrolimus, a medicine that prevents transplant rejection
• anti-inflammatory painkillers (e.g., acetylsalicylic acid, ibuprofen, or ketoprofen) used for a long time
• lithium, used to treat mood disorders
• norepinephrine
• certain anesthetics
• trimethoprim and trimethoprim with sulfamethoxazole
• abiraterone, used to treat prostate cancer.

Finospir with food and drink

A diet rich in potassium 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 have a child, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When starting treatment or changing the dose, dizziness, fatigue, or other side effects may occur (see section 4). These symptoms may have a negative impact on the ability to drive vehicles and operate machinery. At the beginning of treatment and after increasing the dose, you should avoid driving vehicles and operating machinery until you know how the medicine affects your body.

Finospir contains lactose

The tablets contain lactose (in the form of lactose monohydrate) in a dose of: 57 mg (25 mg tablet), 114 mg (50 mg tablet), and 228 mg (100 mg tablet). If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Finospir

Take this medicine always as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. The daily dose can be taken once or divided into two doses. Swallow the tablet with a glass of water or other liquid. The tablets should be taken with food. Remember that the medicine is better absorbed if taken during a meal. To maintain a constant effect of the medicine, take the tablets at the same time every day. Taking the medicine at the same time is also the best way to remember to take it. The dosage of Finospir is determined individually, depending on the disease and the patient's overall health. The usual doses of the medicine are presented below. During treatment, your doctor will regularly check the levels of various chemicals (e.g., electrolytes and creatinine) in your blood.

Adults:

Severe heart failure:The usual initial dose is 25 mg per day. Your doctor may decide to increase the dose to 50 mg per day or decrease it to 25 mg every other day. High blood pressure and swelling:The usual dose is 25 mg to 100 mg per day. Severe swelling:200 mg to 400 mg per day for a short time. Treatment of excessive aldosterone production (hormone produced by the adrenal glands):100 mg to 400 mg per day before surgery. Your doctor will determine the dosage individually for each patient, prescribing the smallest effective dose in cases where surgical treatment is not indicated.

Use in the elderly:

There is usually no need to change the dosage, unless the patient has kidney or liver failure.

Use in children:

Your doctor will determine the dose of the medicine based on the child's body weight and the type of disease. The tablet can be divided into equal doses.

Kidney failure:

When determining the dosage, your doctor will take into account the patient's kidney function. Finospir should not be used in patients with severe kidney failure.

Overdose of Finospir

If you or someone else has taken a larger dose of the medicine than recommended, you should immediately contact a doctor or hospital. Overdose may cause the following symptoms: fatigue, confusion, mood changes, vomiting, dizziness, skin rash, and diarrhea. If you go to a doctor or hospital, take the medicine package with you.

Missed dose of Finospir

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose. Do not take a double dose or two consecutive doses to make up for the missed dose. Before going on vacation or a trip, make sure you have enough medicine. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finospir can cause side effects, although not everybody gets them. Side effects are more common in patients with poor health and multiple diseases. Neurological side effects, such as confusion, headaches, and loss of enthusiasm (apathy), occur mainly in patients with liver function disorders caused by long-term damage (liver cirrhosis). Side effects are presented below by frequency:

• headaches
• gastrointestinal disorders
• nausea
• diarrhea
• vomiting
• dry skin
• drowsiness
• breast enlargement in men
• increased breast sensitivity to touch
• menstrual disorders
• impotence.

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

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

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

• dehydration
• apathy (lack of reaction, 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 function disorders
• hair loss
• increased hair growth on the body
• benign breast tumors.

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

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Faks: + 48 22 49 21 309, Strona internetowa: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finospir

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Package contents and other information

What Finospir contains

• The active substance of the medicine is spironolactone. One tablet contains 25 mg, 50 mg, or 100 mg of spironolactone.
• The other ingredients are: lactose monohydrate, corn starch, povidone, polysorbate 80, peppermint oil, colloidal silica, and magnesium stearate.

What Finospir looks like and contents of the package

25 mg tablets: white or almost white, round, flat tablets with beveled edges and a score line, 7 mm in diameter, with the code ORN85. 50 mg tablets: white or almost white, round, flat tablets with beveled edges and a score line, 9 mm in diameter, with the code ORN213. 100 mg tablets: white or almost white, round, slightly convex tablets with a score line, 11 mm in diameter, with the code ORN352. The tablet can be divided into equal doses. The tablets are packaged in HDPE bottles with HDPE closures. The packages contain: 25 mg: 30, 50, 100, and 250 tablets; 50 mg and 100 mg: 30, 50, and 100 tablets; Blister packs of PVC/Aluminum: 25 mg: 30 tablets; 50 mg and 100 mg: 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Manufacturer

Orion Corporation, 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: Orion Pharma Poland Sp. z o. o., [email protected]. Date of last revision of the package leaflet:07.2025