Spironolactone Orion – Spironolactone uses, dose and side effects


25, 50, and 100 mg tablets

What Spironolactone Orion is and what it is used for

The active substance in this drug, spironolactone, reduces excess fluid in the body by increasing urine output. It differs from many other diuretics in that no potassium is lost in the urine.

This medicine is used to treat:

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

The spironolactone contained in Spironolactone Orion may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Spironolactone Orion

Do not use Spironolactone Orion

  • 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 renal insufficiency
  • if your urine output has stopped
  • if the potassium concentration in your blood is too high
  • if you have low levels of sodium in your blood
  • if it has been shown that you suffer from acute adrenal insufficiency (so-called Addisonian crisis)
  • if you have an inherited disease of the red blood pigment hemoglobin, which causes skin blisters, abdominal pain, and nerve disease ( porphyria ).

Warnings and precautions

Talk to your doctor or pharmacist before taking Spironolactone Orion

  • if you have liver or kidney failure
  • if you have diabetes and also impaired kidney function
  • if you have a stomach ulcer or duodenal ulcer

Concomitant administration of Spironolactone Orion with certain medicines, potassium supplements, and foods high in potassium can cause severe hyperkalemia (increased level of potassium in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, and headache.

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

If you need surgical treatment

If you need surgical treatment while using this medicine, tell the attending physician that you are using this medicine.

Other medicines and Spironolactone Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The simultaneous use of certain medicines can affect their effect or the effect of Spironolactone Orion or cause side effects.

The attending physician needs to know if you are using any of the following medicines:

  • medicines used to treat high blood pressure, heart failure, and kidney disease, especially so-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 to treat heart failure
  • other potassium-sparing diuretics (amiloride or triamterene)
  • aldosterone blockers
  • heparin or low molecular weight heparin (medicines used to prevent blood clots)
  • simultaneous potassium supplementation
  • warfarin to inhibit blood clotting
  • tacrolimus to reduce rejection after transplantation
  • anti-inflammatory painkillers (e.g. aspirin, ibuprofen, or ketoprofen ) with regular and long-term use
  • lithium for the treatment of mood disorders
  • norepinephrine
  • certain anesthetics
  • mitotane for the treatment of cancer
  • trimethoprim and trimethoprim-sulfamethoxazole
  • abiraterone for the treatment of prostate cancer.

Spironolactone Orion with food, drink, and alcohol

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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving ability and use of machinery

Dizziness, fatigue, or other adverse effects (see section 4) may occur especially when starting a treatment or when adjusting the dose. Such effects may impair the ability to drive or use machines. Avoid driving or operating machinery when starting this medication and after increasing the dose until you know how this medicine affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure

Spironolactone Orion contains lactose

The tablets contain lactose (in the form of monohydrate) 57 mg (25 mg tablet), 114 mg (50 mg tablet) or 228 mg (100 mg tablet). If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.

How to use Spironolactone Orion

Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

The daily dose can be taken either as a single dose or divided into two doses. Drink a glass of water or 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 an even medical effect. It is also the best way to remember to take the medicine.

Dosage one of Spironolactone Orion is individual, depending on your illness and general health. The dosages mentioned below are the usual recommended dosages.

Your doctor will regularly monitor the levels of various chemicals (eg, serum electrolytes and creatinine concentrations) in your body during treatment.


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

High blood pressure and swelling: the recommended dose is 25-100 mg per day.

Severe swelling: 200-400 mg per day for a short time.

Treatment of increased secretion of aldosterone (a hormone secreted by the adrenal gland): 100-400 mg one 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.


Dose adjustment is usually not necessary if you do not have kidney or liver failure.


The doctor prescribes a dose based on the child’s body weight and illness.

The tablet can be divided into two equal doses.

Kidney failure

The doctor takes kidney failure into account when determining the dose and when following up on the treatment.

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

If you have used too much Spironolactone Orion 

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, or hospital for an assessment of the risk and advice. Symptoms of overdose are fatigue, confusion, unsteadiness, vomiting, dizziness, skin rash, and diarrhea.

Take the tablet container with you if you seek care at a doctor’s office or a hospital.

If you forget to use Spironolactone 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 doses in a row. Make sure you have enough medication available before you go on vacation or travel.

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

Possible side effects

Like all medicines, Spironolactone Orion can cause side effects, although not everybody gets them.

Side effects are usually more likely in patients in poor condition and with multiple diseases. Neurological side effects, such as confusion, headache, and lack of enthusiasm ( apathy ), occur mainly in patients with impaired liver function caused by long-term damage ( liver cirrhosis ).

Side effects are listed below by frequency:

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

Headache, gastrointestinal discomfort, nausea, diarrhea, vomiting, dry skin, sleepiness, growth of breast tissue in men, sore breasts, menstrual disorders, and impotence.

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

Too much potassium in the blood or too little sodium in the blood, confusion, abnormal sensation of touch, skin rash, itching, hives, leg cramps, and changes in blood creatinine or renin concentrations.

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

Dehydration, apathy (ie, unresponsiveness, loss of initiative), altered sex drive, dizziness, kidney failure, and decreased white blood cell or platelet counts.

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

Impaired liver function, hair loss, increased body hair, benign breast tumors.

Has been reported (occurring in an unknown number of users) :

Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), pemphigoid (a condition that causes fluid-filled blisters on the skin).

How to store Spironolactone Orion

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

Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substance is spironolactone. Each tablet contains 25, 50, or 100 mg of spironolactone.
  • Other ingredients are lactose monohydrate, corn starch, povidone, polysorbate 80, peppermint oil, silicon dioxide ( colloidal, anhydrous), and magnesium stearate.

Appearance and package sizes of the medicine

25 mg tablet: white or off-white, round, flat tablet with a beveled edge and a score line, with a diameter of 7 mm, imprinted with ORN85.

50 mg tablet: white or off-white, round, flat tablet with a beveled edge and a score line, with a diameter of 9 mm, imprinted with ORN213.

100 mg tablet: white or off-white, round, slightly convex, and scored, with a diameter of 11 mm, imprinted with ORN352.

The tablet can be divided into two equal doses.

The tablets are packaged in HDPE plastic cans and closures.

Package sizes

25 mg: 30, 50, 100 and 250 tablets

50 mg and 100 mg: 30, 50 and 100 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Orion Corporation

Orion Indie 1

FI-02200 Espoo



Orion Corporation, Orion Pharma

Orion Indie 1

FI-02200 Espoo


Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo


For further information about this medicine, contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

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