25 mg, 50 mg, 100 mg film-coated tablets 
spironolactone

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

-Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

-If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Aldactone is and what it is used for 
2. What you need to know before you use Aldactone 
3. How to use Aldactone 
4. Possible side effects 
5. How to store Aldactone 
6. Contents of the packaging and other information 

1. What Aldactone is and what it is used for

Aldactone contains the active substance spironolactone. Spironolactone is a potassium-sparing, diuretic (diuretic) that affects the kidneys in such a way that more fluid (urine) is excreted through the body. In addition to the diuretic effect, spironolactone has a blood pressure-lowering effect.

Aldactone is used for various forms of morbid fluid retention ( edema ) and high blood pressure when other treatments have no effect or are insufficient. It is also used in increased production of the adrenal cortex hormone aldosterone (primary aldosteronism) where other therapies are insufficient or inappropriate.

Children should only be treated by a pediatrician.

2. What you need to know before you use Aldactone

Do not use Aldactone

  • if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6)
  • if you have acute renal failure, severe renal impairment, or if you have no urine production
  • if you have Addison’s disease (decreased production of hormones are cortisol and aldosterone )
  • if you have high levels of potassium in your blood

Children with moderate to severe kidney disease should not use Aldactone.

Warnings and cautions

Talk to your doctor or pharmacist before using Aldactone:

  • if you suffer from severe heart failure
  • if you are elderly and/or suffer from impaired kidney or liver function
  • if you suffer from kidney disease, especially children with high blood pressure, or liver disease. Your doctor will routinely evaluate your condition.

In the above conditions, your doctor may perform regular blood tests to check the level of potassium, sodium, and/or urea in your blood.

Concomitant use of Aldactone with certain medicines, potassium supplements, and foods high in potassium can lead to severe hyperkalemia (high blood potassium). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

Aldactone can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Other medicines and Aldactone

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of the treatment can be affected if Aldactone is taken at the same time as certain other medicines, such as

  • drugs containing potassium or drugs that can cause high levels of potassium in the blood, a diet rich in potassium, or salt substitutes containing potassium
  • non-steroidal anti-inflammatory drugs called NSAIDs (used for pain and inflammation )
  • ACE inhibitors, angiotensin II antagonists, aldosterone inhibitors, digoxin (used to treat high blood pressure and heart failure )
  • potassium-sparing diuretic drugs
  • norepinephrine (used under anesthesia)
  • ammonium chloride (used in conditions with too high a pH in the body)
  • cholestyramine (used eg for elevated blood fats)
  • carbenoxolone (used eg for diseases of the esophagus)
  • heparin, low molecular weight heparin (blood thinner)
  • tacrolimus (used after transplantation)
  • trimethoprim and trimethoprim-sulfamethoxazole

Aldactone may affect certain laboratory samples.

Therefore, consult a physician before using other medicines at the same time, including dietary supplements.

Aldactone with food, drink, and alcohol

The tablets should be taken with a meal

Pregnancy, breastfeeding, 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.

Pregnancy

There are no or limited amount of data from the use of spironolactone in pregnant women.

Breast-feeding

Spironolactone passes into breast milk.

Fertility

There are no clinical data available on the effect of spironolactone on fertility. Animal studies have shown reduced fertility in females but there are no animal data on male fertility.

Driving and using machines

Side effects in the form of dizziness and fatigue may occur in some patients, especially at the beginning of treatment. This should be taken into account when sharper attention is required, e.g. while driving.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance.

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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Aldactone

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you. The tablets should be taken with a meal.

The usual dose for adults is 50-100 mg daily, but higher or lower doses may be used in some cases. It may take some time before the treatment takes effect, so it is important not to stop treatment or change dose one without consulting a doctor.

Use for children and adolescents

Aldactone is used in some cases for the treatment of children and the dose is then adjusted according to the child’s weight.

If you forget to use Aldactone

Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience any of the following symptoms or side effects after taking this medicine.

  • Stevens-Johnson syndrome:
    An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals. Occurs in an unknown number of users.
  • Lyell’s syndrome ( toxic epidermal necrolysis ): 
    Severe widespread skin damage (dermal detachment of the epidermis and superficial mucous membranes). Occurs in an unknown number of users.
  • Drug reaction that causes skin rash, fever, inflammation of internal organs, altered blood count ( eosinophilia ), and systemic disease (DRESS). Occurs in an unknown number of users.
  • Agranulocytosis:
    In rare cases, Aldactone can affect the white blood cells so that the defense of the infection deteriorates. If you get an infection with symptoms such as fever with severe deterioration in general condition or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication. Occurs in an unknown number of users.
  • Severe fatigue, nausea, and itching or if you urinate less than usual. It may be a sign of kidney damage. May affect up to 1 in 10 users.

Very common (may affect more than 1 user in 10): 
High levels of potassium in the blood can cause abnormal heart rhythm.

Common (may affect up to 1 in 10 people):
Confusion, headache, dizziness, itching, rash, muscle cramps, difficulty getting and maintaining an erection, breast augmentation in men, chest pain in men, general malaise, drowsiness, fatigue, diarrhea, nausea, and vomiting.

Uncommon (may affect up to 1 in 100 people): 
Benign breast lumps in men missed / absent periods, postmenopausal menstrual bleeding and irregular menstruation, breast pain in women, hives, redness of the skin which is often a sign of infection or inflammation (irritation), abnormal levels of certain salts (eg calcium, potassium, and magnesium ) necessary for the normal functioning of the body, decreased sodium levels in the blood, tingling, and irritation of the skin, abnormal blood test results (increased creatinine ), abnormal liver function.

Has been reported (occurs in an unknown number of users): 
Severe decrease in white blood cell count ( leukopenia ) which increases the risk of infection, a decrease in platelet count

, changed

sexual desire, gastrointestinal upset, hair loss, abnormal hair growth, and pemphigus(a condition that causes fluid-filled blisters on the skin).

Dry mouth, thirst, headache, fatigue, and drowsiness may occur due to sodium deficiency, during concomitant treatment with other diuretics. In that case, contact a doctor who may be able to change the dosage.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aldactone

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

Store below 30 ° C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is spironolactone 25 mg, 50 mg, and 100 mg per tablet respectively.
  • The other ingredients are titanium dioxide (dye E 171), magnesium stearate, povidone, calcium sulfate dihydrate, corn starch, macrogol, hypromellose, peppermint flavor.

What the medicine looks like and the contents of the pack

The 25 mg tablets are white, round, marked Searle 39.

The 50 mg tablets are white, round, marked Searle 916.

The 100 mg tablets are white, round, marked Searle 134.

Printing package containing 100 tablets.

Not all pack sizes and strengths may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Manufacturer

Piramal Healthcare UK Limited

Whalton Road

Morpeth

Northumberland

NE61 3YA

UK

or

Piramal Pharma Solutions (Dutch) BV

Level, 7th floor

Bargelaan 200

2333 CW

Leiden

Netherlands

Muhammad Nadeem

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