Spironolactone Pfizer – Spironolactone uses, dose and side effects

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25 mg, 50 mg and 100 mg tablets
spironolactone

What Spironolactone Pfizer is and what it is used for

spironolactone Pfizer contains the active substance spironolactonespironolactone is a potassium-sparing, diuretic agent 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.

spironolactone Pfizer is used for various forms of morbid fluid accumulation ( edema ) and high blood pressure when other treatment has no effect or is insufficient. It is also used for increased production of the adrenal cortex hormone aldosterone (primary aldosteronism) where another therapy is insufficient or inappropriate.

Children should only be treated by a pediatrician.

What you need to know before you use Spironolactone Pfizer

Do not use Spironolactone Pfizer

  • if you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6)
  • if you have acute kidney failure, severely impaired kidney function, or if you have no urine production
  • if you have Addison’s disease (reduced production of the hormones cortisol and aldosterone )
  • if you have elevated levels of potassium in your blood

Children with moderate to severe kidney disease should not use spironolactone Pfizer.

Warnings and precautions

Talk to your doctor or pharmacist before using spironolactone Pfizer:

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

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

Concomitant use of spironolactone Pfizer with certain medicines, potassium supplements, and food containing a lot of potassium can lead to severe hyperkalemia (increased level of potassium in the blood). The symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

spironolactone Pfizer can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or vomiting, you should see a doctor as soon as possible so that a lack of white blood cells ( agranulocytosis ) can be ruled out via a blood test. It is important that you then information about your medication.

Other medicines and Spironolactone Pfizer

Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. The effect of the treatment can be affected if spironolactone Pfizer is taken at the same time as certain other medicines, such as

  • medicines containing potassium or medicines that can cause excessive 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 for high blood pressure and heart failure )
  • potassium-sparing diuretics
  • norepinephrine (used in anesthesia)
  • ammonium chloride (used in conditions with too high a pH in the body)
  • cholestyramine (e.g. used for elevated blood lipids)
  • carbenoxolone (used e.g. in case of the disease in the esophagus)
  • heparin, low molecular weight heparin (blood thinner)
  • abiraterone (used to treat prostate cancer)
  • tacrolimus (used after a transplant)
  • trimethoprim and trimethoprim-sulfamethoxazole

spironolactone Pfizer may affect certain laboratory tests.

Therefore, consult a doctor before the simultaneous use of other medicines, including dietary supplements.

Spironolactone Pfizer with food, drink, and alcohol

The tablets should be taken with a meal.

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.

Pregnancy

There is no or limited amount of data on 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 regarding male fertility.

Driving ability and use of machinery

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 increased attention is required, e.g. when 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.

Spironolactone Pfizer contains lactose

spironolactone Pfizer tablets contain lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.

How to use Spironolactone Pfizer

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

The dose 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 a certain amount of time before the treatment has an effect, it is therefore important not to interrupt the treatment or change the dose without consulting a doctor.

Use for children and adolescents

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

If you have used too much Spironolactone Pfizer  

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.

If you forget to use Spironolactone Pfizer

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

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

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 side effects symptoms after taking this medicine.

  • Stevens-Johnson syndrome:
    An extremely strong allergic reaction with a skin rash is usually in the form of blisters or sores in the mouth and eyes as well as other mucous membranes such as the genitals. Occurs in an unknown number of users.
  • Lyell´s syndrome ( toxic epidermal necrolysis ):
    Severe widespread skin damage (skin shedding of the epidermis and superficial mucous membranes). Occurs in an unknown number of users.
  • Drug reaction causing skin rash, feverinflammation of internal organs, altered blood count ( eosinophilia ), and systemic disease (DRESS). Occurs in an unknown number of users.
  • Agranulocytosis :
    spironolactone Pfizer can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with a greatly worsened general condition or fever with local symptoms of infection such as sore throat/pharynx/mouth or difficulty urinating, you should see a doctor as soon as possible so that a lack of white blood cells can be ruled out via a blood test ( 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 could be a sign of kidney damage. May affect up to 1 in 10 users.

Very common (may affect more than 1 in 10 users): 

High levels of potassium in the blood, can cause abnormal heart rhythms.

Common (may affect up to 1 in 10 users):
Confusion, headache, dizzinessitching, skin rash, muscle cramps, problems getting and keeping an erection, breast enlargement in men, pain in the breasts in men, feeling generally unwell, drowsiness, tiredness, diarrhea, nausea, and vomiting.

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

Benign breast lumps in men, missed/absent periods, post-menopause vaginal bleeding and irregular periods, breast pain in women, hives, redness of the skin which is often a sign of infection or inflammation (irritation), abnormal levels of certain salts (e.g. calcium, potassium, and magnesium ) which are necessary for the body to function normally, reduced sodium content in the blood, tingling and tingling in the skin, abnormal blood test results (increased creatinine ), abnormal liver function.

Has been reported (occurring in an unknown number of users): 
Severe decrease in the number of white blood cells ( leukopenia ) which increases the risk of infection, decrease in the number of platelets, change in 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 simultaneous treatment with other diuretics. In that case, contact a doctor who may be able to change the dosage.

How to store Spironolactone Pfizer

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

No special storage instructions.

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

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 25 mg, 50 mg, and 100 mg respectively per tablet.
  • Other ingredients are lactose monohydrate 97 mg, 125 mg, and 136 mg respectively, corn starch, magnesium stearate, peppermint aroma, povidone, and colloidal silicon dioxide.

Appearance and package sizes of the medicine

Tablet

Package sizes for all strengths are:

  • Blister, 49 x 1 tablets
  • Jar, 100 tablets
  • Jar, 250 tablets

Not all pack sizes and strengths may be marketed.

Marketing Authorisation Holder

Pfizer AB

191 90 Sollentuna

Phone: 08-550 520 00

Email: eumedinfo@pfizer.com

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