25 mg, 50 mg, 100 mg tablets
spironolactone
What Spironolactone Takeda is and what it is used for
Spironolactone Takeda contains the active substance spironolactone. It is a potassium-sparing, diuretic agent that affects the kidneys in such a way that more fluid (urine) is secreted through the body. In addition to the diuretic effect, spironolactone has a blood pressure-lowering effect.
Spironolactone Takeda 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.
Spironolactone may also be approved to treat other conditions not mentioned in this leaflet. 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 Takeda
Do not use Spironolactone Takeda
- 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 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
Concomitant use of Spironolactone Takeda 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.
Children with moderate to severe kidney disease should not use Spironolactone Takeda.
Warnings and precautions
Talk to your doctor or pharmacist before using Spironolactone Takeda
- if you have severe heart failure
- if you are elderly and/or suffer from reduced kidney or liver function
- if you have kidney disease, especially in 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.
In rare cases, spironolactone can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with fever and a greatly worsened general condition or fever and 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 Takeda
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 Takeda is taken at the same time as certain other medicines, e.g
- medicines containing potassium or medicines that can cause excessive levels of potassium in the blood
- 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 (e.g. used in diseases of the esophagus)
- heparin, low molecular weight heparin (blood thinner)
- tacrolimus (used after a transplant)
- trimethoprim and trimethoprim-sulfamethoxazole (used against infections )
- abiraterone for the treatment of prostate cancer.
Therefore, consult a doctor before the simultaneous use of other medicines and also dietary supplements.
Spironolactone Takeda may affect certain laboratory tests.
Spironolactone Takeda with food and drink
The tablets should be taken with a meal. Avoid potassium-rich diet or salt substitutes containing potassium because of the risk of hyperkalemia.
Pregnancy and breastfeeding
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. Spironolactone Takeda should therefore not be used during pregnancy.
Breast-feeding
Spironolactone passes into breast milk.
Driving ability and use of machinery
Side effects in the form of dizziness and fatigue may occur in some patients. 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 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 a doctor or pharmacist if you are unsure.
Spironolactone Takeda contains lactose and sodium
The tablets contain lactose. If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Spironolactone Takeda contains less than 23 mg of sodium per tablet, i.e. it is almost “sodium-free”. This amount of sodium also applies to doses of up to 350 mg daily.
A dose of 400 mg of Spironolactone Takeda contains 23.9 mg of sodium (the main ingredient in common/table salt). This corresponds to 1.2% of the maximum recommended daily intake of sodium for adults.
How to use Spironolactone Takeda
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.
The tablets can be split by light pressure. The tablet can be divided into two equal doses.
Use for children
Spironolactone Takeda 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 Takeda
If you have ingested too much medicine or if, for example, if a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Spironolactone Takeda
Do not take a double dose to make up for a missed tablet.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Stop taking Spironolactone Takeda and contact your doctor immediately if you experience the following symptoms:
Common (may affect up to 1 in 10 users):
- Severe fatigue, nausea, and itching, or if you urinate less than usual. It could be a sign of kidney damage.
Has been reported (occurring in an unknown number of users):
- Stevens-Johnson syndrome / Lyell’s syndrome ( toxic epidermal necrolysis ) / DRESS: Extremely strong and serious skin side effects such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of spironolactone. The skin side effects can consist of a rash with or without blisters. Skin redness, sores or swelling in the mouth, throat, eyes, nose, and around the genitals ( Stevens-Johnson syndrome ), edema (DRESS), and fever and flu-like symptoms can also occur. The skin rash can develop into serious widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) with life-threatening consequences. Symptoms of DRESS usually develop around 2-6 weeks (possibly up to 8 weeks) after starting treatment.
- Agranulocytosis:
fever in combination with the greatly worsened general condition or fever in combination with sore throat/pharynx/mouth or difficulty urinating, which are signs of infection. As spironolactone can in rare cases lead to a weakened defense against infection due to a lack of white blood cells, infections can become serious. Therefore, it is important that in these situations you also information about your medication.
Other side effects that may occur:
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, dizziness, itching, skin rash, muscle cramps, trouble getting and keeping an erection, male breast enlargement, male breast pain, general malaise, 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 problems, 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 Takeda
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label 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 53 mg, 24 mg, and 48 mg respectively, microcrystalline cellulose, rice starch, sodium lauryl sulfate, povidone, magnesium stearate, colloidal anhydrous silica, and peppermint oil. Spironolactone Takeda tablets 25 mg also contain agar. Spironolactone Takeda tablets 50 mg and 100 mg also contain menthol and sodium starch glycolate.
Appearance and package sizes of the medicine
Spironolactone Takeda 25 mg is a white, round tablet with a score and a diameter of 8 mm. It is stamped with AB 43 on one side.
Spironolactone Takeda 50 mg is a white, round tablet with a score and a diameter of 8 mm. It is stamped with AB 72 on one side.
Spironolactone Takeda 100 mg is a white, round tablet with a score and a diameter of 11 mm.
Package size: 100 tablets in a plastic jar.
Marketing Authorisation Holder
Orifarm Healthcare A/S
Energizer 15
5260 Odense S
Denmark
info@orifarm.com
Local Representative
Orifarm Healthcare
Box 56048
102 17 Stockholm
Manufacturer
Takeda Pharma AS
Jaama in 55b
Põlva linn
Põlvamaa 63308
Estonia
Takeda GmbH, Production Site Oranienburg
Lehnitzstr. 70-98
16515 Oranienburg
Germany