SPIRONOLACTONE 100 mg * 30 tablets CHAIKAPHARMA

1. What is Spironolactone-Chaikafarma and what is it used for
Spironolactone-Chaikapharma is a potassium-sparing diuretic - a medicine that increases the amount of urine excreted. It exerts its effect by counteracting the hormone aldosterone released by the adrenal glands. Increases the release of extra accumulated fluids in the tissues in various diseases of the heart, kidneys, liver and others.

It lowers high blood pressure and corrects the potassium content in conditions where the concentration of potassium in the body is reduced.

Spironolactone-Chaikapharma is used for the complex treatment of edema accompanying the following diseases:

Congestive heart failure - heart disease that can lead to easy fatigue, shortness of breath, swelling of the ankles;
Liver cirrhosis combined with edema and/or ascites - chronic liver disease;
Nephrotic syndrome - kidney disease, accompanied by damage to kidney function and development of edema.
In these diseases, the product is applied alone, but more often simultaneously with other drugs and diuretics, especially when its potassium-sparing effect is needed and in cases where a sufficient effect was not achieved with the other means used.
Spironolactone-Chaikapharma is used for the diagnosis and treatment of primary aldosteronism - a condition in which the release of the adrenal hormone aldosterone increases.

Children should be treated only under the guidance of a pediatrician.

2. What you should know before taking Spironolactone-Chaikafarma
Do not take Spironolactone-Chaikafarma if:
you are allergic to spironolactone or any of the other ingredients of this medicine (listed in section 6);
you suffer from acute kidney failure, including cases where no or very little urine is produced (anuria);
suffer from rapidly progressive or severe kidney disease;
you have hypercalcemia (increased levels of potassium in the blood);
you suffer from Addison's disease (the adrenal glands do not produce enough of the hormone cortisol and in some cases the hormone aldosterone);
you are taking other potassium-sparing diuretics (of the same group as spironolactone, including eplerenone), or the dual RAAS blockade with a combination of an angiotensin-converting enzyme (ACE) inhibitor and an angiotensin-receptor blocker (ARB);
you are pregnant or breastfeeding;
you take potassium supplements.
Children
Children with moderate to severe kidney disease should not take Spironolactone-Chaikapharma.

Warnings and precautions
Talk to your doctor or pharmacist before taking Spironolactone-Chaikafarma.

If you have persistent vomiting or persistent diarrhea;
If you are receiving treatment with infusions through a vein;
If you are aged 65 and over;
If you suffer from liver or kidney disease;
If you are taking medicines known to increase the amount of potassium in the blood - eg drainage drugs (diuretics), ACE inhibitors (enalapril, benazepril, captopril, ramipril) and angiotensin II receptor antagonists (valsartan, losartan, telmisartan, irbesartan, etc.), which are used to treat high blood pressure, nonsteroidal anti-inflammatory drugs (ibuprofen , mefenamic acid, diclofenac, etc.), potassium supplements, potassium salt substitutes;
If your condition is severe and urine output is reduced or absent;
If you have low levels of sodium in your blood (hyponatremia);
If you have ever had or have an accumulation of acidic products in the body (so-called acidosis), especially if you also suffer from liver cirrhosis;
If you suffer from porphyria (a type of hemoglobin disorder);
If you are a woman and have menstrual disorders;
If you are a man and have enlarged mammary glands. If during treatment with spironolactone your breasts become enlarged (unilaterally or bilaterally), treatment should be discontinued;
For long-term treatment in young patients with spironolactone, the physician must carefully weigh the benefits against the long-term adverse effects.
All patients taking diuretics should be monitored for signs of water and/or electrolyte imbalance through periodic control of certain laboratory parameters. You need to know that warning signs of water-electrolyte disorders are: dry mouth, feeling thirsty, weakness, lethargy, confusion, muscle pains and cramps, gastrointestinal complaints (eg nausea, vomiting), low blood pressure, decreased urine output, palpitations, heart rhythm disturbances, changes in the electrocardiogram.
Elevated potassium levels can cause heart rhythm disturbances, which in some cases can be fatal.

Concomitant use of Spironolactone-Chaikapharma with certain medicines, nutritional supplements containing potassium and foods with a high potassium content can lead to severe hyperkalemia (increased level of potassium in the blood). Symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, or headache.

Low concentrations of sodium in the blood (hyponatremia) as a result of blood thinning may be seen in patients with edema in hot weather. It is corrected by limiting fluid intake and in some rarer cases by adding salt to food.

Other medicines and Spironolactone-Chaikafarma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is important that your doctor knows if you are taking:
Digoxin (for the treatment of heart failure) - spironolactone can lead to an increase in digoxin blood levels and a risk of intoxication;
Medicines used to treat high blood pressure - spironolactone enhances their effect. When used simultaneously with products from the group of so-called angiotensin II antagonists (such as valsartan, losartan, etc.), the risk of severe hyperkalemia increases. ACE inhibitors (enalapril, lisinopril, etc.) reduce the production of aldosterone, therefore they should not be used simultaneously with spironolactone;
Nonsteroidal anti-inflammatory drugs (NSAIDs) - these products (eg indomethacin, diclofenac, naproxen, mefenamic acid), as well as drugs containing acetylsalicylic acid can lead to a weakening of its effect and a significant increase in potassium levels in the blood;
diuretics (drainage) - simultaneous use with other products of this group leads to an increased diuretic effect, and with potassium-sparing diuretics there is a risk of developing a significant increase in potassium in the blood;
Cyclosporine (prevents the rejection of transplanted organs) - hyperkalemia may develop during simultaneous administration with spironolactone;
Corticosteroids (anti-inflammatory drugs) - it is possible to increase the excretion of potassium in the urine;
Anticoagulants (medicines that suppress blood clotting) - spironolactone reduces their effect, it is possible to adjust the dose of these products. With simultaneous administration with spironolactone, it is necessary for the doctor to periodically control the prothrombin time;
Lithium products (for the treatment of depression) - spironolactone, like other diuretic products, reduces the excretion of lithium by the kidneys, which can lead to lithium intoxication;
Potassium-containing drugs, nutritional supplements - there is a risk of severe hyperkalemia;
Carbenoxolone (to treat an ulcer) - may reduce the effectiveness of spironolactone;
Noradrenaline (used to increase blood pressure) - spironolactone suppresses the normal response of vessels to the action of noradrenaline;
Tacrolimus (for suppressing the immune system) - there is an increased risk of hyperkalemia with simultaneous administration;
Chlorpropamide (for blood sugar control) - may increase the risk of hyponatremia;
Antipyrine - spironolactone accelerates the breakdown of antipyrine;
Trimethoprim and the trimethoprim/sulfamethoxazole combination.
You should tell your doctor if you are using abiraterone to treat prostate cancer.

If you are having surgery under general anesthesia, the anesthetist should know that you are taking spironolactone.

During treatment with the product, a change in the results of some laboratory and diagnostic tests is possible - a temporary increase in the values ​​of urea in the blood, which is more common in the presence of kidney disease, a false increase in the plasma levels of digoxin, increased plasma levels of cortisol.

Spironolactone-Chaikapharma with food, drink and alcohol
There is no evidence of the need for a special diet or restrictions on certain types of food and drink during treatment with the product.

During treatment with the product, it is necessary to avoid alcohol intake, due to an increased risk of developing the so-called orthostatic hypotension (a sharp and significant drop in blood pressure when standing up).

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Spironolactone-Chaikafarma can be used during pregnancy only after a careful assessment by the attending physician of the benefit/risk ratio.

Pregnancy
The product should not be used during pregnancy due to the risk of harm to the fetus. In pregnant women, spironolactone is used only at the discretion of the doctor in exceptional cases.

Breastfeeding
Some of the breakdown products of spironolactone in the liver are excreted in breast milk, therefore the product should not be administered during breast-feeding to avoid possible harm to the nursing infant. If treatment with the product is necessary, discontinuation of breast-feeding should be discussed.

Fertility
Spironolactone can cause impotence and menstrual irregularities.

Driving and working is machines
Some patients, especially at the beginning of treatment, may experience drowsiness when operating machinery. Do not drive until you know how the medicine affects you.

Important information about some of the ingredients of Spironolactone-Chaikapharma
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Spironolactone-Chaikafarma
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Depending on the complaints, the doctor will determine the dose necessary for the treatment of your disease, as well as the duration of treatment.

Adults
The recommended dose is 100 mg daily, administered as a single or multiple dose. The dose can vary from 25 mg to 400 mg of spironolactone daily. If you are not sure how much to take, ask your doctor or pharmacist.

You should take the tablets with a meal. If the total dose is more than 100 mg per day, it should be given in divided doses spread throughout the day.

Old age
It is recommended for elderly patients to start with the lowest possible dose, gradually increasing until the desired effect is achieved. It is recommended to approach with caution and to carry out regular medical examinations, especially in case of kidney damage.

Remember to take this medicine. Taking the tablets at the same time every day gives the best effect. This also helps you remember when you should take the tablets.

Use in children
The recommended dose is 1-3 mg per kg of body weight per day, in several divided doses. In order to facilitate intake in children, the tablets can first be ground or crushed and then, by stirring, dissolved in a glass of water.

If you have taken more than the required dose of Spironolactone-Chaikafarma
If you have taken more than the prescribed dose, contact your doctor immediately or visit the nearest medical facility. Your doctor will decide what, if any, measures are possible depending on the severity of the overdose. To avoid overdose, you should not use the medicine more often or for a longer time than prescribed. Acute overdose is manifested by symptoms such as dizziness, confusion, nausea, vomiting, dizziness, diarrhea and others. Symptoms characteristic of high levels of potassium in the blood may appear, such as: numbness and tingling in the limbs, weakness, muscle cramps and spasms, changes in the electrocardiogram, and others.

If you forget to take Spironolactone-Chaikafarma
Do not take a double dose to make up for a missed dose. Take the usual dose as soon as you remember and then continue with your normal intake.

If in doubt, consult your doctor or pharmacist.

If you have stopped taking Spironolactone-Chaikafarma
It is important to take Spironolactone-Chaikapharma until your doctor tells you to stop, even if you start to feel better. If you stop taking the tablets too soon, your condition may get worse.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

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

Side effects are classified by frequency as: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), not known (frequency cannot be estimated from the available data).

If you notice any of the following serious side effects, stop taking Spironolactone-Chaikapharma and contact a doctor immediately.
Sudden difficulty breathing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction), which has been seen in very rare cases.
Redness of the skin and blistering of the skin, eyes, mouth or genitals or peeling, which may be accompanied by fever and joint pain - these are severe, life-threatening skin reactions (Stevens-Johnson syndrome or severe toxic epidermal necrolysis) , drug rash with eosinophilia and systemic symptoms (DRESS).
During treatment with spironolactone, the following side effects have also been observed:

Neoplasms - benign, malignant and unspecified (including cysts and polyps)
There are very rare reports of breast cancer.

Disorders of the blood and lymphatic system
Rarely reported: a decrease to a severe decrease in the number of certain white blood cells, which increases the likelihood of infection; increased blood eosinophils (a type of blood cell); a decrease in the number of platelets, which increases the risk of bleeding or bruising.

Disorders of the immune system
The development of allergic reactions (usually of moderate severity) is rarely observed, but in very rare cases they can have a severe course with the development of edema, shock and collapse. Difficulty breathing, skin rashes or itching have been reported rarely.

Disorders of the endocrine system
Mild androgenic effects, including hirsutism, have been reported with an unknown frequency.

Disorders of metabolism and nutrition
There are frequent reports of increased potassium and decreased sodium in the blood.

Disorders of the nervous system
Headache and vertigo are very commonly reported, as are balance disturbances, dizziness, ataxia, although these side effects are of unknown frequency.

Mental disorders
Not known: confusion.

Biliary-hepatic disorders
Impaired liver function is very rarely observed.

Gastrointestinal disorders
Gastritis, gastric bleeding and cramping, diarrhea, vomiting, and ulceration are the more common side effects.

Disorders of the skin and subcutaneous tissue
Urticaria and hair loss have been reported rarely. Skin rashes have been reported. Pemphigoid (a disease characterized by fluid-filled blisters on the skin) has been reported with an unknown frequency.

Kidney and urinary tract disorders
Severe renal impairment, especially in patients with previous renal disease.

Disorders of the reproductive system and breasts
It is possible to develop enlargement of the mammary glands (gynaecomastia) in men in connection with taking spironolactone. This adverse reaction is usually reversible after discontinuation of treatment.

There have been reports of the development of sexual weakness and decreased libido, which are usually reversible after discontinuation of treatment.

There are reports of breast tenderness and increased hair growth in women, as well as menstrual irregularities and swelling.

General disorders and administration site conditions
Fatigue, drowsiness, malaise are the more common side effects.

Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly by:

Executive Agency for Medicines, "Damyan Gruev" Street No. 8 1303 Sofia, Bulgaria Tel.: +359 2 8903417 website: www.bda.bg

By reporting side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store Spironolactone-Chaikafarma
Keep out of the reach of children.

To be stored at a temperature below 25° C, in a dry place, in the original packaging.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.