Spironolacton 25 mg. 30 tablets

€9

Spironolactone  belongs to the so-called potassium-sparing diuretics (drugs increasing the amount of urine). It increases the excretion of fluids accumulated overtime in diseases related to their detention in tissues, such as heart failure, impaired function of the liver and kidneys.

Quantity

Spironolacton 25 mg. 30 tablets

Actavis spironolactone 25 mg, coated tablets. spironolactone

Drug substance in a coated tablet: Spironolactone 25 mg. Excipients in tablet: lactose monohydrate, corn starch, gelatin, talc, magnesium stearate, silica, colloidal anhydrous;

Excipients in the shell: sucrose, talc, titanium dioxide, acacia, povidone, macrogol 6000, silica colloidal anhydrous; colorant E 132.

Spironolactone Actavis is available in packs of 30 coated tablets.

1. WHAT Spironolacton Actavis AND WHAT IT IS USED?

Spironolactone Actavis belongs to the so-called potassium-sparing diuretics (drugs increasing the amount of urine). It increases the excretion of fluids accumulated overtime in diseases related to their detention in tissues, such as heart failure, impaired function of the liver and kidneys,

lowering high blood pressure and adjust the potassium content in conditions of low concentration of potassium in the body. Its effect is mediated by counteracting adrenal hormone - aldosterone.

Spironolactone Actavis is used for:

• Primary aldosteronism (states with increased secretion of adrenal hormone aldosterone):

- As a diagnostic test;

- For short-term preoperative treatment;

- For long-term maintenance therapy in patients with minimal aldosterone-producing adrenal adenomas (benign tumors), who are at increased operational risk or refuse surgery;

- For long-term maintenance therapy in patients with bilateral adrenal hyperplasia (diffuse expansion of the adrenal tissue)

- Idiopathic aldosteronism.

• For the treatment of edema in patients with:

- Congestive heart failure;

- Liver cirrhosis combined with edema and / or ascites (freely moving fluid in the abdomen);

- Nephrotic syndrome (swollen state due to the impairment of renal function).

Under these conditions Spironolactone Actavis used alone or more often to the combined diuretic therapy swollen, especially if need its potassium-sparing effect when insufficiently effect of other therapeutic measures.

• In addition to the comprehensive treatment of hypertension in combination with other antihypertensive agents, especially in the tendency to hypokalemia.

• Prevention and treatment of hypokalemia, particularly in danger or hypokalemia occurred as a result of treatment with other diuretics (furosemide, ethacrynic acid, thiazide diuretics) and digitalis.
2. WHAT YOU NEED TO KNOW BEFORE Spironolacton Actavis?
Spironolactone Actavis does not apply to:

• Hypersensitivity (allergy) to the active substance or to any of

the excipients;

• Anuria (production of urine);

• Acute renal failure;

• Severe renal impairment (creatinine clearance <10 ml / min);

• Hyperkalemia (high potassium levels);

• Metabolic acidosis (increased acidity of the blood);

• Pregnancy.

In the application of this product, please note the following:

All patients receiving diuretic therapy should be monitored for clinical signs of impaired water or electrolyte imbalance (hypomagnesemia, hyponatremia, hypochloremic alkalosis and hyperkalemia) subject and periodic monitoring of serum electrolytes.

Close monitoring of serum electrolytes is particularly important in patients with persistent vomiting or receiving treatment with intravenous infusions. Warning signs of fluid or electrolyte imbalance are dry mouth, thirst, weakness, lethargy, confusion, muscle aches and cramps, gastrointestinal complaints such as nausea and vomiting, low blood pressure, reduced urine output, heart rate, heart rhythm disturbances and electrocardiographic changes.

Concomitant administration of spironolactone Actavis with certain medicinal products (potassium-sparing diuretics, ACE inhibitors and NSAIDs) is associated with a risk of severe hyperkalemia (high potassium levels in the blood). In the elderly, should be used with caution due to increased risk of hyperkalemia.

When expressed concern renal or hepatic function should be used with caution and at reduced doses in constant monitoring of electrolyte content.

Hyponatremia dilution may occur in edematous patients in hot weather. It is adjusted to limit intake of fluids and in rare cases with the addition of salt.

In establishing gynecomastia (unilateral or bilateral breast enlargement in men) or some other signs of aldosterone suppression is recommended discontinuation.

Spironolactone Actavis can change some laboratory and diagnostic tests - transient increase in blood urea nitrogen (especially in patients with pre-existing impaired renal function); falsely elevated plasma level of digoxin; increased plasma concentrations of cortisol / if is determined by the method fluorestsentten / mild acidosis.

Application of Spironolactone Actavis with food and drink:

No evidence of the need for special diets or restrictions on certain types of foods and beverages during treatment with this product.

pregnancy

Before intake of any medicine, consult your doctor with your pharmacist.

Because of the potential risk to the fetus, this product not be used during pregnancy.

breastfeeding

Before intake of any medicine, consult your doctor or pharmacist for.

Its primary active metabolite is excreted in human milk. Because of the potential risk of harm to the infant should be decided or discontinue breast-feeding or discontinuation of therapy with spironolactone Actavis.

Driving and using machines

In some patients, early treatment can be observed some drowsiness and dizziness. As a result, it may temporarily impair the ability to drive and use machines.

Important information about some of the ingredients of Spironolactone Actavis

This medicinal product contains lactose as an excipient, which makes it unsuitable for patients with lactase intolerance.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they have not been prescribed by your doctor.

Diuretics: Concomitant use of spironolactone with other diuretics increases diuretic effect. Not be used concomitantly with other potassium-sparing diuretics, due to the risk of developing severe hyperkalemia.

LSE inhibitors (medicines for the treatment of arterial hypertension); concomitant administration of ACE inhibitors and potassium-sparing diuretics can cause the development of severe hyperkalemia.

Potassium: Spironolactone not be used concomitantly with potassium-containing products, food additives or food because of the risk of hyperkalemia.

Antihypertensive (blood pressure lowering): Concurrent use enhances the effect of antihypertensive products. Anticoagulants (decreasing blood clotting): Concomitant administration of spironolactone with anticoagulants (coumarin, indandionovi derivatives or heparin) may lead to a reduction of antikoagulantiiya their effect, and you may need a dose adjustment of the latter.

Alcohol, barbiturates and drugs: Co-administration with spironolactone, can cause orthostatic hypotension (a sharp decrease in blood pressure when standing up).

Pressor amines (noradrenaline, etc.): Spironolactone reduces the vascular response to norepinephrine.

Non-depolarizing muscle relaxants (eg. Tubocurarine): Increases muscle reactivity to these products.

Lithium products: Diuretics, including spironolactone should not be administered concomitantly with lithium and lithium-containing products because they reduce its renal secretion, increasing the risk of lithium toxicity.

Systemic non-steroidal anti-inflammatory drugs: Co-administration with spironolactone may weaken its diuretic and antihypertensive activity and provoke the development of severe hyperkalemia.

Digoxin: Spironolactone extended plasma half-life of digoxin, which can lead to increased plasma digoxin levels and accordingly to a risk of digoxin toxicity.

3. HOW TO TAKE Spironolacton Actavis?

Always Spironolactone Actavis exactly as your doctor has instructed.

The dosage is individual and determined by the physician. The coated tablets are taken before meals with a little liquid.

Primary aldosteronism:

• as a diagnostic test, a long test - 400 mg per day for three to four weeks; transient test - 400 mg a day for four days;

• As a preparation before surgery is administered at a dose of 100 to 400 mg (4-16 coated tablets), divided into three or four doses. In patients unsuitable for surgery, need for continuous maintenance therapy usually applied minimum doses, as they are determined individually.
Treatment of edema (congestive heart failure, liver cirrhosis, nephrotic syndrome):

When swelling from heart, kidney and other origins main treatment is carried out with other diuretics (loop and thiazide) and in the absence of the desired effect is added spironolactone. The initial dose is generally 100-200 mg (4-8 coated tablets) per day, divided into 2-4 doses, after achieving the desired therapeutic effect is reduced to 25-75 mg (1-3 coated tablets) three times a day.

Ascites and edema in liver cirrhosis - initial dose of 50 mg (2 coated tablets) 2-4 times a day. After the occurrence of diuresis the dose is reduced. In the event that the diuretic effect is not satisfactory, then the 5th day is recommended addition of saluretichno agent (from the group of chlorothiazide) in its normal dose after breakfast. The dose of spironolactone may be increased if necessary to 75 mg (3 coated tablets) 4 times daily.

In addition to the comprehensive treatment of hypertension in combination with other antihypertensive agents:

The usual starting dose is 50-100 mg (2-4 coated tablets) daily, divided into 2-4 doses. The maximum effect is achieved after two weeks, the dose is adjusted according to the individual therapeutic response and patient tolerance.

Prevention and treatment of hypokalemia:

For the prophylaxis and treatment of diuretic-induced hypokalemia treatment was administered at doses of 25 to 100 mg (1 to 4 coated tablets) per day.

Children - This product is not recommended for children. Its safety and efficacy have not been established.

If you have the impression that the effect of the application of Spironolactone Actavis is too strong or too weak, talk to your doctor or pharmacist.

If you used a higher dose of Spironolactone Actavis prescribed:

When taking a higher dose than prescribed immediately consult a doctor!

Symptoms of overdose include dry mouth, thirst, weakness, dizziness, lethargy, drowsiness, muscle pain and cramps, nausea, vomiting, diarrhea, low blood pressure, reduced urine output and disorders of fluid and electrolyte balance / hyperkalemia, hyponatremia, hyperchloraemic metabolic acidosis - in decompensated cirrhosis), accompanied by disturbances of cardiac rhythm and conduction. In overdose is necessary to evacuate the stomach contents by induced vomiting, gastric lavage probe and then must be carefully evaluated and correction of fluid and electrolyte balance and support of vital functions. In hyperkalemia is administered IV solutions of calcium chloride, sodium bicarbonate and glucose with the addition of short-acting insulin. In refractory hyperkalemia may perform dialysis. There is no specific antidote.

If symptoms of overdose, immediately contact a doctor!

If you forget to use Spironolactone Actavis

If you miss a dose, take it at the next regular intake.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Spironolactone Actavis can cause side effects.

In treatment with spironolactone may develop gynecomastia (unilateral or bilateral breast enlargement in men), which is related to both the size of the dose administered and duration of treatment. It usually being reversed after discontinuation of therapy, but in some cases may continue after that.

During treatment with spironolactone Actavis can be any of the following side effects: Common: malaise.

Gastro-intestinal system: nausea, vomiting, diarrhea, gastritis, rare cases of gastric ulceration and bleeding.

Endocrine System: gynecomastia, tension and tenderness in the breast, impaired libido, menstrual disorders or amenorrhea (absence of menstruation), postmenopausal bleeding.

Changes in blood composition, changes in the cell composition of blood (leucopenia, thrombocytopenia, agranulocytosis).

Skin and allergic reactions: fever, urticaria, pruritus, rash, anaphylactic reactions and vascular, hair thinning, increased body hair.

Nervous system / psychiatric disorders: drowsiness, weakening of attention, dizziness, balance disorders, headaches.

Electrolyte changes: hyperkalemia, hyponatremia (low sodium).
Musculoskeletal: muscle cramps in the legs.

Liver / biliary system: hepatic dysfunction, hepatitis, in very rare cases, a severe intoxication (mixed hepatocellular and cholestatic type).

Kidney: abnormal renal function, including acute renal failure.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage

Keep out of reach of children. At temperatures below 25 ° C.

Do not use after the expiry date stated on the package! Shelf life: 3 (three) years from date of manufacture.

 

 

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