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4.5. Interactions with other medicinal products and other forms of interaction

ALDACTAZIDE® has been shown to increase the half-life of digoxin. This increases serum digoxin concentration followed by digitalis toxicity. When digoxin is taken with spironolactone, it may be necessary to lower the dose of digitalization. Such patients should be carefully monitored.

The ALDACTAZIDE treatment, as it may increase the effects of antihypertensive drugs® is dose of these drugs may need to be adjusted when added to the. Especially in patients with renal impairment, ACE inhibitors ALDACTAZIDE reduces aldosterone production® should not be used routinely with it.

Combination of carbenoxolone and spironolactone may reduce the efficacy of both agents.

Non-steroidal anti-inflammatory drugs reduce the natriuretic activity of diuretics by inhibiting prostaglandin intrarenal synthesis.

Simultaneous use of lithium and thiazides may reduce lithium clearance, which may lead to intoxication.

Both spironolactone and hydrochlorothiazide reduce the vascular response to neuroprephrine.ALDACTAZIDE® Caution should be exercised if patients treated with have to take local or general anesthesia.

The use of alcohol, barbiturates or narcotics ALACTASIA® together with may lead to the formation of orthostatic hypotension.

Antidiabetic drugs (insulin, or orally taken): Antidiabetic drugs may require dosage adjustment.

Corticosteroids, ACTH: Intensive electrolyte consumption, especially hypokalemia, may occur.

Musculoskeletal relaxants (such as tubocurarine): may increase the response to muscle relaxants.

Aspirin, indomethacin and mefenamic acid have been shown to reduce the diuretic effect of spironolactone.

Spironolactone enhances the metabolism of antipyrine.

The absorption of some drugs containing thiazide decreases when used in combination with cholestyramine and colestipol.

Spironolactone supplied with ammonium chloride or cholestyramine has been reported to cause hyperkalemic metabolic acidosis.

Additional information on

specific populations An interaction study of specific populations has not been conducted.

Pediatric population

An interaction study of the pediatric population has not been performed.

4.6. Pregnancy and lactation

General recommendation

Pregnancy category: C

Women with childbearing potential / Contraception The

safety of ALDACTAZIDE®in pregnancy has not yet been established.

For this reason, birth control may be considered during the treatment period for women with childbearing potential.

Pregnancy:

Spironolactone

teratogenic effects were observed in studies on mice. In rabbits given spironolactone, reduction in pregnancy rate, increase in resorption rates and decrease in the number of live births were observed. No embryotoxic effects were observed in high-dose spironolactone rats. However, in male rat fetuses, there was a decrease in plasma prolactin level and ventral prostate and seminal vesicle weight in a dose-dependent manner, while it was reported that the luteinizing hormone was more secreted in the female fetuses and an increase in ovarian and uterine weight was observed. In another study performed on rats, feminization was observed in male rat fetuses.

No studies were performed on pregnant women.

Hydrochlorothiazide:

Reproduction toxicity was not found in pregnant mice and rats given hydrochlorothiazide. Thiazide group diuretics may decrease placental perfusion by passing through the placental barrier and may cause uterine laziness to prevent birth.

Studies on the use of thiazide diuretics especially in the first trimester of pregnancy are limited. According to the effect of the pharmacological mechanism of thiazides, diuretics in this group may increase the risk of placental perfusion in the first two and first three months of pregnancy and may cause fatal and neonatal effects such as jaundice, fluid-electrolyte balance deterioration and thrombocytopenia.

Thiazide group diuretics should not be used in patients with congenital edema, hypertension or preeclampsia due to decreased plasma volume and increased risk of placental hypoperfusion.

Thiazides should not be used except in exceptional conditions in which pregnant women with essential hypertension cannot be identified with another treatment option.

Animal studies are insufficient in terms of the effects on pregnancy and-or embryonal / fetal development and-or birth and / or postnatal development. The potential risk for humans is unknown.

The use of ALDACTAZIDE®in pregnancy should be after the benefit-risk assessment for mother and fetus. ALDACTAZIDE should not be used during pregnancy unless necessary.

Lactation

Spironolactone:

The main active metabolite of spironolactone, kanrenon, was detected in breast milk.

Hydrochlorothiazide:

thiazide diuretics were observed in small amounts in breast milk. Thiazides taken in high doses may prevent milk secretion due to excessive diuresis. The ALDACTAZIDEduring breastfeeding® use ofis not recommended. If ALDACTAZIDE is used during lactation, doses should be kept as low as possible or an alternative method for infant feeding should be determined.

Fertility

Spironolactone:

Spironolactone applied to the female mouse reduced fertility. The potential risk for humans is unknown.

Hydrochlorothiazide: Hydrochlorothiazide

administered to mice and rats did not affect fertility. The potential risk for humans is unknown.

4.7. Effects on driving and machine use

Some patients have reported drowsiness and dizziness. Patients should be warned to be careful about activities such as vehicle and machine use.

8.4. Adverse effects

Adverse effects by system-organ class: Very common (>1/10); common (>1/100, <1/10); non-widespread ( > 1/1000, <1/100); infrequently (>1/10000, <1/1000); very rare (<1/10000), unknown (unpredictable).

Spironolactone:

Blood and lymphatic systemdisease:

Unknown Leukopenia, (including agranulocytosis),

Endocrine

Not knowndisorders: gynecomastia, impotence, inability to protect the erection, menstrual irregularities, post-menopausal bleeding

nervous systemillness:

Unknown dizziness, confusion, ataxia, headache, drowsiness,

gastrointestinal diseases

Unknown: stomach bleeding, ulcers, gastritis, diarrhea, cramps, vomiting, nausea

Hepatobiliary disorders

Unknown: cholestatic / hepatocellular toxicity,

kidney andurinary tract

Unknowndisorders: renal failure

General disorders anddisease on the implementation

Unknownof: restlessness, fever, urticaria, anaphylactic reactions, vasculitis, maculopapular or erythomatous cutaneous eruption

Breast cancer has been reported in patients using spironolactone, but it has not been shown to be related to the effect of drug use.

Hydrochlorothiazide

Blood and lymphatic systemdisease:

Unknown aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia

Metabolism andnutrition

Unknowndisorders: Electrolyte disturbances, hyperglycemia, glycosuria, hyperuricaemia

Nervous systemillness:

Unknown dizziness headache, dizziness, restlessness

Eye disorders

Not known: Transient blurred vision, xanthopsia

Cardiovascular diseases

Unknown: Hypotension including orthostatic hypotension

Gastrointestinal disorders

Unknown: Gastrointestinal disorders, pancreatitis, diarrhea, vomiting, sialadenitis, cramp, constipation, gastric irritation, nausea, anorexia

Hepato-biliary diseases

Unknown: Jaundice (intrahepatic cholestatic) jaundice), diarrhea, vomiting, sialadenitis, cramp, constipation, gastric irritation, nausea, anorexia

Skin and subcutaneous tissue disorders

Unknown: Erythema multiform, pruritus

Musculoskeletal disorders, connective tissue and bone disease Disorders

unknown: Muscle cramps

Kidney and urinary tract diseases:

Unknown: Renal impairment, renal failure

General disorders and diseases related to the application area

Unknown: Anaphylactic reactions, necrotizing agents (vasculitis and cutaneous vasculitis) sensitivity, fever, urticaria, redness, purpura, weakness

4.9 Overdose and treatment

Symptoms

Acute overdose may manifest itself in the form of dizziness, confusion, nausea, maculopapular or erythematous rash, vomiting, or diarrhea.

Rarely, hyponatremia may develop hyperkalemia or cause hepatic coma in patients with severe liver disease, but these effects are not associated with acute overdose.

Symptoms of hyperkalemia occur in the form of paresthesia, weakness, paracetamol or muscle spasm, and may be difficult to distinguish from hypokalemia. Electrocardiographic changes are evident early signs of potassium irregularities.

Treatment

Pouching can be done, lavage can be applied. A particular antidote has not been identified. An improvement is expected after discontinuation of the drug. Fluid and electrolyte replacement is general supportive treatment. For hyperkalemia, potassium intake should be reduced, diuretics causing potassium loss, intravenous glucose and regular insulin or oral ion exchange resins should be used. Persistent hyperkalemia may require dialysis.

5. PHARMACOLOGICAL PROPERTIES

5.1.properties

Pharmacodynamic Pharmacotherapeutic group: Aldosterone antagonists

ATC code: C03EA01

ALDACTAZIDE® consists of a combination of two different diuretic agents with complementary action mechanisms and regions, thus providing additional diuretic and antihypertensive effects. In addition, the spironolactone content minimizes the potassium-reducing effect of the thiazide content.

Spironolactone, as a competitive aldosterone antagonist, has a diuretic effect by binding to the aldosterone-bound sodium-potassium region in distal renal tubules. Hydrochlorothiazide increases the excretion of water and sodium by preventing reabsorption in the cortical diluent segment in the distal renal tubules.

ALDACTAZINE® has a significantly lowering effect on systolic and diastolic blood pressure in patients with essential hypertension, even if the aldosterone secretion is within limits.

Spironolactone and hydrochlorothiazide have a reducing effect on blood pressure, body weight, plasma volume and convertible sodium. When spironolactone and hydrochlorothiazide are administered together, the diuretic and antihypertensive effect of each component is increased.

5.2

Pharmacokinetic properties

Spironolactone

Absorption:

The effect of food on the absorption of spironolactone (Aldactone two 100 mg tablets) was assessed using a single dose study on 9 healthy volunteers, free of medication. With the effect of food, the bioavailability of non-metabolized spironolactone increased by 100%. The clinical significance of these findings is unknown.

Distribution

Spironoklato and metabolites in the plasma at a rate pretense binds more than 90%.

Biotransformation:

Spironolactone is rapidly and widely metabolized. Spironolactone is generally metabolised to its active metabolites with the following proportions: Sulfide-containing metabolites (80%), and partially cannabone (20%).

Although the

half-life of spironolactone is short (1.3 hours), the half-life of its active metabolites is long (ranging from 2.8 to 11.2 hours).

The excretion of metabolites takes place primarily through urine, and secondly through the bile through the faeces.

Following administration of 100 mg spironolactone daily in healthy volunteers for 15 days, tmax, peak plasma concentration (Cmax) and elimination half-life (t1 / 2) were determined for spironolactone, respectively; 2.6 hours, 80 ng / ml and average 1.4 hours. 7-alpha- (thiomethyl) spironolactone and canrenone for metabolites; tmax was 3.2 hours and 4.3 hours, Cmax was 391 ng / ml and 181 ng / ml, and t1 / 2 was 13.8 hours and 16.5 hours.

The pharmacological activity of spironolactone metabolites is unknown. However, in adrenalectomized rats, the antimineralocorticoid activity of C, TMS and HTMS metabolites were 1.10, 1.28 and 0.32, respectively, compared to spironolactone. The binding to rat kidney aldosterone receptors was 0.19, 0.86 and 0.06, respectively, compared to spironolactone.

TMS and 7-alpha-thio spironolactone potency for conversion of synthetic mineralocorticoid and fludrocortisone in urinary electrolyte composition in humans were found to be 0.33 and 0.26 compared to spironolactone. However, since serum concentrations of these steroids could not be determined, their absorption as a reason for decreased in vivo activity and / or initial-transition metabolism could not be rejected.

Hydrochlorothiazide:

Absorption:

Hydrochlorothiazide is rapidly absorbed following oral administration. The effect of hydrochlorothiazide begins to be observed within 1 hour and continues for 6 to 12 hours. The plasma concentration of hydrochlorothiazide reaches peak level in 1 to 2 hours, and has a half-life of 4 to 5 hours.

Distribution:

Disperses in the area other than the cells and does not accumulate in any tissue other than the kidney.

Biotransformation:

Not indicated.