TRIPLIXAM PILLS 5MG + 2.5 MG + 10MG

Composition

TRIPLIXAM ® 2.5 mg / 0.625 mg / 5 mg

active ingredients: 1 pill contains Perindopril arginine 2.5 mg (corresponding to 1.6975 mg perindopril), Indapamide 0.625 mg, and Amlodipine besylate 6.935 mg (which corresponds to 5 mg amlodipine)

TRIPLIXAM ® 5 mg / 1.25 mg / 5 mg

active ingredients: 1 pill contains perindopril arginine 5 mg (which corresponds to 3.395 mg of perindopril), indapamide 1.25 mg and amlodipine besylate 6.935 mg (which corresponds to 5 mg of amlodipine)

TRIPLIXAM ® 5 mg / 1.25 mg / 10 mg

active ingredients: 1 pill contains perindopril arginine 5 mg (corresponding to 3.395 mg perindopril), 1.25 mg indapamide and amlodipine besylate 13.870 mg (which corresponds to 10 mg amlodipine)

TRIPLIXAM ® 10 mg / 2.5 mg / 5 mg

active ingredients: 1 pill contains perindopril arginine 10 mg (which corresponds to 6.790 mg of perindopril), indapamide 2.5 mg and amlodipine besylate 6.935 mg (which corresponds to 5 mg of amlodipine)

TRIPLIXAM ® 10 mg / 2.5 mg / 10 mg

active ingredients: 1 pill contains perindopril arginine 10 mg (which corresponds to 6.790 mg of perindopril), indapamide 2.5 mg and amlodipine besylate 13.870 mg (which corresponds to 10 mg of amlodipine)

excipients: tablet: a mixture of Calcium carbonate and starch, microcrystalline cellulose, sodium croscarmellose, Magnesium stearate, colloidal silicon dioxide, corn starch; film coat: glycerin, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171).

Dosage Form

Tablets, film coated.

Pharmacological group

ACE inhibitors, other combinations. Perindopril, amlodipine and indapamide.

Indications

Triplixam ® is indicated for the treatment of arterial hypertension in patients who need treatment with perindopril, indapamide and amlodipine in a dose that is available in a fixed combination.

Contraindications

Use for patients on hemodialysis;

use in patients with untreated decompensated heart failure,

severe renal failure (creatinine clearance below 30 ml / min);

Medium-grade renal failure (creatinine clearance below 60 ml / min) when taking Triplixam ® containing a combination of active ingredients in doses of 10 mg / 2.5 mg / 5 mg or 10 mg / 2.5 mg / 10 mg

Hypersensitivity to the active substances, other sulfonamide preparations, dihydropyridine derivatives, any other ACE inhibitor, or to any excipients listed in the “Composition” section;

pregnant women or women planning to become pregnant (see section “Use during pregnancy or lactation”);

breastfeeding period (see the section “Use during pregnancy or lactation”);

history of angioedema (angioedema) associated with previous treatment with ACE inhibitors

congenital or idiopathic angioedema

hepatic encephalopathy

severe liver dysfunction

hypokalemia

severe hypotension

shock including cardiogenic shock

obstruction of exit from the left ventricle (for example, severe aortic stenosis);

heart failure with unstable hemodynamics after acute myocardial infarction

simultaneous use with preparations containing the active ingredient aliskiren, in patients with diabetes mellitus or renal insufficiency (glomerular filtration rate <60 ml / min / 1.73 m 2) (see section "Interaction with other drugs and other types of interactions").

Dosage and administration

For oral administration.

1 pill Tripliksam ® once a day, preferably in the morning before meals.

The use of a fixed combination is not intended for initial therapy.

If necessary, the dose of the fixed combination Triplixam ® can be changed or the individual selection of doses can be recommended separately for each component.

Adverse reactions

The most frequent adverse reactions that have been observed with perindopril, indapamide and amlodipine alone are: dizziness, headache, paresthesia, vertigo, drowsiness, blurred vision, tinnitus, palpitation, hot flashes, arterial hypotension (and associated symptoms), cough, shortness of breath, gastrointestinal disturbances (abdominal pain, constipation, diarrhea, taste perversion (dysgeusia), dyspepsia, nausea, vomiting), itching, skin rashes, maculopapular rashes, muscle spasms, asthenia, ankle swelling, edema and backwardness.

During treatment with perindopril, indapamide, or amlodipine, the following adverse reactions were observed, which are distributed in frequency as follows: very often (≥ 1/10); often (≥ 1/100, <1/10); infrequently (> 1/1000, <1/100) rarely (> 1/10000, <1/1000); very rarely (<1/10000); frequency unknown (cannot be determined from the available information).

Infections and invasions.Rhinitis: perindopril - very rarely, amlodipine - infrequently.

From the circulatory and lymphatic systems. Agranulocytosis: perindopril and indapamide - very rarely; aplastic anemia: indapamide - very rarely; pancytopenia: perindopril - very rarely; leukopenia: perindopril, indapamide, amlodipine - very rarely; neutropenia: perindopril - very rarely; hemolytic anemia: perindopril, indapamide - very rarely; thrombocytopenia: perindopril, indapamide, amlodipine - very rarely; eosinophilia: perindopril - infrequently *.

On the part of the immune system. Hypersensitivity reactions: amlodipine - very rarely, indapamide - infrequently.

On the part of metabolism and metabolism. Hyperkalemia, which disappears after discontinuation of the drug: perindopril - infrequently *; hyperglycemia: amlodipine - very rarely; hypercalcemia: indapamide - very rarely; hypoglycemia: perindopril - infrequently *; a decrease in the level of potassium with hypokalemia, in particular, serious in high-risk patients: indapamide - the frequency is unknown; hyponatremia: perindopril - infrequently * indapamide - frequency unknown.

From the psyche. Confusion of consciousness: perindopril - very rarely, amlodipine - rarely; insomnia: amlodipine - infrequently; mood changes (including anxiety): amlodipine - infrequently, perindopril - infrequently; depression: amlodipine - infrequently; sleep disorders: perindopril - infrequently.

From the nervous system. Dizziness: perindopril and amlodipine - often; headache: perindopril and amlodipine - often, indapamide - rarely; paraesthesia: perindopril - often, indapamide - rarely, amlodipine - infrequently; vertigo: perindopril - often, indapamide - rarely; confusion: perindopril - very rarely; hypertension: amlodipine - very rarely; peripheral neuropathy: amlodipine - very rarely; hypesthesia: amlodipine - infrequently; taste perversion (dysgeusia): perindopril — often amlodipine — infrequently; tremor: amlodipine - infrequently; syncope: perindopril - rarely * indapamide - frequency unknown, amlodipine - infrequently; drowsiness: perindopril - infrequently * amlodipine - often, extrapyramidal disorders (extrapyramidal symptoms): amlodipine - frequency unknown; stroke, possibly due to excessive lowering of blood pressure in high-risk patients: perindopril is very rare.

From the organs of sight.Visual impairment: perindopril - often, indapamide - frequency unknown, amlodipine - infrequently; double vision: amlodipine - infrequently; myopia: indapamide - frequency unknown; blurred vision: indapamide - frequency unknown.

On the part of the ear and the labyrinth of the ear. Tinnitus: perindopril - often amlodipine - infrequently.

From the side of the heart. Angina pectoris: perindopril - very rarely; arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation): perindopril, indapamide, amlodipine - very rarely; myocardial infarction may occur due to excessive lowering of blood pressure in high-risk patients: perindopril and amlodipine - very rarely; palpitation: perindopril - infrequently * amlodipine - often; paroxysmal ventricular tachycardia of the “pirouette” type (torsade de pointes), which can be fatal: indapamide - frequency unknown; tachycardia: perindopril - infrequently *.

From the vascular system. Hot flashes: amlodipine - often; hypotension (and associated symptoms): perindopril - often, indapamide - very rarely, amlodipine - infrequently; vasculitis: perindopril - infrequently * amlodipine - very rarely.

On the part of the respiratory system, organs of the chest and mediastinum. Cough: perindopril - often, amlodipine - very rarely; shortness of breath: perindopril - often amlodipine - infrequently; bronchospasm: perindopril - infrequently; eosinophilic pneumonia: perindopril is very rare.

From the digestive system. Abdominal pain in the abdomen: perindopril and amlodipine - often; constipation: perindopril - often, indapamide - rarely, amlodipine - infrequently; diarrhea: perindopril - often, amlodipine - infrequently; dyspepsia: perindopril - often, amlodipine - infrequently; nausea: perindopril and amlodipine - often, indapamide - rarely; vomiting: perindopril - often, indapamide and amlodipine - infrequently; dry mouth: perindopril and amlodipine - infrequently, indapamide - rarely; change in rhythm of defecation: amlodipine - infrequently; gum hyperplasia: amlodipine - very rarely; perindopril pancreatitis, indapamide and amlodipine - very rarely; gastritis: amlodipine - very rarely.

From the digestive system. Hepatitis: perindopril and amlodipine - very rarely, indapamide - the frequency is unknown; jaundice: amlodipine - very rarely; indapamide - very rarely; in the presence of liver failure, hepatic encephalopathy may occur: indapamide - the frequency is unknown.

From the skin and subcutaneous tissue.Quincke’s edema: amlodipine - very rarely; pruritus: perindopril — often amlodipine — infrequently; rash: perindopril — often amlodipine — infrequently; maculopapular rash: indapamide - often; urticaria: perindopril - infrequently, indapamide and amlodipine - very rarely; angioedema: perindopril - infrequently, indapamide and amlodipine - very rarely; alopecia: amlodipine - infrequently; purpura: indapamide and amlodipine - infrequently; skin discoloration: amlodipine - infrequently; hyperhidrosis: perindopril and amlodipine - infrequently; exanthema: amlodipine - infrequently; erythema multiforme: perindopril and amlodipine - very rarely; Stevens-Johnson syndrome: indapamide and amlodipine - very rarely; exfoliative dermatitis: amlodipine - very rarely; toxic epidermal necrolysis: indapamide - very rarely; photosensitization reactions: perindopril - infrequently * indapamide - frequency unknown, amlodipine - very rarely; possibly increasing manifestations of existing systemic lupus erythematosus: indapamide - the frequency is unknown; pemphigoid: perindopril - infrequently *.

From the musculoskeletal system and connective tissue. Muscle cramps: perindopril — often amlodipine — infrequently; ankle swelling: amlodipine - often; arthralgia: perindopril - infrequently * amlodipine - infrequently; myalgia: perindopril - infrequently * amlodipine - infrequently; back pain: amlodipine - infrequent.

On the part of the kidneys and urinary. Urination disorders, nocturia, frequent urination: amlodipine - infrequently; acute renal failure : perindopril - very rarely; renal failure: perindopril - infrequently, indapamide - very rarely.

From the reproductive system and mammary glands. Erectile dysfunction: perindopril and amlodipine - infrequently; gynecomastia: amlodipine - infrequently.

Common disorders. Asthenia: perindopril - often amlodipine - infrequently; increased fatigue: indapamide - rarely, amlodipine - often; Amlodipine swelling - often; chest pain: perindopril - infrequently * amlodipine - infrequently; pain: amlodipine - infrequently; malaise: perindopril - infrequently * amlodipine - infrequently; Perindopril peripheral edema - infrequently *; hyperthermia: perindopril - infrequently *.

Study. Increase / decrease in body weight: amlodipine - infrequently; increased levels of bilirubin in the blood: perindopril - rare; elevated liver enzymes: perindopril - rare,indapamide - the frequency is unknown, amlodipine - very rarely; increase in the level of creatinine in the blood: perindopril - infrequently *; increased blood urea levels: perindopril - infrequently *; decrease in hemoglobin and hematocrit: perindopril - very rarely; prolongation of the QT interval on the electrocardiogram: indapamide - frequency unknown; increase in blood glucose level: indapamide - frequency unknown; increased uric acid in the blood: indapamide - frequency unknown.

Overdose

There are no data on drug overdose Triplixam ®.

For the combination of perindopril / indapamide, frequent undesirable reactions in overdose are hypotension, which can sometimes be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, confusion, oliguria, which can progress to anuria (due to hypovolemia). Disorders of water and electrolyte balance (decrease in the level of potassium and sodium in the blood plasma) may occur.

First aid measures include the rapid elimination of the drug from the body: gastric lavage and / or the appointment of activated charcoal, and then the restoration of water and electrolyte balance in the hospital, until these figures return to normal.

In the event of significant hypotension, the patient should be given a horizontal position with a low head. If necessary, isotonic solution is administered intravenously or any other method of blood volume recovery is used.

Perindopril, the active form of perindopril, can be removed from the body through hemodialysis (see the Pharmacokinetics section).

Data on a conscious overdose of amlodipine are limited.

According to available data, it can be assumed that taking very large doses will lead to excessive peripheral vasodilation and reflex tachycardia. It was reported about the expressed, probably long-term systemic hypothesis and shock with a fatal outcome.

Clinically pronounced hypotension caused by an overdose of amlodipine requires active cardiovascular care, in particular, frequent monitoring of heart function and respiratory function, elevation of the extremities, as well as monitoring of circulating blood volume and urination.

Appointment of a vasoconstrictor may be useful to restore vascular tone and blood pressure, if there are no contraindications. The introduction of Calcium gluconate can help eliminate the effects of calcium channel blockade.

In some cases, gastric lavage is advisable. A study with healthy volunteers showed that as a result of the use of Activated carbon 2:00 after taking 10 mg of amlodipine, the rate of absorption of amlodipine in the body decreases. Since amlodipine has a high level of binding to blood proteins, hemodialysis is considered ineffective.

Use during pregnancy and lactation

Perindopril. The use of ACE inhibitors is contraindicated in pregnancy. Epidemiological data on the risk of a teratogenic effect due to the use of ACE inhibitors during the first trimester of pregnancy are inconclusive, so a slight increase in risk cannot be ruled out. The drug should not be used by pregnant women or women who are planning to become pregnant. If pregnancy is confirmed during drug treatment, its use must be immediately discontinued and replaced with another drug approved for use in pregnant women.

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