Active substanceHydrochlorothiazide + IrbesartanHydrochlorothiazide + Irbesartan
Dosage form: & nbspFilm-coated tablets.
Composition:

1 tablet contains (mg):

Active substances

for tablets 12.5 mg + 150 mg: hydrochlorothiazide - 12.5; irbesartan - 150.0;

for tablets 12.5 mg + 300 mg: hydrochlorothiazide - 12.5; irbesartan - 300.0;

for tablets 25 mg + 300 mg: hydrochlorothiazide - 25.0; irbesartan - 300.0.

Excipients

The core of the tablet

for tablets 12.5 mg + 150 mg: mannitol - 97.05; povidone - 11.60; polysorbate 80 - 1.45;

crospovidone - 11.60; silicon dioxide colloidal - 1,45; magnesium stearate - 4.35;

for tablets 12.5 mg + 300 mg: mannitol 206.6; povidone - 23.2; polysorbate 80 - 2.9;

crospovidone - 23.2; silicon dioxide colloidal - 2,9; magnesium stearate - 8.7;

for tablets 25 mg + 300 mg: mannitol - 194.1; povidone - 23.2; polysorbate 80 - 2.9;

crospovidone - 23.2; silicon dioxide colloidal - 2,9; magnesium stearate - 8.7.

Shell

for tablets 12.5 mg + 150 mg: Opadrai II pink (hypromellose - 5.6, titanium dioxide - 3.36, lactose monohydrate - 2.94, macrogol 3000 - 1.12, triacetin - 0.84, iron dye oxide yellow - 0.09, iron dye oxide red - 0,045; iron dye oxide black-0,005) - 14,0;

for tablets 12.5 mg + 300 mg: Opadrai II pink (hypromellose - 11.2, titanium dioxide - 6.72, lactose monohydrate - 5.88, macrogol 3000 - 2.24, triacetin - 1.68, iron dye oxide yellow - 0.18, iron dye oxide red - 0.09, iron dye oxide black-0.01) -28.0;

for tablets 25 mg + 300 mg: Opadrai II pink (hypromellose - 11.2, titanium dioxide - 6.36, lactose monohydrate - 5.88, macrogol 3350 - 2.24, triacetin - 1.68, iron dye oxide yellow - 0.24, iron oxide dye red - 0.36, iron oxide oxide black - 0.04) - 28.0.

Description:

For tablets 12.5 mg + 150 mg: oblong, biconvex tablets covered with a filmy coating of light pink color with a brownish tinge, on a white break with a light pink with a brownish tinge.

For tablets 12.5 mg + 300 mg: oblong, biconvex tablets with a risk on both sides, covered with a filmy coating of light pink color with a brownish tinge, on a fracture of white color with a light pink with a brownish tinge.

For tablets 25 mg + 300 mg: oblong, biconvex tablets with a risk on one side, covered with a filmy coat of pink color with a brownish tinge, on a broken white with a pinkish tinge with a brownish tinge.

Pharmacotherapeutic group:hypotensive combined agent (angiotensin II receptor antagonist [ARA II] + diuretic).
ATX: & nbsp

C.09.D.A.04   Irbesartan in combination with diuretics

C.09.D.A   Angiotensin II antagonists in combination with diuretics

Pharmacodynamics:

Combined drug with antihypertensive effect. The composition includes an angiotensin II receptor antagonist and a thiazide diuretic. The combination of these drugs has an additive antihypertensive effect, reducing blood pressure more than each of the drugs individually. Irbesartan is a selective antagonist of angiotensin II receptors (type AT1) for oral administration. Irbesartan blocks all physiologically significant effects of angiotensin II, mediated by receptors AT1, regardless of the source or route of synthesis of angiotensin II. Selective antagonism to angiotensin II receptors (AT1) leads to an increase in blood plasma concentrations of renin and angiotensin II and a decrease in aldosterone in the blood plasma. Serum potassium content usually does not change significantly when taking irbesartan in recommended doses. Irbesartan does not inhibit kinase II. Irbesartan does not require metabolic activation. Reduces blood pressure with a minimum change in heart rate.

Hydrochlorothiazide is a thiazide diuretic. Affects the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chloride ions in approximately equal amounts. Diuretic effect of hydrochlorothiazide leads to a decrease in the volume of blood plasma, increased renin activity in the blood plasma, increased secretion of aldosterone and an increase in the content of potassium ions and bicarbonates in urine and hypokalemia. Simultaneous administration with irbesartan leads to a decrease in the loss of potassium ions, mainly due to the blockade of the renin-angiotensin-aldosterone system. When taking hydrochlorothiazide, an increase in diuresis occurs after 2 hours and reaches a maximum after 4 hours. The action of hydrochlorothiazide lasts about 6-12 hours.

Reduction of arterial pressure in the appointment of irbesartan in combination with hydrochlorothiazide is manifested even with the first intake of the drug inside and persists for 1-2 weeks, followed by its gradual strengthening and development of maximum effect at 6-8 weeks.

Pharmacokinetics:

The simultaneous administration of hydrochlorothiazide and irbesartan does not affect

pharmacokinetics of each of the drugs.

Suction

After ingestion, the absolute bioavailability of irbesartan is 60-80%, hydrochlorothiazide - 50-80%. Eating does not affect their bioavailability. The maximum concentration (CmOh) irbesartan in the blood plasma is achieved 1.5-2 hours after ingestion, hydrochlorothiazide - after 1 -2.5 hours.

Distribution

Irbesartan binds 96% with plasma proteins. Volume of distribution (Vd) irbesartan is 53-93 liters. The pharmacokinetic parameters of irbesartan are linear and proportional in the dose range from 10 mg to 600 mg. At doses in excess of 600 mg (a dose twice the recommended maximum dose of the drug), the pharmacokinetics of irbesartan become nonlinear (decrease in absorption).

Hydrochlorothiazide binds 68% to plasma proteins, Vd - 0.83-1.14 l / kg.

Metabolism

Irbesartan is metabolized in the liver by conjugation with glucuronic acid and oxidation. The main metabolite circulating in the blood is irbesartan glucuronide (about 6%). Research in vitro showed that irbesartan is oxidized, mainly by isoenzyme CYP2C9 cytochrome P450. Effect of isoenzyme CYP3A4 slightly.

Hydrochlorothiazide is not metabolized. It penetrates through the placental barrier and is excreted in breast milk. Does not penetrate the blood-brain barrier.

Excretion

The total clearance and renal clearance are 157-176 and 3.0-3.5 ml / min, respectively.

The half-life of irbesartan (T1/2) is 11-15 hours. Irbesartan and its metabolites are excreted through the intestine (80%) and kidneys (20%), with less than 2% of the accepted dose of irbesartan excreted by the kidneys unchanged. T1/2 hydrochlorothiazide - 5-15 hours. It is excreted by the kidneys. At least 61% of the dose taken internally is excreted unchanged for 24 hours.

Pharmacokinetics in special clinical cases

Several higher concentrations of irbesartan in blood plasma are noted in female patients. However, the differences in the magnitude T1/2 and no cumulation of irbesartan. Correction of irbesartan dose in female patients is not required. The values ​​of the area under the curve "concentration - time" (AUC) and CmOh irbesartan in blood plasma were slightly higher in elderly patients (over 65 years) than in younger patients (up to 65 years of age). T1/2 Irbesartan did not differ significantly. Correction of irbesartan dose in elderly patients is not required.

Impaired renal function: in patients with impaired renal function or who are on hemodialysis, the pharmacokinetic parameters of irbesartan are changed insignificantly.

Impaired liver function: in patients with impaired liver function of mild or moderate severity, the pharmacokinetic parameters of irbesartan were changed insignificantly. In patients with severe impairment of liver function, no studies have been performed.

Indications:Arterial hypertension (treatment of patients who are shown combined therapy).
Contraindications:
- Hypersensitivity to any of the components of the drug or to other derivatives of the sulfonamide;

- Renal failure of severe severity (creatinine clearance <30 ml / min), anuria;

- Liver failure of severe severity (class C / more than 9 points / Child-Pugh scale), biliary cirrhosis and cholestasis;

- Refractory hypokalemia, hypomagnesemia, hypercalcemia;

- Primary hyperaldosteronism;

- Hereditary lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome;

- Pregnancy and lactation;

- Age to 18 years (effectiveness and safety not established).
Carefully:
- With stenosis of the aortic or mitral valve; hypertrophic obstructive cardiomyopathy.

- With dehydration, hyponatremia, diarrhea, vomiting, adherence to a diet with restriction of consumption of table salt, treatment with diuretics.

- In bilateral or unilateral renal artery stenosis, chronic heart failure III-IV stage according to NYHA classification (as with other drugs affecting the renin-angiotensin-aldosterone system, one can not exclude the risk of developing arterial hypotension, oliguria and / or azotemia and progressing acute renal failure).

- With ischemic heart disease and / or atherosclerotic lesions of cerebral vessels.

- With renal insufficiency of mild and moderate severity (creatinine clearance from 60 to 30 ml / min), hemodialysis; with recent kidney transplantation (lack of clinical experience).

- With hepatic failure (lack of experience in clinical use).

- With diabetes mellitus; increased content of cholesterol and triglycerides in the blood; gout; latent hyperparathyroidism; sympathectomy.

- With giperkaliemii, simultaneous intake of potassium-sparing drugs and potassium-containing substitutes for table salt, while taking other antihypertensive drugs.

- With systemic lupus erythematosus.
Pregnancy and lactation:The use of the drug Ibertan Plus is contraindicated in pregnancy, since the effects on the fetus of medicines that affect the renin-angiotensin-aldosterone system can lead to damage and death of the developing fetus. Thiazide diuretics penetrate the placental barrier and are found in the umbilical cord blood. Usually, the use of diuretics in healthy pregnant women is not recommended and exposes the mother and the fetus to unnecessary risk, including the development of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that occur in adults.Especially it is not recommended to take hydrochlorothiazide in the first trimester of pregnancy. The drug is contraindicated in the II and III trimesters of pregnancy. If pregnancy is diagnosed, the drug Ibertan Plus should be discontinued as soon as possible. If the patient takes the drug with the II trimester of pregnancy, it is necessary to conduct ultrasound examination of the skull and renal function. The drug Ibertan Plus is contraindicated during the lactation period.
Dosing and Administration:

Inside, once a day, regardless of food intake.

Preparation Ibertan Plus 12.5 / 150 mg (a tablet containing hydrochlorothiazide / irbesartan 12.5 / 150 mg, respectively) can be administered to patients whose blood pressure is not adequately controlled only purpose of hydrochlorothiazide (12.5 mg / day) or irbesartan ( 150 mg / day) in monotherapy.

Preparation Ibertan Plus 12.5 / 300 mg (a tablet containing hydrochlorothiazide / irbesartan 12.5 / 300 mg, respectively) can be administered to patients if the blood pressure is not adequately controlled by assignment of irbesartan (300 mg / day) or preparation Ibertan Plus (12, 5/150 mg).

Preparation Ibertan Plus 25/300 mg (tablets,containing hydrochlorothiazide / irbesartan 25/300 mg, respectively) can be given to patients if the blood pressure is not adequately controlled by the prescription of the drug Ibertan Plus (12.5 / 300 mg). Do not administer doses higher than 25 mg hydrochlorothiazide / 300 mg irbesartan 1 time per day.

If necessary, the drug Ibertan Plus can be prescribed together with other antihypertensive drugs.

Impaired renal function: due to the fact that the composition of the drug Ibertan Plus includes hydrochlorothiazide, the drug is not recommended for patients with impaired renal function of severe severity (creatinine clearance <30 mL / min). In patients in this population, the appointment of "loop" diuretics is more preferable. No dose adjustment is required in patients with impaired renal function with creatinine clearance> 30 mL / min.

Impaired liver function: it is not recommended to administer Ibertan Plus in patients with severe hepatic impairment. In patients with hepatic insufficiency of mild and moderate severity, dose adjustment of the Iberto Plus preparation is not required.

Elderly patients: It is not necessary to correct the dose of the drug Ibertan Plus in elderly patients.

Decreased circulating blood volume: before the appointment of the drug, Ibertan Plus, it is necessary to adjust the volume of circulating blood and / or the sodium content.

Side effects:

The following side effects are given according to the following gradations of their frequency: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1 000, <1/100); rarely (> 1/10 000, <1/1 000); very rarely (<1/10 000). Within each frequency of occurrence, adverse reactions are indicated in the sequence according to a decrease in their severity.

The combination of hydrochlorothiazide / irbesartan:

From the central nervous system: often - dizziness; infrequently - orthostatic dizziness.

From the cardiovascular system: infrequently - syncope, a marked decrease in blood pressure, tachycardia, peripheral edema, "hot flashes" of blood to the skin of the face.

From the digestive system: often - nausea, vomiting; infrequently diarrhea.

From the urinary system: often - violation of urination.

From the genitourinary system: infrequently - sexual dysfunction, a violation of libido.

Other: often - increased fatigue.

Laboratory indicators: often - an increase in the concentration of urea nitrogen, creatinine and creatine phosphokinase plasma; infrequently - a decrease in the content of potassium and sodium in the blood serum. These changes in laboratory parameters were rarely clinically significant.

Adverse reactions detected with the combination of hydrochlorothiazide / irbesartan, reported in the postmarketing period:

Allergic reactions: rarely - skin rash, hives, angioedema.

From the side of metabolism: very rarely - hyperkalemia.

From the central nervous system: very rarely - a headache.

From the sense organ: very rarely - ringing in the ears.

From the respiratory system: very rarely - cough.

From the digestive system: very rarely - dyspepsia, dysgeusia, dryness of the oral mucosa, hepatitis, violations of the liver.

From the musculoskeletal system: very rarely - arthralgia, myalgia.

From the urinary system: very rarely - renal dysfunction, incl. individual cases of renal failure in patients at high risk. Additional information on individual components:

In addition to the already mentioned adverse reactions, other side effects previously reported for each of the components that may be possible side effects and in the case of the Iberto Plus drug are listed below.

Irbesartan

Other: infrequently - pain in the chest.

Hydrochlorothiazide (without specifying frequency of occurrence)

From the hematopoiesis: aplastic anemia, bone marrow depression, hemolytic anemia, leukopenia, neutropenia / agranulocytosis, thrombocytopenia.

From the central nervous system: depression, sleep disorders, dizziness, paresthesia, anxiety.

From the sense organ: transient vagueness of vision, xantopsy.

From the cardiovascular system: arrhythmia, postural hypotension.

From the respiratory system: respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the digestive system: jaundice (intrahepatic cholestatic jaundice).

Allergic reactions: anaphylactic reactions, toxic epidermal necrolysis, lupus-like syndrome, necrotizing angiitis (vasculitis, cutaneous vasculitis), photosensitivity reactions, skin rash, exacerbation of systemic lupus erythematosus, urticaria.

From the musculoskeletal system: muscle spasms, weakness.

From the urinary system: interstitial nephritis, kidney dysfunction.

Other: fever.

Laboratory indicators: violations of water-electrolyte balance (including hypokalemia and hyponatremia), glucosuria, hyperglycemia, hyperuricemia, increased cholesterol and triglycerides.

Overdose:

Symptoms (presumed): irbesartan - marked decrease in arterial pressure, tachycardia, bradycardia. Hydrochlorothiazide - hypokalemia, hyponatremia, dehydration as a result of excessive diuresis. The most frequent manifestations of an overdose are nausea and drowsiness. Hypokalemia can lead to seizures and / or the development of heart rhythm disorders associated with the combined use of cardiac glycosides and antiarrhythmics.

Treatment: depends on the time elapsed since the moment of taking and the severity of the symptoms. Proposed measures include provoking vomiting and / or gastric lavage, the use of activated carbon, careful monitoring of the patient's condition, symptomatic and maintenance therapy. It is necessary to monitor the concentration of electrolytes and creatinine in the blood plasma.In the case of a pronounced decrease in blood pressure, the patient should be placed on his back with raised lower limbs and as soon as possible to recover salt and liquid. Irbesartan not excreted by hemodialysis.

Interaction:

Other antihypertensive drugs: the antihypertensive effect of the drug Ibertan Plus can be strengthened by the concomitant use of other antihypertensive drugs. Hydrochlorothiazide and irbesartan (in doses up to 25 mg hydrochlorothiazide / 300 mg irbesartan) can safely be used in combination with other antihypertensive drugs, including "slow" calcium channel blockers and beta-blockers. Previously treated with high doses of diuretics can lead to hypovolemia and increase the risk of developing arterial hypotension.

Lithium: there are reports of a reversible increase in serum lithium concentrations and toxicity when combined with lithium drugs and angiotensin-converting enzyme inhibitors. With respect to irbesartan, similar effects have been extremely rare to date. In addition, the renal clearance of lithium decreases with the use of thiazide diuretics, so when prescribing the drug, Ibertan Plus has an increased risk of developing a toxic effect of lithium.If the appointment of this combination is necessary, it is recommended that careful monitoring of lithium content in serum is recommended.

Drugs affecting the content of potassium in the blood: the hypokalemic effect of hydrochlorothiazide is weakened by the potassium-sparing effect of irbesartan. However, this effect of hydrochlorothiazide can be intensified by other drugs, the purpose of which is associated with potassium loss and hypokalemia (for example, diuretics, laxatives, amphotericin, carbenoxolone, sodium salt of penicillin G, derivatives of salicylic acid). On the contrary, based on the experience of using drugs that reduce the activity of the renin-angiotensin-aldosterone system, the concomitant use of potassium-sparing diuretics, dietary supplements, salt substitutes containing potassium, or other drugs that can lead to an increase in serum potassium (for example , sodium salt of heparin), can cause an increase in potassium in the blood serum. It is recommended to conduct proper control of potassium content in blood serum in patients at risk of hyperkalemia.

Drugs affected by a violation of the potassium balance in the blood serum: it is recommended to carry out a thorough control of the potassium content in the blood serum when the drug is prescribed by Ibertan Plus together with preparations influenced by a violation of the potassium balance in the blood serum (for example, cardiac glycosides, antiarrhythmics).

Non-steroidal anti-inflammatory drugs: when angiotensin II receptor antagonists are prescribed in combination with non-steroidal anti-inflammatory drugs (for example, with selective inhibitors of cyclooxygenase-2 (COX-2), acetylsalicylic acid (> 3 g / day) and nonselective non-steroidal anti-inflammatory drugs), we can expect an attenuation of antihypertensive action. As with the use of angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists in combination with nonsteroidal anti-inflammatory drugs, there is an increased risk of renal dysfunction, including acute renal failure, an increase in potassium in the blood serum, especially in patients with renal impairment .This combination of drugs should be administered with caution, especially in elderly patients. Patients should not be dehydrated. Monitoring of kidney function should be performed after the initiation of combination therapy and periodically thereafter.

Additional information on the drug interaction of irbesartan: Hydrochlorothiazide does not affect the pharmacokinetics of irbesartan. When prescribing irbesartan in combination with warfarin metabolized with the participation of inducers of isoenzyme CYP2C9, no significant pharmacokinetic and pharmacodynamic interactions were detected. Effect of inducers of isoenzyme CYP2C9, for example, rifampicin, on the pharmacokinetics of irbesartan, were not evaluated. With the appointment of irbesartan in combination with digoxin, the pharmacokinetics of the latter did not change.

Additional information on the drug interaction of hydrochlorothiazide: The following drugs can interact with thiazide diuretics when administered concomitantly:

Ethanol, barbiturates or narcotic drugs: there may be an increase in orthostatic hypotension.

Hypoglycemic drugs (oral and insulin): it may be necessary to correct the dose of hypoglycemic agents.

Kolestyramine and colestipol: in the presence of anion-exchange resins, hydrochlorothiazide absorption is impaired. The interval between taking these drugs should be at least 4 hours.

Glucocorticosteroids, adrenocorticotropic hormone: a pronounced disturbance of the water-electrolyte balance, in particular, an increase in hypokalemia.

Catecholamines (for example, norepinephrine): the effectiveness of these medicines may be reduced.

Nondepolarizing muscle relaxants (eg, tubocurarine): hydrochlorothiazide can potentiate the effects of nondepolarizing muscle relaxants.

Anti-gouty drugs: It may be necessary to adjust the dose of drugs used to treat gout, since hydrochlorothiazide can increase the level of uric acid in the blood plasma. An increase in the dose of probenecid or sulfinpyrazone may be required. Co-administration with thiazide diuretics can increase the incidence of hypersensitivity reactions by allopurinol.

Salts of calcium: Thiazide diuretics can increase the calcium content of the plasma because of the decrease in its excretion. If necessary, the appointment of calcium supplements or drugs that affect the calcium content (for example, vitamin D), accordingly, it is necessary to adjust the dose of these drugs and monitor the calcium content in the blood plasma.

Other types of drug interactions: Thiazide diuretics can enhance the hyperglycemic effect of beta-blockers and diazoxide. Anticholinergic drugs (eg, atropine) can increase the bioavailability of thiazide diuretics due to a decrease in the motility of the gastrointestinal tract and the rate of gastric emptying. Thiazide diuretics may increase the risk of adverse reactions caused by amantadine. Thiazide diuretics can reduce the excretion of cytotoxic drugs by the kidneys (eg, cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

Special instructions:

Patients with arterial hypotension and reduced volume of circulating blood: In patients with hypertension, the drug Ibertan Plus rarely causes symptomatic arterial hypotension.Symptomatic arterial hypotension can be observed in patients with a reduced volume of circulating blood or a low sodium content against diuretic therapy, with a diet with restriction of table salt, with diarrhea or vomiting. Such conditions should be corrected before the initiation of therapy with Iberto Plus.

Renovascular hypertension. Have patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning kidney, there is an increased risk of developing severe arterial hypotension and renal failure with medications that affect the renin-angiotensin-aldosterone system. Although against the background of taking the drug Ibertan Plus, no such data were found, this kind of effects can be expected during the application of angiotensin II receptor antagonists.

Renal failure and condition after kidney transplantation. In the case of the use of the drug Ibertan Plus in patients with impaired renal function, periodic monitoring of potassium, creatinine and uric acid in the serum is indicated. There is no experience with the use of Iberthan Plus in patients after a recentkidney transplantation.

Stenosis of the aortic or mitral valve, hypertrophic obstructive cardiomyopathy. As with the use of other vasodilators, caution should be exercised in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy when prescribing Iberto Plus.

Primary hyperaldosteronism. Hypotensive drugs acting through inhibition of the renin-angiotensin-aldosterone system are usually ineffective in patients with primary hyperaldosteronism. Therefore, the use of the drug Ibertan Plus in such cases is impractical.

Metabolic and endocrine effects. Thiazide diuretics can reduce glucose tolerance. Patients with diabetes may require a dose adjustment of insulin or hypoglycemic drugs for oral administration. Against the background of taking thiazide diuretics, it is possible to develop latent diabetes mellitus.

With thiazide diuretics, hyperuricemia or exacerbation of gout may occur in some patients.

Violation of the water-electrolyte balance. Thiazide diuretics, including hydrochlorothiazide, can cause a violation of the water-electrolyte balance (hypokalemia, hyponatremia and hypochloraemic alkalosis). Although the use of thiazide diuretics may develop hypokalemia, simultaneous administration with irbesartan can reduce hypokalemia caused by taking a diuretic. The risk of hypokalemia increases in patients who receive glucocorticosteroids or adrenocorticotropic hormone. On the contrary, due to irbesartan, which is part of the drug Ibertan Plus, hyperkalemia is possible, especially in the presence of renal failure and / or heart failure, or diabetes mellitus. Regular monitoring of serum potassium in patients at risk is recommended.

Thiazide diuretics can reduce the excretion of calcium ions by the kidneys and cause transient hypercalcemia in the absence of confirmed violations of calcium metabolism. Expressed hypercalcemia may indicate latent hyperparathyroidism. Thiazide diuretics should be discontinued before the study of parathyroid function.

It is shown that thiazide diuretics can increase the excretion of magnesium ions by the kidneys, which can lead to the development of hypomagnesemia.

Doping tests: hydrochlorothiazide can cause a positive result in the conduct of doping control.

Other. As with other antihypertensive drugs that affect the renin-angiotensin-aldosterone system, a significant reduction in blood pressure (BP) in patients with coronary heart disease and / or atherosclerotic lesions of the cerebral vessels can lead to myocardial infarction or stroke. Treatment of such patients should be carried out under strict control of blood pressure.

There are reports of a weighting or exacerbation of the systemic lupus erythematosus in the administration of thiazide diuretics.

Effect on the ability to drive transp. cf. and fur:Effect of the drug Ibertan Plus on the ability to drive vehicles and perform work that requires increased attention has not been studied. However, during the period of taking the drug, care must be taken when driving vehicles and working with mechanisms, since dizziness and fatigue are possible during treatment.
Form release / dosage:
Tablets, film-coated 12.5 mg + 150 mg; 12.5 mg + 300 mg; 25 mg + 300.
Packaging:
For 7, 10, 14 or 15 tablets in a foil foil A1 / PVC / PCTFE.
4 blisters of 7 tablets or 3 blisters of 10 tablets, or 2 blisters of 14 tablets, or 2 blisters of 15 tablets, along with instructions for use are placed in a cardboard box.
Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.
Shelf life:
2 years.
Do not use after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:PL 002045
Date of registration:10.04.2013
Date of cancellation:2018-04-10
The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland
Manufacturer: & nbsp
Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
Information update date: & nbsp20.12.2015
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