Ordiss H® (Ordiss N®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrochlorothiazide + CandesartanHydrochlorothiazide + Candesartan
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  • Ordiss H®
    pills inwards 
    Teva Pharmaceutical Enterprises Co., Ltd.     Israel
    • Dosage form: & nbspPills.
    Composition:

    1 tablet contains: active substances: candesartan cilexetil 16.0 mg / 32.0 mg / 32.0 mg; hydrochlorothiazide 12.5 mg / 12.5 mg / 25.0 mg; Excipients: pregelatinized starch 15.0 mg / 30.0 mg / 30.0 mg; povidone-KZO 16.0 mg / 32.0 mg / 32.0 mg; carmellose calcium 6.60 mg / 13.20 mg / 13.20 mg; poloxamer 188 1.0 mg / 2.0 mg / 2.0 mg; cellulose microcrystalline 72.0 mg / 148.00 mg / 144.00 mg; lactose monohydrate 177,60 mg / 363,90 mg / 355,20 mg; dye iron oxide red (E172) 0.10 mg / - / 0.20 mg; magnesium stearate 3.20 mg / 6.40 mg / 6.40 mg.

    Description:

    Tablets 12.5 mg + 16 mg. Two-convex capsule shaped pills of light pink color with a risk on both sides. On one side of the engraving "C" and "16" on different sides of the risks.

    Tablets 12.5 mg + 32 mg. Biconvex capsule shaped tablets white or almost white with a risk on both sides. On one side of the engraving "C" and "32" on different sides of the risks.

    Tablets 25 mg + 32 mg. Two-convex capsule shaped pills of light pink color with a risk on both sides. On one side of the engraving "H" and "25" on different sides of the risks. On the other side of the engraving "C" and "32" on different sides of the risks.

    Pharmacotherapeutic group:Hypotensive drug combined (diuretic + angiotensin II receptor antagonist).
    ATX: & nbsp

    C.09.D.A.06   Candesartan in combination with diuretics

    Pharmacodynamics:

    Code ATX: C09DA06 Pharmacological properties Pharmacodynamics.

    Angiotensin II is the main hormone of the renin-angiotensin-aldosterone system (RAAS), which plays an important role in the pathogenesis of arterial hypertension, heart failure and other cardiovascular diseases. The main physiological effects of angiotensin II are vasoconstriction, stimulation of aldosterone production, regulation of water-electrolyte balance and stimulation of cell growth. Effects are mediated by the interaction of angiotensin II with angiotensin receptors of type 1 (AT1-receptors).

    Candesartan - selective antagonist AT1receptors of angiotensin II, does not inhibit angiotensin-converting enzyme (ACE),carrying out the conversion of angiotensin I into angiotensin II, which destroys bradykinin, does not lead to accumulation of bradykinin or substance P. As a result of blocking AT1receptors of angiotensin II, a dose-dependent increase in the concentration of renin, angiotensin I, angiotensin II, and a decrease in aldosterone in the blood plasma. When comparing candesartan with ACE inhibitors, the development of cough was less common in patients who received candesartan.

    Candesartan does not bind to the receptors of other hormones and does not block the ion channels involved in the regulation of cardiovascular functions.

    Hydrochlorothiazide - a thiazide-like diuretic, depresses active reabsorption of sodium, mainly in the distal sections of the renal tubules and enhances the release of sodium, chlorine and water ions. The excretion of potassium and magnesium by the kidneys intensifies depending on the dose, while calcium begins to be reabsorbed in larger quantities than before.

    Hydrochlorothiazide reduces the volume of blood plasma and extracellular fluid, reduces the intensity of blood transport in the heart, lowers blood pressure (BP).During long-term treatment, the hypotensive effect develops due to the expansion of arterioles. With prolonged use of hydrochlorothiazide, the risk of cardiovascular disease and mortality decreases.

    Candesartan and hydrochlorothiazide have a combined hypotensive effect. In patients with arterial hypertension, the use of candesartan / hydrochlorothiazide causes an effective and prolonged decrease in blood pressure without increasing the heart rate (heart rate). Orthostatic arterial hypotension with the first intake of the drug is not observed, after the end of treatment, hypertension is not increased.

    After a single administration of candesartan / hydrochlorothiazide, the main antihypertensive effect develops within 2 hours. The use of the drug once a day effectively and gently reduces blood pressure within 24 hours with an insignificant difference between the maximum and average effect of action. With prolonged treatment, a stable decrease in blood pressure occurs within 4 weeks after starting the drug and can be maintained with a long course of treatment.

    In clinical trials, the incidence of side effects, especially cough,was less common with candesartan / hydrochlorothiazide than with the combination of ACE inhibitors with hydrochlorothiazide.

    There is currently no data on the use of candesartan / hydrochlorothiazide in patients with renal failure, nephropathy, decreased left ventricular function, acute heart failure, and myocardial infarction. The efficacy of candesartan / hydrochlorothiazide does not depend on the sex and age of the patient.

    Pharmacokinetics:

    Suction and distribution

    Candesartan. When absorbed from the gastrointestinal tract (GIT) candesartan cileksetil through ether hydrolysis quickly turns into an active substance - candesartan, is strongly associated with AT1receptors and dissociates slowly, does not have the properties of an agonist. The absolute bioavailability of candesartan after oral administration is about 40%. The relative bioavailability of the tablet form compared to the oral solution is approximately 34%. Thus, the calculated absolute bioavailability of the tablet form of the drug is 14%. Eating does not have a significant effect on the area under the concentration-time curve (AUC), those. food does not significantly affect the bioavailability of the drug.

    The maximum concentration in the blood plasma (CmOh) is achieved 3-4 hours after taking the tablet form of the drug. With an increase in the dose of the drug within the recommended limits, the concentration of candesartan rises linearly. The binding of candesartan to plasma proteins is more 99%. Plasma Volume Distribution (Vd) candesartan is 0.1 l / kg.

    The pharmacokinetic parameters of candesartan do not depend on the sex of the patient. Hydrochlorothiazide. Hydrochlorothiazide quickly absorbed from the digestive tract. Bioavailability is approximately 70%. Simultaneous food intake increases suction by approximately 15%. Bioavailability can be reduced in patients with heart failure and severe swelling.

    Binding to plasma proteins is approximately 60%. Visible Vd is approximately 0.8 l / kg.

    Metabolism and excretion

    Candesartan. Candesartan mainly excreted from the body by the kidneys and through the intestines with bile in unchanged form and only marginally metabolized in the liver.

    The half-life (T1/2) candesartan is approximately 9 hours. Cumulation of the drug in the body is not observed.

    The total clearance of candesartan is about 0.37 ml / min / kg, with a kidney clearance of about 0.19 ml / min / kg. Renal excretion of candesartan is carried out by glomerular filtration and active tubular secretion.

    When administered radically-labeled candesartan, about 26% of the administered amount is excreted in the urine in the form of candesartan and 7% in the form of an inactive metabolite, whereas in feces 56% of the administered amount in the form of candesartan and 10% in the form of an inactive metabolite is detected.

    Hydrochlorothiazide. Hydrochlorothiazide is not metabolized and is released almost completely as an active form of the drug by glomerular filtration and active tubular secretion in the proximal part of the nephron. T1/2 is about 8 hours and does not change with simultaneous application with candesartan. Approximately 70% of the dose taken orally is excreted by the kidneys within 48 hours. When using the combination of drugs, no additional accumulation of hydrochlorothiazide is found in comparison with monotherapy.

    Pharmacokinetics in special clinical cases

    Candesartan. In patients older than 65 years of age, CmOh and AUC candesartan increased by 50% and 80%, respectively, compared with young patients.However, the hypotensive effect and incidence of side effects with candesartan / hydrochlorothiazide do not depend on the age of the patients.

    In patients with mild to moderate renal impairment, CmOh and AUC candesartan increased by 50% and 70% respectively, while T1/2 the drug does not change in comparison with patients with normal renal function.

    In patients with severe renal dysfunction and / or on hemodialysis CmOh and AUC candesartan increased by 50% and 110%, respectively, and T1/2 of the drug increased 2-fold.

    In patients with mild and moderate impairment of liver function, there was an increase AUC candesartan by 23%.

    Hydrochlorothiazide. T1/2 more prolonged in patients with renal insufficiency.

    Indications:Treatment of arterial hypertension in patients who are shown combined therapy.
    Contraindications:Hypersensitivity to candesartan, hydrochlorothiazide, other components of the drug and to other sulfonamide derivatives; pregnancy; the period of breastfeeding; lactose intolerance; deficiency of lactase; syndrome of glucosogalactose malabsorption;primary hyperaldosteronism; gout; severe renal dysfunction (creatinine clearance (CK) less than 30 ml / min); severe violations of liver function; cholestasis; refractory hypokalemia, hypercalcemia; condition after kidney transplant, children under 18 years.
    Carefully:The simultaneous use of other antihypertensive drugs kaliynesberegayuschimi diuretics, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid derivatives, cardiac glycosides, antiarrhythmic drugs, lithium preparations, nonsteroidal antiinflammatory drugs (NSAIDs), colestipol, colestyramine, tubocurarine, beta-blockers, anticholinergics , amantadine, cytotoxic drugs, glucocorticosteroids (GCS), adrenocorticotropic hormone (ACTH), alkog Lemma, barbiturates, general anesthetics, epinephrine, iodine-containing drugs; impaired renal function (QC more than 30 ml / min), liver failure; severe chronic heart failure; bilateral stenosis of the renal arteries; stenosis of the artery of a single kidney; hemodynamically significant stenosis of the aorticand / or mitral valve; cardiac ischemia; hypertrophic obstructive cardiomyopathy; a decrease in the volume of circulating blood (BCC); diabetes mellitus, cerebrovascular diseases; acute myopia; angle-closure glaucoma; systemic lupus erythematosus.
    Pregnancy and lactation:
    The drug Ordiss H® is contraindicated for use during pregnancy and during breastfeeding.
    Patients taking the drug should be warned about this before planning pregnancy so that they can switch to alternative therapy with a proven safety profile for use during pregnancy. In the case of pregnancy diagnosis, the drug should be discontinued immediately. Means that affect RAAS can cause fetal developmental disorders and / or have a negative impact on the newborn, even fatal, when the drug is used during pregnancy. It is known that therapy with angiotensin II receptor antagonists can cause fetal development disorders (renal dysfunction, oligohydramnion, delayed ossification of the skull bones) and development of complications in the newborn (renal dysfunction, arterial hypotension, hyperkalemia).The experience of using hydrochlorothiazide during pregnancy is limited. Hydrochlorothiazide penetrates the placenta. Given the mechanism of action of hydrochlorothiazide, its use during pregnancy can cause violations of the feto-placental circulation and undesirable effects in the fetus and newborn in the form of jaundice, violations of water-electrolyte balance and thrombocytopenia. It is not known whether the candesartan in breast milk. Candesartan is excreted in the milk of lactating rats. Hydrochlorothiazide penetrates into breast milk.
    Dosing and Administration:

    Inside, regardless of food intake. The recommended dose is 1 tablet once a day. It is recommended to titrate the dose of candesartan before transferring the patient to Ordiss H® therapy. If necessary, patients are transferred from monotherapy with candesartan to therapy with Ordiss H®. The main antihypertensive effect is achieved, as a rule, in the first 4 weeks after the start of treatment.

    Have patients with impaired renal function preferable to the use of "loop" diuretics compared with thiazide. Prior to the initiation of Ordiss H® therapy in patients with mild to moderate renal impairment (creatinine clearance greater than 30 mL / min), including patients on hemodialysis,It is recommended to titrate the dose of candesartan, starting at 4 mg.

    Ordis® H® is contraindicated patients with severe renal insufficiency (SC less than 30 ml / min).

    For patients at risk of arterial hypotension (eg, with reduced BCC), titration of the dose of candesartan is recommended starting with 4 mg in monotherapy. Patients with impaired liver function of medium degree Before starting therapy with Ordiss H®, titration of candesartan dose starting from 2 mg is recommended.

    Patients with impaired hepatic function the use of Ordiss H® is contraindicated.

    Have elderly patients correction of the dose is not required.

    Side effects:

    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including individual messages) - less than 0.01%.

    Candesartan

    On the part of the blood system: very rarely - leukopenia, neutropenia, agranulocytosis.

    From the side of metabolism and nutrition: very rarely - hyperkalemia, hyponatremia.

    From the central nervous system (CNS): often - dizziness; very rarely - a headache.

    From the digestive tract: very rarely - nausea.

    On the part of the respiratory system: very rarely - cough.

    From the liver and bile ducts: very rarely - increased activity of "liver" transaminases, a violation of liver function, hepatitis.

    From the skin and subcutaneous tissues: very rarely - skin rash, itching, hives, angioedema.

    From the musculoskeletal system and connective tissue: very rarely - back pain, arthralgia, myalgia.

    From the side of the kidneys and urinary tract: very rarely - renal failure (see Fig.

    section "Special instructions").

    Hydrochlorothiazide

    On the part of the blood system: rarely - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, oppression of bone marrow function, hemolytic anemia, hemoglobin decrease.

    From the immune system: rarely an anaphylactic reaction.

    From the side of metabolism and nutrition: often - hyperglycemia, hyperuricemia, hyponatremia, hypokalemia.

    From the side of the central nervous system: often - dizziness, vertigo; rarely - sleep disorders, anxiety, depression, paresthesia.

    From the side of the organ of vision: rarely - reduced clearness of vision, acute myopia, acute angle-closure glaucoma.

    From the cardiovascular system: infrequently - postural hypotension; rarely - arrhythmia, vasculitis.

    From the respiratory system, chest and mediastinum: rarely - respiratory distress syndrome, pneumonitis, pulmonary edema.

    On the part of the digestive system: infrequently - anorexia, loss of appetite, constipation, diarrhea, irritation of the gastric mucosa; rarely - pancreatitis.

    From the liver and bile ducts: rarely intrahepatic cholestatic jaundice.

    From the skin and subcutaneous tissues: infrequent - skin rash, hives, photosensitization reaction; rarely - toxic epidermal necrolysis, erythematous reactions, recurrence of cutaneous erythematosis.

    From the musculoskeletal system and connective tissue: rarely - muscle spasm.

    From the side of the kidneys and urinary tract: often - glycosuria; rarely - renal dysfunction, interstitial nephritis.

    Other: often - weakness, increased concentration of cholesterol, triglycerides in the blood plasma; rarely - a fever, an increase in the concentration of creatinine, urea in the blood plasma.


    Overdose:

    Symptoms: analysis of the pharmacological properties of the drug suggests that the main manifestation of an overdose may be a clinically pronounced decrease in blood pressure, dizziness. Individual cases of drug overdose (up to 672 mg candesartan), which resulted in the recovery of patients without severe consequences, were described. The main manifestation of an overdose of hydrochlorothiazide is a decrease in BCC and a disturbance of the water-electrolyte balance. Symptoms such as dizziness, marked decrease in blood pressure, dryness of the oral mucosa, tachycardia, ventricular arrhythmia, loss of consciousness and muscle cramps were also observed.

    Treatment: When developing a clinically pronounced BP reduction, symptomatic treatment and monitoring of the patient's condition should be performed. Lay the patient on his back and raise his legs. If necessary, increase BCC, for example, by intravenous administration of 0.9% sodium chloride solution. If necessary, sympathomimetic agents can be prescribed. The withdrawal of candesartan and hydrochlorothiazide by hemodialysis is unlikely.

    Interaction:In pharmacokinetic studies, the simultaneous use of candesartan / hydrochlorothiazide with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol / levonorgestrel), glibenclamide, nifedipine, and enalapril has been studied. Clinically significant drug interactions were not identified.
    Candesartan is metabolized in the liver to an insignificant extent with the participation of the CYP2C9 isoenzyme. The conducted studies on the interaction did not reveal the effect of the drug on the isozymes CYP2C9 and CYP3A4, the effect on other isoenzymes of the cytochrome P450 system has not been studied.

    With simultaneous use of angiotensin II receptor antagonists and NSAIDs, including cyclooxygenase-2 inhibitors and nonselective NSAIDs, for example, acetylsalicylic acid more than 3 grams per day, may decrease the hypotensive effect of candesartan.

    The simultaneous use of candesartan / hydrochlorothiazide with other antihypertensive agents enhances the hypotensive effect. Double blockade of RAAS with angiotensin receptor blockers, ACE inhibitors or aliskiren is associated with an increased risk of hypotension,hyperkalemia and impaired renal function (including acute renal failure) compared with monotherapy with these drugs. It is necessary to carefully monitor blood pressure, kidney function and water-electrolyte balance in patients receiving candesartan / hydrochlorothiazide and other drugs that affect RAAS.

    Do not apply candesartan / hydrochlorothiazide simultaneously with aliskiren in patients with diabetes mellitus. It is recommended that candesartan / hydrochlorothiazide be avoided simultaneously with aliskiren in patients with moderate to severe renal insufficiency.

    The action of hydrochlorothiazide, leading to a loss of potassium, can be intensified by other means leading to a loss of potassium and hypokalemia (for example, diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium, derivatives of salicylic acid).

    The experience of using other drugs acting on RAAS shows that concomitant therapy with potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, and other means that increase the serum potassium content (for example, heparin) can lead to the development of hyperkalemia.

    Hypokalemia and hypomagnesemia caused by the use of diuretic drugs predispose to the development of the cardiotoxic effect of cardiac glycosides and antiarrhythmic drugs. When taking candesartan / hydrochlorothiazide simultaneously with such drugs, control of the potassium content in the blood plasma is required.
    With the simultaneous use of lithium preparations with ACE inhibitors, a reversible increase in the concentration of lithium in the serum and the development of toxic reactions occur. Similar reactions can occur with the use of angiotensin II receptor antagonists, and therefore it is recommended to monitor the lithium content in serum.

    Diuretic, natriuretic and hypotensive actions of hydrochlorothiazide are weakened with the simultaneous use of NSAIDs.

    The absorption of hydrochlorothiazide is weakened by the use of colestipol, colestyramine.

    The action of nondepolarizing muscle relaxants (eg, tubocurarine) can be enhanced by hydrochlorothiazide.

    Thiazide diuretics can cause an increase in calcium in the blood plasma due to a decrease in its excretion.If it is necessary to use calcium-containing food supplements or vitamin D, you should monitor the calcium content in the blood plasma and, if necessary, adjust the dose. Thiazide-like diuretics increase the hyperglycemic effect of beta-adrenoblockers and diazoxide.

    Anticholinergics (for example, atropine, biperidene) may increase the bioavailability of thiazide diuretics due to decreased GI motility. Thiazide-like diuretics may increase the risk of adverse effects of amantadine.

    Thiazide-like diuretics can slow down the excretion of cytotoxic drugs (such as cyclophosphamide, methotrexate) from the body and enhance their myelo-suppressing effect.

    The risk of hypokalemia may increase with concurrent administration of SCS or ACTH. Against the background of the use of Ordiss H®, the frequency of orthostatic arterial hypotension may increase with ethanol, barbiturates or general anesthetics.

    In the treatment of thiazide diuretics, a decrease in glucose tolerance is possible, which may require a dose of hypoglycemic drugs (including insulin).

    Hydrochlorothiazide can reduce the effect of vasoconstrictive amines (eg, epinephrine).

    Hydrochlorothiazide may increase the risk of developing acute renal failure, especially when combined with large doses of iodinated excipients.
    There was no significant interaction of hydrochlorothiazide with food.
    Special instructions:
    In patients with renal failure, the use of "loop" diuretics is preferable to thiazide. For patients with renal insufficiency, when using Ordiss H®, it is recommended to constantly monitor the potassium content, the concentration of creatinine and uric acid.

    Data on the use of Ordiss H® in patients who have recently undergone a kidney transplant are not available.

    Drugs that affect RAAS (eg, ACE inhibitors) can lead to increased urea concentrations in the blood and serum creatinine concentrations in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney. A similar effect should be expected from angiotensin II receptor antagonists.

    In patients with deficiency of bcc and / or sodium, symptomatic arterial hypotension may develop, therefore, it is not recommended to use Ordiss H® until these symptoms disappear.

    Patients receiving angiotensin II antagonists may develop arterial hypotension as a result of RAAS blockade during anesthesia and during surgical interventions. Very rarely, cases of severe arterial hypotension, requiring intravenous fluids and / or vasoconstrictors, can be noted. Patients with impaired liver function or progressive liver disease should use thiazide diuretics with caution. slight fluctuations in the volume of fluid and water-electrolyte balance can cause hepatic coma. Data on the use of Ordiss H® in patients with severe hepatic insufficiency are absent.

    Care should be taken when prescribing Ordiss H® to patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic or mitral valve.

    Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive agents that affect RAAS, so the use of Ordiss H® in such patients is not recommended.

    As in all cases of taking drugs that have a diuretic effect,should monitor the content of electrolytes in the blood plasma. Preparations based on thiazides that have a diuretic effect, can reduce the excretion of calcium by the kidneys and can cause abrupt changes and a slight increase in the calcium content in the blood plasma.

    Thiazides, incl. and hydrochlorothiazide, can cause disturbances in the water-electrolyte balance (hypercalcemia, hypokalemia, hyponatremia, hypomagnesemia and hypochloraemic alkalosis).

    The revealed hypercalcemia can be a sign of latent hyperparathyroidism. The use of thiazide diuretics should be discontinued until the results of parathyroid examinations are obtained.

    Hydrochlorothiazide increases the release of potassium in a dose-dependent manner, which can cause hypokalemia. This action of hydrochlorothiazide is less apparent when applied simultaneously with candesartan. The risk of hypokalemia appears to be elevated in patients with cirrhosis of the liver, increased diuresis, taking a fluid with a reduced salt content, concurrently treated with SCS or ACTH.

    Based on the experience of using drugs that affect RAAS,the simultaneous use of Ordiss H® and diuretic drugs that increase the release of potassium can be compensated for by using dietary supplements containing potassium or other drugs that can increase the level of potassium in the blood plasma. The use of Ordiss H® can cause hypokalemia, especially in patients with cardiac or renal insufficiency (such cases have not been documented).

    Thiazide diuretics increase the release of magnesium, which can cause hypomagnesemia.

    The use of thiazide diuretics can change the concentration of glucose in the blood until the manifestation of latent diabetes mellitus. You may need to adjust the dose of hypoglycemic agents, including insulin.

    With the use of thiazide diuretics, an increase in the concentration of cholesterol and triglyceride in the blood plasma is associated. However, with the use of Ordiss H®, a minimal or no such effect was observed. Thiazide diuretics increase the concentration of uric acid in the blood plasma and can contribute to the development of gout symptoms in predisposed patients.Patients who have vascular tone and renal function are mostly dependent on RAAS activity (eg, patients with severe chronic heart failure, kidney disease, including renal artery stenosis), especially
    sensitive to drugs acting on RAAS. The appointment of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria and, more rarely, acute renal failure. The possibility of developing these effects is not excluded even when angiotensin II receptor antagonists are used. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular disease of ischemic genesis with the use of any antihypertensive drugs, can lead to the development of myocardial infarction or stroke.

    The manifestation of hypersensitivity reactions to hydrochlorothiazide is most likely in patients with bronchial asthma, allergic reactions in the anamnesis, which does not exclude the appearance of allergic symptoms in other patients. With the use of thiazide diuretics, cases of exacerbation or the appearance of symptoms of congestive seborrhea are noted.

    With the use of thiazide diuretics, there were cases of worsening of the systemic lupus erythematosus.

    Hydrochlorothiazide can cause an idiosyncratic reaction leading to the development of acute myopia and secondary closed-angle glaucoma. Symptoms include: sudden loss of vision or pain in the eyes, which usually occur within a few hours or weeks of initiating hydrochlorothiazide therapy. In the absence of treatment, acute closed-angle glaucoma can lead to persistent loss of vision. Treatment - as soon as possible stop taking hydrochlorothiazide. If intraocular pressure remains uncontrolled, immediate medical treatment or surgery may be required. Risk factors for the development of acute angle-closure glaucoma are allergic reactions to sulfonamides or benzylpenicillins in the anamnesis.

    The drug contains lactose, so it should not be taken to patients with rare hereditary diseases, manifested in the absence of lactose tolerance, lactase deficiency or impaired absorption of glucose and galactose.

    Pediatric Use

    The safety and effectiveness of the use of Ordiss H® in children under the age of 18 years have not been established.
    Effect on the ability to drive transp. cf. and fur:When there are undesirable effects from the central nervous system during therapy with Ordiss H®, caution should be exercised when performing actions requiring an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets 12.5 mg + 16 mg, 12.5 mg + 32 mg and 25 mg + 32 mg.

    Packaging:
    For 10 tablets in blisters from PVC / A1 / OPA-PVC / PVAH / A1. 3 blisters with instructions for use in a cardboard bundle.

    For 5 tablets in PVC / A1 / OPA-PVC / PVAH / A1 blisters. 6 blisters with instructions for use in a cardboard pack.
    Storage conditions:Store at a temperature not 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:LP-002097
    Date of registration:10.06.2013
    Date of cancellation:2018-06-10
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp19.12.2015
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