Medicinal Products

ECAZIDE 50 mg / 25 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Captopril, Hydrochlorothiazide
laboratory: Bristol Myers Squibb

Tablet breackable
Box of 30
All forms

Indication

Treatment of essential hypertension.

This fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled by captopril alone or hydrochlorothiazide alone.

Dosage ECAZIDE 50 mg / 25 mg Tablet scored 30

ECAZIDE may be administered once or twice daily with or without food in patients whose blood pressure is not adequately controlled with captopril alone or hydrochlorothiazide alone.

The maximum daily dosage of 50mg captopril / 25mg hydrochlorothiazide should not be exceeded.

If a satisfactory decrease in blood pressure has not been obtained, another antihypertensive treatment may be associated (see section 4.5). Interactions with other medicinal products and other forms of interaction Interactions with other medicinal products and other forms of interaction .

adults

Administration of a fixed combination of captopril and hydrochlorothiazide is usually recommended after titration of individual components. The usual maintenance dose is 50mg / 25mg once a day, in the morning. When this is clinically justified, a direct transition from monotherapy to fixed association may be considered.

Renal failure

Creatinine clearance between 30 and 80 ml / min: the initial dose is usually 25 mg / 12.5 mg once daily in the morning.

Captopril / hydrochlorothiazide is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml / min).

Special populations

In patients with water-soluble depletion, elderly patients, and diabetic patients, the usual starting dose is 25 mg / 12.5 mg once daily.

children

There is no appropriate indication for the use of ECAZIDE in children.

Against indications

· Hypersensitivity to the active substance (s) or to any of the excipients or other inhibitors of angiotensin-converting enzyme or other sulfonamides.

· History of angioedema associated with the use of an angiotensin converting enzyme inhibitor.

· Hereditary / idiopathic angioedema.

· Severe renal insufficiency (creatinine clearance <30 ml / min).

· Severe hepatic insufficiency.

· Second and third trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

Ecazide side effects

The frequency is defined using the following convention:

frequent (> 1/100, 1/1000, 1/10 000, <1/1000) and very rare (<1/10000).

RELATED TO CAPTOPRIL

Adverse reactions reported during treatment with captopril and / or angiotensin converting enzyme inhibitors include the following effects:

Blood and lymphatic system disorders

Very rare : neutropenia / agranulocytosis (see Warnings and precautions for use section Special warnings and special precautions for use), pancytopenia, especially in patients with impaired renal function (see Warnings and precautions for use section) Special warnings and special precautions for use), anemia (including aplastic and hemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, autoimmune diseases and / or positive nuclear antibodies.

Metabolism and nutrition disorders .

Rare: anorexia.

Very rare: hyperkalemia, hypoglycemia (see Warnings and precautions for use section Special warnings and special precautions for use).

Psychiatric disorders

Frequent : sleep disorders.

Very rare: confusion, depression.

System disorders nerveaux

Frequent: alteration of taste, dizziness.

Rare: somnolence, headache and paresthesia.

Very rare: cerebrovascular events, including cerebrovascular accident and syncope.

Eye disorders

Very rare: blurred vision.

Heart conditions

Rare: tachycardia or tachyarrhythmia, angina, palpitations.

Very rare: cardiac arrest, cardiogenic shock.

Vascular disorders

Rare: hypotension (see Warnings and precautions for use section Special warnings and special precautions for use), Raynaud's syndrome, flush, paleness.

Respiratory, thoracic and mediastinal disorders

Frequent: dry, irritating cough (nonproductive) (see Warnings and Precautions for Use section Special warnings and special precautions for use) and dyspnea.

Very rare: bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Gastrointestinal disorders

Frequent: nausea, vomiting, gastric irritation, abdominal pain, diarrhea, constipation, dry mouth.

Rare: Aphthous stomatitis / ulceration, intestinal angioedema (see Warnings and precautions for use section Warnings and precautions for use).

Very rare: glossitis, peptic ulcer, pancreatitis.

Hepatobilary disorders

Very rare: hepatic failure and cholestasis (including jaundice), hepatitis, possibly necrotic, elevated liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders

Frequent: pruritus with or without rash, rash and alopecia.

Rare: angio-edema (see Warnings and precautions for use section Special warnings and special precautions for use).

Very rare: urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.

Musculoskeletal and systemic disorders

Very rare: myalgia, arthralgia.

Renal and urinary disorders

Rare: impaired renal function including renal failure, polyuria, oliguria, increased frequency of urination.

Very rare: nephrotic syndrome.

Disorders of reproductive organs and breast

Very rare: impotence, gynecomastia.

General disorders and administration site conditions

Rare: chest pain, fatigue, malaise.

Very rare: fever.

investigations

Very rare: proteinuria, eosinophilia, hyperkalemia, hyponatremia, increased uremia, serum creatinine and bilirubin, decreased hemoglobin, hematocrit, leukocytes, platelets, positive antinuclear antibodies, increased sedimentation rate.

Hydrochlorothiazide-related

Infections and infestations

Sialadenitis.

Blood and lymphatic system disorders

Leukopenia, neutropenia / agranulocytosis, thrombocytopenia, aplastic anemia, hemoytic anemia, spinal aplasia.

Metabolism and nutrition disorders

Anorexia, hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance (including hyponatremia and hypokalemia), increased cholesterol and triglycerides.

Psychiatric disorders

Agitation, depression, sleep disorders.

Nervous system disorders

Loss of appetite, paresthesia, feeling of empty head.

Eye disorders

Xanthopsie, transient blurred vision.

Affections of the ear and labyrinth

Dizziness.

Heart conditions

Orthostatic hypotension, cardiac arrhythmia.

Vascular disorders

Necrotizing vasculitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders

Respiratory distress (especially pneumonitis inflammatory and pulmonary edema).

Gastrointestinal disorders

Gastric irritation, diarrhea, constipation, pancreatitis.

Hepatobiliary disorders

Jaundice (jaundice by intrahepatic cholestasis).

Skin and subcutaneous tissue disorders

Photosensitivity reaction, rash, systemic lupus erythematous reaction, reactivation of systemic lupus erythematosus, urticaria, anaphylactic reaction, toxic epidermal necrolysis.

Musculoskeletal and systemic disorders

Muscle spasm.

Renal and urinary disorders

Alteration of renal function, interstitial nephritis.

General disorders and administration site conditions

Fever, weakness.

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