Medicinal Products

ENALAPRIL / HYDROCHLOR TEVA 20 mg / 12.5 mg

Generic drug of CO Renitec
Therapeutic class: Cardiology and angiology
Active ingredients: Enalapril, Hydrochlorothiazide
laboratory: Teva Sante

Tablet breackable
Box of 90
All forms

Indication

Treatment of essential hypertension.

This fixed combination is indicated in patients whose blood pressure is not adequately controlled by enalapril alone.

This fixed combination may also replace the combination of 20 mg enalapril maleate and 12.5 mg hydrochlorothiazide in patients stabilized with the same dose of each active substance administered separately.

This fixed combination is not suitable for initiation of treatment.

Dosage ENALAPRIL / HYDROCHLOR TEVA 20 mg / 12.5 mg Breakable tablet Box of 90

Enalapril / Hydrochlorothiazide can be given in a single dose / day during or after meals.

Gradual adaptation of the doses of each individual component may be recommended.

The direct switch from conversion inhibitor treatment alone to this fixed combination may be considered, depending on the clinical situation.

Dosage in patients with normal renal function

The usual dosage is one tablet in one daily dose.

Dosage in case of renal failure

· Creatinine clearance ≥ 30 ml / min: In patients with renal insufficiency with a creatinine clearance ≥ 30 ml / min, the dosage of enalapril should be instituted gradually before switching to the fixed combination. Loop diuretics are preferable to thiazides in this population. The dose of enalapril maleate and hydrochlorothiazide should be as low as possible (see Warnings and Precautions ). In these patients, periodic monitoring of potassium and creatinine is required, for example every two months when the treatment has been stabilized (see Warnings and Precautions ).

· Creatinine clearance <30 ml / min: see section Contraindications .

Special populations

In patients with water-soluble depletion, the initial dose is 5 mg of enalapril or lower. Individual and progressive initiation of enalapril and hydrochlorothiazide is recommended.

Elderly

Use in elderly subjects was as good as in younger hypertensive patients. In case of physiological renal failure, it is recommended to start treatment gradually with enalapril alone before using the combination.

Child and teenager (<18 years old)

The safety and efficacy of Enalapril / Hydrochlorothiazide have not been established in children and adolescents.

Against indications

Linked to enalapril

This medication should not be used in patients with:

Hypersensitivity to enalapril, other ACE inhibitors or any of the excipients,

· A history of angioedema (angioedema) associated with previous ACE inhibitor therapy and / or familial or idiopathic angioedema.

· During the 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and breast-feeding ).

Hydrochlorothiazide-related

This medication should not be used in patients with:

· Hypersensitivity to hydrochlorothiazide or other sulfonamides - derived substances;

· Severe renal impairment (creatinine clearance <30 ml / min);

· Severe hepatic impairment / hepatic encephalopathy;

· During breastfeeding.

Adverse effects Enalapril / Hydrochlor Teva

The frequency of adverse events is evaluated as follows:

very common (> 1/10);

frequent (≥ 1/100 to <1/10);

uncommon (≥ 1/1000 to <1/100);

rare (≥ 1 / 10, 000 to <1/1000);

very rare (<10, 000);

unknown (impossible to estimate from available data).

Linked to enalapril

Hematological and lymphatic system disorders:

Uncommon: anemia (including aplastic and hemolytic).

Rare: neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, medullary depression, pancytopenia, lymphadenopathy, autoimmune diseases.

Endocrine disorders:

Not known: inappropriate secretion of antidiuretic hormone.

Metabolism and nutritional disorders:

Uncommon: hypoglycaemia (see section Warnings and precautions for use with diabetes).

Psychiatric disorders:

Frequent: depression.

Nervous system disorders:

Frequent: headache.

Uncommon: confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo.

Rare: strange dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Labyrinth and ear disorders:

Uncommon: tinnitus.

Heart problems:

Frequent: chest pain, rhythm disturbances, angina pectoris, tachycardia.

Uncommon: palpitations.

Vascular disorders:

Very common: dizziness.

Frequent: hypotension (including orthostatic hypotension), syncope, myocardial infarction or stroke, which may be secondary to excessive hypotension in patients at risk (see Warnings and Precautions section ).

Uncommon: orthostatic hypotension.

Rare: Raynaud's syndrome.

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Common: dyspnoea

Uncommon: rhinorrhea, sore throat, hoarseness, bronchospasm / asthma.

Rare: pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia.

Gastrointestinal disorders:

Very common: nausea.

Frequent: diarrhea, abdominal pain, taste disturbance.

Uncommon: intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, gastric irritations, dry mouth, peptic ulcer.

Rare: stomatitis / aphthous ulcers, glossitis.

Very rare: intestinal angioedema.

Hepatobiliary disorders:

Rare: hepatic failure, hepatitis - cytolytic or cholestatic, hepatitis with necrosis, cholestasis (with jaundice).

Skin and subcutaneous tissue disorders:

Common: rash, hypersensitivity / angioedema, angioedema of the face, extremities, lips, tongue, glottis and / or larynx (see Warnings and Precautions for Use section ).

Uncommon: diaphoresis, pruritus, urticaria, alopecia.

Rare: erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

A symptom complex has been reported which may include some or all of the following symptoms: fever, serous inflammation, vasculitis, myalgia / myositis, arthralgia / arthritis, NAA positive, high VS, eosinophilia, and leukocytosis. Rash, photosensitization or other dermatological manifestations may occur.

Musculoskeletal and Connective Tissue Disorders

Uncommon: muscle cramps.

Renal and urinary disorders:

Uncommon: renal dysfunction, renal failure, proteinuria.

Rare: oliguria.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: gynecomastia.

General disorders and anomaly at the sites of administration:

Very common: asthenia.

Frequent: tiredness

Uncommon: flushing, malaise, fever.

Biology report :

Frequent: hyperkalemia, increased serum creatinine.

Uncommon: increases in blood urea content, hyponatremia.

Rare: hepatic enzyme elevations, elevations of serum bilirubin.

RELATED TO HYDROCHLOROTHIAZIDE

Infections and infestations: Sialadenitis

Hematologic and lymphatic system disorders: leukopenia, neutropenia / agranulocytosis, thrombocytopenia, aplastic anemia, haemolytic anemia, spinal aplasia.

Metabolism and nutrition disorders : anorexia, hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance (including hyponatremia and hypokalemia), increased cholesterol and triglycerides.

Psychiatric disorders: nervousness, depression, sleep disorders.

Nervous system disorders: loss of appetite, paresthesia, lightheadedness.

Eye disorders: xanthopsia, transient blurred vision.

Ear and labyrinth disorders: vertigo.

Cardiac disorders: cardiac arrhythmias.

Vascular disorders: orthostatic hypotension, necrotizing vasculitis (vasculitis and cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders: respiratory distress (including pneumonitis and pulmonary edema).

Gastrointestinal disorders: gastric irritation, diarrhea, constipation, pancreatitis.

Hepatobiliary disorders: jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders: photosensitization reactions, rash, cutaneous lupus erythematosus reactions, reactivation of cutaneous lupus erythematosus, urticaria, anaphylactic reactions, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders: muscle spasms.

Renal and urinary disorders: renal dysfunction, interstitial nephritis.

General disorders and administration site abnormality: fever, weakness.

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