Medicinal Products

ENALAPRIL / HYDROCHLOR PHR LAB 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 arterial hypertension in case of therapeutic failure of monotherapy with a conversion enzyme inhibitor.

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

Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.

Normal renal function : the usual dosage is 1 tablet in one daily dose.

Renal failure:

· Creatinine clearance between 30 and 80 ml / min: the usual dosage is ½ tablet in one daily dose.
In these patients, normal medical practice includes a periodic control of potassium and creatinine, for example every two months in times of therapeutic stability.
creatinine clearance less than 30 ml / min or serum creatinine greater than 250 μmol / l: see section Contraindications .

Elderly : It is recommended to initiate treatment at the dosage of half a tablet, in case there is a physiological decline in renal function (see section Warnings and precautions for use Precautions) .

Against indications

Linked to enalapril

This medicine MUST NEVER BE USED in case of:

Hypersensitivity to enalapril, or to any of the excipients,

· History of angioedema (angioedema) associated with the use of an angiotensin converting enzyme inhibitor and / or hereditary or idiopathic angioedema,

· During the 2nd and 3rd trimesters of pregnancy.

This medicine IS GENERALLY NOT RECOMMENDED in case of:

· Combination with potassium diuretics, potassium salts, lithium and estramustine (see section 4.5, Interactions with other medicinal products and other forms of interaction ),

Bilateral stenosis of the renal artery or functionally unique kidney,

· Hyperkalemia,

During the first trimester of pregnancy and in the woman who is breastfeeding.

Hydrochlorothiazide-related

This medicine MUST NEVER BE USED in case of:

· Hypersensitivity to sulfonamides,

· Severe renal impairment (creatinine clearance less than 30 ml / min),

· Hepatic encephalopathy,

· During breastfeeding.

This medicine IS GENERALLY NOT RECOMMENDED in the following situations:

· Pregnancy (first trimester),

· In combination with lithium and sultopride (see section Interactions with other medicinal products and other forms of interaction ),

· In case of bilateral stenosis of the renal artery or functionally unique kidney,

· In case of hyperkalemia.

Side effects Enalapril / Hydrochlor Phr Lab

Clinically

RELATED TO ENALAPRIL

· Headache, asthenia, dizziness, syncope;

Hypotension, orthostatic or not (see Warnings and Precautions ) section

· Rash, rash, photosensitization, severe bull rash (erythema multiforme, Stevens Johnson syndrome, a well-documented case of toxic epidermal necrolysis), exfoliative dermatitis, pemphigus, urticaria, alopecia, pruritus;

· Nausea, diarrhea, constipation, abdominal pain, vomiting, anorexia, cholestatic or cytolytic hepatitis, liver failure, pancreatitis, jaundice;

· Muscle cramps, dysgeusia;

· Depression, confusion nervousness, bronchospasm, dyspnea;

· Dry cough has been reported with the use of angiotensin-converting enzyme inhibitors. It is characterized by its persistence as well as its disappearance at the end of treatment. The iatrogenic etiology should be considered in the presence of this symptom;

· Exceptionally: angioedema (angioedema) (see Warnings and Precautions section );

· Very rarely: impotence, flushing, tinnitus, glossitis, blurred vision;

· Other symptoms that may be associated: fever, inflammation of the serosae, vasculitis, myalgia, arthralgia, anti-antinuclear body, elevated sedimentation rate, eosinophilia, leukocytosis.

RELATED TO HYDROCHLOROTHIAZIDE

· In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see sections Contraindications and Warnings and precautions for use );

· Possibility of worsening of pre-existing systemic lupus erythematosus, necrotizing vasculitis, exceptional Lyell syndrome;

· Nausea, constipation, dizziness, asthenia, paresthesia, headache, rarely seen and usually giving way to a reduction in dosage;

· Exceptionally: pancreatitis, visual disturbances at the beginning of treatment.

Biologically

RELATED TO ENALAPRIL

· Moderate increase in urea and plasma creatinine, reversible upon discontinuation of treatment. This increase is more frequently encountered in cases of stenosis of the renal arteries, arterial hypertension treated with diuretics, renal failure.

· In case of glomerular nephropathy, administration of a conversion enzyme inhibitor may result in proteinuria;

· Hyperkalemia, usually transient;

· Increased liver enzymes and / or bilirubin .;

· Neutropenia and agranulocytosis, when high doses are administered in areas of renal failure and collagen [LED, scleroderma] (see Warnings and Precautions Warnings section);

Anemia has been reported with angiotensin-converting enzyme inhibitors on specific sites (kidney transplant, hemodialysis - see Warnings and Precautions for Use Precautions).

RELATED TO HYDROCHLOROTHIAZIDE

· Potassium depletion with hypokalemia, especially in the case of intensive diuresis, and particularly severe in certain at-risk populations (see Warnings and Precautions for Use section );

· Hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension or even confusional syndrome.
The concomitant loss of chlorine ions may secondarily cause a compensatory metabolic alkalosis: the incidence and the amplitude of this effect are small;

Elevated serum uric acid and blood glucose levels during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects;

· An increase in plasma lipids in high doses;

Haematological disorders, much rarer, thrombocytopenia, leukopenia, agaranulocytosis, bone marrow suppression, haemolytic anemia;

· An exceptional hypercalcemia.

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