Medicinal Products

ENALAPRIL / HYDROCHLOROTHIAZIDE ARROW 20 mg / 125 mg

Generic drug of CO Renitec
Therapeutic class: Cardiology and angiology
active ingredients: Enalapril + Hydrochlorothiazide
laboratory: Arrow Generic

Compressed cable
box of 84
All forms

Indication

Treatment of arterial hypertension in case of therapeutic failure of monotherapy with a converting enzyme inhibitor.

Dosage ENALAPRIL / HYDROCHLOROTHIAZIDE ARROW 20 mg / 125 mg tablet box of 84

Treatment of arterial hypertension in case of therapeutic failure of monotherapy with a converting enzyme inhibitor.

Against indications

Links to Énalapril

This medicine MUST NEVER BE USED in case of:

· Hypersensitivity to Énalapril,

· Previous angioedema (Quincke's edema) related to the intake of an angiotensin converting enzyme inhibitor and / or hereditary angioedema or idiopathic,

· The combination of ENALAPRIL / HYDROCHLOROTHIAZIDE ARROW with medicinal products containing aliskiren is contraindicated in patients with diabetes or renal insufficiency (DFG). glomerular filtration] <60 ml / min / 1.73 m 2 ) (see sections Interactions with other medicinal products and other forms of interaction and pharmacodynamic properties ).

THIS MEDICINE IS GENERALLY NOT RECOMMENDED in case of:

 · Combinations with hyperkaliemic 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 on functionally unique kidney,

· Hyperkaliemia,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and Precautions and Pregnancy and Lactation ).

Hydrochlorothiazide binders

This medicine MUST NEVER BE USED in case of:

· Hypersensitivity to sulfonamides,

Severe renal insufficiency (clearance of creatinine less than 30 ml / min),

· Hepatic encystopathy.

This medicinal product is usually not recommended in the following situations: pregnancy (1st trimester), combination with lithium and sultopride (see section Interactions with other medicinal products and other forms of interaction ), in case of stenosis Bilateral of the renal artery or on functionally unique kidney and in cases of hyperkalemia.

Side effects Enalapril / hydrochloride Arrow

Clinically

RELATED TO ENALAPRIL

 · cephalà © es, asthà © nie, dizziness, syncope.

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

· Rash, rash, photosensitization, severe bullous eruptions (polymorphic rhythms, 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, hepatic insufficiency, pancreatitis, jaundice.

· Muscle cramps, dysgeusia.

· Depression, confusion nervosity, bronchospasm, dyspnea.

· A 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. 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 serous, vasculitis, myalgia, arthralgia, antinuclear antibodies, elevated sedation rate, hyperacute © osinophilia, leukocytosis.

RELATED TO HYDROCHLOROTHIAZIDE

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

 · Possibility of worsening of pre-existing high-grade acute lupus, vasculitis necrosis, exceptional Lyell syndrome.

· Skin and subcutaneous tissues: not common: photosensitivity reactions have been reported (see Warnings and Precautions section ).

· Nausea, constipation, dizziness, asthenia, paresthesia, cephalitis, rarely seen and most often occurring at a dose reduction.

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

Biologically

RELATED TO ENALAPRIL

Moderate increase in urea and plasma creatinine, reversible at the end of treatment. This increase is more frequently encountered in case of renal artery stenosis, diuretic treated hypertension, renal insufficiency.

 · In case of glomerular nephritis, administration of a conversion enzyme inhibitor may give rise to proteinuria.

Hyperkaliemia, usually transient.

 · increase in hepatic enzymes and / or bilirubin.

· Neutropenia and agranulocytosis, when high doses are administered in areas of renal insufficiency and collagen [LED, scleroderma] (see Warnings and Precautions section). safeguards for use ).

 · Anemia has been reported with angiotensin-converting enzyme inhibitors, on particular sites (renal transplant, hemodialysis - see Warnings and Precautions section). safeguards for use ).

RELATED TO HYDROCHLOROTHIAZIDE

· A potassium drop with hypokalemia, especially in cases of intensive diuretics, and particularly severe in certain populations at risk (see section Warnings and Precautions ).

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 magnitude of this effect are small.

· An elevation of uricemia and glycaemia during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects.

 · an increase in plasma lipids in high doses.

· Hemological disorders, much rarer, thrombocytopenia, leukopenia, agaranulocytosis, medullary aplasia, hemolytic anemia.

· An exceptional hypercalcemia.

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Health and Medical Products Safety Authority (Ansm) and Network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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