Medicinal Products

ENALAPRIL / HYDROCHLOR ACTAVIS 20 mg / 12.5 mg

Generic drug of CO Renitec
Therapeutic class: Cardiology and angiology
Active ingredients: Enalapril, Hydrochlorothiazide
laboratory: Actavis Group Ptc Ehf

Tablet breackable
Box of 28
All forms

Indication

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

Dosage ENALAPRIL / HYDROCHLOR ACTAVIS 20 mg / 12.5 mg Breakable tablet Box of 28

Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
- Normal kidney function:
The usual dosage is one tablet in one daily dose.
- Renal failure :
. creatinine clearance between 30 and 80 ml / min : the usual dosage is half a 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 : contraindication.
- Elderly:
It is recommended to start the treatment at the dosage of half a tablet, in case there is a physiological decline in renal function (see warnings and precautions for use, precautions for use).

Against indications

Linked to enalapril

This medicine MUST NEVER BE USED in case of:

Hypersensitivity to enalapril,

· History of angioedema (angioedema) associated with the use of a hereditary or idiopathic angiotensin-converting enzyme inhibitor and / or angioedema.

This medicine IS GENERALLY NOT RECOMMENDED in case of:

· Combinations 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,

· 2nd and 3rd trimesters of pregnancy (see sections Warnings and precautions for use and Pregnancy and lactation ).

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.

This medicine IS GENERALLY 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 bilateral stenosis of the renal artery or on functionally unique kidney and hyperkalemia.

Adverse effects Enalapril / Hydrochlor Actavis

Clinically

Linked to enalapril:

· Headache, asthenia, dizziness, syncope.

Hypotension, orthostatic or not (see section Warnings and precautions for use ).

· 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.

· Endocrine disorders.

Not known: syndrome of inappropriate secretion of antidiuretic hormone (SIHAD).

Linked to hydrochlorothiazide:

· In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see section 4.3. Contraindications and Warnings and precautions for use ).

· Possible aggravation of pre-existing systemic lupus erythematosus, necrotizing vasculitis, exceptional Lyell syndrome.

· Skin and subcutaneous tissue: Uncommon: Cases of photosensitivity reaction have been reported (see Warnings and Precautions ) section.

· Nausea, constipation, dizziness, asthenia, paresthesia, headache, rarely seen and usually giving way to a dose reduction.

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

Biologically

Linked 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, the administration of a conversion enzyme inhibitor may give rise to 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 for Use section ).

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

Linked to hydrochlorothiazide:

· Potassium depletion with hypokalemia, especially in case of intensive diuresis, and particularly severe in certain at-risk populations (see Warnings and precautions for use ).

· 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 at high doses.

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

· An exceptional hypercalcemia.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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