This medicinal product should NEVER BE USED in case of

· A history of hypersensitivity to one of the excipients

· A history of hypersensitivity to quinapril or to any other angiotensin-converting enzyme inhibitor

· History of angioedema (edema of Quincke) related to the use of an enzyme inhibitor, conversion of angiotensin and / or angioedema, hereditary or idiopathic

(See Precautions and Precautions for Use and Pregnancy and Breastfeeding).

This medication is GENERALLY NOT RECOMMENDED in case

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

· Bilateral stenosis of the renal artery or functionally unique kidney

· Hyperkalemia

· 1st trimester of pregnancy

This medicinal product contains lactose and is not recommended for use in patients with galactose intolerance, lapp lactase deficiency or malabsorption syndrome, glucose or galactose (hereditary or rare diseases). Br>

Warnings, special

Risk of neutropenia / agranulocytosis in the field: Immunodepressed: Conversion enzyme inhibitors have unusually resulted in agranulocytosis and / or medullary depression, when administered at high doses, in patients with renal impairment, Systemic diseases (collagenases such as systemic lupus erythematosus or scleroderma), with immunosuppressive and / or potentially leucopenic treatment. However, if an ACE inhibitor is to be administered to this type of patient, the benefit / risk ratio will be carefully monitored Measured.

Angioedema (edema of Quincke): angioedema of the face, extremities, lips, tongue, glottis and / or larynx has been rarely reported, in patients treated with an inhibitor Of the enzyme conversion, quinapril included. In such cases, ACUITEL should be stopped immediately and the patient monitored until the edema has disappeared.When edema is of interest only to the face and lips, the course is generally regressive without Treatment, although antihistamines have been used to relieve symptoms.

Angioedema associated with laryngeal edema may be fatal When tongue, glottis, or larynx is involved, which can lead to airway obstruction, a subcutaneous adrenaline 1/1000 (0.3 ml to 0.5 ml) should be administered rapidly and other appropriate treatments should be applied. The prescription of an ACE inhibitor should no longer be considered in these patients (see section Contraindications).

Patients with a history of unrelated angioedema, an angiotensin-converting enzyme (ACE) inhibitor, have an increased risk of angioedema under inhibition of the enzyme.

Hemodialysis: Anaphylactoid reactions (edema of the tongue and lips with dyspnea and a drop in blood pressure) have also been observed during hemodialysis using high permeability membranes (polyacrylonitrile) in patients treated with inhibitors of The conversion enzyme. It is recommended to avoid this association

Pregnancy

ACE inhibitors should not be started during pregnancy. Unless IEC treatment is considered essential, it is recommended that patients considering pregnancy modify their antihypertensive therapy for a drug with a well established safety profile during pregnancy. In case of diagnosis of pregnancy, treatment with IEC should be stopped immediately and if necessary an alternative treatment will be started (see sections Contraindications and Pregnancy and lactation). >

Precautions for use

Cough: A dry cough has been reported with the use of ACE inhibitors. It is characterized by its persistence as well as by its disappearance at the end of the treatment.iatrogenic etiology should be considered in the presence of this symptom. In cases where the prescription of an inhibitor of the conversion enzyme is essential, further processing may be considered.

Child: The efficacy and safety of quinapril in children have not been established.

Risk of arterial hypotension and / or renal insufficiency (in case of cardiac insufficiency, hydrosodic depletion, etc.): an important stimulation of the system, renin-angiotensin-aldosterone is observed, especially during (Deodorized, strict diuretic or prolonged diuretic treatment) in patients with initially low blood pressure, renal artery stenosis, congestive heart failure or cirrhosis, edema-ascitic. The blockage of this system by an ACE inhibitor may then cause, especially during the first dose and during the first two weeks of treatment, a sudden fall in blood pressure and / or, rarely and in a More variable, elevated creatinine, plasma showing functional renal failure, sometimes acute

In all these cases, the initiation of treatment should be progressive (see section Dosage and mode of administration).

Elderly: renal function and serum potassium are appreciated prior to initiation of therapy (see Dosage and Mode of Administration). The starting dose is subsequently adjusted according to the function of the blood pressure response, a fortiori in cases of hydrosodic depletion, in order to avoid any sudden onset hypotension. >

Renal insufficiency: in cases of renal insufficiency (creatinine clearance less than 40 ml / min), the treatment is initiated by a weak initial dose and then adjusted according to the therapeutic response . In these patients and in patients with glomerular nephropathy, normal medical practice includes periodic control of potassium and creatinine (see section Dosage and Mode of Administration).

Hepatic impairment: In patients with hepatic impairment or progressive liver disease, the combination of ACUITEL with a diuretic and in particular a thiazide diuretic should be performed with caution due to the possible occurrence of alterations Hydroelectricity that can lead to hepatic coma. If signs of hepatic coma appear, discontinuation of treatment should be immediate. In patients with alcoholic cirrhosis, concentrations of quinaprilate, metabolite, and quinapril are reduced. The metabolism of quinapril to quinaprilate is normally dependent on hepatic esterase and in patients with alcoholic cirrhotic, the deesterification of quinalapril is lower. >
Patients with known atherosclerosis: since the risk of hypotension exists in all patients, especially in those with heart disease, ischemic or circulatory insufficiency, cerebral by starting treatment at low dosage.

Renovascular hypertension, treatment of high blood pressure, renovascular is revascularization. However, ACE inhibitors may be useful for patients with hypertension, renovascular awaiting corrective intervention, or when this is not possible. The treatment should be instituted with a low dose and monitoring of renal function and serum potassium should be performed, some patients having developed renal insufficiency, functional, reversible upon discontinuation of treatment. >

Other populations at risk

In patients with severe cardiac insufficiency (Stage IV) or in patients with insulin-dependent diabetes (tendency, spontaneous to hyperkalaemia), treatment will be initiated under medical supervision with a reduced initial dose. Code>
Do not interrupt beta-blocker therapy in hypertensive patients with coronary artery disease: IEC will be added to the beta-blocker.

Anemia: anemia with decreased hemoglobin has been demonstrated in patients with kidney transplant or hemodialysis, decreased as much as the initial values, are high, this effect does not appear to be dose- Dependent but linked to the mechanism of action of the enzyme-converting inhibitors

This decrease is moderate, occurs within 1 to 6 months and then remains stable. It is reversible upon cessation of treatment. This can be prosecuted in this type of patient, by performing a regular hematological control.

Surgical intervention: in cases of anesthesia, and more so when anesthesia is performed with agents with hypotensive potential, inhibitors of the conversion enzyme are at the origin of hypotension. Therapeutic interruption, if feasible, is therefore recommended on the day before surgery for long-acting converting enzyme inhibitors, such as quinapril.

Pregnancy

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see Warnings and Precautions for Use).
The use of ACE inhibitors is contraindicated in the 2 nd and 3 rd trimesters of pregnancy (see sections Contraindications and Warnings and Precautions)

The available epidemiological data concerning the risk of malformation after exposure to IEC in the first trimester of pregnancy are not conclusive. However, a small increase in the risk of congenital malformations can not be ruled out. A, unless treatment with ACE inhibitors is considered essential, it is recommended that patients considering pregnancy modify their antihypertensive treatment for a drug with a well-established safety profile during pregnancy. In case of pregnancy diagnosis, treatment with IEC should be discontinued immediately and, if necessary, an alternative treatment will be started.

Exposure to ACE inhibitors during the 2 nd and 3 rd trimesters of pregnancy is known to result in fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of skull bones) and toxicity in; Newborn (renal insufficiency, hypotension, hyperkalaemia) (see section on safety data, preclinical). In case of exposure to an IEC from the second trimester of pregnancy, it is recommended to perform a fetal ultrasound in order to verify the renal function and the bones of the vault of the skull. Newborns of mothers treated with IEC should be monitored for blood pressure (see section Contraindications and Warnings and Precautions for Use)


Breastfeeding

Limited pharmacokinetic data show very low concentrations in milk (see Properties, Pharmacokinetics). Although these concentrations do not appear to have any real clinical consequences, administration of ACUITEL 5 mg tablets is not recommended in premature infants and in the first weeks after delivery because of Hypothetical risk of side effects at cardiovascular and renal level and clinical experience inadequate

In the case of breastfeeding of an older child, administration of ACUITEL 5 mg scored coated tablet may be considered in the nursing mother if this treatment is necessary for the mother, Child is monitored for the purpose of detecting possible side effects.

At the clinical level

Have been found

· Headache, asthenia, dizziness, discomfort

Hypotension, orthostatic or not (see section Caveats and precautions for use), more rarely chest pain, angina pectoris, syncope
Pruritus, rash, photosensitisation or other manifestations, cutaneous, more rarely pemphigus, increased sweating, very rare cases of exfoliative dermatitis and erythroderma have been reported with other IEC

· Gastralgia, anorexia, nausea, abdominal pain, more rarely pancreatitis

· A dry cough has been reported with the use of ACE inhibitors. It is characterized by its persistence as well as by its disappearance at the discontinuation of the treatment The iatrogenic etiology must be considered in the presence of this symptom
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Anaphylactoid / angioedema (angioedema) (see Warnings and Precautions for Use)

· Pneumopathy

· More rarely: hepatitis.

At the biological level

Moderate increase in urea and plasma creatinine, reversible at cessation of treatment. This increase is more frequently encountered in cases of renal artery stenosis, arterial hypertension, treated with diuretics, insufficiency, renal

· In the case of glomerular nephropathy, administration of an ACE inhibitor may cause proteinuria

· Hyperkalemia, usually transient

· Anemia (see section Caveats and precautions for use) has been reported with enzyme inhibitors, conversion on special sites (renal transplant, hemodialysis)
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· Thrombocytopenia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the drug is important. It permits continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Pharmacovigilance Centers -