TENORETIC

Arterial hypertension in case of therapeutic failure of monotherapy with a diuretic or a beta-blocker.

Pregnancy

The presence of a thiazide diuretic determines the non-use of this combination during pregnancy.

Related to atenolol

Animal studies have not shown any teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, substances responsible for malformations in the human species have proven to be teratogenic in animals during well-conducted studies on two species.

In clinical practice, no teratogenic effect has been reported to date and the results of controlled prospective studies with some beta-blockers have not reported malformations at birth.

In the newborn of a treated mother, the beta-blocking action persists for several days after birth: although this persistence is most often without clinical consequence, heart failure may nevertheless occur requiring hospitalization in intensive care (see section 4.9), avoiding volume replacement solutions (risk of pulmonary edema); furthermore, bradycardia, respiratory distress, and hypoglycemia have been reported.

Consequently, beta-blockers, under normal conditions of use, can be prescribed during pregnancy if needed. In case of treatment until delivery, careful monitoring of the newborn (heart rate and blood glucose during the first 3 to 5 days of life) is recommended in a specialized setting.

Related to chlortalidone

As a general rule, the administration of thiazide and related diuretics should be avoided in pregnant women and must never be prescribed during physiological oedema (and therefore not requiring treatment) of pregnancy. Diuretics can, in fact, lead to fetal-placental ischaemia, with a risk of fetal hypotrophy.

Diuretics remain, nevertheless, an essential element of the treatment of oedema of cardiac, hepatic and renal origin occurring in pregnant women.

Breastfeeding

Related to atenolol

Beta-blockers are excreted in milk (see section 5.2).

The risk of occurrence of hypoglycemia and bradycardia has not been evaluated: consequently and as a precaution, breastfeeding is not recommended during the duration of treatment.

Related to chlortalidone

As chlortalidone passes into breast milk, breastfeeding is not recommended.

The effects on the ability to drive vehicles and use machines have not been studied.

However, vehicle drivers and machine users should take into account the possible occurrence of dizziness and fatigue

In clinical studies, adverse effects are generally attributable to the pharmacological actions of the components of TENORETIC.

Adverse effects are classified by system organ class and frequency, very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), and frequency not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Rare: purpura, thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia (linked to chlortalidone).

Psychiatric disorders:

Uncommon: sleep disturbances (of the same nature as those observed with other beta-blockers).

Rare: mood disturbances, nightmares, confusion, psychoses and hallucinations.

Frequency not known: depression.

Nervous system disorders:

Rare: dizziness, headache, paresthesia.

Eye disorders:

Rare: dry eyes, visual disturbances. Not known: choroidal effusion.

Cardiac disorders:

Common: bradycardia.

Rare: heart failure, worsening of pre-existing heart failure, slowing of atrioventricular conduction, intensification of atrioventricular block.

Vascular disorders:

Common: cold extremities.

Rare: orthostatic hypotension which may be associated with syncope, worsening of existing intermittent claudication, Raynaud's syndrome.

Respiratory, thoracic and mediastinal disorders:

Rare: Bronchospasm in patients with asthma or a history of asthma.

Gastrointestinal disorders:

Common: gastrointestinal disorders (including nausea, gastralgia and vomiting linked to chlortalidone).

Rare: dry mouth. Unknown: constipation.

Hepatobiliary disorders:

Rare: hepatic toxicity including intrahepatic cholestasis, pancreatitis (linked to chlortalidone). In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see section 4.3 and 4.4).

Skin and subcutaneous tissue disorders:

Rare: alopecia, psoriasiform rashes, exacerbation of psoriasis, and skin rashes.

Not known: hypersensitivity reaction essentially dermatological, in subjects predisposed to allergic and asthmatic manifestations, maculopapular rashes, possibility of worsening of pre-existing acute disseminated lupus erythematosus.

Musculoskeletal and systemic disorders:

Not known: Lupus-like syndrome

Reproductive system and breast disorders:

Rare: impotence

General disorders and administration site conditions:

Common: asthenia.

Investigations:

Common (linked to chlortalidone): hyperuricemia, hyponatremia, hypokalemia, decreased glucose tolerance. Hyponatremia with hypovolemia causing dehydration and orthostatic hypotension. The concomitant loss of chloride ions can secondarily lead to compensatory metabolic alkalosis: the incidence and amplitude of this effect are low.

Very rare: hypercalcemia.

Uncommon: elevation of transaminase levels. Not known: hypoglycemia.

Rare: The appearance of antinuclear antibodies, only exceptionally accompanied by clinical manifestations of the lupus syndrome type, which resolves upon discontinuation of treatment. An increase in antinuclear antibodies has been observed; however, the clinical relevance of these data has not been demonstrated. Lupus syndrome.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reaction via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .