GENPRESS

· Treatment of hypertension.

· Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:

o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or

o diabetes with at least one cardiovascular risk factor (see section 5.1).

· Treatment of nephropathy:

o incipient diabetic glomerular nephropathy, as defined by the presence of microalbuminuria;

o manifest diabetic glomerular nephropathy, as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1);

o manifest non-diabetic glomerular nephropathy, as defined by macroproteinuria ≥ 3 g/day (see section 5.1).

· Treatment of symptomatic heart failure.

· Secondary prevention following acute myocardial infarction: reduction of mortality in the acute phase of myocardial infarction in patients with clinical signs of heart failure, starting > 48 hours after the myocardial infarction.

Pregnancy

Available epidemiological data concerning the risk of malformation after exposure to ACE inhibitors during the 1st trimester of pregnancy do not allow for a conclusion. However, a small increase in the risk of congenital malformations cannot be excluded. Unless ACE inhibitor treatment is considered essential, it is recommended that patients planning a pregnancy change their antihypertensive treatment to a medication with an established safety profile during pregnancy. In case of diagnosis of pregnancy, ACE inhibitor treatment must be stopped immediately and if necessary an alternative treatment will be started.

Exposure to ACE inhibitors during the 2nd and 3rd trimesters of pregnancy is known to cause fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of skull bones) and toxicity in the newborn (renal failure, hypotension, hyperkalemia) (see section 5.3). In case of exposure to an ACE inhibitor from the 2nd trimester of pregnancy, it is recommended to perform a fetal ultrasound to check renal function and the bones of the skull vault. Newborns of mothers treated with ACE inhibitors must be closely monitored to look for any sign of hypotension, oliguria and hyperkalemia (see sections 4.3 and 4.4).

Breastfeeding

Due to the insufficiency of available information on the use of RAMIPRIL TEVA SANTE during breastfeeding (see section 5.2), RAMIPRIL TEVA SANTE is not recommended. It is preferable to use other treatments having a well established safety profile during breastfeeding, particularly in the newborn or premature infant.

Some side effects (for example, symptoms of reduced blood pressure such as dizziness) may impair the patient's ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of particular importance (such as driving a vehicle or using a machine).

This may occur particularly at the start of treatment, or when replacing other treatments. After the first dose or subsequent dose increases, it is not recommended to drive or use machines for several hours.

Summary of the safety profile

The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia / agranulocytosis.

Summary table of adverse reactions

The frequency of adverse reactions is defined according to the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse effects are presented in order of decreasing seriousness.

Paediatric population

The safety of ramipril has been monitored in 325 children and adolescents aged 2 to 16 years, during 2 clinical trials. While the nature and severity of the adverse events are similar to those of adults, the frequency of the following adverse events is higher in children:

· tachycardia, nasal congestion and rhinitis, "common" (≥ 1/100 to < 1/10) in the paediatric population and "uncommon" (≥ 1/1 000 to < 1/100) in the adult population;

· conjunctivitis "common" (≥ 1/100 to < 1/10) in the paediatric population, and "rare" (≥ 1/10 000 to < 1/1 000) in the adult population;

· tremor and urticaria "uncommon" (≥ 1/1 000 to < 1/100) in the paediatric population, and "rare" (≥ 1/10 000 to < 1/1 000) in the adult population.

The overall safety profile of ramipril in the paediatric population does not differ significantly from the safety profile in the adult population.

Reporting of suspected adverse reactions

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