LODIPINE

Treatment of hypertension in adults, adolescents and children aged 6 years or older.

Treatment of stable chronic angina in adults.

Treatment of vasospastic angina (Prinzmetal syndrome) in adults.

Pregnancy

In women, the safety of amlodipine during pregnancy has not been established.

In animal studies, reproductive toxicity was observed at high doses (see section 5.3).

Use during pregnancy is only recommended if no safer alternative is available and when the disease itself carries greater risks for the mother and the fetus.

Breastfeeding

Amlodipine is excreted in human milk. The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 to 7 %, with a maximum of 15 %. The effect of amlodipine on infants is unknown. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with amlodipine should be made taking into account the benefit of breastfeeding to the child and the benefit of amlodipine therapy to the mother.

Fertility

Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In a study conducted in rats, adverse effects were detected on male fertility (see section 5.3).

Amlodipine may have a minor or moderate influence on the ability to drive vehicles and use machines. If patients treated with amlodipine experience sensations of dizziness, headache, fatigue or nausea, their ability to react may be impaired. Precautions are recommended, particularly at the start of treatment.

Summary of the safety profile

The most frequently reported adverse effects during treatment are somnolence, dizzy sensations, headache, palpitations, vasomotor flushing, abdominal pain, nausea, ankle oedema, oedema and fatigue.

List of adverse effects

The following adverse effects have been observed and reported during treatment with amlodipine according to the following frequencies:

· very frequent (≥ 1/10) ;

· frequent (≥ 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) ;

· indeterminate frequency (cannot be estimated on the basis of available data).

In each frequency group, the adverse effects are presented in descending order of severity.

* Generally suggesting cholestasis.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation 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 effect 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/ .