INEGY /

Prevention of cardiovascular events

EZETIMIBE/SIMVASTATINE ALMUS is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary artery disease with a history of acute coronary syndrome (ACS), previously treated or not with a statin.

Hypercholesterolaemia

EZETIMIBE/SIMVASTATINE ALMUS is indicated as an adjunct to diet in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia when the use of a combination is appropriate:

· patients not adequately controlled by a statin alone.

· patients already receiving a statin and ezetimibe.

Homozygous familial hypercholesterolaemia (HFHo)

EZETIMIBE/SIMVASTATINE ALMUS is indicated as an adjunct to diet in patients with HFHo. These patients may also receive adjunct treatments (example: LDL apheresis).

Pregnancy

Atherosclerosis is a chronic disease, and in general, stopping lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolemia.

EZETIMIBE/SIMVASTATINE ALMUS

EZETIMIBE/SIMVASTATINE ALMUS is contraindicated during pregnancy. No clinical data are available on the use of EZETIMIBE/SIMVASTATINE ALMUS during pregnancy. Animal studies on the use of the combination have shown reproductive toxicity (see section 5.3).

Simvastatine

Safety of use has not been established in pregnant women. No controlled clinical studies of simvastatine have been conducted in pregnant women. Rare cases of congenital anomalies have been reported following intrauterine exposure to HMG-CoA réductase inhibitors. However, during the analysis of approximately 200 prospectively followed pregnancies exposed during the first trimester to simvastatine or another closely related HMG-CoA réductase inhibitor, the incidence of congenital anomalies was comparable to that observed in the general population. The number of pregnancies was statistically sufficient to exclude an increase ≥ 2,5 times in congenital anomalies compared to the baseline incidence.

Although there is no evidence that the incidence of congenital anomalies in the offspring of patients taking simvastatine or another closely related HMG-CoA reductase inhibitor differs from that observed in the general population, treatment of the mother with simvastatine may reduce fetal mevalonate levels, which is a precursor to cholesterol biosynthesis. For this reason, EZETIMIBE/SIMVASTATINE ALMUS should not be used in pregnant women, women wishing to become pregnant or who think they may be pregnant. Treatment with EZETIMIBE/SIMVASTATINE ALMUS must be interrupted during the duration of pregnancy or until it has been established that the woman is not pregnant (see section 4.3).

Ezétimibe

No clinical data are available on the use of ezétimibe during pregnancy.

Breastfeeding

EZETIMIBE/SIMVASTATINE ALMUS is contraindicated during breastfeeding. Studies conducted in rats have shown that ezétimibe is excreted in breast milk. No data exist on the secretion of the active substances of EZETIMIBE/SIMVASTATINE ALMUS in breast milk in women (see section 4.3).

Fertility

Ezétimibe

No clinical data are available on the effect of ezétimibe on human fertility. Ezétimibe has had no effect on the fertility of male or female rats (see section 5.3).

Simvastatine

No clinical data are available on the effect of simvastatine on human fertility. Simvastatine has had no effect on the fertility of male and female rats (see section 5.3).

The effects on the ability to drive vehicles and use machines have not been studied. However, when driving vehicles or using machines, account must be taken of the fact that dizziness has been reported.