* Coadministration of multiple doses of atorvastatin and phenazone showed little or no detectable effect in the clearance of phenazone.
Increase is indicated as “↑”, decrease as “↓”
OD = once daily; SD = single dose; BID = twice daily
4.6 Fertility, pregnancy and lactation
 Women of childbearing potential
Women of childbearing potential should use appropriate contraceptive measures during treatment (see section 4.3).
Pregnancy
Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering drugs during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.
ATOZET
ATOZET is contraindicated during pregnancy (see section 4.3). No clinical data are available on the use of ATOZET during pregnancy.
The coadministration of ezetimibe and atorvastatin in pregnant rats indicated that there was a test article-related increase in the skeletal variation “reduced ossification of the sternebrae” in the high dose ezetimibe/atorvastatin group. This may be related to the observed decrease in foetal body weights. In pregnant rabbits a low incidence of skeletal deformities (fused sternebrae, fused caudal vertebrae and asymmetrical sternebrae variation) were observed.
Atorvastatin
Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction (see section 5.3).
Ezetimibe
No clinical data are available on the use of ezetimibe during pregnancy.
Breast-feeding
ATOZET is contraindicated during breast-feeding. Because of the potential for serious adverse reactions, women taking ATOZET should not breast-feed their infants. Studies on rats have shown that ezetimibe is secreted into breast milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. It is not known if the active components of ATOZET are secreted into human breast milk. (See section 4.3.)
Fertility
No fertility studies were conducted with ATOZET.
Atorvastatin
In animal studies atorvastatin had no effect on male or female fertility.
Ezetimibe
Ezetimibe had no effect on the fertility of male or female rats.
4.7 Effects on ability to drive and use machines
 ATOZET has negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported.
4.8 Undesirable effects
 Summary of the safety profile
ATOZET (or coadministration of ezetimibe and atorvastatin equivalent to ATOZET) has been eva luated for safety in more than 2400 patients in 7 clinical trials.
Tabulated list of adverse reactions
Frequencies are defined as: very common (≥1/10); common ≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); and very rare (<1/10,000).
ATOZET
System organ class
 Adverse reaction
 Frequency
Infections and Infestations
 in