Hypersensitivity to amlodipine and olmesartan medoxomil, to dihydropyridine derivatives or to any of the excipients of Normetec (see Description).
Due to the component amlodipine, Normetec is also contraindicated in patients with cardiogenic shock, acute myocardial infarction (within the first 4 weeks), unstable angina pectoris.
Severe hepatic insufficiency and biliary obstruction (see Pharmacokinetics under Actions).
Use in Pregnancy: There are no data about the use of Normetec in pregnant patients. Animal reproductive toxicity studies with Normetec have not been performed.
Olmesartan Medoxomil: The use of angiotensin II antagonists is not recommended during the 1st trimester of pregnancy (see Pregnancy under Precautions). The use of angiotensin II antagonists is contraindicated during the 2nd and 3rd trimester of pregnancy.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the 1st trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
While there is no controlled epidemiological data on the risk with angiotensin II antagonists, similar risks may exist for this class of drugs. Unless continued angiotensin receptor blocker therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II antagonists should be stopped immediately and, if appropriate, alternative therapy should be started.
Angiotensin II antagonists therapy exposure during the 2nd and 3rd trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See Toxicology: Preclinical Safety Data under Actions.)
Should exposure to angiotensin II antagonists have occurred from the 2nd trimester on, ultrasound examinations of the renal function and of the skull are recommended. Newborns exposed to angiotensin II antagonists in utero must be closely monitored for the occurrence of hypotension, oliguria and hyperkalaemia.
Amlodipine: Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of prolonged delivery. As a consequence, Normetec is not recommended during the 1st trimester of pregnancy and is contraindicated during the 2nd and 3rd trimesters of pregnancy (see Contraindications).
Use in Lactation: Olmesartan is excreted into the milk of lactating rats. However, it is not known whether olmesartan passes into human milk. It is not known whether amlodipine is excreted in breast milk. Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk. The risks to newborn infants of exposure to Normetec in breast milk are unknown. Therefore, as a precaution, the use of Normetec during lactation is contraindicated. A decision should be made whether to discontinue breastfeeding or discontinue Normetec, taking into account the importance of Normetec to the mother.