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Nervous system disorders:
Common: dizziness, orthostatic dizziness
Not known: vertigo, headache
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Aprovel 75 mg
Each film-coated tablet contains 75 mg of irbesartan.
Excipient: 25.50 mg of lactose monohydrate per film-coated tablet.
Aprovel 150 mg
Each film-coated tablet contains 150 mg of irbesartan.
Excipient: 51.00 mg of lactose monohydrate per film-coated tablet.
Aprovel 300 mg
Each film-coated tablet contains 300 mg of irbesartan.
4.6 Pregnancy and lactation
Pregnancy: Aprovel is contraindicated (see section 4.3) in the second and third trimesters of pregnancy. In the second and third trimesters, substances that act directly on the renin-angiotensin-system can cause foetal or neonatal renal failure, foetal skull hypoplasia and even foetal death.
As precautionary measure, irbesartan should preferably not be used during first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. If pregnancy is diagnosed, irbesartan should be discontinued as soon as possible, skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs. Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (see section 5.3).
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Lactation: Aprovel is contraindicated (see section 4.3) during breast-feeding.It is not known whether irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats.
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