When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 4.2 Posology and method of administration – delete details on the maximum daily dose not being exceeded. Clarification that elderly means age 65 years or older.
Section 4.6 Pregnancy and lactation – update section on lactation and provide information for olmesartan medoxomil and hydrochlorothiazide.
Section 4.8 Undesirable side-effects – Add information on clinical trials in 40 mg strengths and update Adverse Events table to add side-effects and amend the frequencies of existing side-effects for all fixed dose combination strengths. Update Adverse Events tables for olmesartan medoxomil and hydrochlorothiazide also.
Section 9 Date of first authorization/renewal - Date of last renewal added.
Section 10 Date of revision of the test - Date of last revision updated to October 2011
Amend typographical errors throughout the SmPC.
2. Qualitative and Quantitative Composition
Excipients statement added re lactose
4.2 Posology and method of administration
4.4 Special warnings and precautions
5.2 Pharmacokinetic properties
Hepatic impairment – use with caution in patients with mild to moderate hepatic impairment. Do not use in patients with severe hepatic impairment, cholestasis and biliary obstruction.
4.3 Contraindications
Lactation contraindication removed
4.4 Special warnings and precautions for use
4.6 Pregnancy and lactation
Do not use in first trimester of pregnancy. Contra-indication in 2nd and third trimester of pregnancy.
Do not initiate during pregnancy, change to alternative anti-hypertensive treatments for planned pregnancies, stop treatment immediately in pregnancy and start alternative therapy if appropriate.
Lactation: Not recommended and alternative treatments during breast-feeding are preferable.
4.8 Side –effects
Re-formatted tables included with updated frequencies