Trinovum Oral Contraceptive Tablets (Norethisterone and Ethinylestradiol)- Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Norethisterone, Ethinylestradiol, Trinovum

Date published: 01/12/2011 09:27

Type of SPC Change: Revised SPC

Generic drug name: Norethisterone and Ethinylestradiol

Drug brand name: Trinovum Oral Contraceptive Tablets

Legal status: POM

Pharmaceutical manufacturer: Janssen-Cilag Ltd

Summary
by: Atisha Sharma

There has been significant updates to section 4.5 of the SPC, which includes the following:

 

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

 

Potential Reduction in Contraceptive Effectiveness Associated With Co-Administration of Other Drugs:

 

Hepatic enzyme inducers- Drugs or herbal products that induce enzymes, especially CYP3A4, may decrease the plasma concentrations of contraceptive hormones, and may decrease their effectiveness and/or increase breakthrough bleeding.

 
Antibacterial drugs that are not enzyme inducer- There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

 
Please refer to SPC link below for full information on all changes.

SPC

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