Janssen-Cilag Ltd

Tablets

White tablets – small, round, white tablet, engraved  with "C 535" on both faces

Peach tablets - small, round, peach coloured tablet, engraved with “C 135” on both faces

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.

Examples include:

·                      barbiturates

·                      bosentan

·                      carbamazepine

·                      felbamate

·                      griseofulvin

·                      some HIV protease inhibitors (e.g. ritonavir)

·                      modafinil

·                      some non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine)

·                      oxcarbazepine

·                      phenytoin

·                      rifampicin and rifabutin

·                      St. John’s Wort

·                      topiramate

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.

Changes in Plasma Levels of Co-Administered Drugs that may be of Clinical Significance:

Combination hormonal contraceptives may also affect the pharmacokinetics of some other drugs if used concomitantly. 

Drugs whose plasma levels may be increased (due to CYP inhibition)

Examples include:

·                      ciclosporin

·                      prednisolone

·                      theophylline

Drugs whose plasma levels may be decreased (due to induction of glucuronidation)

Examples include:

·                      lamotrigine

Management

Physicians are advised to consult the labelling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives and the possible need to adjust dosages.

Change to section 10 - (Date of revision of the text) to 10 November 2011

In section 4.2 -  Starting treatment’  and ‘Use after miscarriage’ information updated in line with UK FFPRH guidelines.   ‘Post-partum administration’ and ‘to skip a period’ moved from section 4.4.  ‘Missed pill information’  moved from section 4.4 , previously called ‘Forgotten tablets’ updated in line with MHRA guidance. ‘Vomiting and diarrhoea’ updated in line with In line with UK FFPRH First prescription of COC guidelines Updated January 2007 (page 11)

In section 4.3 Substantially changed. Some contraindications added, some , some conditions ‘down-graded’ to just requiring supervision or even where benefit usually outweighs risk in lin e with UK MEC 09 cat 4

In section 4.4  Information moved from section 4.4 to 4.2 .New HIV statement - In line with UK MEC 2009 ‘Conditions requiring supervision’ In line with UK MEC 09 Category 3 .Cervical Cancer and breast cancer information moved from 4.8 Laboratory tests updated. ‘Other condition’ added ;In line with UK MEC09 Category 2

In section 4.6 Updated in line with In line with UK MEC 2009

In section 4.8 Thrombo-embolism risk factors, Breast cancer, smoking risks -moved to 4.4

In section 4.9 Statement updated