Cilest

Shelf life

24 months

Incompatibilities

Not applicable.

List of excipients

Tablet core:

Lactose monohydrate

Croscarmellose sodium

Magnesium stearate

Microcrystalline cellulose

Film coating:

Hypromellose

Carnauba wax

Polyethylene glycol

Polysorbate 80

Purified water

Titanium dioxide

F.D. & C. Blue No. 2 Aluminium Lake (E132)

Preclinical safety data

The toxicology of norgestimate and ethinylestradiol has been extensively investigated in animal studies and through long term clinical experience with widespread use in contraceptives.

Pharmacotherapeutic group

Hormonal Contraceptives for Systemic Use; Progestogens and estrogens, fixed combinations

Date of revision of the text

24 January 2018

Marketing authorisation holder

Janssen-Cilag Limited

50 -100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the strips in the outer carton in order to protect from light.

Nature and contents of container

Cartons containing 1 (Starter Pack), 3 and 6 PVC/foil blister strips of 21 tablets each.

Not all pack sizes may be marketed.

Marketing authorisation number(s)

PL 00242/0209

Special precautions for disposal and other handling

Not applicable.

Date of first authorisation/renewal of the authorisation

1 July 1995 / 7 January 2009