Cilest 35/ 250 micrograms film-coated tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
27-04-2024
Summary of Product characteristics
(SPC)
27-04-2024
Active ingredient:
Norgestimate, ethinylestradiol
Available from:
Janssen-Cilag Ltd
ATC code:
G03AA11
INN (International Name):
Norgestimate, ethinylestradiol
Dosage:
35/ 250 micrograms
Pharmaceutical form:
Film-coated Tablet
Administration route:
Oral use
Units in package:
Blister strips of 21 tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Janssen Pharmaceutica NV
Therapeutic group:
Hormonal Contraceptives for Systemic Use; Progestogens and estrogens, fixed combinations
Therapeutic indications:
Contraception and the recognised indications for such estrogen/progestogen combinations
Authorization status:
Authorised
Authorization date:
1995-07-01
Patient Information leaflet
GB - 10317400
GB - 10317400
© J-C 2014
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leafl et. You may need to read it again.
• If you have any further questions, ask your doctor, family
planning nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them.
• IF YOU GET ANY SIDE EFF ECTS talk to your doctor, family
planning nurse or pharmacist. This includes any possible side
eff ects not listed in this leafl et. See section 4.
WHAT IS IN THIS LEAFL ET:
1
WHAT CILEST DOES
2
MAKE SURE CILEST IS OK FOR YOU
3
TAKING CILEST
3.3
A MISSED PILL
4
POSSIBLE SIDE EFF ECTS
5
HOW TO STORE CILEST
6
WHAT IS IN CILEST AND WHO MAKES IT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ethinylestradiol/norgestimate
Cilest is a registered trademark
35/250 micrograms film-coated tablets
IMPORTANT THINGS TO KNOW ABOUT THE PILL (COMBINED HORMONAL
CONTRACEPTIVES).
• The Pill is one of the most reliable reversible methods of
contraception if used correctly.
• This medicine slightly increases your risk of having a blood clot
in the veins and arteries (especially in the fi rst year or
when restarting the Pill after a break of 4 or more weeks).
• Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see Section 2.1 ‘The Pill and
blood clots’, ‘How to recognise a blood clot’).
• The Pill may reduce your risk of cancer of the ovary and womb if
used for a long time, but increase your risk of breast cancer.
• The Pill will not protect you against sexually transmitted
diseases.
• Some women should not take the Pill because of current medical
problems or illnesses. Please read the leafl et to make
sure Cilest is right for you.
• To prevent pregnancy it is important to take Cilest as instructed
and start each pack on time. Please make sure that you
understand what to do if yo
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Summary of Product characteristics
Cilest 35/ 250 micrograms filmcoated tablets
Summary of Product Characteristics Updated 25Jun2015 | JanssenCilag Ltd
1. Name of the medicinal product
Cilest 35/ 250 micrograms filmcoated tablets
2. Qualitative and quantitative composition
Each filmcoated tablet contains norgestimate 0.25 mg and ethinylestradiol 0.035 mg.
Excipients with known effects:
Lactose monohydrate 57.065 mg, see section 4.4
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Filmcoated tablet
Blue, round, biconvex, coated tablet, imprinted '0 250' on one side and '35' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Contraception and the recognised indications for such oestrogen/progestogen combinations.
The decision to prescribe Cilest should take into consideration the individual woman's current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with Cilest compares with other Combined
Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 Posology and method of administration
For oral administration.
4.2.1 Adults
_How to take Cilest_
One tablet is taken daily at the same time (preferably in the evening) without interruption for 21 days, followed by a
break of 7 tabletfree days. Each subsequent pack is started after the 7 tabletfree days have elapsed. Additional
contraceptive precautions are not then required. During the tabletfree period, bleeding can be expected, usually
beginning 2 to 4 days after the last tablet.
_Starting treatment_
It is preferable that tablet intake from the first pack is started up to and including day 5 of menstruation in which case
no extra contraceptive precautions are necessary.
Cilest can be started at any other time, if pregnancy can reasonably be excluded. In this c
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