Cilique 250/35 micrograms tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Norgestimate; Ethinylestradiol

Inapatikana kutoka:

Consilient Health Limited

ATC kanuni:

G03AA; G03AA11

INN (Jina la Kimataifa):

Norgestimate; Ethinylestradiol

Kipimo:

250 / 35 microgram(s)

Dawa fomu:

Tablet

Njia ya uendeshaji:

oral use

Vitengo katika mfuko:

3 or 6 blister strips of 21 tablets each

Dawa ya aina:

Product subject to prescription which may be renewed (B)

Viwandani na:

CYNDEA PHARMA, S.L

Kundi la matibabu:

Progestogens and estrogens, fixed combinations

Eneo la matibabu:

Progestogens and estrogens, fixed combinations; norgestimate and ethinylestradiol

Matibabu dalili:

Hormonal contraception

Idhini hali ya:

Marketed

Idhini ya tarehe:

2015-12-11

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
CILIQUE
250/ 35 MICROGRAM TABLETS
norgestimate and ethinylestradiol
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 first 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 2.3 ‘The Pill and blood clots’, ‘How to recognise a
blood clot’).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
- If you have any 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 effects, talk to your doctor, family planning
nurse or
pharmacist. This includes any possible side effects not listed in this
leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Cilique is and what it is used for
2. What you need to know before you take Cilique
3. How to take
Cilique
3.3 A missed
pill
4. Possible side effects
5. How to store Cilique
6. Contents of the pack and other information
1. WHAT CILIQUE IS AND WHAT IT IS USED FOR
Cilique is a combined hormonal contraceptive pill (‘the Pill’).
YOU TAKE IT TO STOP
GETTING PREGNANT.
This contraceptive contains two types of female sex hormones,
oestrogen and progestogen.
These hormones prevent an egg being released from your ovaries so you
can’t get pregnant.
Also, Cilique makes the fluid (mucus) in your cervix thicker which
makes it more difficult
for sperm to enter the womb. Cilique is a 21-day Pill - you take one
each day for 21 days,
followed by 7 days when you take no pills.
THE BENEFITS OF TAKING THE PILL INCLUDE:
•
it is one of the most reli

Tabia za bidhaa

Health Products Regulatory Authority
23 November 2021
CRN00CLR8
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cilique 250/35 micrograms tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 micrograms of norgestimate and 35 micrograms
of ethinylestradiol.
Excipients with known effect: Lactose 75.74 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Blue, round, biconvex tablets approximately 6mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormonal contraception.
The decision to prescribe Cilique should take into consideration the
individual woman’s current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Cilique
compares with other Combined Hormonal
Contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
ADULTS:
_How to use Cilique:_
One tablet is to be taken at around the same time of day on each of 21
consecutive days followed by a tablet-free interval of 7
days. Each subsequent pack is started after keeping a tablet-free
interval. Withdrawal bleed occurs usually 2-3 days after the
last tablet and may not finish before the next pack is started.
_How to start Cilique:_
_No preceding hormonal contraceptive use in the last month_
Tablet-taking from the first pack of Ciliqueis started on the 1st day
of the menstrual cycle, i.e. the first day of menstrual
bleeding. If menstruation has already begun, Cilique may be commenced
up to day 5 of the menstrual period, provided
additional contraceptive precautions are taken for the first 7 days of
tablet taking.
- _Changing from a combined contraceptive (combined oral contraceptive
(COC), vaginal ring or transdermal patch) to Cilique:_
The woman should start taking Cilique the next day after having taken
the last active tablet of her previous pack of
contraceptive pills – but no later than the day after the usual
tablet-free or placebo-tablet period of her pre