Juliperla 75microgram/20microgram tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Gestodene; Ethinylestradiol

Доступно од:

Actavis UK Ltd

АТЦ код:

G03AA10

INN (Међународно име):

Gestodene; Ethinylestradiol

Дозирање:

75microgram ; 20microgram

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 07030100; GTIN: 5012617025463

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GESTODENE ETHINYLESTRADIOL 75 20MCG TABLETS PIL UK
Black
BBBA0191
C.Grant
7/11/16
16/11/16
C.Grant
220x680
9pt
Leon Pharma
7/11/16
14/11/16
03
Package leaflet: Information for the user
Juliperla 75micrograms/20micrograms Tablets
Gestodene/Ethinylestradiol
Important things to know about combined hormonal contraceptives
(CHCs):
•
They are one of the most reliable reversible methods of contraception
if used correctly.
•
They slightly increase the risk of having a blood clot in the veins
and
arteries, especially in the first year or when restarting a combined
hormonal contraceptive following 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 “Blood clots”).
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 further questions, ask your doctor, pharmacist or
nurse.
•
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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Juliperla is and what it is used for
2. What you need to know before you take Juliperla
3. How to take Juliperla
4. Possible side effects
5. How to store Juliperla
6. Contents of the pack and other information
1. What Juliperla is and what it is used for
•
Juliperla is a contraceptive

Карактеристике производа

OBJECT 1
JULIPERLA 75MICROGRAMS/20MICROGRAMS TABLETS
Summary of Product Characteristics Updated 16-Jan-2017 | Accord-UK Ltd
1. Name of the medicinal product
Juliperla 75micrograms/20micrograms Tablets
2. Qualitative and quantitative composition
Each white tablet contains 75 micrograms gestodene and 20 micrograms
ethinylestradiol
Excipients with known effect:
Each tablet contains 59.12 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablets
Round, white tablets, with a diameter of 5.7 mm approximately. The
white tablet is debossed with a '_C'_ on
one side and '_34'_ on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
The decision to prescribe Juliperla should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Juliperla
compares with other CHCs (see sections 4.3 and 4.4).
4.2 Posology and method of administration
Posology
_If no preceding hormonal contraceptive use in the past month_
Taking of the tablets should begin on the first day of the woman's
natural cycle (i.e. on the first day of the
woman's menstrual bleeding). One may begin taking the pills on day
2-5, but in these cases, it is
recommended that a barrier method also be used for the first 7 days on
which pills are taken during the
first cycle.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring, _
_or transdermal patch _
The woman should start taking Juliperla on the next day after taking
the last active tablet in her previous
package of contraceptive pills – but no later than the day after the
usual tablet-free or placebo-tablet
period of her previous contraceptive pill. In case a vaginal ring or
transdermal patch has been used, the
woman should start using Juliperla preferably on the day of removal,
but at the latest when the next
application would have been due.
_When changing from progestogen-only preparations (progestoge