GYNERA

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ETHINYLESTRADIOL; GESTODENE

Inapatikana kutoka:

BAYER ISRAEL LTD

ATC kanuni:

G03CA01

Dawa fomu:

COATED TABLETS

Tungo:

ETHINYLESTRADIOL 0.03 MG; GESTODENE 0.075 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

BAYER AG, GERMANY

Kundi la matibabu:

ETHINYLESTRADIOL

Eneo la matibabu:

ETHINYLESTRADIOL

Matibabu dalili:

Hormonal contraception.

Idhini ya tarehe:

2020-09-30

Taarifa za kipeperushi

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS PREPARATIONS – 1986
The edi
i
e is dispe sed ith a do tors pres riptio o ly
Gynera®
Coated Tablets
Each tablet contains:
Ethinylestradiol 0.03 mg
Gestodene 0.075 mg
Inactive ingredients and allergens in the preparation: See se tio
Further Ifor
atio and in
section 2
Important information regarding some of the components of the medicine
.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may harm them
even if it seems to you that their medical condition is similar.
ESSENTIAL
INFORMATION
ABOUT
COMBINED
HORMONAL
CONTRACEPTIVES
AND
ABOUT
THE
MEDICINE
•
When used properly, combined hormonal contraceptives are considered
one of the most reliable
reversible methods of contraception.
•
They slightly increase the risk of a blood clot in the veins and
arteries, especially in the first year or
when resuming treatment with a combined hormonal contraceptive
following a break of 4 or more
weeks.
•
You must be alert and refer to the doctor if you think you may have
symptoms of a blood clot (see
Blood lots i
se tio 2.
•
If taken for prolonged periods, oral contraceptive pills may reduce
your risk of cancer of the ovaries
and womb.
•
Oral contraceptive pills do not protect against sexually transmitted
diseases, such as AIDS or
chlamydia. Only a condom can help with this.
•
This medicine may increase your risk of effects such as blood clots
and breast cancer.
•
Oral contraceptive pills are not suitable for some women due to their
medical condition. Please read
this leaflet to make sure Gynera is suitable for you.
•
To prevent pregnancy, it is important to take Gynera as instructed and
to start each new strip on
time. Please make sure that you understand what to do if you miss a
pill or if you think you are
preg

Tabia za bidhaa

1.
NAME OF THE MEDICINAL PRODUCT
Gynera
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Gestodene
75 micrograms
Ethinylestradiol
30 micrograms
Excipients:
Lactose monohydrate
37.43 mg
Sucrose
19.66 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sugar-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormonal contraception.
The decision to prescribe Gynera should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Gynera compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_First treatment cycle: _
1 tablet daily for 21 days, starting on the first day of the menstrual
cycle.
Contraceptive protection begins immediately.
_Subsequent cycles: _
Tablet taking from the next pack of Gynera is continued after a 7-day
interval,
beginning on the same day of the week as the first pack.
_Changing from 21-day combined oral contraceptives: _
The first tablet of Gynera should be taken on
the first day immediately after the end of the previous oral
contraceptive course. Additional
contraceptive precautions are not required.
_ _
_Changing from a combined Every Day pill (28 day tablets): _
Gynera should be started after taking the last active tablet from the
Every Day Pill pack. The first
Gynera tablet is taken the next day. Additional contraceptive
precautions are not then required.
_Changing from a progestogen-only pill (POP): _
The first tablet of Gynera should be taken on the first day of
bleeding, even if a POP has already
been taken on that day. Additional contraceptive precautions are not
then required. The remaining
progestogen-only pills should be discarded.
_Post-partum and post-abortum use: _
After pregnancy, oral contraception can be started 21 days after
a vaginal delivery, provided that the patient is fully ambulant and
there are no puerperal
complications. Additional contracep