Levonorgestrel HTP 1,5 mg, tabletten

Country: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

LEVONORGESTREL 1,5 mg/stuk

Boleh didapati daripada:

Healthypharm B.V. Nieuwe Donk 3 4879 AC ETTEN-LEUR

Kod ATC:

G03AD01

INN (Nama Antarabangsa):

LEVONORGESTREL 1,5 mg/stuk

Borang farmaseutikal:

Tablet

Komposisi:

LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551),

Laluan pentadbiran:

Oraal gebruik

Kawasan terapeutik:

Levonorgestrel

Ringkasan produk:

Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551);

Tarikh kebenaran:

1900-01-01

Risalah maklumat

PL Levonorgestrel PT1531, deletion of BRS, update of EEA product list
2023-03
PACKAGE LEAFLET
Package leaflet: Information for the user
Levonorgestrel HTP 1,5 mg, tabletten
Levonorgestrel
[FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION:]
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
is an emergency contraceptive that can be used within
72 hours (3 days) of
unprotected sex or if your usual contraceptive method has failed.
It is about the following cases:
•
No contraception was used during the sexual intercourse.
•
The contraception measure was used incorrectly, for example as if a
condom was
penetrated, slipped away or used in a wrong way, if vaginal pessary or
diaphragm
changed position, burst, was broken or taken out ahead of time, in the
case of a failed
interruption during coitus interruptus (e.g. sperm ejaculated in
vagina or on external
genitalia).
contains a synthetic hormone like active substance
called levonorgestrel. It
prevents about 84% of expected pregnancies when you take it within 72
hours of having
unprotected sex. It will not prevent a pregnancy every time and is
more effective if you take it
as soon as possible after unprotected sex. It is better to take it
withi

Ciri produk

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2021-07
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SUMMARY OF PRODUCTS CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levonorgestrel HTP 1,5 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5 mg of levonorgestrel.
Excipient with known effect
Each tablet contains 154 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Round, white to off-white, 8.00 mm diameter, uncoated flat tablets
debossed ‘1.5’ on one side
and other side plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of a
contraceptive method.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet should be taken as soon as possible, preferably within 12
hours, and no later than 72
hours after unprotected intercourse (see section 5.1).
If vomiting occurs within three hours of taking the tablet, another
tablet should be taken
immediately.
Women who have used enzyme-inducing drugs during the last 4 weeks and
need emergency
contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or
take a double dose
of levonorgestrel (i.e. 2 tablets taken together) for those women
unable or unwilling to use Cu-
IUD (see section 4.5).
1.5 mg can be used at any time during the menstrual
cycle unless menstrual
bleeding is overdue.
After using emergency contraception it is recommended to use a barrier
method (e.g. condom,
diaphragm or cap) until the next menstrual period starts. The use of
1.5 mg
does not contraindicate the continuation of regular hormonal
contraception.
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2021-07
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_Paediatric population: _
There is no relevant use of for children of
prepubertal age in the indication
emergency contraception.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the