Levonorgestrel BNM

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Levonorgestrel 1.5mg

Inapatikana kutoka:

Boucher & Muir (New Zealand) Limited t/a BNM Group

Kipimo:

1.5 mg

Dawa fomu:

Tablet

Tungo:

Active: Levonorgestrel 1.5mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Poloxamer 188

Dawa ya aina:

Restricted

Bidhaa muhtasari:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC Al blister in outer cardboard carton - 1 tablets - 36 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

2019-07-10

Taarifa za kipeperushi

1
LEVONORGESTREL BNM
Consumer Medicine Information
LEVONORGESTREL BNM
_LEVONORGESTREL _
Tablet 1.5 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking
Levonorgestrel BNM.
This leaflet answers some common questions about Levonorgestrel BNM.
It does not
contain all the available information. The most up-to-date Consumer
Medicine Information
can be downloaded from www.medsafe.govt.nz.
Reading this leaflet does not take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Levonorgestrel BNM against the benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT LEVONORGESTREL BNM IS USED FOR
Levonorgestrel BNM contains a synthetic luteal hormone-like active
substance called
levonorgestrel.
Levonorgestrel BNM is used as an emergency contraceptive that can be
used within
72 hours (3 days) of unprotected sex or if your usual contraceptive
method has failed.
Levonorgestrel BNM prevents about 85% 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 within
12 hours rather than delay until the third day.
Levonorgestrel BNM is thought to work by:
▪
stopping your ovaries from releasing an egg;
▪
preventing sperm from fertilising any egg you may have already
released.
2
LEVONORGESTREL BNM
Levonorgestrel BNM can only prevent you from becoming pregnant if you
take it within 72
hours of unprotected sex. It does not work if you are already
pregnant. If you have
unprotected sex after taking Levonorgestrel BNM, it will not stop you
from becoming
pregnant. Ask your doctor or pharmacist if you have any questions
about why you are
taking Levonorgestrel BNM.
BEFORE YOU TAKE LEVONORGESTREL BNM
Le

Tabia za bidhaa

1
LEVONORGESTREL BNM
LEVONORGESTREL TABLET 1.5 MG
NEW ZEALAND DATA SHEET
1
LEVONORGESTREL BNM
LEVONORGESTREL BNM
1.5 mg tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel 1.5 mg
EXCIPIENT(S) WITH KNOWN EFFECT:
Each tablet contains 43.3 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Levonorgestrel tablet is a round, biconvex, white tablet, engraved
with “C” on one side
and “1” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of
a contraceptive method.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
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
Pharmacodynamic properties
– Clinical efficacy).
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
2
LEVONORGESTREL BNM
LEVONORGESTREL TABLET 1.5 MG
take a double dose of levonorgestrel (i.e. 2 tablets of 1500
micrograms taken together)
for those women unable or unwilling to use Cu-IUD (see section 4.5
Interaction with
other medicines and other forms of interaction).
Levonorgestrel 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 local
barrier method
(e.g. condom, diaphragm, spermicide, cervical cap) until the next
menstrual period
starts. The use of levonorgestrel does not contraindicate the
continuation of regular
hormonal contraception.
Paediatric population
There is no relevant use of levonorgestrel for children of
pre-pubertal age in the
indication emergency contraception.
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance l