Levonorgestrel 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levonorgestrel

Available from:

Kent Pharma (UK) Ltd

ATC code:

G03AC03

INN (International Name):

Levonorgestrel

Dosage:

1.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030500

Patient Information leaflet

6148
260560
LEVONORGESTREL 1.5MG TABLETS
280 mm
230 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVONORGESTREL 1.5MG TABLETS
Levonorgestrel
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.
·
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 Levonorgestrel 1.5mg tablets are and what
they are used for
2. What
you
need
to
know
before
you
take
Levonorgestrel 1.5mg tablets
3. How to take Levonorgestrel 1.5mg tablets
4. Possible side effects
5. How to store Levonorgestrel 1.5mg tablets
6. Contents of the pack and other information
1. WHAT LEVONORGESTREL 1.5MG TABLETS ARE AND WHAT
THEY ARE USED FOR
A
Levonorgestrel
1.5mg
tablet
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 if a condom was penetrated, slipped
away or used in the 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).
Levonorgestrel
1.5mg
tablets
contain
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 within 12 hours

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levonorgestrel 1.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5mg of levonorgestrel
Excipient(s) with known effect:
Each tablet contains 140.10 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white round shaped tablets, debossed with “LV1” on
one side and plain
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
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
For oral 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
(emergency
contraception), 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).
Levonorgestrel 1.5mg tablets 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 prepubertal
age in the
indication emergency contraception.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Emergency contraception is an occasional method. It shou