Levonorgestrel 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levonorgestrel

Available from:

DE Pharmaceuticals

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

1
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 rather
than delay until the third day.
Levonorg

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