Levonelle 1500microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levonorgestrel

Available from:

Bayer Plc

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; GTIN: 5016703008729

Patient Information leaflet

1
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVONELLE
® 1500 MICROGRAM TABLET
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.
WHAT IS IN THIS LEAFLET:
1.
What Levonelle 1500 microgram tablet (hereinafter Levonelle 1500) is
and what it is used for
2.
What you need to know before you take Levonelle 1500
3.
How to take Levonelle 1500
4.
Possible side effects
5.
How to store Levonelle 1500
6.
Contents of the pack and other information
1.
WHAT LEVONELLE 1500 IS AND WHAT IT IS USED FOR
Levonelle 1500 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).
Levonelle 1500 contains a synthetic hormone like active substance
called levonorgestrel. It prevents
about 84% of expected pr

Summary of Product characteristics

OBJECT 1
LEVONELLE 1500 MICROGRAM TABLET
Summary of Product Characteristics Updated 12-Dec-2017 | Bayer plc
1. Name of the medicinal product
Levonelle
®
1500 microgram tablet
2. Qualitative and quantitative composition
Each tablet contains 1500 micrograms of levonorgestrel
Excipient with known effect: 142.5 mg lactose monohydrate.
For excipients see section 6.1
3. Pharmaceutical form
Tablet
Almost white, flat, rimmed tablet of about 8 mm diameter with an
impressed mark of “G00” on one 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
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, i.e. Cu-IUD or
take a double dose of
levonorgestrel (ie 2 tablets taken together) for those women unable or
unwilling to use Cu-IUD (see
section 4.5).
Levonelle 1500 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 Levonelle
1500 does not contraindicate the
continuation of regular hormonal contraception.
_Paediatric population_:
There is no relevant use of Levonelle 1500 for children of prepubertal
age in the indication emergency
contraception Levonelle 1500 is not recommended in children.
.
4.3 Contraindications
Hypersensitivity to the active substance or 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