Levonelle Tablets 1500mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVONORGESTREL

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

G03AD01

INN (International Name):

LEVONORGESTREL

Pharmaceutical form:

TABLET

Composition:

LEVONORGESTREL 1500 microgram(s)

Prescription type:

OTC

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Product summary:

Licence number in the source country: United Kingdom - PL04854/0150

Authorization status:

Authorised

Authorization date:

2017-01-20

Patient Information leaflet

Page 1 of 5
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.
Always take this medicine exactly as described in this leaflet or as
your pharmacist has told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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 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.
Levonelle 1500 is thought to work by:
lising any egg you may have already released.
Levonelle 1500 can only prevent you becoming pr

Summary of Product characteristics

LEVONELLE 1500 MICROGRAM TABLET
Summary of Product Characteristics Updated 20-Oct-2014 | 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.
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_:
Levonelle 1500 is not recommended in children.
Very limited data are available in women under 16 years of age.
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 should in no
instance replace a regular contraceptive method.
Emergency contraception does not prevent a pregnancy in every
instance. If there is uncertainty about the timing of
the unprotected intercourse or if the woman has had unprotected
intercourse more than 72 hours earlier in the same
menstrual cycle, conception may have occurred. Treatment with
Levon