Levonelle One Step 1.5mg 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: 5016703008668

Patient Information leaflet

v
003_0
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 ONE STEP 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levonelle One Step is and what it is used for
2.
What you need to know before you take Levonelle One Step
3.
How to take Levonelle One Step
4.
Possible side effects
5.
How to store Levonelle One Step
6.
Contents of the pack and other information
1.
WHAT LEVONELLE ONE STEP IS AND WHAT IT IS USED FOR
Levonelle One Step is an emergency contraceptive that can be used
within 72 hours (3 days) of
unprotected sex or if your usual contraceptive method has failed.
Levonelle One Step contains a synthetic hormone like substance called
levonorgetsrel. 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 One Step is thought to work by:

stopping your ovaries from releasing an egg;

preventing sperm from fertilising any egg you may have already
released.
v
003_0
Levonelle One Step can onl

Summary of Product characteristics

OBJECT 1
LEVONELLE ONE STEP
Summary of Product Characteristics Updated 06-Apr-2017 | Bayer plc
1. Name of the medicinal product
Levonelle One Step 1500 microgram tablet
(Also available as Boots Emergency Contraceptive 1.5 mg Tablet)
2. Qualitative and quantitative composition
The tablet contains 1500 microgram of levonorgestrel
Each tablet contains: 142.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
The tablet is round and white 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: 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. The
patient should seek advice from her doctor, nurse, family planning
clinic or pharmacist.
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 (i.e. 2 tablets taken together) for those women unable
or unwilling to use Cu-IUD (see
section 4.5).
Levonelle One Step 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 Levonelle One
Step does not contraindicate the continuation of regular hormonal
contraception.
_Paediatric population_
There is no relevant use of Levonelle One Step 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