NORLEVO® 1.5 mg tablet

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Levonorgestrel

Dostopno od:

Laboratoire HRA Pharma

Koda artikla:

G03AD; G03AD01

INN (mednarodno ime):

Levonorgestrel

Odmerek:

1.5 milligram(s)

Farmacevtska oblika:

Tablet

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Emergency contraceptives; levonorgestrel

Status dovoljenje:

Not marketed

Datum dovoljenje:

2005-08-26

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
NORLEVO 1.5 MG TABLET
Levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or family planning
clinic told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your doctor, pharmacist or family planning clinic, 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 NorLevo 1.5 mg tablet is and what it is used for
2.
What you need to know before you use NorLevo 1.5 mg tablet
3.
How to use NorLevo 1.5 mg tablet
4.
Possible side effects
5.
How to store NorLevo 1.5 mg tablet
6.
Contents of the pack and other information
1.
WHAT NORLEVO 1.5 MG TABLET IS AND WHAT IT IS USED FOR
NorLevo is an oral emergency contraceptive.
WHAT IS EMERGENCY CONTRACEPTION?
Emergency contraception is a rescue method intended to prevent
pregnancy after unprotected intercourse or
in case of failure of a contraceptive method.
WHEN SHOULD EMERGENCY CONTRACEPTION BE USED?
This contraceptive method should be used as soon as possible,
preferably within 12 hours and no later than a
period of 72 hours (3 days), after unprotected sexual intercourse or
failure of a contraceptive method. It is
more effective if you take it as soon as possible after unprotected
sex. NorLevo can only prevent you
becoming pregnant if you take it within 72 hours of unprotected sex.
It does not work if you are already
pregnant. If you have unprotected sex after taking NorLevo, it will
not stop you from becoming pregnant.
NorLevo has been shown to prevent 52% to 85% of expected pregnancies.
If you suspect that you may become pregnant for one of the following
reasons:

if you have had sexual intercourse without contraception;

if you have forgotten to take your contraceptive pill on

Lastnosti izdelka

Health Products Regulatory Authority
17 September 2019
CRN008LNM
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NORLEVO® 1.5 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5 mg levonorgestrel.
Excipient with known effect: each tablet contains 90.90 mg lactose
monohydrate.
For the full list of excipients, see section6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablet engraved with code NL 1.5 on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours after an unprotected sexual
intercourse or in case of failure of a contraceptive
method.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment necessitates the intake of ONE TABLET. The efficacy of
the method is higher the sooner after the unprotected
intercourse the treatment is initiated. Therefore, the tablet must be
taken AS SOON AS POSSIBLE, PREFERABLY WITHIN 12
HOURSAFTER THE UNPROTECTED INTERCOURSE, and no longer than 72 hours (3
days) after the intercourse.
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).
NorLevo can be taken at any moment during the menstrual cycle.
If vomiting occurs within three hours of taking the tablet, another
tablet should be taken immediately.
After using an emergency contraception, it is recommended to use a
local contraceptive mean (condom, spermicide, cervical
cap) until the next menstrual periods resume. The use of NorLevo does
not contraindicate the continuation of regular
hormonal contraception.
_Paediatric population_
There is no relevant use of NorLevo for children of prepubertal age in
the indication emergency contraception.
Method of administration
Oral use.
4.3 CONTRAINDICATIONS
Hypersensitivityto the active substance or to any of the excipients
listed in