NorLevo 1.5 mg tablet

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Levonorgestrel

Предлага се от:

Imbat Limited

АТС код:

G03AC; G03AC03

INN (Международно Name):

Levonorgestrel

дозиране:

1.5 milligram(s)

Лекарствена форма:

Tablet

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Progestogens; levonorgestrel

Статус Оторизация:

Authorised

Дата Оторизация:

2012-03-02

Листовка

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORLEVO
® 1.5MG TABLET
levonorgestrel
Your medicine is available using the above name but will be
referred to as NorLevo throughout this leaflet.
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 is and what it is used for
2.
What you need to know before you use NorLevo
3.
How to use NorLevo
4.
Possible side effects
5.
How to store NorLevo
6.
Contents of the pack and other information
1.
WHAT NORLEVO 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 be pregnant for one of the
following reasons:

if you have had sexual intercourse without
contraception;

if

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NorLevo 1.5 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.5mg levonorgestrel.
Excipients: lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from Italy:_
White round biconvex tablet engraved with code NL 1.5 on one face.
4 CLINICAL PARTICULARS
As per PA1166/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1166/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Povidone
Colloidal anhydrous silica
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Keep the blister in the outer carton in order to protect from light.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister strip of 1 tablet in an over labelled carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2, North Ring Business Park
Santry
Dublin 9
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA 1151/177/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Dat