Prevenelle 1500 microgram Tablet

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Levonorgestrel

Mevcut itibaren:

Imbat Limited

ATC kodu:

G03AD; G03AD01

INN (International Adı):

Levonorgestrel

Doz:

1500 microgram(s)

Farmasötik formu:

Tablet

Uygulama yolu:

Oral use

Paketteki üniteler:

Pack size: 1 Tablet

Reçete türü:

Product not subject to medical prescription

Tarafından üretildi:

Gedeon Richter Ltd

Terapötik grubu:

Emergency contraceptives

Terapötik alanı:

Emergency contraceptives; levonorgestrel

Terapötik endikasyonlar:

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-08-13

Bilgilendirme broşürü

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREVENELLE
® 1500 MICROGRAM TABLET
(levonorgestrel)
Your medicine is available using the above name but will be
referred to as Prevenelle 1500 throughout the leaflet.
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 Prevenelle 1500 is and what it is used for
2.
What you need to know before you take Prevenelle 1500
3.
How to take Prevenelle 1500
4.
Possible side effects
5.
How to store Prevenelle 1500
6.
Contents of the pack and other information
1.
WHAT PREVENELLE 1500 IS AND WHAT IT IS
USED FOR
Prevenelle 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).
Prevenelle 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.
Prevenelle 1500 is

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prevenelle 1500 microgram Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1500 micrograms of levonorgestrel.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from France_
Almost white, flat, rimmed tablet of about 8 mm diameter with an
impressed mark of “G00” on one side.
4 CLINICAL PARTICULARS
As per PA1330/021/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1330/021/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Potato starch
Corn starch
Silica colloidal anhydrous
Magnesium stearate
Talc
Lactose monohydrate
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 marked in
the country of origin
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light.
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6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer carton containing blister.
Pack size: 1 Tablet
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 AUTHORISATI