Noriday 350 micrograms tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Norethisterone

Доступно од:

PCO Manufacturing Ltd.

АТЦ код:

G03AC; G03AC01

INN (Међународно име):

Norethisterone

Дозирање:

350 microgram(s)

Фармацеутски облик:

Tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Progestogens; norethisterone

Статус ауторизације:

Authorised

Датум одобрења:

2013-08-02

Информативни летак

_ _
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_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORIDAY
® 350 MICROGRAMS TABLETS
norethisterone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Noriday is and what it is used for
2.
What you need to know before you take Noriday
3.
How to take Noriday
4.
Possible side effects
5.
How to store Noriday
6.
Contents of the pack and other information
1.
WHAT NORIDAY IS AND WHAT IT IS USED FOR
Noriday is a progestogen-only contraceptive pill, or ‘POP’ for
short.
Noriday contains the active substance norethisterone.
Noriday helps to prevent you becoming pregnant. It does this in
several ways.

It thickens the fluid at the entrance to your womb and this makes it
hard for
sperm to travel through and enter the womb

It also changes the lining of your womb so that a fertilised egg
cannot grow
there

By changing the lining of the fallopian tubes (allows transport of
egg(s) to the
womb), transport of the egg to the womb could be slowed
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORIDAY
DO NOT TAKE NORIDAY

If you are allergic to the active substance, norethisterone, or any of
the other
ingredients of this medicine (listed in section 6).

If you have had blood clots in the legs, blood clots in veins, the
lungs, the
brain or elsewhere, or conditions which would make you more
susceptible to
them e.g. (abnormal heart rhythm (atrial fibrillation), heart and
brain clot
disorders).

If you have had a heart attack or stroke, or have or have had angina
or a
disease of yo

Карактеристике производа

Health Products Regulatory Authority
04 November 2019
CRN00976P
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Noriday 350 micrograms tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 350 micrograms norethisterone.
Excipient(s) with known effect:
contains lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK_
White, round, flat tablets with bevelled edges, inscribed “SEARLE”
on one side and “NY” on the other.
4 CLINICAL PARTICULARS
As per PA0822/131/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 0822/131/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Maize starch
Povidone
Magnesium stearate
Lactose monohydrate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package in order to
protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Nature and contents of container
Noriday tablets are supplied in PVC/foil blister packs of 28 tablets.
Health Products Regulatory Authority
04 November 2019
CRN00976P
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/310/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 2
nd
August 2013
Last updated: Janurary 2017
10 DATE OF REVISION OF THE TEXT
November 2019