Activelle 1 mg/0.5 mg film-coated tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Estradiol; Norethisterone acetate

Beszerezhető a:

PCO Manufacturing Ltd.

ATC-kód:

G03FA01

INN (nemzetközi neve):

Estradiol; Norethisterone acetate

Adagolás:

1 mg/0.5 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

norethisterone and estrogen

Engedélyezési státusz:

Authorised

Engedély dátuma:

2007-10-19

Betegtájékoztató

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACTIVELLE
®
1 MG/0.5 MG FILM-COATED TABLETS
estradiol/norethisterone acetate
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 or pharmacist.
–
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Activelle is and what it is used for
2.
What you need to know before you take Activelle
3.
How to take Activelle
4.
Possible side effects
5.
How to store Activelle
6.
Contents of the pack and other information
1.
WHAT ACTIVELLE IS AND WHAT IT IS USED FOR
Activelle is a continuous combined Hormone Replacement Therapy (HRT).
It contains two types of
female hormones, an oestrogen and a progestagen. Activelle is used in
postmenopausal women
with at least 1 year since their last natural period.
Activelle is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can
cause symptoms such as hot face, neck and chest (‘hot flushes’).
Activelle alleviates these
symptoms after menopause. You will only be prescribed Activelle if
your symptoms seriously hinder
your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should discuss all
available options with your doctor. If you are at an increased risk of
fractures due to osteoporosis and
other medicines are not suitable for you, you can use Activelle to
prevent osteoporosis after
menopause.
Activelle is prescribed for women who have not had their womb removed,
and whose periods
stopped more than a year ago.
There is only limited ex

Termékjellemzők

Health Products Regulatory Authority
23 October 2023
CRN00DV65
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Activelle 1 mg/0.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate
0.5 mg.
Excipient with known effect: lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_ _
_Product imported from Italy, Poland and Czech Republic:_
White, film-coated, round tablets with a diameter of 6 mm, engraved
with 'NOVO 288' on one side and the _Novo Nordisk _bull
logo on the other.
4 CLINICAL PARTICULARS
As per PA0218/052/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0218/052/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Lactose monohydrate
Maize starch
Copovidone
Talc
Magnesium stearate
Film-coating:
Hypromellose
Triacetin
Talc
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.
Health Products Regulatory Authority
23 October 2023
CRN00DV65
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not refrigerate. Keep the container in
the outer carton in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
1 x 28 tablets in a calendar dial pack.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/199/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19th October 2007
10 DATE OF REVISION OF THE TEXT
October 2023