Angeliq 1 mg/2 mg film-coated tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Estradiol; Drospirenone

Dostępny od:

Bayer Limited

Kod ATC:

G03FA; G03FA17

INN (International Nazwa):

Estradiol; Drospirenone

Dawkowanie:

1 mg/2 milligram(s)

Forma farmaceutyczna:

Film-coated tablet

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Progestogens and estrogens, fixed combinations; drospirenone and estrogen

Status autoryzacji:

Marketed

Data autoryzacji:

2004-03-05

Ulotka dla pacjenta

BP23029_REC31756
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANGELIQ 1 MG / 2 MG FILM-COATED TABLETS
Oestradiol / Drospirenone
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
:
For the
LEAFLET
version of the Angeliq package insert the table of content contains
only the major headings 1 to 6:
1.
What Angeliq is and what it is used for
.....................................................................................................................
1
2.
What you need to know before you take Angeliq
......................................................................................................
2
3.
How to take Angeliq
..................................................................................................................................................
7
4.
Possible side effects
...................................................................................................................................................
7
5.
How to store Angeliq
.................................................................................................................................................
9
6.
Contents of the pack and other information
.............................................................................................................
10
1.
WHAT ANGELIQ IS AND WHAT IT IS USED FOR
Angeliq is a Hormone Replacement Therapy (HRT). It contains two types
of female hormone, an oestrogen
and a progestogen. Angeliq is used in postmenopausal women with at
least 1 year since t

Charakterystyka produktu

Health Products Regulatory Authority
06 March 2024
CRN00DXT7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Angeliq 1 mg/2 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: 1 mg estradiol (as oestradiol
hemihydrate) and 2 mg drospirenone
Excipient with known effect: 46 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Medium red, round tablet with convex faces, one side embossed with the
letters DL in a regular hexagon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy for oestrogen deficiency symptoms in
postmenopausal women more than 1 year post
menopause.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of, or contraindicated
for, other medicinal products approved for the prevention of
osteoporosis.
_(See also Section 4.4)_
The experience treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Women who do not take hormone replacement therapy (HRT) or women who
change from another continuous combined
product may start treatment at any time. Women changing from a cyclic,
sequential combined HRT regimen, treatment should
begin the day following completion of the prior regimen.
Posology
One tablet is taken daily. Each blister is for 28 days of treatment.
Method of administration
The tablets are to be swallowed whole with some liquid irrespective of
food intake. Treatment is continuous, which means that
the next pack follows immediately without a break. The tablets should
preferably be taken at the same time every day. If a
tablet is forgotten it should be taken as soon as possible. If more
than 24 hours have elapsed no extra tablet needs to be taken.
If several tablets are forgotten, vaginal bleeding may occur.
For treatment of post menopausal symptoms, the lowest effective dose
should be used.
For initiation and continuation of treatment of postmenopausal
symptoms,