Angeliq 1mg/2mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DROSPIRENONE, ESTRADIOL HEMIHYDRATE

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

G03FA17

INN (International Name):

DROSPIRENONE 2 mg ESTRADIOL HEMIHYDRATE 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DROSPIRENONE 2 mg ESTRADIOL HEMIHYDRATE 1 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Authorised

Authorization date:

2005-10-05

Patient Information leaflet

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 their last natural
period.

Summary of Product characteristics

1
BP23029_REC31756
SUMMARY OF PRODUCT CHARACTERISTICS
2
BP23029_REC31756
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 oestradiol (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
3
BP23029_REC31756
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, the lowest eff