Angeliq 1mg/2mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DROSPIRENONE; ESTRADIOL

Available from:

Bayer PLC

ATC code:

G03FA17

INN (International Name):

DROSPIRENONE; ESTRADIOL

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DROSPIRENONE 2 mg; ESTRADIOL 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

Page 1 of 12
PACKAGE BOOKLET: INFORMATION FOR THE USER
ANGELIQ FILM-COATED TABLETS
Estradiol + Drospirenone
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this booklet. 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 booklet. See section 4.
WHAT IS IN THIS BOOKLET
1.
WHAT ANGELIQ IS AND WHAT IT IS USED FOR
....................................................................................
1
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGELIQ
.................................................................... 2
MEDICAL HISTORY AND REGULAR CHECK-UPS
........................................................................................
2
DO NOT TAKE ANGELIQ
........................................................................................................................
2
WARNINGS AND
PRECAUTIONS.............................................................................................................
3
HRT
AND
CANCER………………………………………………………………………………………………
….4
EFFECTS OF HRT ON YOUR HEART OR
CIRCULATION………………………………………………………………...5
OTHER CONDITIONS
.............................................................................................................................
6
OTHER MEDICINES AND ANGELIQ
........................................................................................................
7
LABORATORY
TESTS…………………..……………………………………………………………………………..
7
PREGNANCY AND BREAST-FEEDING
.................

Summary of Product characteristics

Page 1 of 18
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 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.
Page 2 of 18
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,
the
lowest
effective dose for the shortest du