ANGELIQ TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS DROSPIRENONE 2,0 mg OESTRADIOL HEMIHYDRATE EQUIVALENT TO OESTRADIOL 1,0 mg

Authorization status:

Registered

Authorization date:

2006-04-05

Patient Information leaflet

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM AND STRENGTH:
Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet
PRODUCT PROPRIETARY NAME:
ANGELIQ
CCDS11/0715/SA2/0922
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1
of
9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
ANGELIQ 1 MG/2 MG FILM-COATED TABLET
ESTRADIOL (AS ESTRADIOL HEMIHYDRATE)/DROSPIRENONE
CONTAINS SUGAR (LACTOSE MONOHYDRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ANGELIQ
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse, or other health care provider.
•
ANGELIQ has been prescribed for you personally and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What ANGELIQ is and what it is used for
2.
What you need to know before you take ANGELIQ
3.
How to take ANGELIQ
4.
Possible side effects
5.
How to store ANGELIQ
6.
Contents of the pack and other information
1.
WHAT ANGELIQ IS AND WHAT IT IS USED FOR
ANGELIQ is for hormone replacement therapy.
ANGELIQ provides hormone replacement therapy for the treatment of
climacteric complaints in
postmenopausal women, such as hot flushes and sweating attacks, sleep
disorders, depressed moods,
nervousness and signs of involution of the bladder and genital organs.
It is also used for treating
complaints that are due to greatly decreased activity of the sexual
organs (hypogonadism), following the
removal of the ovaries or when the ovaries do not work (primary
ovarian failure). ANGELIQ is suitable
for women who still have a womb (intact uterus).
Some women are more likely than others to develop osteoporosis in
later life depending on their medical
history and lifestyle. If it is appropriate you may be prescribed
ANGELIQ to prevent osteoporosis. Your
doctor will be able to advise you further.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGELIQ
Your doctor will carry out gynaecological, breast, blood pressure and
other examinations as appropriate.
If you are known to h

Summary of Product characteristics

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM AND STRENGTH:
Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet
PRODUCT PROPRIETARY NAME:
ANGELIQ
CCDS11/0715/SA2/0922
Page
1
of
14
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
ANGELIQ
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The pack contains 28 hormonal red film-coated tablets each with
estradiol 1,0 mg (as estradiol
hemihydrate 1,033 mg) and drospirenone 2,0 mg.
Contains sugar (48,2 mg lactose monohydrate per tablet).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Medium red, round film-coated tablets with convex faces, one side
marked with the letters DL in a
regular hexagon.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Hormone replacement therapy for the treatment of symptoms associated
with the climacteric syndrome
including vasomotor symptoms (such as hot flushes and sweating
attacks), and atrophic urogenital
conditions.
To reduce the risk of postmenopausal osteoporosis in women with an
intact uterus.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One tablet is taken daily. Each blister pack is for 28 days of
treatment.
_How to start ANGELIQ _
Women who do not take estrogens or women who change from a continuous
combination product may
start treatment at any time. Patients changing from a sequential
combined hormone replacement therapy
should start treatment at the end of the scheduled bleeding.
_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.
APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM AND STRENGTH:
Estradiol 1,0 mg plus drospirenone 2,0 mg per tablet
PRODUCT PROPRIETARY NAME:
ANGELIQ
CCDS11/0715/SA2/0922
Page
2
of
14
_Missed tablets _
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