Dianette 2mg/35 microgram coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cyproterone acetate; Ethinylestradiol ph.eur.

Boleh didapati daripada:

Bayer Limited

Kod ATC:

G03HB; G03HB01

INN (Nama Antarabangsa):

Cyproterone acetate; Ethinylestradiol ph.eur.

Dos:

2/35 milligram(s)

Borang farmaseutikal:

Coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Antiandrogens and estrogens; cyproterone and estrogen

Status kebenaran:

Marketed

Tarikh kebenaran:

1988-11-18

Risalah maklumat

BP22046_REC30885
1
INTERNAL
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANETTE
®
2MG/35 MICROGRAM COATED TABLETS
cyproterone acetate/ethinylestradiol
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 Dianette is and what it is used for
2. What you need to know before you take Dianette
Do not take Dianette
Warnings and precautions
Blood clots (thrombosis)
Dianette and cancer
Meningioma
Psychiatric disorders
Bleeding between periods
What to do if no bleeding occurs during the gap week
Other medicines and Dianette
Dianette with food and drink
Laboratory tests
Pregnancy and breast-feeding
Driving and using machines
Dianette contains lactose and sucrose
3. How to take Dianette
When can you start with the first strip?
If you take more Dianette than you should
If you forget to take Dianette
What to do in the case of vomiting or severe diarrhoea
If you stop taking Dianette
4. Possible side effects
5. How to store Dianette
6. Contents of the pack and other information
BP22046_REC30885
2
INTERNAL
1.
WHAT DIANETTE IS AND WHAT IT IS USED FOR
•
Dianette contains ethinylestradiol, an estrogen, and cyproterone
acetate, an anti-
androgen.
•
Dianette is used to treat skin conditions such as acne, very oily skin
and excessive hair
growth in women of reproductive age. Due to its contraceptive
properties it should only
be prescribed for you if your doctor considers that treatment with a
hormonal
contraceptive is appropriate.
•
You should only take Dianette if your skin condition has not improved

Ciri produk

Health Products Regulatory Authority
21 November 2022
CRN00D75R
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dianette 2mg/35 microgram coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0 mg cyproterone acetate and 0.035 mg
ethinylestradiol.
Excipients with known effect
Each tablet contains 31 mg lactose monohydrate and 19 mg sucrose.
Please see section 4.4 for further information.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (tablet).
Beige, sugar-coated, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe acne related to androgen-sensitivity
(with or without seborrhoea) and/or hirsutism, in women
of reproductive age.
For the treatment of acne, Dianette should only be used after topical
therapy or systemic antibiotic treatments have failed.
Since Dianette is also a hormonal contraceptive, it should not be used
in combination with other hormonal contraceptives (see
section 4.3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE DIANETTE
Dianette is to be taken regularly in order to achieve the therapeutic
efficacy and the required contraceptive protection.
Combined oral contraceptives when taken correctly have a failure rate
of approximately 1 % per year.
Tablets must be taken in the order directed on the package every day
at about the same time with some liquid as needed. One
tablet is to be taken daily for 21 consecutive days. Each subsequent
pack is started after a 7-day tablet-free interval, during
which time a withdrawal bleed usually occurs. This usually starts on
day 2 - 3 after the last tablet and may not have finished
before the next pack is started.
HOW TO START DIANETTE

_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e.
the first day of her menstrual bleeding). Starting on days 2
- 5 is allowed, but during the first cycle a barrier method is
recommende