Dianette tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyproterone acetate; Ethinylestradiol

Available from:

Bayer Plc

ATC code:

G03HB01

INN (International Name):

Cyproterone acetate; Ethinylestradiol

Dosage:

2mg ; 35microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13060200; GTIN: 5016703001621

Patient Information leaflet

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1
DIANETTE PATIENT INFORMATION LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANETTE
®
cyproterone acetate/ethinylestradiol.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any questions or need more advice, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them.

IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. WHAT DIANETTE IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANETTE
2.1 BEFORE YOU TAKE DIANETTE
When should you contact your doctor
Dianette and cancer
2.2 MAKE SURE DIANETTE IS OK FOR YOU
Dianette should not be taken by some women
Dianette can make some illnesses worse
Taking other medicines
Taking Dianette with food and drink
Pregnancy and breast-feeding
Driving and using machines
Dianette contains lactose
Dianette and sun-beds or sun-lamps
3. TAKING DIANETTE
Duration of use
How to take it
Starting Dianette
A missed pill
A lost pill
If you are sick or have diarrhoea
Missed a period – could you be pregnant?
Taking more than one pill should not cause harm
When you want to get pregnant
4. POSSIBLE SIDE EFFECTS
4.1 Serious side effects – see a doctor straight away
4.2 Less serious side effects
4.3 Bleeding between periods should not last long
5. HOW TO STORE DIANETTE
6. WHAT IS IN DIANETTE AND WHO MAKES IT
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2
1. WHAT DIANETTE IS AND WHAT IT IS USED FOR
Dianette contains an oestrogen and 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
after use of other
anti-acne treatments, includ

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dianette ®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Cyproterone acetate
2.00 mg
Ethinylestradiol
35 micrograms
Excipients:
Lactose monohydrate
30.965 mg
Sucrose
19.371 mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sugar-coated tablets.
Beige, round tablet, with convex faces.
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
_METHOD OF ADMINISTRATION _
Oral use
_DOSAGE REGIMEN _
_ _
Dianette inhibits ovulation and thereby prevents conception. Patients
who are using
Dianette should not therefore use an additional hormonal
contraceptive, as this will
expose the patient to an excessive dose of hormones and is not
necessary for effective
contraception.
_First treatment course:_ One tablet daily for 21 days, starting on
the first day of the
menstrual cycle (the first day of menstruation counting as Day 1).
_Subsequent courses:_ Each subsequent course is started after 7
tablet-free days have
followed the preceding course.
When the contraceptive action of Dianette is also to be employed, it
is essential that
the above instructions be rigidly adhered to. Should bleeding fail to
occur during the
tablet-free interval, the possibility of pregnancy must be excluded
before the next
pack is started.
When changing from an oral contraceptive and relying on the
contraceptive action of
Dianette, follow the instructions given below:
_Changing from 21-day combined oral contraceptives: _The first tablet
of Dianette
should be taken on the first day immediately after t