Dianette 2 mg/35 microgram coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CYPROTERONE ACETATE; Ethinylestradiol

Available from:

Imbat Limited

ATC code:

G03HB; G03HB01

INN (International Name):

CYPROTERONE ACETATE; Ethinylestradiol

Dosage:

2/35 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiandrogens and estrogens; cyproterone and estrogen

Authorization status:

Authorised

Authorization date:

2012-07-13

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANETTE
® 2MG/35 MICROGRAM COATED TABLETS
(cyproterone acetate/ethinylestradiol)
Your medicine is available using the above name but will be
referred to as Dianette throughout this leaflet.
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.
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 use Dianette
Warnings and precautions
Dianette and venous and arterial blood clots
Dianette and cancer
Bleeding between periods
What to do if no bleeding occurs during the gap week
Other medicines and Dianette
Taking Dianette with food and drink
Laboratory tests
Pregnancy
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
1.
WHAT DIANETTE IS AND WHAT IT IS USED FOR

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,
including topical treatments

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dianette 2 mg/35 microgram coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0mg cyproterone acetate and 0.035mg
ethinylestradiol.
Excipients with known effect: lactose and sucrose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated Tablet
_Product imported from the UK:_
Beige, sugar-coated, biconvex tablets.
4 CLINICAL PARTICULARS
As per PA 1410/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 1410/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose
Maize starch
Povidone
Talc
Magnesium stearate (E572)
Sucrose
Polyethylene glycol 6000
Calcium carbonate (E170)
Titanium dioxide (E171)
Glycerol (E422)
Montan glycol wax
Yellow ferric oxide pigment (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in
the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 21 tablets in an outer cardboard carton.
Pack sizes: 63 tablets and 21 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OT