DIANETTE 2mg/35 Microgram Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CYPROTERONE ACETATE, ETHINYLESTRADIOL

Available from:

IMED Healthcare Ltd.

ATC code:

G03HB01

INN (International Name):

CYPROTERONE ACETATE, ETHINYLESTRADIOL

Dosage:

2mg/35 Microgram

Pharmaceutical form:

Coated Tablets

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiandrogens and estrogens

Authorization status:

Authorised

Authorization date:

2011-09-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANETTE® 2MG/35MICROGRAM COATED TABLETS
_CYPROTERONE ACETATE / ETHINYLESTRADIOL _
▲
_This medicine is subject to additional monitoring. This will allow
quick identification of new safety _
_information. You can help by reporting any side effects you may get.
See the end of section 4 for how to _
_report side effects. _
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 take 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 ta

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Dianette 2 mg/35 microgram coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0 mg cyproterone acetate and 0.035 mg
ethinylestradiol.
Excipients: contains lactose and sucrose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated Tablet (Tablet)
_Product imported from the UK:_
Beige, sugar-coated, biconvex tablets.
4 CLINICAL PARTICULARS
As per PA1410/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core
Lactose
Maize starch
Povidone
Talc
Magnesium stearate (E572)
Tablet Coating
Sucrose
Povidone
Polyethylene glycol 6000
Calcium carbonate (E170)
Talc
Titanium dioxide (E171)
Glycerol (E422)
Montan glycol wax
Yellow ferric oxide pigment (E172)
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6.2 INCOMPATIBILITIES
Not applicable.
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