DIANETTE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-01-2017
Summary of Product characteristics
(SPC)
11-04-2015
Active ingredient:
CYPROTERONE ACETATE ; ETHINYLESTRADIOL
Available from:
LTT Pharma Limited
ATC code:
G03HB01
INN (International Name):
CYPROTERONE ACETATE ; ETHINYLESTRADIOL
Dosage:
2/35 mg/mcg
Pharmaceutical form:
Coated Tablets
Administration route:
Oral use
Units in package:
blister strips of 21 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Bayer Pharma AG
Therapeutic group:
Antiandrogens and estrogens
Therapeutic area:
cyproterone and estrogen
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.
Authorization status:
Authorised
Authorization date:
2015-03-27
Patient Information leaflet
_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._
IN THIS LEAFLET:
What Dianette is and what it is used for
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
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
Possible side effects
How to store Dianette
Contents of the pack and other information
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 and
antibiotics.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANETTE
DO NOT TAKE DIANETTE:
•
if you have a severe or multiple risk factor(s) for blood clots (see
‘Dianette
and blood clots’ and consult your doctor who will decide whether you
may
use Dianette)
_GENERAL NOTES_
Before you can begin taking Dianette, your doctor will ask you some
questions about your personal health history and that of your close
relatives. The doctor will also measure your blood pressure, and
depending
upon your personal situation, may also carry out some other tests.
In this leafl
Read the complete document
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 of the package
leaflet for how to report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Dianette 2mg/35 microgram coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.0mg cyproterone acetate and 0.035mg
ethinylestradiol.
Excipients with known effect: contains lactose and sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (tablet).
_Product imported from Poland:_
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
TABLET CORE:
Lactose monohydrate
Maize starch
Povidone 25 000
Talc
Magnesium stearate (E572)
FILM COATING:
Sucrose
Povidone 700 000
Macrogol 6000
Calcium carbonate (E170)
Talc
Glycerol 85%
Titanium dioxide (E171)
Iron oxide yellow (E172)
Montan glycol wax
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market i
Read the complete document
