Dianette 2 mg/35 microgram coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

CYPROTERONE ACETATE; Ethinylestradiol

Verfügbar ab:

Lexon (UK) Ltd

ATC-Code:

G03HB01

INN (Internationale Bezeichnung):

CYPROTERONE ACETATE; Ethinylestradiol

Dosierung:

2 mg/35 microgram(s)

Darreichungsform:

Coated tablet

Therapiebereich:

cyproterone and estrogen

Berechtigungsdatum:

2020-08-14

Gebrauchsinformation

IN THIS LEAFLET:
What Dianette is and what it is used for
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
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 USE 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)
•
if you have a disturbance of blood clotting (for example, antithrombin
III
deficiency, protein C deficiency, protein S deficiency, Activated
Protein C
(APC) resistance (e.g. Factor V Leiden), hyperhomocysteinaemia, and
antiphospholipid antibodies)
•
if you have (or have ever had) a certain form of migraine (with
so-called
focal neurological symptoms)
•
if you have diabetes with damaged blood vessels
•
if you have (or have ever had) a liver disease and your liver function
is still
not normal
•
if your kidneys are not working we

Fachinformation

Health Products Regulatory Authority
10 December 2020
CRN00C21W
Page 1 of 2
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 2.0 mg cyproterone acetate and 0.035 mg
ethinylestradiol.
Excipients: contains lactose (as monohydrate) and sucrose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet (tablet).
_ _
_Product imported from Romania_
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 monohydrate
Maize starch
Povidone K25
Magnesium stearate
Talc
TABLET COATING
Sucrose
Povidone K90
Macrogol 6000
Calcium carbonate
Talc
Glycerol 85%
Titanium dioxide (E 171)
Iron oxide yellow (E 172)
Montanglycol wax
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
10 December 2020
CRN00C21W
Page 2 of 2
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 in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Dianette tablets are contained in blister packs consisting of the
following standard pharmaceutical packaging material: Deep
drawn strips made of polyvinyl chloride film with counter-sealing foil
made of aluminium with heat sealable coating.
_Presentation:_
Calendar-pack containing 21 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/075/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
August 2020
10 DATE OF REVISION OF THE TEXT
December 2020