Dianette 2 mg/35 microgram coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyproterone acetate; Ethinylestradiol

Available from:

Lexon Pharmaceuticals (Ireland) Limited

ATC code:

G03HB01

INN (International Name):

Cyproterone acetate; Ethinylestradiol

Dosage:

2 mg/35 microgram(s)

Pharmaceutical form:

Coated tablet

Therapeutic area:

cyproterone and estrogen

Authorization date:

2020-08-14

Patient Information leaflet

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
Blood clots (thrombosis)
Dianette and cancer
Meningioma
Psychiatric disorders
Bleeding between periods
What to do if no bleeding occurs during the gap week
Other medicines and Dianette
Dianette with food and drink
Laboratory tests
Pregnancy and 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 Dianett
Possible side effects
How to store Dianette
Contents of the pack and other information
WHAT DIANETTE IS AND WHAT IT IS USED FOR
•
Dianette contains ethinylestradiol, an estrogen, and cyproterone
acetate,
an antiandrogen.
•
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
‘Blood
clots (thrombosis)’ 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 eve

Summary of Product characteristics

Health Products Regulatory Authority
16 March 2022
CRN00CV8V
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
16 March 2022
CRN00CV8V
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 Pharmaceuticals (Ireland) Limited
Block 3
Harcourt Centre
Harcourt Road
Dublin 2
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23176/033/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 14
th
August 2020
10 DATE OF REVISION OF THE TEXT
October 2021