Dianette 2 mg/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:

G03HB; G03HB01

INN (International Name):

Cyproterone acetate; Ethinylestradiol

Dosage:

2/35 mg/microgram

Pharmaceutical form:

Coated tablet

Therapeutic area:

Antiandrogens and estrogens; cyproterone and estrogen

Authorization date:

2021-06-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANETTE
® 2 MG/35 MICROGRAMS COATED TABLETS
cyproterone acetate/ethinylestradiol
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. See
section 4.
WHAT IS 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
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
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 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
tre

Summary of Product characteristics

Health Products Regulatory Authority
21 June 2021
CRN00C6N0
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 with known effect
Each tablet contains lactose monohydrate and sucrose.
For the 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 25 000
Magnesium stearate
Talc
TABLET COATING
Sucrose
Povidone 700 000
Polyethylene glycol 6000
Calcium carbonate
Talc
Glycerol 85%
Titanium dioxide (E 171)
Ferric oxide pigment yellow (E 172)
Montanglycol wax
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
21 June 2021
CRN00C6N0
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container 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 AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/164/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 18
th
June 2021
10 DATE OF REVISION OF THE TEXT