Dianette 2 mg/35 microgram coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cyproterone acetate; Ethinylestradiol

Available from:

PCO Manufacturing Ltd.

ATC code:

G03HB; G03HB01

INN (International Name):

Cyproterone acetate; Ethinylestradiol

Dosage:

2 mg/35 microgram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiandrogens and estrogens; cyproterone and estrogen

Authorization status:

Authorised

Authorization date:

1998-10-16

Summary of Product characteristics

Health Products Regulatory Authority
09 January 2024
CRN00F17L
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: contains lactose and sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (tablet).
_ _
_Product imported from Romania_
Round, beige, sugar-coated 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
Product imported from UK:
Lactose
Maize starch
Povidone
Talc
Magnesium stearate (E572)
Sucrose
Macrogol 6000
Calcium carbonate (E170)
Titanium dioxide (E171)
Glycerol (E422)
Montan glycol wax
Yellow ferric oxide pigment (E172)
Product imported from Romania:
Lactose monohydrate
Maize starch
Povidone 25000
Magnesium stearate
Sucrose
Povidone 700000
Macrogol 6000
Calcium carbonate
Talc
Glycerol 85%
Health Products Regulatory Authority
09 January 2024
CRN00F17L
Page 2 of 2
Titanium dioxide (E171)
Yellow ferric oxide pigment (E172)
Montan glycol wax
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for 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
Do not store above 25 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Dianette tablets come in calendar blister packs of 21 and 63 (3x21)
tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/050/001
9 DATE OF FIRST AUTHORISATIO