Teragezza 2000/35microgram film-coated tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

cyproterone acetate, ethinylestradiol

Available from:

Morningside Healthcare Ltd

ATC code:

G03HB01

INN (International Name):

cyproterone acetate, ethinylestradiol

Dosage:

2000/35microgram

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Packs of 21, 63 and 126 Tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Morningside Pharmaceutical Ltd

Therapeutic group:

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, co-cyprindiol should only be used after topical therapy or systemic antibiotic treatments have failed.

Authorization status:

Authorised

Authorization date:

2015-03-03

Patient Information leaflet

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DOCUMENT OUTLINE * Page 1

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Teragezza 2000/35 microgram film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains: 

Actives: 
Cyproterone acetate  2.00 mg 
Ethinylestradiol 35 
micrograms 

Excipients:  
Lactose monohydrate  57.44mg 

For full list of excipients, see section 6.1 

3 PHARMACEUTICAL 
FORM 
Film-coated tablets. 

4 CLINICAL 
PARTICULARS 

4.1 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, co-cyprindiol should only be used
after topical therapy or 
systemic antibiotic treatments have failed. 

Since co-cyprindiol is also a hormonal contraceptive, it should
not be used in 
combination with other hormonal contraceptives (see section 4.3).  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Co-cyprindiol inhibits ovulation and thereby prevents conception.
Patients who are 
using co-cyprindiol should not therefore use an additional
hormonal contraceptive, as 
this will expose the patient to an excessive dose of hormones and
is not necessary for 
effective contraception.  

_First treatment course:_  One tablet daily for 21 days,
starting on the first day of the 
menstrual cycle (the first day of menstruation counting as
Day 1). 

_Subsequent courses:_  Each subsequent course is started
after 7 tablet-free days have 
followed the preceding course. 

When the contraceptive action of co-cyprindiol is also to
be employed, it is essential 
that the above instructions be rigidly adhered to.  Should
bleeding fail to occur during 
the tablet-free interval, the possibility of pregnancy must
be excluded before the next 
pack is started. 

When changing from an oral contraceptive and relying on
the con