CIRCLET 0.120/0.01 mg/24 hours Unknown
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-05-2024
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Active ingredient:
ETONOGESTREL ETHINYLESTRADIOL
Available from:
Merck Sharp & Dohme Ireland (Human Health) Limited
INN (International Name):
ETONOGESTREL ETHINYLESTRADIOL
Dosage:
0.120/0.01 mg/24 hours
Pharmaceutical form:
Unknown
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Circlet, 0.120 mg/0.015 mg per 24 hours, vaginal delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Circlet contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at
an average amount of 0.120 mg and 0.015 mg respectively per 24 hours, over a period of 3 weeks.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal delivery system.
Circlet is flexible, transparent, and colourless to almost colourless ring, with an outer diameter of 54 mm and a cross-
sectional diameter of 4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
Circlet is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to
40 years.
The decision to prescribe Circlet should take into consideration the individual woman’s current risk factors, particularly
those for venous thromboembolism (VTE), and how the risk of VTE with Circlet compares with other CHCs (see
sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, Circlet must be used as directed (see ‘How to use Circlet’ and ‘How to start
Circlet’).
_Paediatric population_
The safety and efficacy of Circlet in adolescents under the age of 18 have not been studied.
Method of administration
HOW TO USE CIRCLET
The woman herself can insert Circlet in the vagina. The physician should advise the woman how to insert and remove
Circlet. For insertion the woman should choose a position that is most comfortable for her, e.g. standing with one leg
up, squatting, or lying down. Circlet should be compressed and inserted into the vagina until it feels comfortable. The
exact position
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