Raener 2 mg/0.03 mg film-coated tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Dienogest micronized; Ethinylestradiol micronized

Beszerezhető a:

Laboratorios Leon Farma, S.A.

ATC-kód:

G03FA; G03FA15

INN (nemzetközi neve):

Dienogest micronized; Ethinylestradiol micronized

Adagolás:

2 mg/0.03 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Progestogens and estrogens, fixed combinations; dienogest and estrogen

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2018-08-10

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
RAENER 2MG/0.03 MG FILM-COATED TABLETS
ethinylestradiol and dienogest
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in
the first year or when restarting a combined hormonal contraceptive
following a break of 4
or more weeks
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot
(see section 2 “Blood clots”)
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,.
- 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 Raener 2mg/0.03 mg is and what it is used for
2. What you need to know before you take Raener 2mg/0.03 mg
3. How to take Raener 2mg/0.03 mg
4. Possible side effects
5. How to store Raener 2mg/0.03 mg
6. Contents of the pack and other information
1. WHAT RAENER 2MG/0.03 MG IS AND WHAT IT IS USED FOR
Raener 2mg/0.03 mg is s a medicinal product used to
- prevent pregnancy (contraceptive “pill”).
- treatment of women with moderately severe acne, who agree to receive
a contraceptive pill after
failure of suitable local or oral antibiotic treatments.
It contains a small amount of female hormones progesterone namely
(dienogest) and an estrogen
(ethinylestradiol).Raener 2mg/0.03 mg
Contraceptive pills that contain two hormones are called
“combination” pills or combined oral
contraceptives.
Oral (orally administered) contraceptive pills are a very effective
method of family planning. If
taken regularly (wit

Termékjellemzők

Health Products Regulatory Authority
21 November 2022
CRN00D62K
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Raener 2 mg/0.03 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Ethinylestradiol, Dienogest
1 coated tablet contains:
Ethinylestradiol 0.03 mg
Dienogest 2.0 mg
Excipients with known effect:
Lactose monohydrate (60.90 mg)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablets. Approx. 5.0 mm of diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Oral contraception.
- Treatment of moderate acne after failure of suitable topical
therapies or oral antibiotic treatment in women who elect to use
an oral contraceptive.
The decision to prescribe Raener 2 mg/0.03 mg Film-coated tablet
should take into consideration the individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk of VTE with Raener 2 mg/0.03 mg
Film-coated tablet compares with other CHCs (see sections 4.3 and
4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
With proper use of combined oral contraceptives, their failure is
about 1% per year. If the tablet is missed or is taken
incorrectly, the frequency of failure may increase.
HOW TO TAKE RAENER 2MG/0.03 MG
Film-coated tablets are taken daily at the same time (if necessary
with some fluid), according to the sequence printed on the
blister pack. One film-coated tablet a day is taken for 21 consequent
days. Each subsequent pack is started after 7 tablet-free
days; usually a break-through bleeding occurs in this period.
Typically, it starts 2-3 days after the last pill and may still be
present when the first film-coated tablet from the next blister pack
is taken.
Apparent improvement of acne usually takes at least three months and
further improvement has been reported after six
months of treatment. Women should be assessed 3-6 months after
treatment initiation and periodically thereafter to rev