Rosal 28, filmomhulde tabletten

Krajina: Holandsko

Jazyk: holandčina

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktívna zložka:

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Dostupné z:

Laboratorios Leon Farma, S.A. C/Roa de la Vega, 15, 1e 24008 LEON (SPANJE)

ATC kód:

G03AA12

INN (Medzinárodný Name):

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Forma lieku:

Filmomhulde tablet

Zloženie:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Drospirenone And Ethinylestradiol

Prehľad produktov:

Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Dátum Autorizácia:

2011-09-14

Príbalový leták

LF-DRSPEE-CC-NO.H.0202.001. IB.017-D0
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROSAL 28 FILMOMHULDE TABLETTEN
ETHINYLESTRADIOL/DROSPIRENONE
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 no 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.
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”)
WHAT IS IN THIS LEAFLET:
1.
What Rosal 28 is and what it is used for
2.
What you need to know before you take Rosal 28
3.
How to take Rosal 28
4.
Possible side effects
5.
How to store Rosal 28
6.
Contents of the pack and other information
LF-DRSPEE-CC-NO.H.0202.001. IB.017-D0
2
1.
WHAT ROSAL 28 IS AND WHAT IT IS USED FOR
•
Rosal 28 is a contraceptive pill and is used to prevent pregnancy.
•
Each of the 21 yellow tablets contains a small amount of two different
female hormones, namely
drospirenone and ethinylestradiol.
•
The 7 white tablets contain no active substances and are also called
placebo tablets.
•
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROSAL 28
GENERAL NOTES
Before you start using Rosal 28 you should read the information on
blood clots in section 2. It is
partic

Súhrn charakteristických

SPC-DRSPEE-NL-NO.H.0202.001.IA.021-D0_ _
1/21
SUMMARY OF PRODUCT CHARACTERISTICS
SPC-DRSPEE-NL-NO.H.0202.001.IA.021-D0_ _
2/21
1.
NAME OF THE MEDICINAL PRODUCT
Rosal 28 filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect: Each film-coated tablet contains 62 mg
lactose monohydrate
WHITE TABLETS (PLACEBO TABLETS):
The tablet does not contain active substances
Excipient with known effect: Each film-coated tablet contains 89.5 mg
lactose anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets
Placebo tablets: White, round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Rosal 28 should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Rosal
28 compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE ROSAL 28
The tablets must be taken every day at about the same time, if
necessary with a little liquid in the
order shown on the blister pack. Tablet taking is continuous. One
tablet is to be taken daily for 28
consecutive days. Each subsequent pack is started the day after the
last tablet of the previous pack.
Withdrawal bleeding usually starts on day 2-3 after starting the
placebo tablets (last row) and may
not have finished before the next pack is started.
HOW TO START ROSAL 28
•
No preceding hormonal contraceptive use (in the past month)
SPC-DRSPEE-NL-NO.H.0202.001.IA.021-D0_ _
3/21
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual
bleeding).
•
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal
ring or trans