Drospirenone Exeltis 4 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

drospirenon

Tillgänglig från:

Exeltis Healthcare, S.L.

ATC-kod:

G03AC10

INN (International namn):

drospirenone

Dos:

4 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

laktosmonohydrat Hjälpämne; drospirenon 4 mg Aktiv substans; laktos (vattenfri) Hjälpämne

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning); Blister, 13 x 28 tabletter (kalenderförpackning)

Bemyndigande status:

Godkänd

Tillstånd datum:

2019-11-18

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Drospirenone Exeltis 4 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
White active film-coated tablets:
Each tablet contains 4 mg of drospirenone.
Green placebo film-coated tablets:
The tablet does not contain active substances.
Excipient with known effect:
Each white active film-coated tablet contains 17.5 mg of lactose.
Each green placebo film-coated tablet contains 52.7 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The active tablet is a round, white tablet with the letters “E”
and “D” debossed on opposite sides, with a
diameter of 5 mm.
The placebo tablet is a round, green tablet with the letter “E”
and the number “4” debossed on opposite sides,
with a diameter of 5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE
One tablet is to be taken daily for 28 consecutive days, one white
active tablet daily during the first 24 days
and one green inactive tablet daily during the 4 following days.
Tablets must be taken every day at about the
same time of the day so that the interval between two tablets is
always 24 hours. Tablets should be taken in
the order shown on the blister. Stickers marked with the 7 days of the
week are provided. The woman should
choose the sticker that starts with the day she begins taking the
tablets and stick it on the blister.
The first tablet of the treatment should be taken on the first day of
menstrual bleeding. Thereafter tablet
taking is continuous. A subsequent pack is started immediately after
finishing the previous pack, without a
break in daily tablet intake.
3
HOW TO START
_No preceding hormonal contraceptive use (in the past month)_
Tablet-taking has to start on day 1 of the woman’s natural cycle
(first day of her menstrual bleeding). When
doing so, no additional contracep