Leanova 0,15 mg/0,03 mg, omhulde tabletten

Valsts: Nīderlande

Valoda: holandiešu

Klimata pārmaiņas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktīvā sastāvdaļa:

ETHINYLESTRADIOL ; LEVONORGESTREL

Pieejams no:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATĶ kods:

G03AA07

SNN (starptautisko nepatentēto nosaukumu):

ETHINYL ESTRADIOL ; LEVONORGESTREL

Zāļu forma:

Omhulde tablet

Kompozīcija:

CALCIUMCARBONAAT (E 170) ; CARNAUBAWAS (E 903) ; GLYCEROL (E 422) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 90 (E 1201) ; SACCHAROSE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMCARBONAAT (E 170) ; CARNAUBAWAS (E 903) ; GLYCEROL (E 422) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON K 25 (E 1201) ; POVIDON K 90 (E 1201) ; SACCHAROSE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Ievadīšanas:

Oraal gebruik

Ārstniecības joma:

Levonorgestrel And Ethinylestradiol

Produktu pārskats:

Hulpstoffen: CALCIUMCARBONAAT (E 170); CARNAUBAWAS (E 903); GLYCEROL (E 422); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON K 25 (E 1201); POVIDON K 90 (E 1201); SACCHAROSE; TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorizācija datums:

2015-05-19

Lietošanas instrukcija

PL NL-EELevo3148 -- Var006 – PSUSA/00001309/201904
2020-04-08
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEANOVA 0,15 MG/0,03 MG, OMHULDE TABLETTEN
Levonorgestrel/Ethinylestradiol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Leanova is and what it is used for
2. What you need to know before you take Leanova
3. How to take Leanova
4. Possible side effects
5. How to store Leanova
6. Contents of the pack and other information
1. WHAT LEANOVA IS AND WHAT IT IS USED FOR

Leanova is a contraceptive pill and is used to prevent pregnancy.

Each
tablet
contains
a
small
amount
of
two
different
female
hormones,
namely
levonorgestrel and ethinylestradiol.

Contraceptive pills that contain two hormones are called
“combination” pills.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEANOVA
DO NOT TAKE LEANOVA

if you are allergic to levonorgestrel or ethinylestradiol or to any of
the ingredients of this
medicine (listed in section 6).

if you have (or have had in the past) a blood clot (thrombosis) in a
blood vessel of the leg,
lung (embolus) or other organs,

if you have (or have had in the past) a heart attack or stroke

if you have (or have had in the past) a disease that can be a
predictor of a heart attack (for
example, angina pectoris, which causes severe pain in the chest) or of
a stroke (for
example, a transient slight stroke with no residual effects).

if you have a disease that may increase the risk of a thrombosis in
the arteries or veins.
This applies to the following diseases:
o
Diabetes mellitus with damaged bloo

Produkta apraksts

SmPC Ethinylestradiol/Levonorgestrel NL3148 –Var006-
PSUSA/00001309/201904
2020-04-08
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Leanova 0,15 mg/0,03 mg, omhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 150 micrograms levonorgestrel and 30 micrograms
ethinylestradiol.
Excipients with known effects
1 coated tablet contains 52 mg of lactose monohydrate and 14 mg of
sucrose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet
White, circular, biconvex, coated tablets with a diameter of
approximately 5.6 mm and a
thickness of approximately 3.5 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO USE LEANOVA
Tablets must be taken orally in the order directed on the blister
package at about the same
time every day, with some liquid if necessary. One tablet is to be
taken daily for 21 consecutive
days.
Each subsequent pack is started after a 7-day tablet free interval,
during which time a
withdrawal bleed usually occurs.
The bleeding usually starts within 2 to 3 days after the last tablet
and may not end before the
next pack is started.
HOW TO START THE USE OF LEANOVA

no preceding hormonal contraceptive use (in the past month),
tablet-taking is started on
day 1 of the woman’s natural cycle (i.e. the first day of her
menstrual bleeding). Starting on
days 2–5 is allowed but in that case an additional barrier method is
recommended for the first
7 days of the first cycle
_ _

Changing from another combined hormonal contraceptive (combined oral
contraceptive
(COC), vaginal ring, transdermal patch). The use of Leanova tablets is
preferably started on
the day after the last active tablet of the previous COC (or after
removal of the ring or patch),
but at the latest on the day following the usual tablet-free
(ring-free, patch-free) break or the
last placebo tablet of the previous hormonal contraceptive.
SmPC Ethinylestradiol/Levonor