Tansy 750 microgram tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

LEVONORGESTREL 0,75 mg/stuk

Beschikbaar vanaf:

Laboratorios Leon Farma, S.A. C/ La Vallina s/n. P.I Navatejera 24008 NAVATEJERA (LEON) (SPANJE)

ATC-code:

G03AD01

INN (Algemene Internationale Benaming):

LEVONORGESTREL 0,75 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levonorgestrel

Autorisatie datum:

2014-04-30

Bijsluiter

LF-Levo-NL-NL.H.2749.001.IB.012-Day 0
PACKAGE LEAFLET: INFORMATION FOR THE USER
_TANSY 750 MICROGRAM TABLETTEN _
Levonorgestrel
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, 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.
FOR OTC PRODUCTS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist
have told to you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor of pharmacist. This
include any possible
effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Tansy 750 microgram tabletten is and what it is used for
2. What you need to know before you take Tansy 750 microgram tabletten
3. How to take Tansy 750 microgram tabletten
4. Possible side effects
5. How to store Tansy 750 microgram tabletten
6. Content of the pack and other information
1. WHAT TANSY 750 MICROGRAM TABLETTEN IS AND WHAT IT IS SUED
Tansy 750 microgram tabletten is
an emergency contraceptive that can be used within 72 hours (3 days)
of unprotected sex or if your
usual method of contraception has failed.
When should emergency contraception be used?
•
No contraception was used during the sexual intercourse
•
The contraception measure was used incorrectly, for example as if a
condom was penetrated,
slipped away or used in a wrong way, if vaginal pessary or diaphragm
changed position,
burst, was broken or taken ou

Productkenmerken

1
SPC-Levo-NL-NL.H.2749.001.IB.012-Day 0
Page 1/8
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tansy 750 microgram tabletten.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 750 micrograms of levonorgestrel.
Excipient with known effect: 44 mg of lactose monohydrate
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Tansy 750 microgram tabletten tablet is round and white, with
approximate 6 mm of diameter and marked
“C” on one side and “2” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of a contraception
method.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Two tablets should be taken together as soon as possible, preferably
within 12 hours and no later than 72
hours after unprotected intercourse (see section 5.1).
If vomiting occurs within three hours of taking the tablets, another
two tablets should be taken immediately.
Women who have used enzyme-inducing drugs during the last 4 weeks and
need emergency contraception
are recommended to use a non-hormonal EC(emergency contraception),
i.e. Cu-IUD or take a double dose of
levonorgestrel (i.e. 4 tablets taken together) for those women unable
or unwilling to use Cu-IUD (see section
4.5).
Tansy 750 microgram tabletten can be used at any time during the
menstrual cycle unless menstrual bleeding
is overdue.
After using emergency contraception, it is recommended to use a local
barrier method (e.g. condom,
diaphragm, spermicide, cervical cap) until the next menstrual period
starts. The use of Tansy 750 microgram
tabletten does not contraindicate the continuation of regular hormonal
contraception.
2
SPC-Levo-NL-NL.H.2749.001.IB.012-Day 0
Page 2/8
_ _
_ _
_Paediatric population _
_ _
There is no relevant use of Tansy 750 microgram tabletten for children
of prepubertal age in the indication
emergency contraception.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
H