Tyedra 1500 micrograms tablet

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Levonorgestrel micronized

MAH:

Laboratorios Leon Farma, S.A.

ATC_code:

G03AD; G03AD01

INN:

Levonorgestrel micronized

dosage:

1500 microgram(s)

pharmaceutical_form:

Tablet

prescription_type:

Product subject to prescription which may not be renewed (A)

therapeutic_area:

Emergency contraceptives; levonorgestrel

authorization_status:

Not marketed

authorization_date:

2013-11-29

PIL

LF-LEVO-CC- IE.H.1025.001.IB.006-D20
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
_TYEDRA 1500 MICROGRAM TABLET _
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. See section 4.
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 or pharmacist. This
include any
possible side effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Tyedra is and what it is used for
2.
What you need to know before you take Tyedra
3.
How to take Tyedra
4.
Possible side effects
5.
How to store Tyedra
6.
Content of the pack and other information
1.
WHAT TYEDRA IS AND WHAT IT IS USED FOR
Tyedra
is an emergency contraceptive that can
be
used
within 72
hours (3
days)
of
unprotected sex or if your usual
contraceptive
method has failed.
It is about the following cases:
•
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 out ahead of time, in the
case of a failed
interruption during coitus interruptus (e.g. sperm ejaculated in
vagina or on extern

SPC

Health Products Regulatory Authority
18 January 2023
CRN00D8YX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tyedra 1500 micrograms tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1500 micrograms of levonorgestrel.
Excipient with known effect: 43.3 mg of lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Tyedra tablet is round and white, with approximate 6 mm of diameter
and marked “C” on one side and “1” 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
One tablet should be taken 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 tablet, another
tablet 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. 2 tablets taken
together) for those women unable or unwilling to use Cu-IUD (see
section 4.5).
Tyedra 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
Tyedra does not contraindicate the continuation of regular
hormonal contraception.
_ _
_Paediatric population_
_ _
There is no relevant use of Tyedra for children of prepubertal age in
the indication emergency contraception.Tyedra Tyedra
_Method of administration_
For oral administration
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FO