Ramonna 1500 microgram Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Levonorgestrel

Commercializzato da:

Gedeon Richter Plc

Codice ATC:

G03AD; G03AD01

INN (Nome Internazionale):

Levonorgestrel

Dosaggio:

1500 microgram(s)

Forma farmaceutica:

Tablet

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Emergency contraceptives; levonorgestrel

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2006-02-03

Foglio illustrativo

UTAS-3
PIL_140x200_140x400
HORVÁTH Győző
2017.05.17.
140 × 400/140 × 200 mm
/Page1
RAMONNA
IE
PÁLMAI Dorottya
2020.01.22.
K-22595-1.5
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v_01
Mucius Scaevola Kft.
Proc. Black
Futura AOT (8 pt [8,4 pt])
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WHAT IS IN THIS LEAFLET
1. What Ramonna 1500 microgram tablet
(hereinafter Ramonna 1500) is and what it is used for
2. What you need to know before you take
Ramonna 1500
3. How to take Ramonna 1500
4. Possible side effects
5. How to store Ramonna 1500
6. Contents of the pack and other information
1. WHAT RAMONNA 1500 IS AND WHAT IT IS USED FOR
Ramonna 1500 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 external genitalia).
Ramonna 1500 contains a synthetic hormone like
active substance called levonorgestrel. It prevents
about 84% of expected pregnancies when you
take it within 72 hours of having unprotected sex.
It will not prevent a pregnancy every time and is
more effective if you take it as soon as possible
after unprotected sex. It is better to take it within
12 hours rather than delay until the third day.
Ramonna 1500 is thought to work by:
• stopping your ovaries from releasing an egg.
• preventing sperm from fertilising any egg you
may have already released.
Ramonna 1500 can only prevent you becoming
pregnant if you take it within 72 hours of
unprotected sex. It does not work if you are already
pregnant. If another unprotected intercourse takes
place after the use of Ramonna 1500 (also if this is
during the same menstrual cycle), the tablet will not
exert its contraceptive effect and the

Scheda tecnica

Health Products Regulatory Authority
10 September 2021
CRN00C2TL
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramonna 1500 microgram Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1500 micrograms of levonorgestrel
Excipientwith known effect: 142.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Almost white, flat, rimmed tablet of about 8mm diameter with an
impressed mark of “G00” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of a contraceptive 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 threehours 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).
Ramonna 1500 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
levonorgestrel does not contraindicate the continuation of
regular hormonal contraception.
_Paediatric population_
There is no relevant use of Ramonna 1500 for children of prepubertal
age in the indication emergency contraception.
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 FOR USE
Emergency contra