Ezinelle 1.5mg tablet

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: myHealthbox

Viambatanisho vya kazi:

levonorgestrel

Inapatikana kutoka:

Generics (UK) Ltd t/a Mylan

ATC kanuni:

G03AD01

INN (Jina la Kimataifa):

levonorgestrel

Kipimo:

1.5mg

Dawa fomu:

Tablets

Njia ya uendeshaji:

Oral use

Vitengo katika mfuko:

Pack size: 1 tablet

Dawa ya aina:

POM - Prescription Only Medicine

Viwandani na:

Accord Healthcare Limited

Kundi la matibabu:

Sex hormones and modulators of the genital system, emergency contraceptives

Matibabu dalili:

Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.

Idhini hali ya:

Authorised

Idhini ya tarehe:

2015-05-13

Taarifa za kipeperushi

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12 JUN 2015
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LEVONORGESTREL 1.5MG 1
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EZINELLE 1.5 MG TABLET
(levonorgestrel)
Package leaflet: Information for the user
EZINELLE 1.5 MG TABLET
(levonorgestrel)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
Always take this medicine exactly as described in this 
leaflet or as your pharmacist has told 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 includes any possible side effects not 
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.  What Ezinelle is and what it is used for
2.  What you need to know before you take Ezinelle
3.  How to take Ezinelle
4.  Possible side effects
5.  How to store Ezinelle
6.  Contents of the pack and other information
1. WHAT EZINELLE IS AND WHAT IT IS USED FOR
Ezinelle is an emergency contraceptive that can be used 
within 72 hours (3 days) of unprotected sex or if your usual 
contraceptive method has failed.
Ezinelle contains a synthetic hormone-like 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�

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Ezinelle 1.5 mg tablet 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 1.5 mg of levonorgestrel. 
Excipient with known effect 
Each tablet contains 154 mg lactose monohydrate 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Tablet 
The tablet is a round, white to off-white,
uncoated flat tablet debossed ‘145’ on one 
side and plain on the other side. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Emergency contraception within 72 hours of unprotected sexual
intercourse or failure 
of a contraceptive method. 
Ezinelle is indicated in adults and adolescents >16 years of age. 

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. The patient should seek advice from her
doctor, nurse, family 
planning clinic or pharmacist. 
Ezinelle 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 Ezinelle does not contraindicate the
continuation of regular 
hormonal contraception. 

_Paediatric population_:  
Ezinelle is not recommended in
children. Very limited data are available in women 
under 16 years of age. Ezinelle is not recommended for
use by young women under 
16 years of age without medical supervision. 

Method of administration 
Ezinelle should be taken orally. 

4.3 CONTRAINDICATIONS 

Hypersensitivity to the active s