LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100/20 Microgram Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVONORGESTREL ETHINYLESTRADIOL

Available from:

Famy Care Europe Ltd

INN (International Name):

LEVONORGESTREL ETHINYLESTRADIOL

Dosage:

100/20 Microgram

Pharmaceutical form:

Coated Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

 
1

PACKAGE LEAFLET: INFORMATION FOR THE USER 

LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20
MICROGRAMS COATED TABLETS  
(Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
-  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. Do not pass it on
to others. It may harm them. 
-  If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1.  What Levonorgestrel/Ethinylestradiol is and what it is used
for 
2.  Before you take Levonorgestrel/Ethinylestradiol  
3.  How to take Levonorgestrel/Ethinylestradiol  
4.  Possible side effects 
5.  How to store Levonorgestrel/Ethinylestradiol  
6.  Further information 

1. WHAT LEVONORGESTREL/ETHINYLESTRADIOL IS AND WHAT IT IS USED 
FOR 

•  Levonorgestrel/Ethinylestradiol is a contraceptive pill 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. BEFORE YOU USE LEVONORGESTREL/ETHINYLESTRADIOL  

GENERAL NOTES 
Before you can begin taking Levonorgestrel/Ethinylestradiol, your
doctor will ask you some 
questions about your personal health and that of your close
relatives. The doctor will also 
measure your blood pressure and depending upon your personal
situation, may also carry out 
some other tests. 

In this leaflet, several situations are described where you should
stop using 
Levonorgestrel/Ethinylestradiol, or where the reliability of
Levonorgestrel/Ethinylestradiol may 
be decreased. In such situations you should either not have
inte

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levonorgestrel/Ethinylestradiol Famy Care 100 micrograms/20 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms.
Excipients: 1 coated tablet contains 48 mg of lactose monohydrate and 14 mg of sucrose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet
Round, pink, 5.60 mm coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HOW TO USE LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED TABLETS
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 LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED
TABLETS
• 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 Levonorgestrel and Ethinylestradiol coated tablet is preferably started on the day after the last a