FREEDONEL & PLACEBO 0.02 / 3 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DROSPIRENONE, ETHINYLESTRADIOL

Available from:

Rowex Ltd

ATC code:

G03AA12

INN (International Name):

DROSPIRENONE, ETHINYLESTRADIOL

Dosage:

0.02 / 3 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations

Authorization status:

Authorised

Authorization date:

2012-03-30

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

FREEDONEL & PLACEBO 0.02 MG/3 MG FILM-COATED TABLETS 

Ethinylestradiol/Drospirenone 

READ  ALL  OF  THIS  LEAFLET  CAREFULLY  BEFORE  YOU  START  TAKING  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 no pass it on to others. It may harm them 
even if their signs of ilness 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. 

IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):  
•   They are one of the most reliable reversible
methods of contraception if used correctly  
•   They slightly increase the risk of having a blood clot in the veins and arteries, especially in the 
first year or when restarting a combined hormonal contraceptive following a break of 4 or more 
weeks  
•   Please be alert and see your doctor if you think you may have symptoms of a blood clot (see 
section 2 “Blood clots”)  

WHAT IS IN THIS LEAFLET: 
1.  What Freedonel & Placebo is and what it is used for 
2.  What you need to know before you
take Freedonel & Placebo 
3.  How to take Freedonel & Placebo 
4.  Possible side effects 
5.  How to store Freedonel & Placebo 
6.  Contents of the pack and other information 

1.  WHAT FREEDONEL & PLACEBO IS AND WHAT IT IS USED FOR 

Freedonel & Placebo is a contraceptive pill and is used
to prevent pregnancy. 

Each  of  the  21  pink  tablets  contains  a  small  amount  of  two 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Freedonel & Placebo 0.02mg/3mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PINK TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect
Each tablet contains 44 mg lactose monohydrate
WHITE TABLETS (PLACEBO TABLETS):
The tablet does not contain active substances
Excipient with known effect
Each tablet contains 89.5 mg lactose, anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Pink, round film-coated tablets
Placebo tablets: White, round film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Freedonel & Placebo should take into
consideration the individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Freedonel & Placebo
compares with other CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
HOW TO TAKE FREEDONEL & PLACEBO
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order shown on the
blister pack. Tablet taking is continuous. One tablet is to be taken
daily for 28 consecutive days. Each subsequent pack
is started the day after the last tablet of the previous pack.
Withdrawal bleeding usually starts on day 2-3 after starting
the placebo tablets (last row) and may not have finished before the
next pack is started.
HOW TO START FREEDONEL & PLACEBO
• No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual bleeding).
• Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC)), vaginal ring, or
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