Lucette 0.03mg/3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Gedeon Richter (UK) Ltd

ATC code:

G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

3mg ; 30microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5391512451691

Patient Information leaflet

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 Lucette is and what it is used for
2. What you need to know before you use Lucette
3. How to take Lucette
4. Possible side effects
5. How to store Lucette
6. Contents of the pack and other information
1. WHAT LUCETTE IS AND WHAT IT IS USED FOR
•
Lucette is a contraceptive pill and is used to prevent pregnancy.
•
Each tablet contains a small amount of two different female hormones,
namely ethinylestradiol and drospirenone.
•
Contraceptive pills that contain two hormones are called
“combination” pills.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LUCETTE
GENERAL NOTES
Before you start using Lucette you should read the information on
blood clots in section 2. It is particularly important to read
the symptoms of a blood clot – see Section 2 “Blood clots”).
Before you can begin taking Lucette, your doctor will ask you some
questions about your personal health history 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 Lucette, or where the reliability of Lucette may be
decreased. In such situations you should either not have sex or you
should take extra non-hormonal contraceptive precautions,
e.g. use a condom or another barrier method. Do not use rhythm or
temperature methods. These methods can be unreliable
because Lucette alters the monthly changes of body temperature and
cervical mucus.
LUCETTE,

Summary of Product characteristics

OBJECT 1
LUCETTE 0.03 MG/3 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 17-Nov-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Lucette 0.03 mg/ 3 mg film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
Excipients with known effect:
Each film-coated tablet contains 48.17 mg of lactose monohydrate and
0.070 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White or almost white, round, biconvex film-coated tablet. Engraving
on one side: “G63”, other side is
without engraving.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Lucette should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Lucette
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Method of administration
Oral use
Posology
HOW TO TAKE LUCETTE
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. 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. This
usually starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
HOW TO START LUCETTE
- 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 another combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal
ring or transdermal patch)
The woman should start with Lucette preferably on the day after the
last active tablet (the last tablet
containing the active substances) of her previous COC, but at the
lat