Ellanite 0.03mg/3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Kent Pharma (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

Manufactured by:

Haupt Pharma Münster

Product summary:

BNF: 07030100; GTIN: 5060098730390

Authorization status:

Marketed

Authorization date:

2014-12-16

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”)
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 not pass it on
to
others. It may harm them.
• 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 ELLANITE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLANITE
3. HOW TO TAKE ELLANITE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ELLANITE
1. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ELLANITE IS AND WHAT IT IS USED FOR
• Ellanite is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female
hormones,
namely drospirenone and ethinylestradiol.
•
Contraceptive pills that contain two hormones are called
“combination” pills.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLANITE
_GENERAL NOTES_
Before you start using Ellanite 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
Ellanite, 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
situatio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ellanite 0.03 mg / 3 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone
Excipient with known effect: lactose 57.07 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round with a diameter of about 6 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Ellanite should take into consideration the
individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Ellanite 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 ELLANITE
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 ELLANITE
_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 transdermal patch) _
The woman should start with Ellanite preferably on the day after the
last active tablet
(the last tablet containing the active substances) of her previous
COC, but at the latest
on the day following the usual tablet-free or placebo tablet interval
of her previous
COC. In case a vaginal ring or transdermal patch has been used, the
woman should
start using Ellanite preferably on the day of removal, but at the
latest w