Cleosensa 0.03mg/3mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Drospirenone; Ethinylestradiol

Beszerezhető a:

Actavis UK Ltd

ATC-kód:

G03AA12

INN (nemzetközi neve):

Drospirenone; Ethinylestradiol

Adagolás:

3mg ; 30microgram

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 07030100; GTIN: 5012617024565

Betegtájékoztató

Drospirenone Ethinylestradiol 3mg 30mcg Tablets PIL UK
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TECHNICAL APPROVAL
black
AAAI0410
5
22.6.15
db
8.9.15
db
León Farma
222 x 510
7 pt
22.6.15
8.9.15
* Please note that only Actavis Global Artwork Studios are permitted
to make changes to the above
artwork. No changes are permitted by any 3rd party other than added
notes and mark ups for
required changes.
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 Cleosensa is and what it is used for
2.
What you need to know before you take Cleosensa
3.
How to take Cleosensa
4.
Possible side effects
5.
How to store Cleosensa
6.
Contents of the pack and other information
1.
WHAT CLEOSENSA IS AND WHAT IT IS USED FOR
Cleosensa is a contraceptive pill and is used to prevent
pregnancy.
Each tablet contains a small amount of two different female
hormones, namely drospirenone and et

Termékjellemzők

OBJECT 1
CLEOSENSA 0.03MG/3MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 20-Nov-2015 | Accord-UK Ltd
1. Name of the medicinal product
Cleosensa 0.03mg/3mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg
drospirenone.
Excipient with known effect:
Each film-coated tablet contains 62 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow, round, plain, 5.7x3.5 mm, film-coated tablets.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
The decision to prescribe Cleosensa should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Cleosensa
compares with other CHCs (see sections 4.3 and 4.4).
4.2 Posology and method of administration
Posology
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 Cleosensa
- 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 Cleosensa 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 Cleosensa