Yiznell 0.03mg/3mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Drospirenone; Ethinylestradiol

Mevcut itibaren:

Lupin Healthcare (UK) Ltd

ATC kodu:

G03AA12

INN (International Adı):

Drospirenone; Ethinylestradiol

Doz:

3mg ; 30microgram

Farmasötik formu:

Oral tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 07030100; GTIN: 8901107025946

Bilgilendirme broşürü

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
YIZNELL 0.03 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 not pass it on to
others. It may harm
them, even if their signs of illness 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 Yiznell is and what it is used for
2.
What you need to know before you take Yiznell
When you should not use Yiznell
Warnings and precautions
Blood clots
Yiznell and cancer
Bleeding between periods
What to do if no bleeding occurs during the seven pill-free days
Other medicines and Yiznell
Yiznell with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
3.
How to take Yiznell
When can you start with the first strip?
If you take more Yiznell than you should
If you forget to take Yiznell
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
4.
Possible side effects
5.
How to store Yiznell
6.
Contents of the pack and other information
1.
WHAT YIZNELL IS AND WHAT IT IS USED FOR

Ürün özellikleri

OBJECT 1
YIZNELL 0.03 MG/3 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Apr-2018 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Yiznell 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: lactose 65.97 mg per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Yellow coloured, round, biconvex, film coated tablet debossed with
'DR' on one side and plain on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
The decision to prescribe Yiznell should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Yiznell
compares with other CHCs (see sections 4.3 and 4.4).
4.2 Posology and method of administration
Method of administration: oral use
Dosage regimen
HOW TO TAKE YIZNELL
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 YIZNELL
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 Yiznell 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