Daylette 0.02mg/3mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

Consilient Health Ltd

ATC code:

G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

3mg ; 20microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5391512452889

Patient Information leaflet

BLOOD CLOTS
Using a combined hormonal contraceptive such as Daylette increases
your risk of
developing a blood clot compared with not using one. In rare cases a
blood clot can
block blood vessels and cause serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’,
‘arterial thromboembolism’
or ATE).
Recovery from blood clots is not always complete. Rarely, there may be
serious
lasting effects or, very rarely, they may be fatal.
IT IS IMPORTANT TO REMEMBER THAT THE OVERALL RISK OF A HARMFUL BLOOD
CLOT DUE TO
DAYLETTE IS SMALL.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs
or symptoms:
BLOOD CLOTS IN A VEIN
WHAT CAN HAPPEN IF A BLOOD CLOT FORMS IN A VEIN?
•
The use of combined hormonal contraceptives has been connected with an
increase in the risk of blood clots in the vein (venous thrombosis).
However,
these side effects are rare. Most frequently, they occur in the first
year of use of a
combined hormonal contraceptive.
•
If a blood clot forms in a vein in the leg or foot it can cause a deep
vein
thrombosis (DVT).
•
If a blood clot travels from the leg and lodges in the lung it can
cause a
pulmonary embolism.
•
Very rarely a clot may form in a vein in another organ such as the eye
(retinal vein
thrombosis).
WHEN IS THE RISK OF DEVELOPING A BLOOD CLOT IN A VEIN HIGHEST?
The risk of developing a blood clot in a vein is highest during the
first year of taking
a combined hormonal contraceptive for the first time. The risk may
also be higher if
you restart taking a combined hormonal contraceptive (the same product
or a
different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly
higher than if you were
not using a combined hormonal contraceptive.
When you stop Daylette your risk of a blood clot returns to normal
within a few
weeks.
WHAT IS THE RISK OF DEVE

Summary of Product characteristics

OBJECT 1
DAYLETTE 0.02 MG /3 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 15-Jan-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Daylette 0.02 mg /3 mg film-coated tablets
2. Qualitative and quantitative composition
24 white or almost white _(active)_ film-coated tablets:
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipients with known effect:
Each film-coated tablet contains 48.53mg of lactose monohydrate and
0.070 mg of soya lecithin.
4 green placebo (inactive) film-coated tablets:
The tablet does not contain active substances.
Excipients with known effect: lactose anhydrous 37.26 mg, sunset
yellow (E110) 0.003 mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet.
The active tablet is white or almost white, round, biconvex
film-coated tablet, diameter about 6 mm.
Engraving on one side: “G73“, the other side is without engraving.
The placebo tablet is green, round, biconvex film-coated tablet,
diameter about 6 mm, without engraving.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Daylette should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Daylette
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Method of administration
For oral use
Posology
HOW TO TAKE DAYLETTE
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 green placebo
tablets (last row) and may not have
finished before the next pack is started.
HOW TO START DAYLETTE
• No preceding hormonal co