Zoely 2.5mg1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nomegestrol acetate; Estradiol hemihydrate

Available from:

Merck Sharp & Dohme Ltd

INN (International Name):

Nomegestrol acetate; Estradiol hemihydrate

Dosage:

2.5mg ; 1.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 5013945300154

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOELY® 2.5 MG/1.5 MG FILM-COATED TABLETS
Nomegestrol acetate/estradiol
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zoely is and what it is used for
2.
What you need to know before you use Zoely
3.
How to use Zoely
4.
Possible side effects
5.
How to store Zoely
6.
Contents of the pack and other information
1.
WHAT ZOELY IS AND WHAT IT IS USED FOR
Zoely is a contraceptive pill that is used to prevent pregnancy.

All 24 white film-coated tablets are active tablets that contain a
small amount of two different
female hormones. These are nomegestrol acetate (a progestogen) and
estradiol (an oestrogen).

The 4 yellow tablets are inactive tablets that do not contain hormones
and are called placebo
tablets.

Contraceptive pills that contain two different hormones, like Zoely,
are

Summary of Product characteristics

OBJECT 1
ZOELY 2.5 MG/1.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Mar-2017 | Merck Sharp &
Dohme Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Zoely
®
2.5 mg/1.5 mg film-coated tablets
2. Qualitative and quantitative composition
White active film-coated tablets: Each film-coated tablet contains 2.5
mg nomegestrol acetate and 1.5 mg
estradiol (as hemihydrate).
Yellow placebo film-coated tablets: The tablet does not contain active
substances.
Excipients with known effect
Each white active film-coated tablet contains 57.71 mg of lactose
monohydrate.
Each yellow placebo film-coated tablet contains 61.76 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Active film-coated tablets: white, round and coded 'ne' on both sides.
Placebo film-coated tablets: yellow, round and coded 'p' on both
sides.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception.
The decision to prescribe Zoely should take into consideration the
individual woman's current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Zoely
compares with other combined hormonal contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2 Posology and method of administration
Posology
One tablet is to be taken daily for 28 consecutive days. Each pack
starts with 24 white active tablets,
followed by 4 yellow placebo tablets. A subsequent pack is started
immediately after finishing the
previous pack, without a break in daily tablet intake and irrespective
of presence or absence of withdrawal
bleeding. Withdrawal bleeding usually starts on day 2-3 after intake
of the last white tablet and may not
have finished before the next pack is started. See 'Cycle control