Elleste Duet Conti tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol; Norethisterone acetate

Available from:

Viatris UK Healthcare Ltd

ATC code:

G03CA53

INN (International Name):

Estradiol; Norethisterone acetate

Dosage:

2mg ; 1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5012882007485

Patient Information leaflet

Package leaflet: Information for the user
Elleste Duet
TM
Conti Tablets
2 MG/1 MG FILM-COATED TABLETS
_(estradiol/norethisterone acetate)_
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 of the 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 Elleste Duet Conti Tablets are and what they are used for
2.
What you need to know before you take Elleste Duet Conti Tablets
3.
How to take Elleste Duet Conti Tablets
4.
Possible side effects
5.
How to store Elleste Duet Conti Tablets
6.
Contents of the pack and other information
1.
WHAT ELLESTE DUET CONTI TABLETS ARE AND WHAT THEY ARE
USED FOR
Elleste Duet Conti Tablets are a Hormone Replacement Therapy (HRT).
They contain
two types of female hormones, an oestrogen (estradiol hemihydrate) and
a progestogen
(norethisterone acetate). Elleste Duet Conti Tablets are used in
postmenopausal women with
at least one year since their last natural period.
Elleste Duet Conti Tablets are used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This
can cause symptoms such as hot face, neck and chest (“hot
flushes”). Elleste Duet Conti
Tablets alleviate these symptoms after menopause. You will only be
prescribed Elleste Duet
Conti Tablets if your symptoms seriously hinder your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should
discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other med

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Elleste Duet Conti Tablets
2 mg/1 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg estradiol (as estradiol
hemihydrate) and
1 mg norethisterone acetate.
Excipient with known effect: 60.8 mg lactose monohydrate.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Grey, round, biconvex tablets embossed with ‘P2’ on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
women one year since last menses. Prevention of osteoporosis in
postmenopausal women at high risk of future fractures who are
intolerant of,
or contraindicated for, other medicinal products approved for the
prevention of
osteoporosis (see also Section 4.4).
The experience of treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For initiation and continuation of treatment of post-menopausal
symptoms the
lowest
effective dose for the shortest duration (see also Section 4.4) should
be used.
The product is a continuous combined HRT. One grey tablet is taken
daily.
The oestrogen and the progestogen are given every day without
interruption.
Therapy may start at any time in patients without prior hormone
replacement
therapy. Patients changing from another cyclical or continuous
sequential
preparation should complete the cycle and may then change to Elleste
Duet Conti
Tablets without a break in therapy. Patients changing from a
continuous
combined
preparation
may
start
therapy
at
any
time
if
amenorrhoea
is
established, or otherwise start on the first day of bleeding.
Missed Tablet: If a tablet is missed it should be taken within 12
hours of when
normally taken; otherwise the tablet should be discarded, and the
usual tablet
should be taken the following day. If a tablet is missed there is an
increased
likelihood of breakthrough bleeding or spotting.
_Elderly_
There are no spec