Activelle film-coated tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NORETHISTERONE ACETATE, ESTRADIOL

Available from:

NovoNordisk A/S Novo Alle, DK – 2880 Bagsvaerd, Denmark

ATC code:

G03FA01

INN (International Name):

NORETHISTERONE ACETATE 0.5 mg ESTRADIOL 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

NORETHISTERONE ACETATE 0.5 mg ESTRADIOL 1 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2006-12-05

Patient Information leaflet

Page 1 of 11
PACKAGE LEAFLET: INFORMATION TO THE PATIENT
ACTIVELLE
® 1 MG/0.5 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 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 Activelle
®
is and what it is used for
2.
What you need to know before you take Activelle
®
3.
How to take Activelle
®
4.
Possible side effects
5.
How to store Activelle
®
6.
Contents of the pack and other information
1.
WHAT ACTIVELLE
®
IS AND WHAT IT IS USED FOR
Activelle
®
is a continuous combined Hormone Replacement Therapy (HRT). It
contains two
types of female hormones, an oestrogen and a progestagen. Activelle
®
is used in
postmenopausal women with at least 1 year since their last natural
period.
Activelle
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This
can cause symptoms such as hot face, neck and chest (‘hot
flushes’). Activelle
®
alleviates
these symptoms after menopause. You will only be prescribed Activelle
®
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 medicines are not
suitable for you, you can use Activelle
®
to prevent osteoporosis after menopause.
Activelle
®
is prescribed for women who have not had their womb removed, and whose
periods stoppe

Summary of Product characteristics

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Activelle 1 mg/0.5 mg film-coated tablets.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains:
Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate
0.5 mg.
Excipient: lactose monohydrate.
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablets.
White film-coated, round, biconvex tablets with a diameter of 6 mm.
The tablets are engraved with
NOVO 288 on one side and the APIS bull on the other.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal
women with more than 1 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.
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Activelle is a continuous combined hormone replacement product
intended for use in women with
an intact uterus. One tablet should be taken orally once a day without
interruption, preferably at the
same time every day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration (see also section 4.4) should be used.
A switch to a higher dose combination product could be indicated if
the response after 3 months is
insufficient for satisfactory symptom relief.
In women with amenorrhea and not taking HRT or women transferring from
another continuous
combined HRT product, treatment with Activelle may be started on any
convenient day. In women
Page 2 of 13
transferring from sequential HRT regimens, treatment should start
right after their withdrawal
bleeding has ended.
If the patient has forgotten to take a tablet, the tablet should be
taken as soon as possible within the
next 12 hours. If more than 12 hours has passed, the tab