Activelle 1 mg/0.5 mg film-coated tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

estradiol anhydrous; Norethisterone acetate

Disponible des:

Novo Nordisk A/S

Codi ATC:

G03FA; G03FA01

Designació comuna internacional (DCI):

estradiol anhydrous; Norethisterone acetate

Dosis:

1 mg / 0.5 milligram(s)

formulario farmacéutico:

Film-coated tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Progestogens and estrogens, fixed combinations; norethisterone and estrogen

Estat d'Autorització:

Marketed

Data d'autorització:

1998-08-28

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 stopped
more than a year ago.
There is only limited experien

Fitxa tècnica

Health Products Regulatory Authority
14 July 2023
CRN00CT45
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Activelle 1 mg/0.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate
0.5 mg.
Excipient with known effect: Each film-coated tablet contains lactose
monohydrate 37.0 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
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 CLINICAL PARTICULARS
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 HRT 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 symptom
relief.
In women with amenorrhoea and not taking HRT or women in transition
from another continuous combined HRT product,
treatment with Activelle may be started on any convenient day. In
women in transition from a sequential HRT regimen,
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 poss