Indivina 1 mg/2.5 mg tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Estradiol valerate; Medroxyprogesterone acetate

Tilgjengelig fra:

Orion Corporation

ATC-kode:

G03FA; G03FA12

INN (International Name):

Estradiol valerate; Medroxyprogesterone acetate

Dosering :

1 mg/2.5 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Progestogens and estrogens, fixed combinations; medroxyprogesterone and estrogen

Autorisasjon status:

Not marketed

Autorisasjon dato:

2000-07-21

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
INDIVINA 1 MG/2.5 MG TABLETS
INDIVINA 1 MG/5 MG TABLETS
INDIVINA 2 MG/5 MG TABLETS
estradiol/medroxyprogesterone
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 Indivina is and what it is used for
2.
What you need to know before you take Indivina
3.
How to take Indivina
4.
Possible side effects
5.
How to store Indivina
6.
Contents of the pack and other information
1.
WHAT INDIVINA IS AND WHAT IT IS USED FOR
Indivina is a Hormone Replacement Therapy (HRT). It contains two types
of female hormones, an
oestrogen and progestogen. Indivina is used in menopausal women with
at least three years since their last
natural period.
Indivina is 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"). Indivina
alleviates these symptoms after
menopause. You will only be prescribed Indivina 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 Indivina to prevent osteoporosis after menopause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDIVINA
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered

Preparatomtale

Health Products Regulatory Authority
08 November 2023
CRN00DQL0
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Indivina 1 mg/2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One Indivina 1 mg/2.5 mg tablet contains:
Estradiol valerate 1 mg
Medroxyprogesterone acetate 2.5 mg
Excipient with known effect
78.9 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, bevelled-edge, diameter 7 mm, flat tablets with a code
on one side with 1+2.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms in
women with an intact uterus more than three years
after menopause_._
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 sections 4.4 and 5.1)
The experience of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Indivina is a continuous combined HRT regimen in which estrogen and
progestagen are given every day without interruption.
Posology
One tablet each day orally without a tablet-free interval. Tablet
should be taken approximately at the same time of the day.
Treatment is recommended to be initiated with Indivina 1 mg/2.5 mg
tablet. Depending on the clinical response to treatment,
the dosage can then be adjusted to individual needs.
Medroxyprogesterone acetate (MPA) 2.5 mg is usually sufficient to
prevent breakthrough bleeding. If breakthrough bleeding
occurs and persists, and endometrial abnormality has been ruled out,
the dose can be increased to 5 mg (Indivina 1mg/5 mg
tablet).
If 1 mg of estradiol valerate (E
2
V) is not sufficient to alleviate oestrogen deficiency symptoms, the
dose can be increased to 2
mg (Indivina 2 mg/5 mg tablet).
In women with amenorrhea and not taking HRT or women who switch from
another continuous combined HRT product,
treatmen