Livial 2.5 mg tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Tibolone

Διαθέσιμο από:

Organon Pharma (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

G03CX; G03CX01

INN (Διεθνής Όνομα):

Tibolone

Δοσολογία:

2.5 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Θεραπευτική περιοχή:

Other estrogens; tibolone

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1987-12-09

Φύλλο οδηγιών χρήσης

LIVIAL®
2.5 MG TABLETS
TIBOLONE
IN THIS LEAFLET:
1. WHAT LIVIAL IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIVIAL
3. HOW TO TAKE LIVIAL
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LIVIAL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LIVIAL IS AND WHAT IT IS USED FOR
Livial is a Hormone Replacement Therapy (HRT). Livial contains
tibolone, and is used in postmenopausal
women with at least 12 months since their last natural period.
Livial is used for:
_ _
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of estrogen, produced by a woman’s
body, drops. This can cause
symptoms such as hot face, neck and chest (“hot flushes”). Livial
alleviates these symptoms after menopause.
You will only be prescribed Livial if your symptoms seriously hinder
your daily life.
If indicated:
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 take Livial to prevent osteoporosis after menopause.
In section 6 “Contents of the pack and other information” you can
find more information about Livial and what
it is used for.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIVIAL
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT or Livial carries risks which need to be considered
when deciding whether to start taking it, or
whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited. If
you have a premature menopause the risks of using HRT or Livial may be
different. Please talk to your doctor.
Before you start (or restart) HRT or Livial, your doctor will ask
about your own and your family's medical
history. Your doctor may decide to perform a physical examination.
This may include an examination of your
breasts and/or an internal examination, if necessary.
Once you've started on Liv

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
30 July 2021
CRN00C8G8
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Livial 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of tibolone.
Excipients: also includes lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White, round and flat tablets with bevelled edges and a diameter of 6
mm and coded “MK” above “2” on one side and
“Organon” and a star on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
• Treatment of estrogen deficiency symptoms in postmenopausal women,
more than one year after menopause.
• Second line therapy for 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.
For all women the decision to prescribe Livial should be based on an
assessment of the individual patient’s overall risks and,
particularly in the over 60s, should include consideration of the risk
of stroke (see sections 4.4 and 4.8).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is one tablet per day. No dose adjustment is necessary for
the elderly. The tablets should be swallowed with some
water or other drink, 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 separate progestogen should not be added with Livial treatment.
STARTING LIVIAL
Women experiencing a natural menopause should commence treatment with
Livial at least 12 months after their last natural
bleed. In case of a surgical menopause, treatment with Livial may
commence immediately.
Any irregular / unscheduled vaginal bleeding, either on or off HRT,
should be investigated to exclude malignancy before
starting Livial (see section 4.3).
SWITCHING FROM A SEQUENTIAL OR CONTINUOUS COMBIN