Tibolone Aristo 2.5 mg tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Tibolone

Disponibil de la:

Aristo Pharma GmbH

Codul ATC:

G03CX; G03CX01

INN (nume internaţional):

Tibolone

Dozare:

2.5 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Other estrogens; tibolone

Statutul autorizaţiei:

Marketed

Data de autorizare:

2018-01-26

Prospect

PACKAGE LEAFLET:
INFORMATION FOR THE USER
TIBOLONE ARISTO 2.5 MG TABLETS
Tibolone
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 Tibolone Aristo is and what it is used for
2. What you need to know before you take Tibolone Aristo
3. How to take Tibolone Aristo
4. Possible side effects
5. How to store Tibolone Aristo
6. Contents of the pack and other information
1. WHAT TIBOLONE ARISTO IS AND WHAT IT IS USED FOR
Tibolone Aristo is a Hormone Replacement Therapy (HRT). It contains
tibolone, a synthetic sex
hormone. Tibolone Aristo is used in postmenopausal women with at least
12 months since their last
natural period.
Tibolone Aristo 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").
Tibolone Aristo alleviates these
symptoms after menopause. You will only be prescribed Tibolone Aristo
if your symptoms seriously
hinder your daily life.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE
TIBOLONE ARISTO
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT or Tibolone Aristo carries risks that 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
Tibolone Aristo may be different.
Please talk to your doctor.
Before you start taking (o

Caracteristicilor produsului

Health Products Regulatory Authority
30 November 2023
CRN00DWFZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tibolone Aristo 2.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg tibolone.
Excipient(s) with known effect: lactose monohydrate:
Each tablet contains approximately 75 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to whitish, flat round tablets of approximately 6 mm diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of oestrogen deficiency symptoms in women more than one year
after the menopause.
For all women the decision to prescribe tibolone 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
Posology
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 Tibolone 2.5 mg
tablets treatment.
Starting Tibolone 2.5 mg tablets
Women experiencing a natural menopause should commence treatment with
Tibolone 2.5 mg tablets at least 12 months after
their last natural bleed. Women experiencing a surgical menopause may
commence treatment with Tibolone 2.5 mg tablets
immediately.
Any irregular/unscheduled vaginal bleeding, either on or off HRT, for
which there is no obvious cause, should be investigated
to exclude malignancy before starting Tibolone 2.5 mg tablets (see
section 4.3).
Switching from a sequential or continuous combined HRT preparation
If changing from a sequential HRT preparation, treatment with Tibolone
2.5 mg tablets should start the da