Tibolon Aristo Dublette 2,5 mg Tabletten

Land: Deutschland

Sprache: Deutsch

Quelle: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

Wirkstoff:

Tibolon

Verfügbar ab:

Aristo Pharma GmbH (3082323)

ATC-Code:

G03CX01

INN (Internationale Bezeichnung):

tibolone

Darreichungsform:

Tablette

Zusammensetzung:

Tibolon (22718) 2,5 Milligramm

Verabreichungsweg:

zum Einnehmen

Berechtigungsstatus:

erloschen

Berechtigungsdatum:

2014-02-17

Gebrauchsinformation

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20150115
TIBOLONE 2.5 MG TABLET
722-1613.00
PACKAGE LEAFLET: INFORMATION FOR THE USER
2.5 MG TABLETS
For adult use
Active substance: 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 of the side effects talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
2.5 mg tablet
The active substance is: tibolone.
is a Hormone Replacement Therapy (HRT). is
used in
postmenopausal women with at least 12 months since their last natural
period.
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").
alleviates these
symptoms after menopause. You will only be prescribed if
your symptoms
seriously hinder your daily life.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT or 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 hav

Fachinformation

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1.3.1 spc-label-pl - common-spc - 5,002
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20141211
TIBOLONE 2.5 MG TABLET
722-1613.00
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains: 2.5 mg tibolone.
Excipient:
One tablet contains approximately 75 mg lactose monohydrate.
For a 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
For oral use
Posology
_Adults and the elderly _
The dosage is one tablet per day without interruption. No dose
adjustment is necessary for the
elderly. 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 treatment.
_Starting _
•
Women
experiencing
a
natural
menopause
should
commence
treatment
with
at least 12 months after their last natural bleed.
•
Women
experiencing
a
surgical
menopause
may
commence
treatment
with
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
(see section 4.3).
Method of administration
The tablets should be swallowed without chewing, with some water or
other drink, preferably
at the same time every day.
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