Tibelia 2,5 mg Tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

tibolon

Dostopno od:

Novalon S.A.

Koda artikla:

G03CX01

INN (mednarodno ime):

tibolone

Odmerek:

2,5 mg

Farmacevtska oblika:

Tablett

Sestava:

tibolon 2,5 mg Aktiv substans; laktosmonohydrat Hjälpämne; mannitol Hjälpämne

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Blister, 28 tabletter; Blister, 30 tabletter; Blister, 3 x 30 tabletter; Blister, 3 x 28 tabletter; Blister, 6 x 28 tabletter; Blister, 6 x 30 tabletter

Status dovoljenje:

Godkänd

Datum dovoljenje:

2016-03-31

Navodilo za uporabo

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIBELIA 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 [(Invented) name] is and what it is used for
2.
What you need to know before you take [(Invented) name]
3.
How to take [(Invented) name]
4.
Possible side effects
5.
How to store [(Invented) name]
6.
Contents of the pack and other information
1.
WHAT [(INVENTED) NAME] IS AND WHAT IT IS USED FOR
This medicine is a Hormone Replacement Therapy (HRT). It contains
tibolone, a substance that has favourable
effects on different tissues in the body, such as brain, vagina and
bone.
This medicine is used in postmenopausal women with at least 12 months
since their last natural period.
This medicine is used for:
RELIEF OF SYMPTOMS OCCURING 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"). [(Invented)
name] alleviates these symptoms after
menopause. You will only be prescribed [(Invented) name] 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 [(Invented) name] to prevent osteoporosis after menopause.
There are three different kinds of HRT:
-
Oestrogen-only HRT
-

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tibelia 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contain contains 2.5 mg tibolone.
Excipient(s) with known effect: each tablet contains 43.2 mg of
lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white round uncoated tablets of 6 mm diameter with
bevelled edge without any marking
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of oestrogen deficiency symptoms in postmenopausal women,
more than one year 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 Section 5.1)
For all women the decision to prescribe {Invented name} 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. 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 {Invented name}
treatment.
STARTING {INVENTED NAME}
Women experiencing a natural menopause should commence treatment with
{Invented name} at least 12
months after their last natural bleed. In case of a surgical
menopause, treatment with {Invented name} may
commence immediately. Women being treated with gonadotrophin releasing
hormone (GnRH) analogues,
for example, for endometriosis, may commence treatment with {Invented
name} immediately.
Any irregular/unscheduled vaginal bleeding, either on or off HRT,
should be investigated to exclude
malignancy before st