Optruma

Land: Europäische Union

Sprache: Englisch

Quelle: EMA (European Medicines Agency)

Wirkstoff:

raloxifene hydrochloride

Verfügbar ab:

Eli Lilly Nederland B.V.

ATC-Code:

G03XC01

INN (Internationale Bezeichnung):

raloxifene

Therapiegruppe:

Sex hormones and modulators of the genital system,

Therapiebereich:

Osteoporosis, Postmenopausal

Anwendungsgebiete:

Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Produktbesonderheiten:

Revision: 26

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

1998-08-05

Gebrauchsinformation

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTRUMA 60 MG FILM COATED TABLETS
raloxifene hydrochloride
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 Optruma is and what it is used for
2.
What you need to know before you take Optruma
3.
How to take Optruma
4.
Possible side effects
5.
How to store Optruma
6.
Contents of the pack and other information
1.
WHAT OPTRUMA IS AND WHAT IT IS USED FOR
Optruma contains the active substance raloxifene hydrochloride.
Optruma is used to treat and prevent osteoporosis in postmenopausal
women. Optruma reduces the
risk of vertebral fractures in women with postmenopausal osteoporosis.
A reduction in the risk of hip
fractures has not been shown.
How Optruma works
Optruma belongs to a group of non-hormonal medicines called Selective
Oestrogen Receptor
Modulators (SERMs). When a woman reaches the menopause, the level of
the female sex hormone
oestrogen goes down. Optruma mimics some of the helpful effects of
oestrogen after the menopause.
Osteoporosis is a disease that causes your bones to become thin and
fragile - this disease is especially
common in women after the menopause. Although it may have no symptoms
at first, osteoporosis
makes you more likely to break bones, especially in your spine, hips
and wrists and may cause back
pain, loss of height and a curved back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPTRUMA
DO NOT TAKE OPTRUMA:
•
If you are being treated or have been treated for blood clots in the
legs (deep vein thrombosi

Fachinformation

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Optruma 60 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 60 mg raloxifene hydrochloride,
equivalent
to 56 mg raloxifene free
base.
Excipient with known effect:
Each tablet contains lactose (149.40 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Elliptically shaped, white tablets imprinted with the code ’4165’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Optruma is indicated for the treatment and prevention of osteoporosis
in postmenopausal women. A
significant reduction in the incidence of vertebral, but not hip
fractures has been demonstrated.
When determining the choice of Optruma or other therapies, including
oestrogens, for an individual
postmenopausal woman, consideration should be given to menopausal
symptoms, effects on uterine
and breast tissues, and cardiovascular risks and benefits (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one tablet daily by oral administration, which
may be taken at any time of
the day without regard to meals. Due to the nature of this disease
process, Optruma is intended for
long term use.
Generally calcium and vitamin D supplements are advised in women with
a low dietary intake.
_Elderly: _
No dose adjustment is necessary for the elderly.
_Renal impairment: _
Optruma should not be used in patients with severe renal impairment
(see section 4.3). In patients with
moderate and mild renal impairment, Optruma should be used with
caution.
_ _
_Hepatic impairment: _
Optruma should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
_Paediatric population: _
Optruma should not be used in children of any age. There is no
relevant use of Optruma in the
paediatric population.
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Must not be used in women with child b