Senshio
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-03-2023
Fachinformation
(SPC)
08-03-2023
Öffentlichen Beurteilungsberichts
(PAR)
05-07-2022
Wirkstoff:
ospemifene
Verfügbar ab:
Shionogi B.V.
ATC-Code:
G03XC05
INN (Internationale Bezeichnung):
ospemifene
Therapiegruppe:
Sex hormones and modulators of the genital system,
Therapiebereich:
Postmenopause
Anwendungsgebiete:
Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.
Produktbesonderheiten:
Revision: 13
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2015-01-14
Gebrauchsinformation
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SENSHIO 60 MG FILM-COATED TABLETS
ospemifene
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 Senshio is and what it is used for
2.
What you need to know before you take Senshio
3.
How to take Senshio
4.
Possible side effects
5.
How to store Senshio
6.
Contents of the pack and other information
1.
WHAT SENSHIO_ _IS AND WHAT IT IS USED FOR
Senshio contains the active substance ospemifene. Ospemifene belongs
to a group of medicines that
do not contain hormones called Selective Estrogen Receptor Modulators
(SERMs).
SENSHIO IS USED TO treat women with moderate to severe post-menopausal
symptoms in and outside
the vagina, such as itching, dryness, burning and pain during sex
(dyspareunia). This is known as
vulvar and vaginal atrophy. It is caused by a lowering in the levels
of the female hormone oestrogen in
your body. When this happens, the vaginal walls can become thinner.
This happens naturally after
menopause (post-menopause).
SENSHIO WORKS in a similar way to some of the helpful effects of
oestrogen, helping to improve these
symptoms and the underlying causes of vulvar and vaginal atrophy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SENSHIO
DO NOT TAKE SENSHIO
-
If you are allergic to ospemifene or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have or have ever had a BLOOD CLOT IN A VEIN (thrombosis), for
example, in your legs (deep
vein thrombosis), lungs (pulmonary embolism), or eyes (retinal
thro
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Senshio 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg ospemifene.
Excipient with known effect
Each film-coated tablet contains 1.82 mg lactose as monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval biconvex, white to off-white, film-coated tablets of dimensions
12 mm x 6.45 mm, debossed
with “60” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Senshio is indicated for the treatment of moderate to severe
symptomatic vulvar and vaginal atrophy
(VVA) in post-menopausal women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 60 mg tablet once daily with food taken at
the same time each day.
If a dose is missed it should be taken with food as soon as the
patient remembers. A double dose
should not be taken in the same day.
Special populations
_ _
_Elderly (>65 years old) _
No dose adjustment is necessary in patients above the age of 65 years
(see section 5.2).
_Renal impairment _
No dose adjustment is necessary for patients with mild, moderate or
severe renal impairment (see
section 5.2).
_Hepatic impairment _
No dose adjustment is necessary for patients with mild to moderate
hepatic impairment_. _Ospemifene
has not been studied in patients with severe hepatic impairment,
therefore Senshio is not
recommended for use in such patients (see section 5.2).
3
_Paediatric population_
There is no relevant use of ospemifene in the paediatric population
for the indication of the treatment
of moderate to severe symptomatic VVA in post-menopausal women.
Method of administration
Oral use.
One tablet should be swallowed whole once daily with food and should
be taken at the same time each
day.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Active or past history of venous thromboembolic events (VTEs),
includin
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