Optinate Septimum 35 mg Enterotablett

国家: 瑞典

语言: 瑞典文

来源: Läkemedelsverket (Medical Products Agency)

有效成分:

risedronatnatrium

可用日期:

Theramex Ireland Limited

ATC代码:

M05BA07

INN（国际名称）:

risedronate

剂量:

35 mg

药物剂型:

Enterotablett

组成:

risedronatnatrium 35 mg Aktiv substans

处方类型:

Receptbelagt

產品總結:

Förpacknings: Blister, 4 tabletter; Blister, 1 tablett; Blister, 2 tabletter; Blister, 12 tabletter; Blister, 10 tabletter; Blister, 16 tabletter

授权状态:

Godkänd

授权日期:

2016-11-28

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OPTINATE SEPTIMUM 35 MG GASTRO-RESISTANT TABLETS
risedronate sodium
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 Optinate Septimum is and what it is used for
2.
What you need to know before you take Optinate Septimum
3.
How to take Optinate Septimum
4.
Possible side effects
5.
How to store Optinate Septimum
6.
Contents of the pack and other information
1.
WHAT OPTINATE SEPTIMUM IS AND WHAT IT IS USED FOR
WHAT OPTINATE SEPTIMUM IS
Optinate Septimum belongs to a group of non-hormonal medicines called
bisphosphonates which are
used to treat bone diseases. It works directly on your bones to make
them stronger and therefore less
likely to break.
Bone is a living tissue. Old bone is constantly removed from your
skeleton and replaced with new
bone.
Postmenopausal osteoporosis is a condition occurring in women after
the menopause where the bones
become weaker, more fragile and more likely to break after a fall or
strain.
Osteoporosis can also occur in men due to a number of causes including
ageing and/or a low level of
the male hormone, testosterone.
The spine, hip and wrist are the most likely bones to break, although
this can happen to any bone in
your body. Osteoporosis–related fractures can also cause back pain,
height loss and a curved back.
Many patients with osteoporosis have no symptoms and you may not even
have known that you had it.
2
WHAT OPTINATE SEPTIMUM IS USED FOR
Treatment of osteoporosis in postmenopausal women, even if
osteoporosis is

产品特点

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Optinate Septimum 35 mg gastro-resistant tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 35 mg risedronate sodium
(equivalent to 32.5 mg risedronic acid).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Oval, yellow, gastro-resistant tablet with “EC 35” engraved on one
side.
The dimensions of the tablet are as follows: width 13 mm, length 6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one Optinate Septimum 35 mg
gastro-resistant tablet orally once a
week. The tablet should be taken on the same day each week.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks of
risedronate on an individual patient basis, particularly after 5 or
more years of use.
Special populations
_Elderly_
Of the patients receiving risedronate 35 mg gastro-resistant tablets
in postmenopausal osteoporosis
studies, 59% were 65 and over, while 13 % were 75 and over. No overall
differences in safety and
effectiveness were observed between these patients and younger
patients.
_Patients with renal impairment_
No dosage adjustment is required for those patients with mild to
moderate renal impairment. The use
of risedronate sodium is contraindicated in patients with severe renal
impairment (creatinine clearance
lower than 30 ml/min) (see sections 4.3 and 5.2).
_Paediatric population_
Risedronate sodium is not recommended for use in children below age 18
due to insufficient data on
safety and efficacy (also see section 5.1).
Method of administration
Optinate Septimum 35 mg gastro-resistant tablets should be taken
orally in the morning immediately