Avestra Septimum 35 mg Filmdragerad tablett

Country: Sweden

Bahasa: Sweden

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

risedronatnatrium

Boleh didapati daripada:

Orifarm AB

Kod ATC:

M05BA07

INN (Nama Antarabangsa):

risedronate

Dos:

35 mg

Borang farmaseutikal:

Filmdragerad tablett

Komposisi:

laktosmonohydrat Hjälpämne; risedronatnatrium 35 mg Aktiv substans

Jenis preskripsi:

Receptbelagt

Kawasan terapeutik:

Risedronsyra

Status kebenaran:

Avregistrerad

Tarikh kebenaran:

2008-11-26

Risalah maklumat

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVESTRA SEPTIMUM 35 MG FILM-COATED 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 Avestra Septimum is and what it is used for
2.
What you need to know before you take Avestra Septimum
3.
How to take Avestra Septimum
4.
Possible side effects
5.
How to store Avestra Septimum
6.
Contents of the pack and other information
1.
WHAT AVESTRA SEPTIMUM IS AND WHAT IT IS USED FOR
WHAT AVESTRA SEPTIMUM IS
Avestra 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.
WHAT AVESTRA SEPTIMUM IS USED FOR
Treatment of osteoporosis in postmenopausal women, even if
osteoporosis

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Avestra Septimum 35 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium (equivalent
to 32.5 mg risedronic acid).
Excipient with known effect
Each film-coated tablet contains 126.0 mg lactose monohydrate
(equivalent to 119.7 mg lactose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Oval light-orange 11.7 x 5.8 mm film-coated tablet with RSN on one
side and 35 mg on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures. Treatment of
established postmenopausal osteoporosis, to reduce the risk of hip
fractures (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 35 mg tablet orally once a week.
The tablet should be taken on
the same day each week.
Special populations
_Elderly_
No dosage adjustment is necessary since bioavailability, distribution
and elimination were similar in
elderly (>60 years of age) compared to younger subjects.
This has also been shown in the very elderly, 75 years old and above
postmenopausal population.
_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 (see section 5.1).
Method of administration
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients
should take Avestra Septimum 35 mg:
Page 3 of 11
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Before breakfast: At least 30 minutes before the first food, other
med