Avestra Septimum 35 mg Filmdragerad tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

risedronatnatrium

Tillgänglig från:

Theramex Ireland Limited

ATC-kod:

M05BA07

INN (International namn):

risedronate

Dos:

35 mg

Läkemedelsform:

Filmdragerad tablett

Sammansättning:

risedronatnatrium 35 mg Aktiv substans; laktosmonohydrat Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Risedronsyra

Produktsammanfattning:

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

Bemyndigande status:

Godkänd

Tillstånd datum:

2002-07-19

Bipacksedel

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

Produktens egenskaper

Produktinformationen för Avestra Septimum 35 mg filmdragerad tablett,
MTnr 17859, gäller
vid det tillfälle då läkemedlet godkändes. Informationen kommer
inte att uppdateras eftersom
läkemedlet inte marknadsförs i Sverige. Av samma anledning finns
inte någon svensk
produktinformation.
Den engelska produktinformationen kommer dock att uppdateras när
Sverige är referensland
för produkten.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Avestra Septimum 35 mg film-coated tablets.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium (equivalent
to 32.5 mg risedronic acid).
Excipients: Each film-coated tablet contains lactose.
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablet.
Oval light-orange film-coated tablet with RSN on one side and 35 mg on
the other.
4
C
LINICAL
P
ARTICULARS
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
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.
The absorption of risedronate sodium is affected by food, thus to
ensure adequate absorption patients
should take Avestra Septimum 35 mg:

Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink
(other than plain water) of the day.
Patients should be instructed that if a dose is missed, one Avestra
Septimum 35 mg tablet should be
taken on the day that the tablet is remembered. Patients should then
return to taking one tablet once a
week on the day the