Avestra 5 mg Filmdragerad tablett

Land: Schweden

Sprache: Schwedisch

Quelle: Läkemedelsverket (Medical Products Agency)

Wirkstoff:

risedronatnatrium

Verfügbar ab:

Theramex Ireland Limited

ATC-Code:

M05BA07

INN (Internationale Bezeichnung):

risedronate

Dosierung:

5 mg

Darreichungsform:

Filmdragerad tablett

Zusammensetzung:

risedronatnatrium 5 mg Aktiv substans; laktosmonohydrat Hjälpämne

Klasse:

Apotek

Verschreibungstyp:

Receptbelagt

Therapiebereich:

Risedronsyra

Produktbesonderheiten:

Förpacknings: Blister, 14 tabletter; Blister, 28 tabletter; Blister, 84 tabletter; Blister, 98 tabletter; Blister, 140 tabletter (sjukhusförpackning); Blister, 20 x 1 tablett (endos och sjukhusförpackning)

Berechtigungsstatus:

Godkänd

Berechtigungsdatum:

1999-10-07

Gebrauchsinformation

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVESTRA 5 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 is and what it is used for
2.
What you need to know before you take Avestra
3.
How to take Avestra
4.
Possible side effects
5.
How to store Avestra
6.
Contents of the pack and other information
1.
WHAT AVESTRA IS AND WHAT IT IS USED FOR
WHAT AVESTRA IS
Avestra 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 is more likely to occur in women who have reached the
menopause early and also in
patients treated long-term with steroids.
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 IS USED FOR
The treatment of osteoporosis

in postmenopausal women
The prevention of osteoporosis

in women with an increased risk of osteoporosis (includ

Fachinformation

Produktinformationen för Avestra 5 mg filmdragerad tablett, MTnr
15292, 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 5 mg film-coated tablets.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent
to 4.64 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 yellow film-coated tablet with RSN on one side and 5 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. Prevention of
osteoporosis in postmenopausal women with increased risk of
osteoporosis (see section 5.1).
To maintain or increase bone mass in postmenopausal women undergoing
long-term (more than 3
months), systemic corticosteroid treatment at doses

7.5mg/day prednisone or equivalent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily dose in adults is one 5 mg tablet orally. The
absorption of Avestra is affected
by food, thus to ensure adequate absorption patients should take
Avestra:

Before breakfast: At least 30 minutes before the first food, other
medicinal product or drink
(other than plain water) of the day.
In the particular instance that before breakfast dosing is not
practical, Avestra can be taken between
meals or in the evening at the same time