Avestra 75 mg Filmdragerad tablett

Država: Švedska

Jezik: švedski

Izvor: Läkemedelsverket (Medical Products Agency)

Aktivni sastojci:

risedronatnatrium

Dostupno od:

Theramex Ireland Limited

ATC koda:

M05BA07

INN (International ime):

risedronate

Doziranje:

75 mg

Farmaceutski oblik:

Filmdragerad tablett

Sastav:

risedronatnatrium 75 mg Aktiv substans

Razred:

Apotek

Tip recepta:

Receptbelagt

Područje terapije:

Risedronsyra

Proizvod sažetak:

Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 6 tabletter; Blister, 8 tabletter

Status autorizacije:

Godkänd

Datum autorizacije:

2009-02-20

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVESTRA 75 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.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AVESTRA
DO NOT TAKE AVESTRA

If you are allergic to risedronate sodium or any of the other
ingredients of this medicine (listed
in section 6)

If your doctor has told you that you have a condition

Svojstava lijeka

Produktinformationen för Avestra 75 mg film-dragerad tablett, MTnr
24568, 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.
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 75mg film-coated tablets.
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 75 mg risedronate sodium, (equivalent
to 69.6 mg risedronic acid).
For a full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablet.
Oval pink film-coated tablet engraved with RSN on one side and 75 mg
on the other.
4
C
LINICAL
P
ARTICULARS
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
The recommended dose in adults is one 75mg tablet orally on two
consecutive days a month. The first
tablet should be taken on the same day each month, followed by the
second tablet the next day.

The absorption of risedronate sodium is affected by food and
polyvalent cations (see section
4.5), thus to ensure adequate absorption patients should take Avestra
75
mg before breakfast:
at least 30 minutes before the first food, other medicinal product or
drink (other than plain
water) of the day. Plain water is the only drink that should be taken
with Avestra 75mg
tablet. Please note that some mineral water may have a higher
concentration of calcium and
therefore should not be used (see section 5.2).

Patients who miss a dose of Avestra 75mg should be instructed to take
one Avestra 75 mg
tablet the morning after the day it is remembered, unless the time to
the next month’s
scheduled doses are within 7 days. Patients should then return to
taking Avestra 7