Alendronat ratiopharm Veckotablett 70 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

natriumalendronattrihydrat

Tillgänglig från:

ratiopharm GmbH

ATC-kod:

M05BA04

INN (International namn):

sodium

Dos:

70 mg

Läkemedelsform:

Tablett

Sammansättning:

natriumalendronattrihydrat 91,36 mg Aktiv substans; laktosmonohydrat Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Alendronsyra

Produktsammanfattning:

Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 12 tabletter; Blister, 8 tabletter; Blister, 40 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2004-12-03

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ALENDRONAT RATIOPHARM VECKOTABLETT 70 MG TABLETS_
Alendronic acid
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 Alendronat ratiopharm Veckotablett is and what it is used for
2.
What you need to know before you take Alendronat ratiopharm
Veckotablett
3.
How to take Alendronat ratiopharm Veckotablett
4.
Possible side effects
5.
How to store Alendronat ratiopharm Veckotablett
6.
Contents of the pack and other information
1.
WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS AND WHAT IT IS USED FOR
WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS
Alendronat ratiopharm Veckotablett belongs to a group of medicines
(called bisphosphonates) that are
used in the treatment of bone disorders. The medicine works directly
on your bones, making them
stronger and thus less likely to break.
The bone is a living tissue, i.e. the body is continuously breaking
down old bone tissue in the skeleton
and replacing it with new tissue. In women after the menopause, bone
loss (postmenopausal
osteoporosis) can occur. The bones become thinner and more brittle and
are more likely to break
following a fall or a sprain.
WHAT ALENDRONAT RATIOPHARM VECKOTABLETT IS USED FOR
Alendronat ratiopharm Veckotablett is used in the treatment of bone
loss (osteoporosis) in women
after the menopause, in order to reduce the risk of spinal and hip
fractures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONAT RATIOPHARM
VECKOTABLETT
DO NOT TAKE ALENDRONAT RATIOPHARM VECKOTABLETT
•
if you are allergic to a

Produktens egenskaper

Produktinformationen för Alendronat ratiopharm Veckotablett 70 mg
veckotablett MTnr
21346, 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 för de
produkter där Sverige
är referensland.
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 PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alendronat ratiopharm Veckotablett 70 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as sodium alendronate
trihydrate).
Excipient with known effect: 136 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, oval tablet, embossed "AN 70" on one side and the
Arrow logo on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis.
Alendronate reduces the risk of vertebral and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Posology
The recommended dosage is one 70 mg tablet once weekly. 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
alendronate on an individual
patient basis, particularly after 5 or more years of use.
Method of administration
_To permit adequate absorption of alendronate_
Alendronat ratiopharm Veckotablett must be taken at least 30 minutes
before the first food, beverage
or medicinal product of the day with plain water only. Other beverages
(including mineral water), food
and some medicinal products are likely to reduce the absorption of
alendronate (see section 4.5).
_To facilitate delivery to the stomach and thus reduce the potentia