Alendrostad 10 mg Tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

natriumalendronattrihydrat

Available from:

STADA Arzneimittel AG

ATC code:

M05BA04

INN (International Name):

sodium

Dosage:

10 mg

Pharmaceutical form:

Tablett

Composition:

natriumalendronattrihydrat 13,05 mg Aktiv substans; laktosmonohydrat Hjälpämne

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Alendronsyra

Authorization status:

Avregistrerad

Authorization date:

2004-12-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDROSTAD 10 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 Alendrostad is and what it is used for
2. What you need to know before you take Alendrostad
3. How to take Alendrostad
4. Possible side effects
5. How to store Alendrostad
6. Contents of the pack and other information
1. WHAT ALENDROSTAD IS AND WHAT IT IS USED FOR
Alendronate belongs to a group of medicines called bisphosphonates.
Alendronate prevents
the loss of bone, and reduces the risk of spine and hip fractures.
ALENDROSTAD IS USED

to treat OSTEOPOROSIS. It is also used to prevent osteoporosis in
people who are taking
medicines called glucocorticoids (medicines which may be used to treat
inflammations).
Alendrostad has been shown to REDUCE THE RISK OF SPINE AND HIP
FRACTURES in women
and SPINE FRACTURES in men.
Osteoporosis is a thinning and weakening of the bones. Early on,
osteoporosis usually has
no symptoms, but if left untreated it can cause fractured bones.
Although these usually hurt,
fractures in the spine may go unnoticed until they cause height loss.
Fractures can happen
during normal, everyday activity, such as lifting, or from minor
injury that would not damage
healthy bone. Fractures usually occur at the hip, spine, or wrist and
can lead not only to pain
but also to considerable problems like stooped posture (‘dowager’s
hump’) and loss of
mobility.
As well as your treatment with Alendrostad, your doctor may suggest
you make changes to
your

Summary of Product characteristics

Produktinformationen för Alendrostad 10 mg tablett, MTnr 21347,
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 PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alendrostad 10 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg alendronic acid (as sodium alendronate
trihydrate).
Excipients: each tablet contains 103.95 mg lactose monohydrate
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, capsule-shaped tablet, embossed "AN 10" on one
side and "Arrow logo"
on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis.
Alendronate reduces the risk of vertebral and hip fractures.
Treatment of osteoporosis in men at increased risk of fracture. A
reduction in the incidence of
vertebral, but not of non-vertebral fractures has been demonstrated.
Prophylaxis of glucocorticoid-induced osteoporosis
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
_Post-menopausal osteoporosis:_
The recommended dosage is 10 mg once daily.
_Osteoporosis in men at increased risk of fracture:_
The recommended dosage is 10 mg once daily.
_Glucocorticoid-induced osteoporosis:_
For post-menopausal women who are not receiving oestrogen treatment
the recommended
dose is one 10 mg tablet daily. For other populations, see summary of
product characteristics
for preparations that contain 5 mg alendronate.
_To obtain satisfactory absorption of alendronate_
Alendrostad tablets must be taken on an empty stomach immediately on
rising in the morning,
_ _
with