Alendrostad Veckotablett 70 mg Tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

natriumalendronattrihydrat

Dostopno od:

STADA Arzneimittel AG

Koda artikla:

M05BA04

INN (mednarodno ime):

sodium

Odmerek:

70 mg

Farmacevtska oblika:

Tablett

Sestava:

laktosmonohydrat Hjälpämne; natriumalendronattrihydrat 91,36 mg Aktiv substans

Razred:

Apotek

Tip zastaranja:

Receptbelagt

Terapevtsko območje:

Alendronsyra

Status dovoljenje:

Avregistrerad

Datum dovoljenje:

2004-12-03

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDROSTAD 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 Alendrostad Veckotablett is and what it is used for
2. What you need to know before you take Alendrostad Veckotablett
3. How to take Alendrostad Veckotablett
4. Possible side effects
5. How to store Alendrostad Veckotablett
6. Contents of the pack and other information
1. WHAT ALENDROSTAD VECKOTABLETT 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 VECKOTABLETT IS USED

to treat OSTEOPOROSIS. Alendrostad Veckotablett has been shown to
reduce the risk of
spine and hip fractures in WOMEN.
ALENDROSTAD VECKOTABLETT IS A ONCE WEEKLY TREATMENT.
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 Veckotablett, your doctor
may suggest you make
changes to you

Lastnosti izdelka

Produktinformationen för Alendrostad Veckotablett 70 mg tablett, MTnr
21348, 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 Veckotablett 70 mg tablett
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70mg alendronic acid (as sodium alendronate
trihydrate)
Excipients: each tablet contains 142.64 mg lactose monohydrate
For a 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 post-menopausal osteoporosis.
Alendronate reduces the risk of vertebral and hip fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
The recommended dose is one 70 mg tablet per week.
_To obtain satisfactory absorption of alendronate_
Alendrostad Veckotablett 70mg tablets must be taken on an empty
stomach immediately on
rising in the morning, with plain water only, at least 30 minutes
before the first food, drink or
other medication of the day. Other drinks (including mineral water),
food and some medicines
are likely to reduce the absorption of alendronate (see section 4.5).
_To assist delivery to the stomach and thus reduce the risk of
irritation/side effects locally and _
_in the oesophagus (see section 4.4)_

Alendrostad Veckotablett 70mg tablets should only be swallowed on
arising for the day
with a whole glass of water (not less than 200 ml or 7 fl. oz).

Alendrostad Veckotablett tablets should be swallowed whole.