Alendropol Veckotablett 70 mg Tablett

País: Suècia

Idioma: suec

Font: Läkemedelsverket (Medical Products Agency)

ingredients actius:

natriumalendronattrihydrat

Disponible des:

Pharmaceutical Works Polpharma S.A.

Codi ATC:

M05BA04

Designació comuna internacional (DCI):

sodium

Dosis:

70 mg

formulario farmacéutico:

Tablett

Composición:

natriumalendronattrihydrat 91,36 mg Aktiv substans; laktosmonohydrat Hjälpämne

clase:

Apotek

tipo de receta:

Receptbelagt

Área terapéutica:

Alendronsyra

Estat d'Autorització:

Avregistrerad

Data d'autorització:

2008-07-03

Informació per a l'usuari

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDROPOL VECKOTABLETT 70 MG TABLETS
_sodium alendronate_
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 Alendropol Veckotablett is and what it is used for
2. What you need to know before you take Alendropol Veckotablett
3. How to take Alendropol Veckotablett
4. Possible side effects
5. How to store Alendropol Veckotablett
6. Contents of the pack and other information
1.
WHAT ALENDROPOL VECKOTABLETT IS AND WHAT IT IS USED FOR
Alendropol Veckotablett belong to a group of medicines called
bisphosphonates. They do not contain
hormones. Alendropol Veckotablett help to rebuild bone and prevent
reduction of bone mass that
occurs in women in relation to menopause. Alendropol Veckotablett
reduces the risk for spinal and hip
fractures.
Your doctor has prescribed Alendropol Veckotablett to treat your
osteoporosis. Alendropol
Veckotablett reduce the risk for spinal and hip fractures.
WHAT IS OSTEOPOROSIS?
Osteoporosis leads to thinner and weaker bones. It is usual in women
after the menopause. With
menopause the ovaries stop producing the female hormone oestrogen
which helps keep a woman’s
bones healthy. Consequently bone mass is lost and bones become weaker.
The earlier a woman
reaches menopause, the greater the risk for osteoporosis.
At an early stage, osteoporosis usually has no symptoms. Without
treatment however, osteoporosis can
lead to fractures. Although fractures usually cause pain, spinal
fractures can go unnoticed until they
lead to a reduction

Fitxa tècnica

1
Produktinformationen för Alendropol Veckotablett 70 mg tablett, MTnr
23710, 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.
PDF rendering: Titel 00117955, Version 7.1, Namn Alendropol
Veckotablett 70 mg tablet SmPC
2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendropol Veckotablett 70 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Every tablet contains 70 mg alendronate (as alendronate sodium
(trihydrate)).
Excipient with known effect: lactose monohydrate.
Each tablet contains 128.64 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Tablets are white, oblong and biconvex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Alendronate minimises the
risk of hip and spinal fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
Recommended dosage is one 70 mg tablet once a week.
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.
_In order to achieve satisfactory absorption of alendronate:_
Alendropol Veckotablett should only be taken with normal water a
minimum of 30 minutes before the
day’s first meal, drink or other medicinal products. Other drinks
(including mineral water), food and
certain medicinal products are likely to reduce the absorption of
alendronate (see section 4.5).
_In order to facilitate t