Alendronat 1A Farma Veckotablett 70 mg Filmdragerad tablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

natriumalendronattrihydrat

Prieinama:

1A Farma A/S

ATC kodas:

M05BA04

INN (Tarptautinis Pavadinimas):

sodium

Dozė:

70 mg

Vaisto forma:

Filmdragerad tablett

Sudėtis:

natriumalendronattrihydrat 91,35 mg Aktiv substans

Klasė:

Apotek

Recepto tipas:

Receptbelagt

Gydymo sritis:

Alendronsyra

Produkto santrauka:

Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 6 tabletter; Blister, 8 tabletter; Blister, 12 tabletter; Blister, 40 tabletter; Blister, 16 tabletter; Blister, 20 tabletter; Blister, 24 tabletter

Autorizacija statusas:

Avregistrerad

Leidimo data:

2008-09-05

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONAT 1A FARMA VECKOTABLETT 70 MG FILM-COATED 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.
It is particularly important to understand the information in section
3. How to take Alendronat 1A
Farma Veckotablett before taking this medicine.
WHAT IS IN THIS LEAFLET
1. What Alendronat 1A Farma Veckotablett is and what it is used for
2. What you need to know before you take Alendronat 1A Farma
Veckotablett
3. How to take Alendronat 1A Farma Veckotablett
4. Possible side effects
5. How to store Alendronat 1A Farma Veckotablett
6. Contents of the pack and other information
1.
WHAT ALENDRONAT 1A FARMA VECKOTABLETT IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONAT 1A FARMA VECKOTABLETT?
Alendronat 1A Farma Veckotablett is a film-coated tablet containing
the active substance alendronate
sodium.
WHAT IS ALENDRONATE?
Alendronate belongs to a group of non-hormonal medicines called
bisphosphonates. Alendronate
prevents the loss of bone that occurs in women after they have been
through the menopause, and helps
to rebuild bone. It reduces the risk of spine and hip fractures.
WHAT IS ALENDRONAT 1A FARMA VECKOTABLETT USED FOR?
Your doctor has prescribed Alendronat 1A Farma Veckotablett to treat
your osteoporosis. Alendronat
1A Farma Veckotablett reduces the risk of spine and hip fractures.
Alendronat 1A Farma Veckotablett is a once weekly treatment.
WHAT IS OSTEOPOROSIS?
Osteoporosis is a thinning and weakening of the bones. It is common in
women after the menopause.
At the me

Prekės savybės

Produktinformationen för Alendronat 1A Farma Veckotablett 70 mg
filmdragerad tablett,
MTnr 25385, 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.
S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Alendronat 1A Farma Veckotablett 70 mg Film-coated tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 70 mg alendronic acid (as sodium
alendronate).
For a full list of excipients see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Film-coated tablet.
White, round, biconvex film coated tablet, debossed with "ALN 70" on
one side.
4
C
LINICAL
P
ARTICULARS
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.
The recommended dose is one 70 mg tablet per week.
_To obtain satisfactory absorption of alendronate_
Alendronat 1A Farma Veckotablett 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)._
• Alendronat 1A Farma Veckotablett should only be swallowed on
arising for the day with a
whole glass of water (not less than 200 ml or 7 fl.oz).
• Alendronat 1A Farma Veckotablett should be swallowed whole. The
tablets should not be
chewed, sucked or allowed to dissolve in the mouth on account of the
risk of oropharyngeal
ulceration. Pat