Alendronic Acid 70mg Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ALENDRONIC ACID

Disponible depuis:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Code ATC:

M05BA04

DCI (Dénomination commune internationale):

ALENDRONIC ACID 70 mg

forme pharmaceutique:

TABLET

Composition:

ALENDRONIC ACID 70 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

DRUGS FOR TREATMENT OF BONE DISEASES

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2010-03-18

Notice patient

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 70MG 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 Alendronic Acid_ _70mg Tablets is and what it is used for
2.
What you need to know before you take Alendronic Acid_ _70mg Tablets
3.
How to take Alendronic Acid_ _70mg Tablets
4.
Possible side effects
5.
How to store Alendronic Acid_ _70mg Tablets
6.
Contents of the pack and other information
1. WHAT ALENDRONIC ACID 70MG TABLETS IS AND WHAT IT IS USED FOR
Alendronic acid belongs to a group of non-hormonal medicines known as
bisphosphonates, which
prevent bone loss from the body.
Alendronic acid is used to treat a condition called osteoporosis
(brittle bones). This condition is
common in women after the menopause. The earlier a woman reaches the
menopause, the greater
the risk of her developing osteoporosis.
Without treatment, osteoporosis can cause thinning and weakening of
the bones in the skeleton
which can then lead to fractures, usually of the hip, backbone and
wrists. Fractures can occur easily
in people suffering from osteoporosis including during normal everyday
activities such as heavy
lifting or from a minor injury or fall.
Alendronic acid helps to prevent bone loss and to build up bone which
may have been lost due to
osteoporosis. It can therefore reduce the risk of back and hip
fractures.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID 70MG TABLETS
DO NOT TAKE ALENDRONIC ACID 70MG TABLETS:
- If you are allergic to alendronic aci

Résumé des caractéristiques du produit

Page 1 of 10
S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Alendronic Acid 70mg Tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each tablet contains 70mg alendronic acid (as sodium alendronate
trihydrate)
Excipient with known effect:
Each tablet contains 142.64 mg lactose monohydrate
For the full list of excipients see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Tablet.
White to off-white, oval tablet, embossed "AN 70" on one side and the
Arrow logo on the other.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of post-menopausal osteoporosis.
Alendronic Acid 70mg Tablets reduces the risk of vertebral and hip
fractures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one 70 mg tablet per 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 Alendronic Acid 70mg Tablets on an individual patient basis,
particularly after 5 or more
years of use.
_Use in the elderly_: In clinical studies there was no age-related
difference in the efficacy or safety
profiles of alendronate. Therefore no dosage adjustment is necessary
for the elderly.
_Use in renal impairment_: No dosage adjustment is necessary for
patients with GFR greater than 35
ml/min. Alendronate is not recommended for patients with renal
impairment where GFR is less than
35 ml/min, due to lack of experience.
_Paediatric population:_ Alendronate sodium is not recommended for use
in children under the age of
18 years due to insufficient data on safety and efficacy in conditions
associated with paediatric
osteoporosis (also see section 5.1).
_ _
Method of administration
For oral use.
Page 2 of 10
_To permit adequate absorption of alendronate: _
Alendronic Acid 70mg Tablets 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 s