Alendronic Acid 70mg Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ALENDRONIC ACID

Disponible depuis:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

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:

Authorised

Date de l'autorisation:

2014-05-19

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALENDRONIC ACID 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 Alendronic Acid is and what it is used for
2.
What you need to know before you take Alendronic Acid
3.
How to take Alendronic Acid
4.
Possible side effects
5.
How to store Alendronic Acid
6.
Contents of the pack and other information
1. WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONIC ACID?
Alendronic Acid is a tablet containing the active substance alendronic
acid (commonly called
alendronate) and belongs to a group of non-hormonal medicines called
bisphosphonates. Alendronic
Acid 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 ALENDRONIC ACID USED FOR?
Your doctor has prescribed Alendronic Acid to treat your osteoporosis.
Alendronic Acid reduces the
risk of spine and hip fractures.
ALENDRONIC ACID 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 menopause, the ovaries stop producing the female hormone,
oestrogen, which helps to keep a
woman’s skeleton healthy. As a result, bone loss occurs and bones
become weaker. The earlier a
woman reaches the menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left untreated,
however, it can result in broken
bones. Altho

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 70 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (equivalent to 91.363 mg of
sodium alendronate
trihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, oval, biconvex, uncoated tablets debossed with
‘F’ on one side and ‘21’ on the
other side. The size is 12.8 mm X 7.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronic acid is indicated in adults for the treatment of
post-menopausal osteoporosis.
Alendronic acid reduces the risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 70 mg tablet once weekly.
Patients should be instructed that if they miss a dose of Alendronic
Acid Once Weekly, they should
take one tablet on the morning after they remember. They should not
take two tablets on the same day
but should return to taking one tablet once a week, as originally
scheduled on their chosen day.
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.
_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.
_ _
_Renal impairment_
:
No dosage adjustment is necessary for patients with creatinine
clearance greater than 35 ml/min.
Alendronate is not recommended for patients with renal impairment
where creatinine clearance is less
than 35 ml/min, due to lack of experience.
_ _
_Paediatric population_
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Alendronate 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
oste