Alendronic acid 70mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Alendronate sodium

Disponibil de la:

Teva UK Ltd

Codul ATC:

M05BA04

INN (nume internaţional):

Alendronate sodium

Dozare:

70mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 06060200; GTIN: 5017007029854

Prospect

1
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.

It is particularly important to understand the information in section
3. before taking this medicine.
WHAT IS IN THIS LEAFLET
1.
What Alendronic Acid 70 mg Tablets is and what it is used for
2.
What you need to know before you take Alendronic Acid 70 mg Tablets
3.
How to take Alendronic Acid 70 mg Tablets
4.
Possible side effects
5.
How to store Alendronic Acid 70 mg Tablets
6.
Contents of the pack and other information
1.
WHAT ALENDRONIC ACID 70 MG TABLETS IS AND WHAT IT IS USED FOR
WHAT IS ALENDRONIC ACID 70 MG TABLETS?
Alendronic Acid 70 mg 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 70
mg tablets 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 70 MG TABLETS USED FOR?
Your doctor has prescribed
Alendronic Acid 70 mg tablets
to treat your osteoporosis. It reduces the risk of spine
and hip fractures.
ALENDRONIC ACID 70 MG TABLETS 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 res

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Alendronic acid 70 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as 81.2 mg alendronate
sodium monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off-white, flat-faced bevel-edged round tablet, debossed with
T on one side, plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alendronic acid is indicated in adults for the treatment of
postmenopausal osteoporosis. It 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 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 alendronic acid 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 _
The safety and efficacy of Alendronic acid in children less than 18
years of age has not been
established. This medicinal product should not be used in children
less than 18 years of age.
Currently available data for alendronic acid in the paediatric
population is described in section 5.1.
_ _
Method of administratio