Alendronic acid 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alendronate sodium

Available from:

Viatris UK Healthcare Ltd

ATC code:

M05BA04

INN (International Name):

Alendronate sodium

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5016695000060

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALENDRONIC ACID 10 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 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
Alendronic Acid contains the active substance sodium alendronate.
Your medicine is in the form of a tablet. Alendronic Acid belongs to a
group of medicines
called bisphosphonates. Bisphosphonates can be used to help bone
disease such as
osteoporosis. Alendronic Acid can treat osteoporosis in men and
post-menopausal women, by
stopping bones becoming thinner and weaker. Alendronic Acid can also
be used to treat and
prevent osteoporosis in patients at risk of bone loss, who are on
long-term steroid treatment
(such as prednisolone and dexamethasone).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALENDRONIC ACID
DO NOT TAKE ALENDRONIC ACID:

if you are allergic to sodium alendronate or any of the other
ingredients of this
medicine (listed in section 6)

if you have problems with your gullet (oesophagus – the tube that
connects your
mouth with your stomach) causing difficulty swallowing or food to
become stuck

if you are unable to stand or sit upright for at least 30 minutes

if you know you have very low blood levels of calcium (hypocalcaemia).

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alendronic acid as sodium alendronate.
Excipient with known effect:
Each tablet contains 129.95 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White oval shaped tablet embossed ‘AD10’ on one side and a ‘G’
on the reverse,
approximately 9.9mm x 5.9mm
4.1
THERAPEUTIC INDICATIONS
Treatment of osteoporosis in post-menopausal women to prevent
fractures.
Treatment of osteoporosis in men to prevent fractures.
Treatment of glucocorticoid-induced osteoporosis and prevention of
bone loss in
post-menopausal women considered at risk of developing the disease.
Risk factors often associated with the development of osteoporosis
include thin body
build, family history of osteoporosis, early menopause, moderately low
bone mass
and long-term glucocorticoid therapy, especially with high doses (
≥
15 mg/day).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treatment of osteoporosis in post-menopausal women:_ The recommended
dosage is
10 mg once a day.
_Treatment of osteoporosis in men_: The recommended dosage is 10 mg
once a day.
_Treatment and prevention of glucocorticoid-induced osteoporosis: _
For post-
menopausal women not receiving hormone replacement therapy (HRT) with
an
oestrogen, the recommended dosage is 10 mg once a 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.
Method of administration
For oral administration.
_To permit adequate absorption of alendonate:_
Alendronic Acid 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), f