Alendronic acid 70mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alendronate sodium

Available from:

DE Pharmaceuticals

ATC code:

M05BA04

INN (International Name):

Alendronate sodium

Dosage:

70mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200

Patient Information leaflet

very
P0010 / 00
Marketing Authorisation holder:
Somex Pharma, Seven Kings, IIford, Essex IG3 8BS, UK.
Manufacturer:
Somex Pharma, Seven Kings, IIford, Essex IG3 8RA, UK.
Name of the Artwork: Leaflet -
Alendronic Acid
Artwork code: P0010/00
Dimenion:
Open: 138 x 275 mm
Folded: 138 x 34.38 mm,± 0.5
Code: TN00003031
If you stop taking Alendronic Acid 70 mg
Tablets:
If you forget to take Alendronic Acid 70 mg
Tablets:
If you take more Alendronic Acid 70 mg
Tablets than you should:
This leaflet was last updated in 11/2011
- An allergic reaction (angioedema): swelling of the
Each tablet is white, oval, biconvex and marked with a
“70” on one side.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alendronic Acid 70 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70mg alendronic acid (as sodium alendronate
trihydrate)
Excipients: Each tablet contains 142.64 mg lactose monohydrate
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, oval tablet, embossed "AN 70" on one side and the
Arrow logo on
the other.
4
CLINICAL PARTICULARS
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.
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.
_To permit adequate absorption of alendronate: _
Alendronic Acid 70 mg 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 some medicinal
products
are likely to reduce the absorption of alendronate (see section 4.5).
_To facilitate delivery to the stomach and thus reduce the potential
for local _
_and oesophageal irritation/adverse experiences (see _section _4.4)_:
•
Alendronic Acid 70 mg Tablets should only be swallowed upon arising
for the day with a full glass of water (not less than 200 ml or 7
fl.oz.).
•
Patients should only swallow Alendronic Acid 70 mg Tablets whole.
Patients should not crush or chew the tablet or allow the tablet to
dissolve in their mouths because of a potential for oropharyngeal
ulceration.
•
Patients should not lie down until after their first food of the day
which
should be at least 30 minutes after taking the tablet.
•
Patients should not lie down for at le