Alendronic acid 70mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Alendronate sodium

थमां उपलब्ध:

Fannin (UK) Ltd

ए.टी.सी कोड:

M05BA04

INN (इंटरनेशनल नाम):

Alendronate sodium

डोज़:

70mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 06060200

सूचना पत्रक

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.

उत्पाद विशेषताएं

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 (as sodium trihydrate).
Each tablet contains 192.03 mg of lactose (as cellecatose 80).
Excipients with known effect
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round, biconvex conventional tablets, marked with ‘70’ on
one side and plain
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Alendronic Acid 70 mg
Tablets reduce
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. 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.
_ _
_To permit adequate absorption of alendronic acid:_
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 alendronic acid (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 70mg Tablets whole.
Patients
should not 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