ALENDRONIC ACID CEFT ONCE WEEKLY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
SODIUM ALENDRONATE
Available from:
Ceft Limited
Dosage:
70 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2011-10-07
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alendronic Acid Ceft Once Weekly 70mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 70 mg alendronic acid (as sodium alendronate).
For a 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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of vertebral and hip fractures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dosage is one 70 mg tablet once weekly.
_To permit adequate absorption of alendronic acid:_
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), 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 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 ' 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 least 30 minutes after taking alendronic acid.
Alendronic acid should not be taken at bedtime or before arising for the day.
Patient
Read the complete document
