BONEFURBIT Film Coated Tablet 150 Base Milligrams
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
IBANDRONATE SODIUM MONOHYDRATE
Available from:
Laboratorios LICONSA, S.A.
Dosage:
150 Base Milligrams
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-11-12
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bonefurbit 150mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg ibandronic acid (as ibandronate sodium hydrate).
Excipients:
Each film-coated tablet contains 88.60 mg lactose monohydrate. For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White film-coated tablets of oblong shape and scored “LC” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).
A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been
established.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The recommended dose is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the
same date each month.
Bonefurbit should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than
water) of the day (see section 4.5) or any other oral medicinal products or supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one Bonefurbit 150 mg tablet the morning after the tablet
is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their
dose once a month on their originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one
tablet once a month as originally scheduled.
Patients should not take two tablets within the same week.
Patients should receive supplemental calcium and / or vitamin D if dietary intake is inadequate
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