BONVIVA TABLET 150 MG [SIN13206P]

Product Info

BONVIVA TABLET 150 MG

[SIN13206P]

4.1 Therapeutic indications
Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.

The optimal duration of use of bisphosphates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

4.2 Posology and method of administration

Posology
For oral use.
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.
Bonviva 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or any other oral medicinal products or supplementation (including calcium):

Method of administration
Tablets should be swallowed whole with a glass of plain water (180 to 240 ml) while the patients is sitting or standing in an upright position. Patients should not lie down for 1 hour after taking Bonviva.

• Plain water is the only drink that should be taken with Bonviva. Please note that some mineral waters may have a higher concentration of calcium and therefore, should not be used.

• Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.

In case a dose is missed, patients should be instructed to take one Bonviva 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 (see section 4.4 and section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations
Patients with renal impairment
No dosage adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 micromole/l (2.3 mg/dl) or where creatinine clearance is ≥ 30 ml/min. Bonviva is not recommended for use in patients who have a serum creatinine above 200 micromole/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30ml/min, because of limited clinical data available from studies including such patients. (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment
No dosage adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly population (≥ 65 years)
No dosage adjustment is required (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children and adolescents
Safety and efficacy have not been established in patients less than 18 years old.

4.3 Contraindications

• Patients with uncorrected hypocalcaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). As with all bisphosphonates indicated in the treatment of osteoporosis, pre-existing hypocalcaemia needs to be corrected before initiating therapy with Bonviva.

• Hypersensitivity to ibandronic acid or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• As with several bisphosphonates Bonviva is contraindicated in patients with abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Bonviva is contraindicated in patients who are unable to stand or sit upright for at least 60 minutes (see sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).