BONVIVA Film-coated tablet Ref.[109772] Active ingredients: Ibandronic acid

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.

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) or any other oral medicinal products or supplementation (including calcium).

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).

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 Bonviva on an individual patient basis, particularly after 5 or more years of use.

Special populations

Patients with renal impairment

Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min due to limited clinical experience (see section 4.4 and section 5.2).

No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 ml/min.

Patients with hepatic impairment

No dose adjustment is required (see section 5.2).

Elderly population (>65 years)

No dose adjustment is required (see section 5.2).

Paediatric population

There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population. (see section 5.1 and section 5.2).

Method of administration

For oral use.

• Tablets should be swallowed whole with a glass of water (180 to 240 ml) while the patient is sitting or standing in an upright position. Water with a high concentration of calcium should not be used. If there is a concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
• Patients should not lie down for 1 hour after taking Bonviva.
• Water is the only drink that should be taken with Bonviva.
• Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.

No specific information is available on the treatment of overdose with Bonviva.

However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia. Milk or antacids should be given to bind Bonviva, and any adverse reactions treated symptomatically. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

5 years.

This medicinal product does not require any special storage conditions.

Bonviva 150 mg film-coated tablets are supplied in blisters (PVC/PVDC, sealed with aluminium foil) containing 1 or 3 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The release of pharmaceuticals in the environment should be minimized.