BONDRONAT Film-coated tablets Ref.[7989] Active ingredients: Ibandronic acid

Bondronat therapy should only be initiated by physicians experienced in the treatment of cancer.

Posology

The recommended dose is one 50 mg film-coated tablet daily.

Special populations

Patients with hepatic impairment

No dose adjustment is required (see section 5.2).

Patients with renal impairment

No dose adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).

For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one 50 mg film-coated tablet every second day is recommended (see section 5.2).

For patients with severe renal impairment (CLcr <30 mL/min) the recommended dose is one 50 mg film-coated tablet once weekly. See dosing instructions, above.

Elderly population (>65 years)

No dose adjustment is necessary (see section 5.2).

Paediatric population

The safety and efficacy of Bondronat in children and adolescents below the age of 18 years have not been established. No data are available. (see section 5.1 and 5.2).

Method of administration

For oral use.

Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting should be continued for at least 30 minutes after taking the tablet. Water may be taken at any time during the course of Bondronat treatment (see section 4.5). Water with a high concentration of calcium should not be used. If there is 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.

• The tablets should be swallowed whole with a full glass of water (180 to 240 ml) while the patient is standing or sitting in an upright position.
• Patients should not lie down for 60 minutes after taking Bondronat.
• Patients should not chew, suck or crush the tablet because of a potential for oropharyngeal ulceration.
• Water is the only drink that should be taken with Bondronat.

No specific information is available on the treatment of overdosage with Bondronat. However, oral overdosage may result in upper gastrointestinal events, such as upset stomach, heartburn, oesophagitis, gastritis or ulcer. Milk or antacids should be given to bind Bondronat. Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

5 years.

Store in the original package in order to protect from moisture.

Bondronat 50 mg film coated tablets are supplied in blisters (aluminium) containing 7 tablets, which are presented as packs containing 28 or 84 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.