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Intended for UK patients and members of the public

Ibandronic Acid Tablets

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Ibandronic acid 50mg Film-coated Tablets

PL Number:
0142/0964
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Variation Description: To update SmPC sections 2, 4.4, 4.5, 4.8 and 6.1. Sections 2 and 4.4 have been updated in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for lactose and sodium; Section 4.5 has been updated to correct the spelling of `Ph' to `pH'; Section 4.8 and leaflet have been updated in line with EMA National ADR reporting system wording for the UK; Section 6.1 has been updated to correct the spelling of `sylica' to `silica' in line with module 3 M.3.2.P.1. Consequently, the PIL has been updated. Additionally, the wording on how to take with food has been updated in PIL section 3 to improve readability. The active substance wording in PIL section 6 has been updated to align with SmPC section 2, as well as an update to the tablet description to align with SmPC section 3. The PIL has been updated throughout to align with the latest QRD template as well as the correction of grammar and spelling.

    SmPC sections updated – 2, 4.4, 4.5, 4.8, 6.1 and 10.

  • Variation Description: To update SmPC sections 2, 4.4, 4.5, 4.8 and 6.1. Sections 2 and 4.4 have been updated in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for lactose and sodium; Section 4.5 has been updated to correct the spelling of `Ph' to `pH'; Section 4.8 and leaflet have been updated in line with EMA National ADR reporting system wording for the UK; Section 6.1 has been updated to correct the spelling of `sylica' to `silica' in line with module 3 M.3.2.P.1. Consequently, the PIL has been updated. Additionally, the wording on how to take with food has been updated in PIL section 3 to improve readability. The active substance wording in PIL section 6 has been updated to align with SmPC section 2, as well as an update to the tablet description to align with SmPC section 3. The PIL has been updated throughout to align with the latest QRD template as well as the correction of grammar and spelling.

    PIL sections updated – Index, 2, 3, 4, 5 and 6.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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