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Intended for UK patients and members of the public

Betahistine 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

Betahistine dihydrochloride 16mg Tablets

PL Number:
20075/0315
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • The following change has been notified:

    • Type IA (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.

    • Type IA (B.II.b.1.b) : To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for primary packaging site.

    • Type IA (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

  • Update to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1, and the PIL in line with information of reference product.

    Variation approved 20/06/2025.

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

Discontinued Other versions of this medicine may still be available. Information for reference purposes.

Betahistine dihydrochloride 8mg Tablets

PL Number:
20075/0314
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Discontinued

Product Documentation

  • Update to SmPC sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 6.1, and the PIL in line with information of reference product.

    Variation approved 20/06/2025

  • The following change has been notified:

    • Type IA (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.

    • Type IA (B.II.b.1.b) : To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for primary packaging site.

    • Type IA (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

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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