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Intended for UK patients and members of the public

Hydralazine 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

Hydralazine Tablets BP 25mg

PL Number:
0142/0499
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • IB C.I.2.a - SmPC section 4.2 has been updated in line with the reference product Apresoline 25 mg Tablets – PL 20072/0026 (MAH: Amdipharm UK Limited) dated 13/03/2024. No consequential update to the PIL. SmPC section 4.4 for the 25mg strength has been updated to correct the spelling of ‘lactose’ to ‘lactase’ in the lactose excipient warning.

  • Description of update:

    To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC and PIL in line with reference product, Apresoline 25 mg Tablets, PL 20072/0026, MAH: Amdipharm UK Limited, SPC updated 13/03/2024. In addition, editorial update has been made to section 4.2 of the SmPC to amend the dosing for the 25mg strength which was incorrectly updated with the 50mg fragment during variation approval for PL 00142/0499 - 0048. Moreover, section 2 of PIL in line with the excipient guideline (SANTE-2017-11668) dated 22 November 2019 and section 4 of PIL has been updated to remove an ADR not listed in the SmPC or reference PI (enlargement of the spleen).

    PIL sections updated: 1, 2, 3, 4 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

Hydralazine Tablets BP 50mg

PL Number:
0142/0500
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • IB C.I.2.a - SmPC section 4.2 has been updated in line with the reference product Apresoline 25 mg Tablets – PL 20072/0026 (MAH: Amdipharm UK Limited) dated 13/03/2024. No consequential update to the PIL. SmPC section 4.4 for the 25mg strength has been updated to correct the spelling of ‘lactose’ to ‘lactase’ in the lactose excipient warning.

  • Description of update:

    To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC and PIL in line with reference product, Apresoline 25 mg Tablets, PL 20072/0026, MAH: Amdipharm UK Limited, SPC updated 13/03/2024. In addition, editorial update has been made to section 4.2 of the SmPC to amend the dosing for the 25mg strength which was incorrectly updated with the 50mg fragment during variation approval for PL 00142/0499 - 0048. Moreover, section 2 of PIL in line with the excipient guideline (SANTE-2017-11668) dated 22 November 2019 and section 4 of PIL has been updated to remove an ADR not listed in the SmPC or reference PI (enlargement of the spleen).

    PIL sections updated: 1, 2, 3, 4 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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