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Intended for UK patients and members of the public

Lercanidipine 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

Lercanidipine hydrochloride 10mg Film-coated tablet

PL Number:
0142/1154
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Variation approval date: 14/10/2022

     

    Single Variation

    Variation Type: IB, C.I.2.a

     

    Variation Description: SmPC & PIL update in line with the reference product, Zanidip. An editorial update has been made to SmPC section 3 for the 20mg SmPC to change the word “colored” to “coloured”.

     

    SmPC sections updated – 3 (20mg only), 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10

    PIL sections updated – Introduction, Contents, 1, 2, 3, 4, 5 and 6.

  • 1.Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.

     

    2.Type IAIN (B.II.b.2.C.2) variation application to add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

    Consequentially updated UK PIL mock-up.

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

Lercanidipine hydrochloride 20mg Film-coated tablet

PL Number:
0142/1155
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Variation approval date: 14/10/2022

     

    Single Variation

    Variation Type: IB, C.I.2.a

     

    Variation Description: SmPC & PIL update in line with the reference product, Zanidip. An editorial update has been made to SmPC section 3 for the 20mg SmPC to change the word “colored” to “coloured”.

     

    SmPC sections updated – 3 (20mg only), 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10

    PIL sections updated – Introduction, Contents, 1, 2, 3, 4, 5 and 6.

  • 1.Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.

     

    2.Type IAIN (B.II.b.2.C.2) variation application to add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

    Consequentially updated UK PIL mock-up.

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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