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Intended for UK patients and members of the public

Gramegran 50 mg Film-coated Tablets

Gramegran 50 mg Film-coated Tablets

PL Number:
0142/1304
MA Holder:
Accord-UK Ltd
Product Classification:
P
Product Status:
Active

Product Documentation

  • Description of update:

    IAin C.I.3.a: To register an update SmPC sections 4.6, 4.8 & PIL in line with PRAC update (PSUSA/00002832/202409) for a causal relationship between sumatriptan and breast pain in breast-feeding and non-breast-feeding women.

    IA A.6: To register an update SmPC section 5.1 in line with WHO ATC Index; the pharmacotherapeutic group has been updated.

    Date of approval: 10/09/2025

    PIL sections updated: 2, 3, 4 and 6

  • Description of update:

    IAin C.I.3.a: To register an update SmPC sections 4.6, 4.8 & PIL in line with PRAC update (PSUSA/00002832/202409) for a causal relationship between sumatriptan and breast pain in breast-feeding and non-breast-feeding women.

    IA A.6: To register an update SmPC section 5.1 in line with WHO ATC Index; the pharmacotherapeutic group has been updated.

    Date of approval: 10/09/2025

    SmPC sections updated: 4.6, 4.8, 5.1 and 10

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

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