Accord Logo

Intended for UK patients and members of the public

Tadalafil 5mg Film-coated Tablets

Tadalafil 5mg Film-coated Tablets

PL Number:
20075/0414
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 2 (2.5mg, 5mg only), 4.1 (2.5mg, 5mg, 10mg only), 4.2, 4.3, 4.4, 4.5, 4.6 (2.5mg, 5mg, 10mg only), 4.8, 5.1 (2.5mg, 5mg, 20mg only), 5.2 (2mg only) in-line with the reference product (Cialis 2.5mg, 5mg, 10mg & 20mg filmcoated tablets; EU number: EU/1/02/237; MAH: Eli Lilly Nederland B.V., The Netherlands). Consequently, the PIL has been updated.

    SmPC Sections updated: 2, 4.1, 4.2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 10.

  • Description of update: To submit Type IB (C.I.2.a) variation application to update SmPC sections 2 (2.5mg, 5mg only), 4.1 (2.5mg, 5mg, 10mg only), 4.2, 4.3, 4.4, 4.5, 4.6 (2.5mg, 5mg, 10mg only), 4.8, 5.1 (2.5mg, 5mg, 20mg only), 5.2 (2mg only) in-line with the reference product (Cialis 2.5mg, 5mg, 10mg & 20mg filmcoated tablets; EU number: EU/1/02/237; MAH: Eli Lilly Nederland B.V., The Netherlands). Consequently, the PIL has been updated.

    PIL sections updated: 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

For any further assistance, please get in touch.

View product information as a: