EMA has concluded that the benefits of medicines containing methocarbamol and paracetamol continue to outweigh their risks in the short-term treatment of painful muscle spasms.
EMA’s review was started because recent publications1,2,had raised questions about the effectiveness of the combination of these substances at treating conditions such as low back pain in the doses at which they are present in these medicines.

EMA’s human medicines committee (CHMP) considered all available data on medicines containing methocarbamol 380 mg and paracetamol 300 mg and concluded that the available evidence was not enough to question their effectiveness in the treatment of painful muscle spasms.

In addition, the Committee considered that the safety profile of each substance contained in these medicines is well known, and no new significant safety concerns were identified for the fixed dose combination. However, a few cases of dry mouth and diarrhoea have been reported and may be caused by methocarbamol. The Committee therefore recommended including these as side effects in the product information.

1Saragiotto BT, Machado GC, Ferreira ML, Pinheiro MB, Abdel Shaheed C, Maher CG. Paracetamol for low back pain. Cochrane Database Syst Rev. 2016 Jun 7;(6):CD012230.
2Emrich OM, Milachowski KA, Strohmeier M. Methocarbamol in acute low back pain. A randomized double-blind controlled study. MMW Fortschr Med. 2015 Jul;157 Suppl 5:9-16

Posted on the EMA website on 27 March 2020