EMA concluded that the benefits of medicinal products containing the methocarbamol-paracetamol combination continue to outweigh their risks in the short-term treatment of painful muscle spasms.
The EMA review began because recent publications1,2 raised questions about the efficacy of the combination of these substances in conditions such as lower back pain at the doses present in these medicinal products. The CHMP considered all available data on medicinal products containing methocarbamol 380 mg and paracetamol 300 mg and concluded that the available data are not sufficient to call into question their efficacy in the treatment of painful muscle spasms. In addition, the Committee considers that the safety profile of each individual substance contained in these medicinal products is well known, and no new significant safety concerns have been identified for the fixed-dose combination. However, several cases of dry mouth and diarrhea possibly caused by methocarbamol have been reported. Therefore, the Committee recommended including them as adverse effects in the package leaflet.
Information for patients
- You can continue to use products containing methocarbamol 380 mg and paracetamol 300 mg to relieve painful muscle spasms, such as lower back spasms;
- regarding all medicinal products, the recommended dose and duration of treatment specified in the instructions for medical use should be observed;
- if you have any questions, you should talk to your doctor.
Information for healthcare professionals
- the EMA CHMP committee reviewed all available data on fixed-dose combination products from clinical trials, scientific literature and post-marketing data. The Committee concluded that the data do not constitute sufficient evidence to doubt the efficacy of methocarbamol 380 mg/paracetamol 300 mg in the short-term symptomatic treatment of painful muscle spasms associated with acute musculoskeletal disorders;
- in addition, no new significant information was identified regarding the overall safety profile of the fixed-dose combination medicinal product. Although both active substances are metabolized in the liver, there are no data on a possible interaction between the two substances that could lead to hepatotoxicity;
- cases of dry mouth and diarrhea were considered related to methocarbamol, and the CHMP recommended including them as adverse reactions in the package leaflet with the frequency “not known”.
More about medicines
At present, Robaxisal compuesto is the only product authorized in the EU that contains methocarbamol and paracetamol. Methocarbamol is a medicinal product that relieves muscle spasms, and paracetamol is a pain reliever. Robaxisal compuesto is available as tablets and is used to treat painful muscle spasms associated with lower back spasms. Both active substances are authorized as separate medicinal products in other EU countries.
More about the procedure
The review of medicinal products containing methocarbamol and paracetamol was initiated on May 29, 2019, in accordance with Article 31 of Directive 2001/83/EC.
The review was carried out by the CHMP. 09.06.2020 The European Commission issued a legally binding decision applicable in all EU Member States.
Link
https://www.ema.europa.eu/en/medicines/human/referrals/methocarbamol-paracetamol-containing-medicinal-products#all-documents-section
1 Saragiotto 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
2 Emrich 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
