Methocarbamol / paracetamol-containing medicinal products - referral

Current status

European Commission final decision

Overview

Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

On 26 March 2020, EMA 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 publications* 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.

---

*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, 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

Information for patients

• You can continue using medicines containing 380 mg of methocarbamol and 300 mg of paracetamol to relieve painful muscle spasms such as spasms in the lower back.
• As for all medicines, the recommended dose and duration of treatment mentioned in the package leaflet should be followed.
• If you have any questions you should talk to your doctor or pharmacist.

Information for healthcare professionals

• EMA’s CHMP considered all available data on the fixed dose combination medicine from clinical trials, scientific literature and post marketing reports. The Committee concluded that the data available do not constitute sufficient evidence to question the efficacy of methocarbamol/paracetamol 380 mg/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 on the overall safety profile of the fixed dose combination medicine. Although both active substances are metabolised in the liver, there is no evidence of a possible interaction between the 2 substances that may lead to hepatotoxicity.
• Cases of dry mouth and diarrhoea were considered at least possibly related to methocarbamol, and the CHMP recommended including them as side effects in the product information with a frequency unknown.

More about the medicine

Robaxisal compuesto is currently the only medicine authorised in the EU containing methocarbamol and paracetamol. Methocarbamol is a medicine that relieves muscle spasms, and paracetamol a painkiller. Robaxisal compuesto is available as tablets and is used to treat painful muscle spasms associated with short-term muscle disorders, such as spasms in the lower back.

Both active substances in the medicine are authorised as separate medicines in other EU countries.

More about the procedure

The review of medicines containing methocarbamol and paracetamol was initiated on 29 May 2019 at the request of Germany under Article 31 of Directive 2001/83/EC..

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 9 June 2020.

Methocarbamol / paracetamol Article 31 referral - Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

Adopted Reference Number: EMA/317184/2020

Key facts

About this medicine

• Approved name:
  Methocarbamol / paracetamol-containing medicinal products
• International non-proprietary name (INN) or common name:
  • methocarbamol
  • paracetamol
• Associated names:
  Robaxisal compuesto
• Class:
  Analgesic

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-31/1484
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

• Authorisation model:
  Nationally authorised product(s)
• Decision making model:
  CHMP-EC

Key dates and outcomes

• CHMP opinion date:
  26/03/2020
• EC decision date:
  09/06/2020

All documents

Opinion provided by Committee for Medicinal Products for human Use

Methocarbamol / paracetamol Article 31 referral - Notification

Methocarbamol / paracetamol Article 31 referral - Timetable for the procedure

Reference Number: EMA/CHMP/285880/2019 Rev. 2

Methocarbamol / paracetamol Article 31 referral - CHMP list of questions

Reference Number: EMA/CHMP/285881/2019

European Commission final decision

Methocarbamol / paracetamol Article 31 referral - Annex II

Methocarbamol / paracetamol Article 31 referral - Assessment report

Adopted Reference Number: EMA/223791/2020

Methocarbamol / paracetamol Article 31 referral - Annex III

Methocarbamol / paracetamol Article 31 referral - Annex I

Reference Number: EMA/298855/2019

Methocarbamol / paracetamol Article 31 referral - Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

Adopted Reference Number: EMA/317184/2020

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.