Romilar is essentially a regional brand with a scattered international presence. Its marketing authorisation extends to five countries — Argentina, Indonesia, Spain, Peru, and Oman — and its active ingredient is dextromethorphan hydrobromide. The footprint does not cluster within a single region, so the reader most likely encounters this brand in one specific local market rather than across a familiar cross-border zone.
Dextromethorphan hydrobromide is classified as an antitussive and falls within the broader cough and cold preparations category. It is used for the symptomatic relief of cough, particularly the dry, non-productive kind. The structured indication block further down the page lists the registered uses for Romilar exactly as recognised by national regulators in the markets where it is sold.
Travellers familiar with Romilar from one of its registered markets are unlikely to find the same brand on a pharmacy shelf elsewhere, but dextromethorphan itself is one of the most widely distributed cough-suppressant molecules in the world. It circulates under many different brand names internationally, sometimes on its own and sometimes as part of multi-symptom cold preparations. A pharmacist in the destination country can usually identify a comparable dextromethorphan-containing product or a suitable alternative within the same antitussive category.
Regulatory status for cough preparations also varies — in some countries dextromethorphan is available over the counter, while in others it is more tightly controlled. Anyone using Romilar regularly, giving it to a child, or trying to identify an equivalent in a new country should treat the question as a clinical one and seek guidance from a healthcare provider or pharmacist familiar with local rules.
Symptoms:
These include nausea and vomiting, CNS depression, dizziness, dysarthria (slurred speech), myoclonus, nystagmus, somnolence (drowsiness), tremor, excitation, mental confusion, psychotic disorder (psychosis), and respiratory depression.
Management:
Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children.
Hypersensitivity to any of the ingredients.
Taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these medicines, ask a doctor or pharmacist before taking this product..
Use in children under 12 years.
None stated.
Adverse effects are rare, however the following side effects may be associated with dextromethorphan hydrobromide:
Gastrointestinal Disorders
Rare: Gastrointestinal upset
Nervous System Disorders
Rare: Dizziness, drowsiness, mental confusion
Immune System Disorders
Hypersensitivity
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There is no relevant information additional to that already contained elsewhere in the SmPC or of relevance to the prescriber.
For the relief of persistent dry irritant coughs.
Dextromethorphan hydrobromide is a cough suppressant which has a central action on the cough centre in the medulla. It has no analgesic properties and little sedative activity.
Dextromethorphan
Pharmacotherapeutic group: Cough suppressant
ATC code: R05DA09
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration. Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan pharmacokinetics in human volunteers.
It appears that there are distinct phenotypes for this oxidation process resulting in highly variable pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3- hydroxymorphinan and 3-methoxymorphinan have been identified as conjugated products in the urine.
Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.
Patients suffering from chronic cough as occurs with smoking, asthma or patients suffering from an acute asthma attack, or where cough is accompanied by excessive secretions should be advised to consult a Healthcare Professional before use.
Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache. These could be signs of serious conditions.
Cases of dextromethorphan abuse have been reported. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6.).
Keep out of the sight and reach of children.
Do not exceed recommended dose.
Excipient warnings:
- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.
- This product contains Amaranth (E123), which may cause allergic reactions.
- This medicinal product contains 2.5% v/v ethanol (alcohol), up to 196 mg per dose, (equivalent to approx 1.6 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When taking this medicine, patients should be told:
- The medicine is likely to affect your ability to drive
- Do not drive until you know how the medicine affects you
- It is an offence to drive while under the influence of this medicine
- However, you would not be committing an offence (called 'statutory defence') if:
o The medicine has been prescribed taken to treat a medical problem and
o You have taken it according to the information provided with the medicine and
o It was not affecting your ability to drive safely
Oral administration.
Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.
Children under 12 years: Do not use
No special requirements
ADMINISTRATIVE DATA
Romilar is used for the symptomatic relief of cough, specifically the kind of dry, non-productive cough that does not bring up mucus. It belongs to the antitussive category — medications that act centrally to suppress the cough reflex — and is also classified within the broader cough and cold preparations group. The structured indication block further down this page lists the registered uses recognised in the markets where Romilar is sold.
Romilar contains dextromethorphan hydrobromide, an antitussive used in cough and cold preparations. Dextromethorphan is one of the most widely used cough-suppressant molecules globally and circulates under many different brand names depending on the country, sometimes on its own and sometimes combined with other ingredients in multi-symptom cold formulations.
Romilar is registered in five countries: Argentina, Indonesia, Spain, Peru, and Oman — a scattered footprint that does not correspond to a single regional cluster. Travellers outside these markets are unlikely to encounter the Romilar brand specifically, although dextromethorphan-based products are available in most regulated pharmaceutical markets. A local pharmacist can confirm regional availability if your country is not on this list.
Dextromethorphan is sold under a large number of brand names worldwide, both as a single-ingredient cough suppressant and as a component of combination cold and flu preparations. Other antitussives based on different molecules also exist within the same therapeutic category, although they are not freely interchangeable. To identify a local dextromethorphan product, search the active ingredient on Pill2Trip or ask a pharmacist in your country.
Prescription status for dextromethorphan products varies considerably between countries — in some markets they are sold over the counter, in others they require a prescription, and in a few jurisdictions sale is more tightly controlled. Anyone unsure about whether a cough warrants medication, or about an existing condition or other medications they are taking, should speak with a healthcare provider or pharmacist before starting Romilar.
