Leaflet ROFEDEX 10mg tablets

Indicated for: dry cough

Route of administration: oral

Substance: dextromethorphan (expectorant)

ATC: R05DA09 (Respiratory system | Cough suppressants, excl. combinations with expectorants | Opium alkaloids and derivatives)

Dextromethorphan is a medication used to relieve dry, nonproductive cough. It works on the central nervous system by suppressing the cough reflex without affecting respiratory activity. It is commonly used for colds, flu, or other respiratory conditions involving irritating cough.

It is available in the form of syrups, tablets, or capsules and is often included in combination cold and flu medications. Its effect typically begins within 15-30 minutes and lasts about 6 hours.

Side effects may include dizziness, drowsiness, nausea, or, rarely, allergic reactions. At high doses, dextromethorphan can cause psychoactive effects, so misuse is strongly discouraged.

It is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or those with productive (mucus-producing) cough. It is important to use it as directed by a doctor or the product label.

General data about ROFEDEX 10mg

  • Substance: dextromethorphan
  • Date of latest medicines list: 01-08-2023
  • Product code: W61978001
  • Concentration: 10mg
  • Pharmaceutical form: tablets
  • Quantity: 20
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: BIOFARM S.A. - ROMANIA
  • Holder: BIOFARM S.A. - ROMANIA
  • Number: 7982/2015/01
  • Shelf life: 2 years

Pharmaceutical forms available for dextromethorphan

Concentrations available for dextromethorphan

  • 0.1%
  • 0.13%
  • 1.5mg/ml
  • 10mg
  • 15mg
  • 15mg/5ml
  • 20mg
  • 20mg/15ml
  • 3.75mg/5ml
  • 5mg/5ml
  • 6.5mg/5ml
  • 7.5mg/5ml