Leaflet COLDREX SINUS EXTRA 500mg / 3mg / 50mg tablets


Indicated for: cold and flu symptoms

Route of administration: oral

Substance: paracetamol + chlorpheniramine + pseudoephedrine (analgesic and antipyretic + antihistamine + adrenergic decongestant)

ATC: R01BA52 (Respiratory system | Nasal decongestants for systemic use | Sympathomimetics)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Anticholinergic effects
Anticholinergic effects

May cause dry mouth, constipation, urinary retention, or blurred vision.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Paracetamol, chlorpheniramine, and pseudoephedrine are active ingredients used in combination to treat cold and flu symptoms such as fever, headaches, nasal congestion, sneezing, and runny nose. This combination is effective in relieving discomfort associated with mild respiratory infections.

Paracetamol is an analgesic and antipyretic that reduces pain and fever, being well-tolerated by most patients. Chlorpheniramine is an antihistamine that helps reduce allergic symptoms such as sneezing, itching, and nasal discharge. Pseudoephedrine is a nasal decongestant that works by constricting blood vessels in the nasal mucosa, reducing inflammation and congestion.

Although this combination is effective, its use should be approached with caution. Chlorpheniramine may cause drowsiness, dizziness, or dry mouth, while pseudoephedrine may cause increased blood pressure, insomnia, or agitation, especially in sensitive individuals. Additionally, it is important not to exceed the recommended dose of paracetamol, as it can harm the liver.

This combination is available over the counter, but patients should follow the recommended dosage and avoid long-term use. If symptoms persist for more than a few days or worsen, medical advice is necessary. Individuals with high blood pressure, cardiovascular diseases, or other chronic conditions should consult a doctor before use.

General data about COLDREX SINUS EXTRA 500mg / 3mg / 50mg

  • Substance: paracetamol + chlorpheniramine + pseudoephedrine
  • Date of last drug list: 01-07-2021
  • Commercial code: W66806002
  • Concentration: 500mg / 3mg / 50mg
  • Pharmaceutical form: tablets
  • Quantity: 10
  • Product type: generic
  • Prescription restrictions: OTC - Over the Counter = medicines that do not require a prescription.

Marketing authorisation

  • Manufacturer: SANTA S.A. - ROMANIA
  • Holder: SANOSAN S.R.L. - ROMANIA
  • Number: 11391/2019/02
  • Shelf life: 3 years

Pharmaceutical forms available for paracetamol + chlorpheniramine + pseudoephedrine

Concentrations available for paracetamol + chlorpheniramine + pseudoephedrine

  • 500mg/3mg/30mg
  • 500mg/3mg/50mg