Leaflet CALMABEN 50mg sugar-coated tablets

Indicated for: allergic rhinitis; urticaria

Route of administration: oral

Substance: diphenhydramine (antihistamine)

ATC: R06AA02 (Respiratory system | Antihistamines for systemic use | Aminoalkyl ethers)

Precautions:
Driving impairment
Driving impairment

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

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.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Diphenhydramine is a first-generation antihistamine used to treat allergies, insomnia, motion sickness, and cold symptoms. It works by blocking H1 histamine receptors, thereby reducing allergic symptoms such as sneezing, itching, runny nose, and hives.

In addition to its antiallergic effects, diphenhydramine has sedative properties and is commonly used as a sleep aid for short-term insomnia. It is also effective in preventing and treating nausea and vomiting associated with motion sickness.

Diphenhydramine is available in tablet, capsule, syrup, or injectable forms. It is used in both adults and children but should be administered with caution, as it can cause significant drowsiness and impair concentration.

Common side effects include drowsiness, dizziness, dry mouth, constipation, and difficulty urinating. In rare cases, more severe reactions such as confusion, hallucinations, or severe allergic reactions may occur. Patients should avoid alcohol or other sedatives while taking diphenhydramine.

Patients should strictly follow the doctor’s or package instructions regarding dosage. Diphenhydramine is not recommended for long-term use and should be avoided in individuals with glaucoma, prostate enlargement, or other conditions that may be worsened by its anticholinergic effects.

General data about CALMABEN 50mg

  • Substance: diphenhydramine
  • Date of latest medicines list: 01-06-2026
  • Product code: W62020001
  • Concentration: 50mg
  • Pharmaceutical form: sugar-coated tablets
  • Quantity: 10
  • Product type: Generic medicine
  • Price: 11.57 RON
  • 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: PHARMAZEUTISCHE FABRIK MONTAVIT Ges.m.b.H. - AUSTRIA
  • Holder: PHARMAZEUTISCHE FABRIK MONTAVIT Ges.m.b.H. - AUSTRIA
  • Number: 8006/2015/01
  • Shelf life: 3 years

Pharmaceutical forms available for diphenhydramine

Concentrations available for diphenhydramine

  • 30mg/2ml
  • 50mg