Leaflet NITRAZEPAM LPH 2.5mg tablets


Indicated for: insomnia

Route of administration: oral

Substance: nitrazepam (benzodiazepine)

ATC: N05CD02 (Nervous system | Hypnotics and sedatives | Benzodiazepine derivatives)

Nitrazepam is a medication from the benzodiazepine class, primarily used for the treatment of severe and short-term insomnia. It may also be used in some cases to treat seizures, particularly in children, or to reduce anxiety. It works by enhancing the effect of gamma-aminobutyric acid (GABA), a neurotransmitter that decreases brain activity, inducing relaxation, drowsiness, and a sedative effect.

Nitrazepam is taken orally, usually in tablet form, with the dosage adjusted based on age, symptom severity, and patient response. It is recommended for short-term use (typically no more than 2-4 weeks) as prolonged use can lead to dependence, tolerance, and withdrawal effects.

Common side effects include drowsiness, dizziness, fatigue, confusion, muscle weakness, and impaired coordination. In rare cases, it may cause paradoxical reactions such as agitation, irritability, or insomnia. Long-term use can result in physical and psychological dependence.

Nitrazepam is contraindicated in patients with severe respiratory insufficiency, sleep apnea, severe liver impairment, or myasthenia gravis. It is also not recommended for pregnant or breastfeeding women, as it may affect the fetus or infant. Patients should strictly follow their doctor's instructions and avoid abrupt discontinuation of the medication to prevent withdrawal symptoms.

General data about NITRAZEPAM LPH 2.5mg

  • Substance: nitrazepam
  • Date of last drug list: 01-05-2026
  • Commercial code: W12245003
  • Concentration: 2.5mg
  • Pharmaceutical form: tablets
  • Quantity: 30
  • Product type: generic
  • Price: 16.09 RON
  • Prescription restrictions: TAB3 - Medicines that are issued with a special prescription (psychotropic) in green color.

Marketing authorisation

  • Manufacturer: LABORMED PHARMA S.A. - ROMANIA
  • Holder: LABORMED PHARMA S.A. - ROMANIA
  • Number: 9461/2016/03
  • Shelf life: 3 years

Concentrations available for nitrazepam

  • 10mg
  • 2.5mg
  • 5mg

Compensation lists for NITRAZEPAM LPH 2.5mg Labormed

A - Sublist A with 90% discount from the reference price

Price

Copayment

Patient

16.09 RON

2.19 RON

13.90 RON