Leaflet NITRAZEPAM RICHTER 5mg tablets

Product code:
W59781001
Quantity:
20
Indicated for:
insomnia
Route of administration:
oral
Substance:
nitrazepam (benzodiazepine)
ATC
N05CD02 — Nervous system | Hypnotics and sedatives | Benzodiazepine derivatives

Precautions:

Breastfeeding warning

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Pregnancy warning

Use during pregnancy only on medical advice.

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 RICHTER 5mg

Substance:
nitrazepam
Date of latest medicines list:
01-06-2026
Product code:
W59781001
Concentration:
5mg
Pharmaceutical form:
tablets
Quantity:
20
Product type:
Generic medicine
Price:
3.24 RON
Prescription status:
TAB3 — Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

Manufacturer:
GEDEON RICHTER ROMANIA S.A. - ROMANIA
Holder:
GEDEON RICHTER ROMANIA S.A. - ROMANIA
Number:
9762/2017/01
Shelf life:
4 years

Concentrations available for nitrazepam

  • 10mg
  • 2.5mg
  • 5mg

Compensation lists for NITRAZEPAM RICHTER 5mg Gedeon Richter

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

Price
3.24 RON
Copayment
2.92 RON
Patient
0.32 RON