Arem 5 mg Tablets
Clinical Summary
Quick overview from the medicine insert
Indication
Management of insomnia and as a premedication for surgical procedures.
Dosage (summary)
The usual adult dose is 5 mg to 10 mg taken orally at bedtime.
Onset of Action / Duration
Effects typically begin within 30 minutes and can last for several hours.
Special Populations
- Elderly patients
- Patients with hepatic impairment
- Patients with renal impairment
Pregnancy & Breastfeeding
Nitrazepam is contraindicated during pregnancy and lactation due to potential risks to the fetus and infant.
Key Drug Interactions
- CNS depressants (e.g., alcohol, opioids) may enhance sedative effects.
- Antidepressants may increase the risk of sedation.
- Cimetidine may increase nitrazepam levels.
Contraindications
- Hypersensitivity to nitrazepam or any component of the formulation.
- Severe respiratory insufficiency.
- Sleep apnea syndrome.
Common side effects
- Drowsiness
- Dizziness
- Confusion
- Ataxia
- Paradoxical reactions (e.g., agitation, aggression)
Counselling Points
- Avoid alcohol while taking this medication.
- Do not drive or operate machinery until you know how this medication affects you.
- Take the medication exactly as prescribed and do not exceed the recommended dose.
Serious warnings
- Risk of dependence and withdrawal symptoms with prolonged use.
- Use with caution in patients with a history of substance abuse.
- May impair cognitive function and coordination.
Important Disclaimer
The Arem 5 mg Tablets professional information leaflet below is the property of Adcock Ingram and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
