Ivedal 10 mg FC tablets
PDF Leaflet Revision Date: 01 July 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Short term treatment of severe insomnia.
Dosage (summary)
Adults: 10 mg before bedtime; Elderly: 5 mg recommended.
Special Populations
- Elderly
- Hepatic impairment
Pregnancy & Breastfeeding
Not recommended in pregnancy or breastfeeding; potential neonatal risks.
Key Drug Interactions
- Alcohol
- CNS depressants
- Opioids
- CYP450 inhibitors
Contraindications
- Hypersensitivity to zolpidem
- Myasthenia gravis
- Sleep apnoea syndrome
- Severe hepatic insufficiency
- Paediatric patients under 18
Common side effects
- Somnolence
- Dizziness
- Headache
- Nausea
- Fatigue
Counselling Points
- Take immediately before bed
- Avoid alcohol and CNS depressants
- Do not drive or operate machinery after use
- Treatment duration should not exceed 4 weeks
Serious warnings
- Risk of dependence and withdrawal symptoms
- Caution in respiratory insufficiency
- Amnesia risk
- Suicidal tendencies
Important Disclaimer
The Ivedal 10 mg FC tablets professional information leaflet below is the property of Sanofi-Aventis South Africa 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>>
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