Leaflet EXTRAVERAL 80mg / 20mg tablets

Indicated for: mild restlessness; minor sleep disorders

Route of administration: oral

Substance: dry valerian extract + phenobarbital (plant extract + antiepileptic)

ATC: N05CB02 (Nervous system | Hypnotics and sedatives | Barbiturates, combinations)

Precautions:
Driving impairment
Driving impairment

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

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse
Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression
Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol
Avoid alcohol

Avoid alcohol during treatment.

Narrow therapeutic index
Narrow therapeutic index

The dose must be followed strictly.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

The combination of dry valerian extract and phenobarbital is used for the treatment of sleep disorders, anxiety, and other stress-related conditions. Valerian extract has sedative and anxiolytic properties, while phenobarbital, a barbiturate, enhances sedative effects through its action on GABA receptors in the central nervous system.

This combination is administered orally, usually in tablet form, and the dosage is adjusted based on the severity of symptoms and the patient's response. It is recommended for short-term use to avoid the risk of dependence associated with phenobarbital.

Common side effects include drowsiness, dizziness, fatigue, and, in rare cases, allergic reactions. Additionally, phenobarbital may interact with other medications, increasing the risk of adverse effects.

The combination of valerian extract and phenobarbital provides an effective option for managing sleep disorders and anxiety, but its use should be carefully monitored to minimize associated risks.

General data about EXTRAVERAL 80mg / 20mg

  • Substance: dry valerian extract + phenobarbital
  • Date of latest medicines list: 01-06-2026
  • Product code: W60220001
  • Concentration: 80mg / 20mg
  • Pharmaceutical form: tablets
  • Quantity: 20
  • Product type: Generic medicine
  • Price: 33.64 RON
  • Prescription status: TAB3 - Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

  • Manufacturer: ZENTIVA SA - ROMANIA
  • Holder: ZENTIVA S.A. - ROMANIA
  • Number: 6404/2006/01
  • Shelf life: 3 years