Leaflet FENOBARBITAL ZENTIVA 100mg / ml solution for injection

Indicated for: epilepsy

Route of administration: injectable

Substance: phenobarbital (antiepileptic)

ATC: N03AA02 (Nervous system | Antiepileptics | Barbiturates and derivatives)

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.

Phenobarbital is a barbiturate used for the treatment of epilepsy, particularly tonic-clonic and partial seizures. It is also used as a sedative or hypnotic in certain situations. It works by enhancing the inhibitory effect of GABA in the central nervous system.

The medication is administered orally or by injection, as directed by a doctor, usually once daily. It is important for patients to follow the treatment regimen and avoid alcohol consumption during use.

Patients should be aware of potential side effects, such as drowsiness, dizziness, or respiratory depression. It is important to inform the doctor of any unusual symptoms.

Common side effects include drowsiness, dizziness, and coordination disturbances. In rare cases, severe reactions such as liver toxicity or allergic reactions may occur. Patients should be informed of these risks before use.

General data about FENOBARBITAL ZENTIVA 100mg / ml

  • Substance: phenobarbital
  • Date of latest medicines list: 01-06-2026
  • Product code: W42870001
  • Concentration: 100mg / ml
  • Pharmaceutical form: solution for injection
  • Packing volume: 2 ml
  • Product type: Generic medicine
  • Price: 65.39 RON
  • Prescription status: TAB3 - Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

  • Manufacturer: ZENTIVA S.A. - ROMANIA
  • Holder: ZENTIVA S.A. - ROMANIA
  • Number: 12810/2019/01
  • Shelf life: 3 years

Pharmaceutical forms available for phenobarbital

Concentrations available for phenobarbital

  • 10%
  • 100mg
  • 100mg/ml
  • 15mg
  • 219mg/ml

Compensation lists for FENOBARBITAL ZENTIVA 100mg / ml Zentiva

G11 (C1) - Epilepsy

Price

Copayment

Patient

65.39 RON

65.39 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

65.39 RON

65.39 RON

0.00 RON