Leaflet FENITOINA SODICA ACCORD 50mg / ml solution for injection / infusion

Indicated for: epilepsy

Route of administration: injectable / infusion

Substance: phenytoin (antiepileptic)

ATC: N03AB02 (Nervous system | Antiepileptics | Hydantoin 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.

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.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Phenytoin is an antiepileptic medication used to control seizures, particularly tonic-clonic and partial seizures. It works by stabilizing neuronal membranes and reducing their excitability.

The medication is administered orally or intravenously, as directed by a doctor, usually once to three times daily. It is important for patients to follow the treatment regimen and not abruptly discontinue the medication.

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

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

General data about FENITOINA SODICA ACCORD 50mg / ml

  • Substance: phenytoin
  • Date of latest medicines list: 01-03-2022
  • Product code: W64010005
  • Concentration: 50mg / ml
  • Pharmaceutical form: solution for injection / infusion
  • Quantity: 5
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: ACCORD HEALTHCARE LIMITED - MAREA BRITANIE
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 10225/2017/01
  • Shelf life: 2 years

Pharmaceutical forms available for phenytoin

Concentrations available for phenytoin

  • 100mg
  • 250mg/5ml
  • 50mg/ml