Leaflet ORFIRIL LONG 500mg prolonged-release mini-tablets

Product code:
W10222005
Quantity:
100
Indicated for:
epilepsy; bipolar disorder
Route of administration:
oral
Substance:
valproic acid + salts (antiepileptics)
ATC
N03AG01 — Nervous system | Antiepileptics | Antiepileptics | Fatty acid derivatives

Precautions:

Driving impairment

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

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Suicidal ideation / mental changes

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

Teratogenic / fetal risk

This medicine may affect fetal development.

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Valproic acid and its salts, such as sodium valproate or semisodium valproate, are medicines used for epilepsy and bipolar disorder; in some countries they have also been used for migraine prevention. Valproate stabilises electrical activity in the brain and influences certain neurotransmitters. It can be effective but has important risks.

It is taken by mouth or, in hospital, given intravenously according to the doctor’s instructions. The dose is adjusted individually and blood levels may sometimes be monitored. Do not stop treatment suddenly, because seizures or relapse may occur. It is important to take the medicine regularly and tell the doctor about all other treatments.

Side effects may include nausea, tremor, sleepiness, weight gain, hair loss, menstrual changes, liver test abnormalities, low platelets or pancreatitis. Mood changes, confusion or increased ammonia may occur. Blood tests for liver function, blood counts and sometimes medicine levels may be needed during treatment.

Valproate can cause birth defects and developmental disorders in children exposed during pregnancy. Women and girls who can become pregnant must discuss contraception and alternatives with their doctor. Seek urgent help for severe abdominal pain, persistent vomiting, jaundice, bleeding, extreme sleepiness, worsening seizures or thoughts of self-harm.

General data about ORFIRIL LONG 500mg

Substance:
valproic acid + salts
Date of latest medicines list:
01-06-2026
Product code:
W10222005
Concentration:
500mg
Pharmaceutical form:
prolonged-release mini-tablets
Quantity:
100
Product type:
Generic medicine
Price:
125.50 RON
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
DESITIN ARZNEIMITTEL GMBH - GERMANIA
Holder:
DESITIN ARZNEIMITTEL GMBH - GERMANIA
Number:
8679/2016/05
Shelf life:
3 years

Concentrations available for valproic acid + salts

  • 1000mg
  • 100mg
  • 150mg
  • 200mg
  • 200mg/5ml
  • 250mg
  • 300mg
  • 300mg/5ml
  • 400mg/4ml
  • 500mg
  • 50mg/ml
  • 57.64mg/ml
  • 600mg
  • 750mg

Compensation lists for ORFIRIL LONG 500mg Desitin

G11 (C1) - Epilepsy

Price
125.50 RON
Copayment
78.88 RON
Patient
46.62 RON

G15 (C1) - Mental disorders

Price
125.50 RON
Copayment
78.88 RON
Patient
46.62 RON

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

Price
125.50 RON
Copayment
78.88 RON
Patient
46.62 RON