Leaflet OSPOLOT 20mg / ml oral suspension

Indicated for: epilepsy

Route of administration: oral

Substance: sultiam (antiepileptic)

ATC: N03AX03 (Nervous system | Antiepileptics | Other antiepileptics)

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.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

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.

Sultiame is a medication used in the treatment of epilepsy, particularly in focal seizures and Lennox-Gastaut syndrome. It works by inhibiting carbonic anhydrase, reducing neuronal excitability and preventing seizures.

The medication is taken orally, as directed by a doctor, usually two or three times daily. It is important for patients to follow the prescribed dosage and not discontinue treatment without consulting their doctor.

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

Common side effects include fatigue, dizziness, nausea, and loss of appetite. In rare cases, severe reactions such as metabolic acidosis or allergic reactions may occur. Patients should be informed of these risks before starting treatment.

General data about OSPOLOT 20mg / ml

  • Substance: sultiam
  • Date of latest medicines list: 01-08-2024
  • Product code: W70428001
  • Concentration: 20mg / ml
  • Pharmaceutical form: oral suspension
  • Quantity: 1
  • 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: DESITIN ARZNEIMITTEL GMBH - GERMANIA
  • Holder: DESITIN ARZNEIMITTEL GMBH - GERMANIA
  • Number: 15526/2024/01
  • Shelf life: 3 years-after packing for marketing;after the first opening of the bottle-3 months