Leaflet BACLOFEN SINTETICA 0.05mg / ml solution for injection

Indicated for: spasticity; muscle spasms

Route of administration: injectable

Substance: baclofen (muscle relaxant)

ATC: M03BX01 (Musculo-skeletal system | Muscle relaxants, centrally acting agents | Other centrally acting agents)

Baclofen is a muscle relaxant used in the treatment of spasticity associated with neurological conditions such as multiple sclerosis, spinal cord injuries, or cerebral palsy. It works by inhibiting exaggerated spinal reflexes, reducing muscle tone and painful spasms.

Baclofen is administered orally, usually 2-4 times daily, with the dose gradually adjusted to minimize side effects. In severe cases, it can be administered intrathecally via an implantable pump for more effective spasticity control.

Common side effects include drowsiness, dizziness, muscle weakness, and nausea. In rare cases, severe adverse reactions such as respiratory depression, confusion, or hypotension may occur. It is important to taper off the treatment gradually to avoid withdrawal symptoms.

Baclofen is a valuable therapeutic option for patients with severe spasticity, contributing to improved mobility and quality of life.

General data about BACLOFEN SINTETICA 0.05mg / ml

  • Substance: baclofen
  • Date of latest medicines list: 01-06-2026
  • Product code: W69459001
  • Concentration: 0.05mg / ml
  • Pharmaceutical form: solution for injection
  • Quantity: 5
  • Product type: Generic medicine
  • 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: SINTETICA GMBH - GERMANIA
  • Holder: DIRECT PHARMA LOGISTICS S.R.L. - ROMANIA
  • Number: 782/2023/01
  • Shelf life: 5 years

Pharmaceutical forms available for baclofen

Concentrations available for baclofen

  • 0.05mg/ml
  • 0.5mg/ml
  • 10mg
  • 25mg
  • 2mg/ml