Leaflet SASTRAVI 50mg / 12.5mg / 200mg film-coated tablets

Product code:
W61570003
Quantity:
100
Indicated for:
Parkinson's disease
Route of administration:
oral
Substance:
levodopa + carbidopa + entacapone (antiparkinsonian agents)
ATC
N04BA03 — Nervous system | Dopaminergic agents | Dopa and dopa derivatives

Precautions:

Driving impairment

Driving impairment

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

Dizziness / vertigo

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Hypotension / fall risk

Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Drowsiness / sedation

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Levodopa + Carbidopa + Entacapone is a combination medication used in the treatment of Parkinson's disease, particularly in patients experiencing motor fluctuations ('on-off' phenomena) associated with levodopa therapy. This combination enhances treatment efficacy and prolongs the duration of levodopa's action.

- Levodopa is a precursor of dopamine, which helps compensate for the dopamine deficiency in the brain.
- Carbidopa is a peripheral decarboxylase inhibitor that prevents levodopa from being converted into dopamine outside the brain, reducing side effects such as nausea.
- Entacapone is a COMT (catechol-O-methyltransferase) inhibitor that slows the breakdown of levodopa, extending its effect in the brain.

This combination is effective in alleviating symptoms such as tremors, muscle rigidity, bradykinesia (slowness of movement), and motor fluctuations. It is important to take the medication as prescribed by a doctor, with the dosage gradually adjusted to minimize side effects.

Side effects may include nausea, diarrhea, dizziness, drowsiness, urine discoloration (brown-orange), and, in rare cases, hallucinations or compulsive behaviors. Regular monitoring is essential to adjust the treatment based on the progression of the disease.

General data about SASTRAVI 50mg / 12.5mg / 200mg

Substance:
levodopa + carbidopa + entacapone
Date of latest medicines list:
01-03-2022
Product code:
W61570003
Concentration:
50mg / 12.5mg / 200mg
Pharmaceutical form:
film-coated tablets
Quantity:
100
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:
BALKANPHARMA-DUPNITSA AD - BULGARIA
Holder:
ACTAVIS GROUP PTC EHF. - ISLANDA
Number:
13758/2021/01
Shelf life:
2 years

Pharmaceutical forms available for levodopa + carbidopa + entacapone

Concentrations available for levodopa + carbidopa + entacapone

  • 100mg/25mg/200mg
  • 125mg/31.25mg/200mg
  • 150mg/37.5mg/200mg
  • 175mg/43.75mg/200mg
  • 200mg/50mg/200mg
  • 20mg/5mg/20mg/ml
  • 50mg/12.5mg/200mg
  • 75mg/18.5mg/200mg
  • 75mg/18.75mg/200mg