GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Stiripentol Sachets 250mg
B. Stiripentol Sachets 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a)Stiripentol Sachets 250mg
Each sachet of contains:
Stiripentol…………….250mg
aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavor.
b) Stiripentol Sachets 500mg
Each sachet of contains:
Stiripentol…………….500mg
aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavor

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the used as monotherapy in Dravet syndrome.

CAUTION & WARNING:

CAUTION:
Medicine Keep out of reach of children.
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store DIACOMIT for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).Store in the original package to protect from light.
Dosage:As directed by the Physician.
Direction for use: Step 1. Fill measuring cup with 100 mL of water.
Step 2. Pour 100 mL of water into the small drinking cup.
Step 3. Tap the packet of oral suspension to settle the medicine to the bottom of the packet.
Step 4. Using a clean pair of scissors, cut off the top of the packet and make sure the packet is fully open.
Step 5. Empty the packet into the small drinking cup.
• Look inside the packet to make sure there is no medicine left inside.
• If there is medicine left inside, hold the open end of the packet over your small drinking cup and tap the packet again to get all of the medicine out.
To make sure a full dose of oral suspension is given, it is important not to spill any medicine and that there is no medicine left in the packet.
Repeat Steps 3 through 5 for each packet of oral suspension needed for the total prescribed dose.
Step 6. Hold the small drinking cup with one hand. With your other hand, use the spoon to gently mix the medicine and the water until clear.
Steps 7 and 8 must be completed right after mixing the medicine.
Step 7. Have your child drink all of the mixture in the small drinking cup.
Step 8. To make sure there is no mixture left in the small drinking cup, add a small amount (25 mL) of water to the small drinking cup:
• Stir with the spoon.
• Repeat Step 7 above.
Step 9. Wash the small drinking cup and spoon. Allow the small drinking cup and spoon to dry. Throw away the empty packet and clean the work surface.

Stiripentol Sachets 500mg Technical Specification:

Product Name:Stiripentol Sachets
Brand Name:Generic
Strength:250mg, 500mg
Dosage Form:Sachets
Route of Administration:Via Oral Route
Packing:60 Sachets
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP, CTD Dossier, COPP
Therapeutic use:Anticonvulsant
Indication:It is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the used as monotherapy in Dravet syndrome.
Storage:Store in a dry place, at a temperature not exceeding 30°C

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Stiripentol Sachets 250mg
  • Stiripentol Sachets 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Stiripentol Sachets 250mg
    Each sachet of contains:
    Stiripentol…………….250mg
    aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavor.
  • Stiripentol Sachets 500mg
    Each sachet of contains:
    Stiripentol…………….500mg
    aspartame, carmellose sodium, erythrosine, glucose, hydroxyethylcellulose, povidone, sodium starch glycolate, sorbitol, titanium dioxide, tutti frutti flavor

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the used as monotherapy in Dravet syndrome.

CAUTION & WARNING:

CAUTION:Medicine Keep out of reach of children. <br>
WARNING: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical PRACTITIONER.

STORAGE & DOSAGE:

Storage:Store for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
Store in the original package to protect from light.
Dosage:As directed by the Physician.
Direction for use: Step 1. Fill measuring cup with 100 mL of water.
Step 2. Pour 100 mL of water into the small drinking cup.
Step 3. Tap the packet of oral suspension to settle the medicine to the bottom of the packet.
Step 4. Using a clean pair of scissors, cut off the top of the packet and make sure the packet is fully open.
Step 5. Empty the packet into the small drinking cup.

  • Look inside the packet to make sure there is no medicine left inside.
  • If there is medicine left inside, hold the open end of the packet over your small drinking cup and tap the packet again to get all of the medicine out.

To make sure a full dose of oral suspension is given, it is important not to spill any medicine and that there is no medicine left in the packet.
Repeat Steps 3 through 5 for each packet of oral suspension needed for the total prescribed dose.
Step 6. Hold the small drinking cup with one hand. With your other hand, use the spoon to gently mix the medicine and the water until clear.
Steps 7 and 8 must be completed right after mixing the medicine.
Step 7. Have your child drink all of the mixture in the small drinking cup.
Step 8. To make sure there is no mixture left in the small drinking cup, add a small amount (25 mL) of water to the small drinking cup:

  • Stir with the spoon.
  • Repeat Step 7 above.

Step 9. Wash the small drinking cup and spoon. Allow the small drinking cup and spoon to dry. Throw away the empty packet and clean the work surface.