Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 28 2025. However, Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As this drink is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.
Context
In Belgium, Depakine (sodium valproate) is indicated as monotherapy or polytherapy for the treatment of numerous epileptic disorders (summary of product characteristics). Two oral liquid forms of Depakine are currently marketed:
- Depakine 300 mg/5 ml syrup: contains 300 mg valproate per 5 ml (i.e. 60 mg per 1 ml), supplied with a graduated dosing cup for dosing between 150 mg and 600 mg.
- Depakine 300 mg/ml oral solution: contains 300 mg sodium valproate per 1 ml, supplied with a graduated dosing pipette for dosing from 50 mg to 400 mg.
Marketing stop of Depakine 300 mg/5 ml syrup in Belgium
Sanofi Belgium recently informed healthcare professionals that Depakine 300 mg/5 ml syrup will be definitively withdrawn from the Belgian market, and that no further batches of this formulation will be marketed after 28 April 2025.
The oral liquid formulation Depakine 300 mg/ml oral solution will still be available on the market for patients for whom an oral liquid form of Depakine is required or preferred.
Recommendations for prescribers and pharmacists
To prepare for the future unavailability of Depakine 300 mg/5 ml syrup, prescribers and pharmacists are advised to:
- inform patients/healthcare professionals/parents and to discuss with them the need to switch to Depakine 300 mg/ml oral solution if the oral liquid formulation of sodium valproate is essential or preferred by the patient;
- in agreement with patients/healthcare professionals/parents, to prescribe Depakine 300 mg/ml oral solution instead of Depakine 300 mg/5 ml syrup. It is recommended to maintain the same total daily dosage in mg and the same number of doses;
- draw the attention of patients/healthcare professionals/parents to the fact that Depakine 300 mg/ml oral solution is 5 times more concentrated in active substance than Depakine 300 mg/5 ml syrup and to check with them the volume of medicinal product corresponding to the desired dosage in order to avoid any medication error when changing formulation (overdose or underdose);
- emphasise to patients/healthcare professionals/parents that Depakine 300 mg/ml oral solution must be measured out and administered using the graduated pipette provided in the packaging carton. The old measuring cups supplied with Depakine 300 mg/5 ml syrup must not be used to measure Depakine 300 mg/ml oral solution;
- inform patients/healthcare professionals/parents about the potentially serious symptoms of valproate overdose (drowsiness, hypotonia, breathing difficulties, etc.). (See detailed information on overdose in summary of product characteristics);
- advise patients/healthcare professionals/parents transitioning to Depakine 300 mg/ml oral solution to contact a healthcare professional in case of doubt about dosage, symptoms of overdose, or in the event of worsening epileptic manifestations (potential sign of underdose).
Recommendations for patients/healthcare professionals/parents
- If your doctor prescribes Depakine 300 mg/ml oral solution instead of Depakine 300 mg/5 ml syrup, use only the graduated pipette supplied in the packaging carton to take/administer the medication. Never reuse old measuring cups supplied with Depakine 300 mg/5 ml syrup.
- Depakine 300 mg/ml oral solution is 5 times more concentrated than Depakine 300 mg/5 ml syrup. Before using for the first time, discuss with your doctor or pharmacist the volume of Depakine 300 mg/ml solution to be drawn up with the graduated pipette and which corresponds to the dose of Depakine 300 mg/5 ml syrup that you would take with a measuring cup.
- Contact a healthcare professional if you experience symptoms such as drowsiness, generalised weakness, breathing difficulties, or if your epilepsy worsens after switching from Depakine 300 mg/5 ml syrup to Depakine 300 mg/ml oral solution. It is possible that the dose of Depakine 300 mg/ml oral solution you are taking is not correct (overdose or underdose).