In this regard, in conjunction with patient organizations and health professionals, ANSM asks doctors to suspend the initiation of treatment with these drugs until they are generally available and measures are taken to ensure continuity. Treatment of patients treated with these drugs.
In addition, the ANSM allows pharmacists exceptionally and temporarily, and if the initially prescribed drug is not available, to give the patient another drug based on methylphenidate, without presenting a new prescription.
Methylphenidate-based medications are indicated in the management of attention deficit hyperactivity disorder (ADHD) and narcolepsy:
- Quasym LP 10 mg, 20 mg and 30 mg (Takeda);
- Ritalin 10 mg, scored tablet (Medifa);
- Medikinet 5mg, 10mg 20mg 30mg and 40mg (Biocodex);
- Concerta LP 18 mg, 36 mg and 54 mg (Janssen) and its generics methylphenidate Biogran LP 18 mg, 36 mg and 54 mg and methylphenidate Vitris LP 18 mg, 36 mg and 54 mg;
- Ritalin LP 10 mg 20 mg 30 mg and 40 mg (Medifa) and its generic methylphenidate Arrow LP 10 mg 20 mg 30 mg and 40 mg.
In recent months, worldwide supply difficulties have been reported for methylphenidate-based specialties. Overall, laboratories explain this by an overall increase in demand. In addition, Takeda Laboratories must bring the manufacturing site into compliance, and Arrow Laboratories suffered an incident on manufacturing equipment, which delayed the production of Quasim LP and Ritalin LP drugs.
To control sales and prevent shortages, quota measures were put in place as soon as difficulties were identified. Export of these drugs by wholesalers-distributors is currently prohibited.
Additionally, ANSM asks prescribers not to start treatment with Quasim LP, Ritalin LP 10 mg and 20 mg, and its generic methylphenidate Arrow LP 10 mg, 20 mg, 30 mg and 40 mg, until the condition improves. . ANSM also allows pharmacists to substitute an unavailable drug with another available drug subject to the following conditions:
Recommendation for pharmacists
Ritalin LP 10 mg and 20 mg and its generic Methylphenidate Arrow LP 10 mg, 20 mg, 30 mg and 40 mg, Quasym LP (all doses), are in acute supply shortage, or out of stock.
All doses of Medicinate, however, are available in sufficient quantities to meet the needs, including patients currently treated with Quasim LP and Ritalin LP 10 mg and 20 mg or its equivalent.
to know : Stock of Ritalin LP 40 mg covers the needs of patients treated with Methylphenidate Arrow LP 40 mg.
Therefore, you may exceptionally and temporarily dispense one of the drugs in stock to replace one of the unavailable prescribed drugs as detailed below, Without introducing a new prescriptionand provided that the drug dispensed as a replacement permits the administration of a fixed dose.
| prescribed medication | A drug that can be dispensed as a replacement |
| Quasym LP 10 mg, 20 mg or 30 mg, modified release capsule | Medicinate 10 mg, 20 mg or 30 mg, change-release capsules |
| Ritalin LP 10 mg and 20 mg, prolonged release capsules or general: Methylphenidate Arrow LP 10 mg, 20 mg or 30 mg, prolonged-release capsule |
Medicinate 10 mg, 20 mg or 30 mg, change-release capsules |
If you make this replacement:
- The dose of Medicinate dispensed as a replacement must correspond to the prescribed specialty dose, including the number of doses prescribed to achieve the required dose;
- write down the name of the drug dispensed on the prescription and inform the prescriber in any way;
- Inform the patient of the replacement and advise them to contact their doctor in case of an adverse effect or the appearance of a symptom that they consider unusual;
- Inform patients that given the different release kinetics of methylphenidate between these specialties, symptom coverage during the day may differ from that obtained with their usual treatment;
- Recommend that patients take replacement medication (Medicanet, modified release capsule) with or after meals;
- Inform patients who are being treated with methylphenidate arrowroot that Medicinate contains an excipient with sucrose, a known effect, which methylphenidate arrowroot does not contain.
Consult recommendations of 02/22/2024 for pharmacist attention regarding methylphenidate-based features
Information for patients
Due to severe supply limitations or lack of stock, your pharmacist may be able to provide you with another medicine based on Medicinate, methylphenidate, if you or your child is currently being treated with Ritalin LP 10 mg or 20 mg and its generic methylphenidate. by Arrow or Quasym LP (all doses).
About Medicinate given to you as a replacement, you should know:
- Medicinate contains the excipient sucrose. This excipient is also present in Quasym and Ritaline LP. On the other hand, it is not present in methylphenidate arrow medicine. Indeed, excipients can vary between drugs. If you are intolerant or allergic to sucrose, talk to your pharmacist;
- Take Medicinate during or after meals;
- Because Medicinate is a different medicine than what you or your child usually takes, it is possible that its effectiveness on your symptoms may not be exactly the same throughout the day as that provided by your usual treatment;
- Finally, substituting your unavailable medication with another methylphenidate medication may cause side effects. Contact your doctor if you experience any side effects or unusual symptoms.
Report an adverse reaction
Related Document:
02/22/2024 Recommendations for the Attention of Pharmacists Regarding Features Based on Methylphenidate
Source: ANSM News Published on 02/22/2024
