Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Neuraxpharm Pharmaceuticals, S.L., Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, Spain
Tuzulby 20 mg prolonged-release chewable tablets.
Tuzulby 30 mg prolonged-release chewable tablets.
Tuzulby 40 mg prolonged-release chewable tablets.
| Pharmaceutical Form |
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Prolonged-release chewable tablet. Tuzulby 20 mg prolonged-release chewable tablets are speckled, off white, 6.8 x 14.7 mm capsule shaped coated tablet, debossed with "N2" "N2" on one side and bisect on the other side. The chewable tablet can be divided into equal doses. Tuzulby 30 mg prolonged-release chewable tablets are speckled, off white, 7.7 x 16.8 mm capsule shaped coated tablet, debossed with "N3" "N3" on one side and bisect on the other side. The chewable tablet can be divided into equal doses. Tuzulby 40 mg prolonged-release chewable tablets are speckled, off white, 8.5 x 18.5 mm capsule shaped coated tablet, debossed with "NP14" on one side and plain on the other side. |
Each tablet contains 20 mg methylphenidate hydrochloride equivalent to 17.30 mg of methylphenidate.
Excipient with known effect: Each tablet contains 6.1 mg aspartame (E951).
Each tablet contains 30 mg methylphenidate hydrochloride equivalent to 25.95 mg of methylphenidate.
Excipient with known effect: Each tablet contains 9.15 mg aspartame (E951).
Each tablet contains 40 mg methylphenidate hydrochloride equivalent to 34.59 mg of methylphenidate.
Excipient with known effect: Each tablet contains 12.2 mg aspartame (E951).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Methylphenidate HCl is a mild central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of noradrenaline and dopamine into the presynaptic neurone and increase the release of these monoamines into the extraneuronal space. |
| List of Excipients |
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Sodium polystyrene sulfonate |
Pack size: 30 prolonged-release chewable tablets in a 60 mL HDPE bottle including a 2 g desiccant canister with a child-resistant cap (PP).
Neuraxpharm Pharmaceuticals, S.L., Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, Spain
EU/1/24/1907/001 (20 mg x 30 prolonged-release chewable tablets)
EU/1/24/1907/002 (30 mg x 30 prolonged-release chewable tablets)
EU/1/24/1907/003 (40 mg x 30 prolonged-release chewable tablets)
Date of first authorisation: 28.02.2025
| Drug | Countries | |
|---|---|---|
| TUZULBY | Austria, Estonia, France, Italy, Lithuania |
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