MADOPAR DISPERSIBLE TABLETS 125 mg

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET

**2.2. Dosage and Administration** _Method of administration_ When taking standard Madopar capsules or Madopar HBS, patients must always ensure that they swallow the whole capsule without chewing it. Standard Madopar tablets are breakable to facilitate swallowing. Madopar dispersible tablets are to be dispersed in a quarter of a glass of water (approx. 25–50 ml). The tablets disintegrate completely, producing a milky-white dispersion within a few minutes. Because of rapid sedimentation, it is advisable to stir the dispersion before drinking. Madopar dispersible tablets should be taken within half an hour of preparing the dispersion. _Parkinson’s disease:_ When possible, immediate release (Standard and Dispersible forms) Madopar should be taken at least 30 minutes before or 1 hour after meals so that the competitive effect of dietary protein on levodopa uptake can be avoided (see section 2.8 Interactions with other Medicinal Products and other Forms of Interaction – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) and to facilitate a more rapid onset of action. Undesirable gastrointestinal effects, which may occur mainly in the early stages of the treatment, can largely be controlled by taking Madopar with a low protein snack \[e.g. biscuits\] or liquid or by increasing the dose slowly. HBS formulations can be taken with or without food (see section 3.2 Pharmacokinetics Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Standard dosage_ Treatment with Madopar should be introduced gradually; dosage should be assessed individually and titrated for optimal effect. The following dosage instructions should therefore be regarded as guidelines. _Initial therapy_ In the early stages of Parkinson’s disease it is advisable to start treatment with ½ tablet of Madopar ‘125’ three to four times daily. As soon as tolerability of the initial dosing schedule is confirmed, the dosage should be increased slowly in accordance with the patient’s response. An optimal effect is generally achieved with a daily dosage of Madopar corresponding to 300–800 mg levodopa + 75–200 mg benserazide, to be divided into 3 or more doses. Between 4 and 6 weeks may be needed to achieve the optimal effect. If it proves necessary to further increase the daily dosage, this should be done on a monthly basis. _Maintenance therapy_ The average maintenance dosage is 1 capsule or tablet of Madopar ‘125’ 3 to 6 times daily. The number of individual doses (not less than 3) and their distribution throughout the day must be titrated for optimal effect. A combination of Madopar HBS and Madopar dispersible may substitute standard Madopar to achieve an optimal effect. **2.2.1. Special dosage instructions** _Renal Impairment:_ No dose reduction is considered necessary in case of mild or moderate renal insufficiency (see sections 2.3 Contraindications, 2.5.6 Renal Impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic Impairment:_ The safety and efficacy of Madopar have not been established in patients with hepatic impairment (see sections 2.3 Contraindications, 2.5.7 Hepatic Impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Parkinson’s disease:_ Dosage must be carefully titrated in all patients (see section 2.2 Dosage and Administration). Patients on other anti-parkinsonian agents may receive Madopar. However, as treatment with Madopar proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or these drugs gradually withdrawn. Madopar dispersible tablets are particularly suitable for patients with dysphagia (difficulties in swallowing) or in situations where a more rapid onset of action is required e.g. patients suffering from early morning and afternoon akinesia, or who exhibit ‘delayed on’ or ‘wearing off’ phenomenon. Patients who experience large fluctuations in the drug’s effect in the course of the day (on-off phenomena) should receive smaller, more frequent single doses, or be switched to Madopar HBS. The switch from standard Madopar to Madopar HBS is preferably made from one day to the next, beginning with the morning dose. The daily dose and dosing interval should initially be the same as with standard Madopar. After 2–3 days, the dosage should be gradually increased by about 50%. Patients should be informed that their condition may temporarily deteriorate. Due to the pharmacokinetic properties of Madopar HBS, the onset of action is delayed. The clinical effect may be achieved more rapidly by administering Madopar HBS together with standard Madopar or Madopar dispersible. This may prove especially useful for the first morning dose, which should preferably be higher than the subsequent daily doses. The individual titration for Madopar HBS must be carried out slowly and carefully, allowing intervals of at least 2–3 days between dose changes. In patients with nocturnal immobility, positive effects have been reported after gradually increasing the last evening dose up to 250 mg of Madopar HBS on retiring. Excessive responses to Madopar HBS (dyskinesia) can be controlled by increasing the interval between doses rather than by reducing the single doses. Treatment with standard Madopar or Madopar dispersible should be resumed if the response to Madopar HBS is inadequate.