MADOPAR 125 CAPSULE 125 MG [SIN06121P]

Product Info

MADOPAR 125 CAPSULE 125 MG

[SIN06121P]

2.1. Therapeutic Indications

Parkinson’s disease:
Madopar is indicated for the treatment of Parkinson’s disease with the exception of drug-induced Parkinsonism.

Madopar dispersible is a formulation which is suitable for patients with dysphagia (difficulties in swallowing) or who require a formulation with a more rapid onset of action, e.g. patients suffering from early morning and afternoon akinesia, or who exhibit ‘delayed on’ or ‘wearing off’ phenomenon.

Madopar HBS is indicated for patients presenting with all types of fluctuations (i.e. ‘peak dose dyskinesia’ and ‘end of dose deterioration’ – such as nocturnal immobility).

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.

2.3. Contraindications

Madopar is contraindicated in:

• patients with known hypersensitivity to levodopa or benserazide or any of the excipients.

• patients receiving non-selective monoamine oxidase (MAO) inhibitors due to the risk of hypertensive crisis (see section 2.4.1 Warnings and Precautions, General – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, selective MAO-B inhibitors, such as selegiline and rasagiline or selective MAO-A inhibitors, such as moclobemide, are not contraindicated. Combination of MAO-A and MAO-B inhibitors is equivalent to non-selective MAO inhibition, and hence this combination should not be given concomitantly with Madopar (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).

• patients with decompensated endocrine, renal or hepatic function, cardiac disorders, psychiatric diseases with a psychotic component or closed angle glaucoma.

• patients less than 25 years old (skeletal development must be complete).

• pregnant women or women of childbearing potential in the absence of adequate contraception (see 2.5.2 Pregnancy and 2.5.3 Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If pregnancy occurs in a woman taking Madopar, the drug must be discontinued (as advised by the prescribing physician).