Roche Products Limited

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6.1       List of Excipients

Capsule contents:

Hypromellose (E464)

Hydrogenated vegetable oil

Calcium hydrogen phosphate, anhydrous (E341)

Mannitol (E421)

Talc (E553b)

Povidone (E1201)

Magnesium stearate (E572)

Capsule shell:

Gelatin

Indigo carmine (E132)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Laboratory abnormalities:

-        Transient rises in SGOT, SGPT and alkaline phosphatase values have been noted.

-        Increase of gamma-Glutamyltransferase has been reported.

-        Serum uric acid and blood urea nitrogen levels are occasionally increased.

4.9       Overdose symptoms, emergency procedures, antidotes

Symptoms and signs

Symptoms and signs of overdosage are qualitatively similar to the side-effects of Madopar in therapeutic doses but may be of greater severity.magnitude.

Overdose may lead to cardiovascular side effects (e.g. cardiac arrhythmias), psychiatric disturbances (e.g. confusion and insomnia), gastro-intestinal effects (e.g. nausea and vomiting) and abnormal involuntary movements (see section 4.8).

If a patient has taken an overdose of Madopar CR, occurrence of symptoms and signs may be delayed due to delayed absorption of the active substances from the stomach.

Treatment

Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state.  In particular patients may require symptomatic treatment for cardiovascular effects (e.g. antiarrhythmics) or central nervous system effects (e.g. respiratory stimulants, neuroleptics).

In addition, for Madopar CR further absorption should be prevented using an appropriate method.

Treatment should include gastric lavage, general supportive measures, intravenous fluids and the maintenance of an adequate airway.

Electrocardiographic monitoring should be instituted and the patient carefully observed for the possible development of arrhythmias.  If necessary, anti-arrhythmic therapy should be given and other symptoms treated as they arise.

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4.4              Special warnings and precautions for use

Pathological gambling, increased libido and hypersexuality have been reported in patients treated with dopamine agonists and/or levodopa for Parkinson’s disease.  Madopar is not a dopamine agonist, however caution is advised as Madopar is a dopaminergic drug.

4.8              Undesirable effects

-          Patients treated with dopamine agonists and/or levodopa for treatment of Parkinson’s disease, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose of treatment discontinuation.  Madopar is not a dopamine agonist, however there is the possibility that these adverse effects may occur as Madopar is a dopaminergic drug.

Section 1

Any reference to 125mg has been changed to read 100mg/25mg.

Section 4.2:

Any reference to 125mg has been changed to read 100mg/25mg.

Section 6.4:

Reference to "container" changed to "bottle"

Section 9:

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Section 10:

Date of revision changed