Source: Υπουργείο Υγείας (CY) Revision Year: 2026 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate 3056 Limassol, Cyprus, EU
Antiparkinsonian agent.
For treatment of Parkinson's disease and syndrome.
The optimum daily dosage of Credanil must be determined by careful titration in each patient.
Credanil tablets are available in a ratio of 1:4 or 1:10 of carbidopa to levodopa to provide facility for fine dosage titration for each patient.
Studies show that the peripheral dopa-decarboxylase is fully inhibited (saturated) by carbidopa at doses between 70 and 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.
Standard antiparkinsonian drugs, other than levodopa alone, may be continued while Credanil is being administered, although their dosage may have to be adjusted.
Because both therapeutic and adverse effects are seen more rapidly with Credanil than with levodopa, patients should be carefully monitored during the dosage adjustment period. Involuntary movements, particularly blepharospasm, are a useful early sign of excess dosage in some patients.
Dosage may be best initiated with one tablet of Credanil 100 mg/25 mg tablets three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet of Credanil 100 mg/25 mg tablets every day or every other day, as necessary, until a dosage equivalent of eight tablets of Credanil 100 mg/25 mg tablets a day is reached.
If Credanil 100 mg/10 mg tablets is used, dosage may be initiated with one tablet three or four times a day. Titration upward may be required in some patients to achieve optimum dosage of Carbidopa. The dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets q.d.s.) is reached.
Response has been observed in one day, and sometimes after one dose. Fully effective doses usually are reached within seven days as compared to weeks or months with levodopa alone.
Credanil 100 mg/10 mg tablets may be used to facilitate dosage titration according to the needs of the individual patient.
Discontinue levodopa at least 12 hours (24 hours for slow-release preparations) before starting therapy with Credanil. The easiest way to do this is to give Credanil as the first morning dose after a night without any levodopa. The dose of Credanil should be approximately 20% of the previous daily dosage of levodopa.
Patients taking less than 1,500 mg levodopa a day should be started on one tablet of Credanil 100 mg/25 mg tablets three or four times a day dependent on patient need. The suggested starting dose for most patients taking more than 1,500 mg levodopa a day is one tablet of Credanil 250 mg/25 mg tablets three or four times a day.
Therapy with Credanil should be individualised and adjusted gradually according to response. When a greater proportion of carbidopa is required, each tablet of Credanil 100 mg/10 mg tablets may be replaced with a tablet of Credanil 100 mg/25 mg tablets.
When more levodopa is required, Credanil 250 mg/25 mg tablets should be substituted at a dosage of one tablet three or four times a day. If necessary, the dosage of Credanil 250 mg/25 mg tablets may be increased by one tablet every day to a maximum of eight tablets a day. Experience with a total daily dosage greater than 200 mg carbidopa is limited.
When transferring a patient to Credanil from levodopa combined with another decarboxylase inhibitor, discontinue dosage at least 12 hours before Credanil is started. Begin with a dosage of Credanil that will provide the same amount of levodopa as contained in the other levodopa/decarboxylase inhibitor combination.
Current evidence indicates that other antiparkinsonian agents may be continued when Credanil is introduced, although dosage may have to be adjusted in line with manufacturers recommendations.
The safety and efficacy of Credanil in children under the age of 18 years have not been established and its use in patients below the age of 18 is not recommended.
There is wide experience in the use of this product in elderly patients. The recommendations set out above reflect the clinical data derived from this experience.
Oral administration.
Management of acute overdosage with Credanil is basically the same as management of acute overdosage with levodopa; however pyridoxine is not effective in reversing the actions of Credanil. ECG monitoring should be instituted, and the patient carefully observed for the possible development of arrhythmias; if required, appropriate anti-arrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Credanil should be taken into consideration. To date, no experience has been reported with dialysis, and hence its value in the treatment of overdosage is not known.
The terminal half-life of levodopa is about two hours in the presence of carbidopa.
12 months.
For product packed in container: After first opening, store below 25°C and use within 2 months.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.
For storage conditions after first opening of the medicinal product, see section 6.3.
Cardboard box containing aluminium-OPA/Alu/PVC blisters, of 10 tablets. Pack sizes of 20, 30, 50, 90 or 100 tablets.
Cardboard box containing one high density polyethylene (HDPE) bottle closed with a plastic child-resistant closure. Pack size of 100 tablets.
Not all pack sizes may be marketed.
Not applicable.
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