Consumer medicine information

1. Why am I using this medicine?

This medicine contains the active ingredient levodopa and carbidopa monohydrate. This medicine is used to treat some of the symptoms of Parkinson's disease.
For more information, see Section 1. Why am I using this medicine? in the full CMI.

2. What should I know before I use this medicine?

Do not use if you have ever had an allergic reaction to this medicine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use this medicine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with this medicine and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use this medicine?

• Your doctor will tell you how many tablets to take each day. Follow all directions given to you by your doctor carefully.

• Swallow the levodopa/carbidopa tablet whole or as half tablets, with a glass of water.

5. What should I know while using this medicine?

6. Are there any side effects?

The most common side effects are nausea, hallucinations, confusion, dizziness, abnormal uncontrolled movements and dry mouth.
Serious side effects include blood in the urine, difficult or painful urination, changes in mood, forgetfulness, signs of anaemia such as tiredness and shortness of breath, frequent or worrying infections, bruising or bleeding, fainting, skin changes, numbness or tingling in the feet.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Levodopa and carbidopa monohydrate.

2 Qualitative and Quantitative Composition

Levodopa and carbidopa (as monohydrate) 250 mg/25 mg.
Levodopa and carbidopa (as monohydrate) 100 mg/25 mg.
Carbidopa. Carbidopa, an inhibitor of aromatic amino acid decarboxylase, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-) L-alpha- hydrazino-alpha-methyl-beta-(3,4-dihydroxy-benzene) propanoic acid monohydrate. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-) L-alpha-amino- beta-(3,4- dihydroxybenzene) propanoic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Levodopa/carbidopa is supplied as uncoated tablets for oral administration.
250 mg/25 mg. Round, light blue uncoated tablets with 'C' on one side and '20' on the other side.
100 mg/25 mg. Round, light yellow uncoated tablets with 'C' on one side and '19' on the other side.

4 Clinical Particulars

4.9 Overdose

Management of acute overdosage with APO-Levodopa/Carbidopa is basically the same as management of acute overdosage with levodopa; however, pyridoxine is not effective in reversing the actions of levodopa/carbidopa.
In the event of overdosage, general supportive measure should be employed. Intravenous fluids should be administered judiciously and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient observed carefully for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as levodopa/carbidopa should be taken into consideration. To date, no experience has been reported with dialysis, hence its value in overdosage is not known.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. Not data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Carbidopa monohydrate. The empirical formula is C₁₀H₁₄N₂O₄.H₂O and the structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCARBID.gif Levodopa. The empirical formula is C₉H₁₁NO₄ and the structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVODO.gif CAS number. Carbidopa monohydrate. 38821-49-7.
Levodopa. 59-92-7.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APLECAST.gif