Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Carbidopa monohydrate; Levodopa
Orion Corporation
N04BA02
Carbidopa monohydrate; Levodopa
Tablet
levodopa and decarboxylase inhibitor
Marketed
2022-12-16
PACKAGE LEAFLET: INFORMATION FOR THE USER CARBIDOPA/LEVODOPA ORION 25 MG/100 MG TABLETS CARBIDOPA/LEVODOPA ORION 12.5 MG/50 MG TABLETS carbidopa/levodopa READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Carbidopa/Levodopa Orion is and what it is used for 2. What you need to know before you take Carbidopa/Levodopa Orion 3. How to take Carbidopa/Levodopa Orion 4. Possible side effects 5. How to store Carbidopa/Levodopa Orion 6. Contents of the pack and other information 1. WHAT CARBIDOPA/LEVODOPA ORION IS AND WHAT IT IS USED FOR Carbidopa/Levodopa Orion improves the signs of Parkinson’s disease in adults. Parkinson's disease is a long-term illness where: - you become slow and unsteady - your muscles feel stiff - you may develop shaking or trembling (called “tremor”). If not treated, Parkinson's disease can make it hard for you to continue your normal daily activities. Carbidopa/Levodopa Orion contains two different medicines called: levodopa and carbidopa. - levodopa turns into a material called “dopamine” in your brain. The dopamine helps to improve the signs of your Parkinson’s disease. - carbidopa belongs to a group of medicines called “aromatic amino acid decarboxylase inhibitors”. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBIDOPA/LEVODOPA ORION DO NOT TAKE CARBIDOPA/LEVODOPA ORION - if you are allergic to levodopa, carbidopa or any of the other ingredients of this medici Прочитать полный документ
Health Products Regulatory Authority 17 October 2023 CRN00DTLC Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbidopa/Levodopa Orion 12.5 mg/50 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains carbidopa monohydrate equivalent to 12.5 mg carbidopa and 50 mg levodopa. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White or off-white, round tablet, 7 mm in diameter which is scored and marked "LC 50" on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbidopa/Levodopa Orion is indicated for the treatment of Parkinson's disease in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The optimal Carbidopa/Levodopa Orion dosage should be determined individually by careful titration. The ratio of carbidopa and levodopa in Carbidopa/Levodopa Orion tablets is 1:4 (Carbidopa/Levodopa Orion 25 mg/100 mg and Carbidopa/Levodopa Orion 12.5 mg/50 mg). _General considerations: _The dosage should be adjusted to individual patient needs. This may require adjusting both the individual dose and the frequency of administration. Studies show that carbidopa inhibits the function of peripheral dopadecarboxylase at daily doses of about 70–100 mg. Patients receiving smaller carbidopa doses than this are more likely to experience nausea and vomiting. Standard antiparkinsonian drugs, other than levodopa alone, may be continued while Carbidopa/Levodopa Orion is being administered, although their dosage may have to be adjusted. _The usual initial dose: _ The recommended initial dose is one Carbidopa/Levodopa Orion 25 mg/100 mg tablet three times daily. The daily dose of carbidopa is then 75 mg. The dosage may be increased by adding one tablet to the regimen every day or every other day as necessary, until the total daily dose is equivalent to eight Carbidopa/Levodopa Orion 25 mg/100 mg tablets. Carbidopa/Levodopa Orion 12.5 mg Прочитать полный документ