MACLORAS TABLETS is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
1. What MACLORAS TABLETS is and what it is used for.
2. What you need to know before you take/use MACLORAS TABLETS.
Contraindications
MACLORAS TABLETS is contraindicated:
- in patients with a history of hypersensitivity to the active substance rasagiline or to any of the excipients listed in 6.1.
- Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicines and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5). At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
- Moderate to severe hepatic impairment.
Special warnings and precautions for use
The concomitant use of MACLORAS TABLETS and fluoxetine or fluvoxamine should be avoided (see section 4.5). At least five weeks should elapse between discontinuation of fluoxetine and initiation of treatment with MACLORAS TABLETS. At least 14 days should elapse between discontinuation of MACLORAS TABLETS and initiation of treatment with fluoxetine or fluvoxamine.
3. How to take/use MACLORAS TABLETS.
MACLORAS TABLETS is administered orally, at a dose of 1 mg once daily with or without levodopa. May be taken with or without food.
4. Possible side effects.
Summary of the safety profile
In clinical studies in Parkinson's disease patients the frequently reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Tabulated summary of adverse reactions
Monotherapy:
- System organ class: Frequent: Influenza
- Neoplasms, benign, malignant and unspecified (including cysts and polyps): Skin carcinoma
5. How to store MACLORAS TABLETS.
Special precautions for storage
Store at or below 25 °C. Protect from moisture. Keep the blisters in the carton until required for use. Do not store in a refrigerator.