Negara: Inggris
Bahasa: Inggris
Sumber: myHealthbox
ropinirole
Milpharm Limited
N04BC04
ropinirole
8mg
Prolonged-release tablet
Oral use
21, 28, 30, 42 & 84 tablets
POM - Prescription Only Medicine
APL Swift Services (Malta) Limited
Dopamine agonists
Treatment of Parkinson's disease under the following conditions: Initial treatment as monotherapy, in order to delay the introduction of levodopa In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur ("end of dose" or "on-off" type fluctuations)
Authorised
2012-10-24
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 more questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Don’t pass it on to other people. It may harm them even if their signs of illness seem to be 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. WHAT IS IN THIS LEAFLET: 1. What ROPIQUAL XL is and what it is used for 2. What you need to know before you take ROPIQUAL XL 3. How to take ROPIQUAL XL 4. Possible side effects 5. How to store ROPIQUAL XL 6. Contents of the pack and other information ROPIQUAL XL prolonged-release tablets are used to treat Parkinson’s disease. The active ingredient in ROPIQUAL XL is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. People with Parkinson’s disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson’s disease. DO NOT TAKE ROPIQUAL XL • if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6) • if you have serious kidney disease • if you have liver disease. Tell your doctor if you think any of these may apply to you. WARNINGS AND PRECAUTIONS Your doctor needs to know before you take ROPIQUAL XL: • if you are pregnant or think you may be pregnant • if you are breast feeding • if you are under 18 years old • if you have a serious heart complaint • if you have a mental health problem • if you have a history of any unusual urges and/or behaviours (such as excessive gambling or excessive se Baca dokumen lengkapnya
ROPIQUAL XL 8 mg prolongedrelease tablets Summary of Product Characteristics Updated 16Sep2015 | Aurobindo Pharma Milpharm Ltd. 1. Name of the medicinal product ROPIQUAL XL 8 mg prolongedrelease tablets 2. Qualitative and quantitative composition Each prolongedrelease tablet contains 8 mg of ropinirole (as hydrochloride). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolongedrelease tablet. 8 mg prolongedrelease tablets: red, oval biconvex tablets 19.2x 10.2 ± 0.2 mm. 4. Clinical particulars 4.1 Therapeutic indications Treatment of Parkinson's disease under the following conditions: • Initial treatment as monotherapy, in order to delay the introduction of levodopa • In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur ("end of dose" or "onoff" type fluctuations) 4.2 Posology and method of administration Oral use Adults Individual dose titration against efficacy and tolerability is recommended. Ropinirole prolongedrelease tablets should be taken once a day, at a similar time each day. The prolongedrelease tablets may be taken with or without food A high fat meal may double the AUC and Cmax in some individuals (See 5.2 Pharmacokinetics). ROPIQUAL XL prolongedrelease tablets must be swallowed whole and must not be chewed, crushed or divided. _Initial titration_ The starting dose of ropinirole prolongedrelease tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolongedrelease tablets. Patients who initiate treatment with a dose of 2 mg/day of ropin Baca dokumen lengkapnya