ROPIQUAL XL 2mg prolonged-release tablets

国家: 英国

语言: 英文

来源: myHealthbox

有效成分:

ropinirole

可用日期:

Milpharm Limited

ATC代码:

N04BC04

INN（国际名称）:

ropinirole

剂量:

2mg

药物剂型:

Prolonged-release tablet

给药途径:

Oral use

每包单位数:

21, 28, 30, 42 & 84 tablets

处方类型:

POM - Prescription Only Medicine

厂商:

APL Swift Services (Malta) Limited

治疗组:

Dopamine agonists

疗效迹象:

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)

授权状态:

Authorised

授权日期:

2012-10-24

资料单张

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

产品特点

ROPIQUAL XL 2 mg prolonged­release tablets
Summary of Product Characteristics Updated 16­Sep­2015 | Aurobindo Pharma ­ Milpharm Ltd.
1. Name of the medicinal product
ROPIQUAL XL 2 mg prolonged­release tablets
2. Qualitative and quantitative composition
Each prolonged­release tablet contains 2 mg of ropinirole (as hydrochloride).
Excipients with known effect: 1.8 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged­release tablet.
2 mg prolonged­release tablets: pink, round biconvex tablets 6.8 ± 0.1 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 in