ROPIQUAL XL 2mg prolonged-release tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
ropinirole
Available from:
Milpharm Limited
ATC code:
N04BC04
INN (International Name):
ropinirole
Dosage:
2mg
Pharmaceutical form:
Prolonged-release tablet
Administration route:
Oral use
Units in package:
21, 28, 30, 42 & 84 tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
APL Swift Services (Malta) Limited
Therapeutic group:
Dopamine agonists
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 "on-off" type fluctuations)
Authorization status:
Authorised
Authorization date:
2012-10-24
Patient Information leaflet
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
Read the complete document
Summary of Product characteristics
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
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