Requip-Modutab 4 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ropinirole hydrochloride

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

N04BC; N04BC04

INN (International Name):

Ropinirole hydrochloride

Dosage:

4 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopamine agonists; ropinirole

Authorization status:

Marketed

Authorization date:

2008-02-01

Patient Information leaflet

Reason for update: PRAC Recommendation PSUSA/00002661/202207
Agency Approval Date: 05Jun2023 (Type IAIN)
Text Date: 18May2023
Issue and Draft No.: Issue 12 Draft 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
REQUIP-MODUTAB 2 MG PROLONGED-RELEASE TABLETS
REQUIP-MODUTAB 4 MG PROLONGED-RELEASE TABLETS
REQUIP-MODUTAB 8 MG PROLONGED-RELEASE TABLETS
ropinirole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
.
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.
Keep this leaflet. You may need to read it again.
If you have any more questions, ask your doctor or pharmacist.
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 Requip-Modutab
is and what it is used for
2. What you need to know before you take Requip-Modutab
3. How to take Requip-Modutab
4. Possible side effects
5. How to store Requip-Modutab
6. Contents of the pack and other information
1.
WHAT REQUIP
-
MODUTAB
IS AND WHAT IT IS USED FOR
The active ingredient in Requip-Modutab
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.
REQUIP-MODUTAB PROLONGED-RELEASE TABLETS ARE USED TO TREAT
PARKINSON’S DISEASE.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REQUIP
-
MODUTAB
DO NOT TAKE REQUIP-MODUTAB:
▪
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.
Reason

Summary of Product characteristics

Health Products Regulatory Authority
17 July 2023
CRN00DM78
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Requip-Modutab 4 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 4 mg of ropinirole (as
hydrochloride).
Excipients with known effect
Each tablet contains 41.8 mg lactose, 1.24 mg sunset yellow FCF (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablets.
Light brown capsule-shaped, film-coated, marked GS on one side and WXG
on the other.
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
on-off type fluctuations)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Adults
Individual dose titration against efficacy and tolerability is
recommended. Requip-Modutab prolonged-release tablets should
be taken once a day, at a similar time each day. The prolonged-release
tablets may be taken with or without food (see section
5.2).
Requip-Modutab prolonged-release tablets must be swallowed whole and
must not be chewed, crushed or divided.
_Initial titration_
The starting dose of ropinirole prolonged-release 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
prolonged-release tablets.
Patients who initiate treatment with a dose of 2 mg/day of ropinirole
prolonged-release tablets and who experience side
effects that they cannot tolerate, may benefit from switching to
treatment with ropinirole film-coated (immediate release)
tablets at a lower daily dose, divided into three equal doses.
_Thera