Requip-Modutab 8 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ropinirole

Available from:

LTT Pharma Limited

ATC code:

N04BC; N04BC04

INN (International Name):

Ropinirole

Dosage:

8 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:

Authorised

Authorization date:

2014-06-20

Patient Information leaflet

•
Do not use this medicine after the expiry date
which is stated on the carton and blister.
The expiry date refers to the last day of that
month.
•
Do not store above 25 °C. Store in the original
package in order to protect from light.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use.
These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT REQUIP-MODUTAB CONTAINS
•
The active substance is ropinirole.
Each prolonged-release tablet contains 8 mg
of ropinirole (as hydrochloride).
•
The other ingredients are TABLET CORE -
Hypromellose, hydrogenated castor oil,
carmellose sodium, povidone (K29-32),
maltodextrin, magnesium stearate,
lactose monohydrate, anhydrous colloidal silica,
mannitol (E421), iron oxide yellow (E172),
glycerol dibehenate.
FILM COATING: OPADRY red 03B25227
(hypromellose, iron oxide yellow (E172),
titanium dioxide (E171), iron oxide black
(E172), macrogol 400, iron oxide red (E172)).
WHAT REQUIP-MODUTAB LOOKS LIKE AND CONTENTS
OF THE PACK
•
Requip-Modutab is a Red capsule-shaped,
film-coated, marked "GS" on one side and
"5CC" on the other.
•
Requip-Modutab comes in blister packs of 84
prolonged- release tablets.
Parallel Product Authorisation Holder:
LTT Pharma Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire,
B98 0RE.
REPACKAGED BY:
Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
MANUFACTURER
This medicine is manufactured by SmithKline
Beecham Plc T/A SmithKline Beecham
Pharmaceuticals, Manor Royal, Crawley, West
Sussex, RH10 9QJ United Kingdom or Glaxo
Wellcome GmbH & Co. KG, Industriestrasse
32-36, 23843 Bad Oldsloe, Germany or
GlaxoSmithKline Pharmaceuticals S.A ., UI.
Grunwaldzka, 61-322, Poznan, Poland or Glaxo
Wellcome S.A., Avenida de Extremadura 3,
Aranda de Duero, Burgos, Spain.
Requip is a registered trademark of the
GlaxoSmithKline Group of Companies.
Leaflet revision date: 1

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Requip-Modutab 8 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 8 mg of ropinirole (as
hydrochloride).
Excipients: lactose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
_Product imported from Italy:_
Red capsule-shaped, film-coated Tablet, marked "GS" on one side and
"5CC" on the other.
4 CLINICAL PARTICULARS
As per PA1077/037/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/037/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Prolonged-release tablet cores:
Hypromellose, hydrogenated castor oil, carmellose sodium, povidone
(K29
-
32),
maltodextrin, magnesium stearate, lactose monohydrate, anhydrous
colloidal silica, mannitol (E421), iron oxide yellow
(E172), glycerol dibehenate.
Film coating:
OPADRY red 03B25227 (hypromellose, iron oxide yellow (E172), titanium
dioxide (E171), iron oxide
black (E172), macrogol 400, iron oxide red (E172)).
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C
Store in the original package in order to protect from light
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