REQUIP MODUTAB 4 MG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ROPINIROLE AS HYDROCHLORIDE

Διαθέσιμο από:

GLAXO SMITH KLINE (ISRAEL) LTD

Φαρμακολογική κατηγορία (ATC):

N04BC04

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS - PROLONGED RELEASE

Σύνθεση:

ROPINIROLE AS HYDROCHLORIDE 4 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

GLAXO WELLCOME SA, SPAIN

Θεραπευτική ομάδα:

ROPINIROLE

Θεραπευτική περιοχή:

ROPINIROLE

Θεραπευτικές ενδείξεις:

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)."

Ημερομηνία της άδειας:

2014-08-31

Φύλλο οδηγιών χρήσης

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
Requip Modutab 2 mg
Requip Modutab 4 mg
Requip Modutab 8 mg
Film-coated prolonged-release tablets that contain ropinirole (as
hydrochloride)
2 mg, 4 mg or 8 mg.
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 -
Important information about some of the ingredients in the medicine
and
section 6 - Additional information .
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Requip Modutab is indicated for the 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).
The active ingredient in Requip Modutab is ropinirole.
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.
You can take Requip Modutab either on its own or along with L-dopa
(see
section 4 of this leaflet for more details).
Therapeutic group: dopamine agonist.
Dopamine agonists affect the brain in a similar way to a natural
substance called
dopamine.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
• You are sensitive (allergic) to the active ingredient ropinirole
or to any of the
additional ingredients contained in this medicine (listed in sectio

Αρχείο Π.Χ.Π.

Page 1 of 11
REQUIP
MODUTAB 2 MG
REQUIP
MODUTAB 4 MG
REQUIP
MODUTAB 8 MG
1.
NAME OF THE MEDICINAL PRODUCT
Requip
Modutab 2 mg
Requip
Modutab 4 mg
Requip
Modutab 8 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2 / 4 / 8 mg ropinirole (as hydrochloride).
Excipients with known effect:
44.0 mg/41.8 mg/37.5 mg (respectively) Lactose
1.24 mg Sunset yellow (E110) (Requip
Modutab 4 mg only)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
2 mg:
Pink capsule-shaped, film-coated tablets marked "GS" on one side and
"3V2" on the other.
4 mg:
Light brown capsule-shaped, film-coated tablets marked "GS" on one
side and "WXG" on the other.
8 mg:
Red capsule-shaped, film-coated tablets marked "GS" on one side and
"5CC" 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.
Individual dose titration against efficacy and tolerability is
recommended.
Page 2 of 11
Ropinirole prolonged-release tablets should be taken once a day and at
a similar time each day. The tablets
must be swallowed whole and must not be chewed, crushed or divided.
The 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).
ADULTS
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.
THERAPEUTIC REGIMEN
Patients should be maintained on the lowest dose