ROTEQ 5MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

ROPINIROLE HYDROCHLORIDE

Διαθέσιμο από:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Φαρμακολογική κατηγορία (ATC):

N04BC04

INN (Διεθνής Όνομα):

ROPINIROLE

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

ROPINIROLE HYDROCHLORIDE (8000002043) 5,7MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

ROPINIROLE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) PVC/ACLAR/ALU (310014804) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROTEQ_ _5 MG FILM-COATED TABLETS
Ropinirole
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 further questions, ask your doctor or pharmacist.
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.
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 ROTEQ IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROTEQ
3. HOW TO TAKE ROTEQ
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ROTEQ
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ROTEQ IS AND WHAT IT IS USED FOR

ROTEQ IS USED TO TREAT PARKINSON’S DISEASE
The avtive ingredient in Roteq 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROTEQ
DO NOT TAKE ROTEQ:

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
Talk to your doctor or pharmacist before taking Roteq:

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
-1-

if you have a SERIOUS MENTAL HEALTH PROBLEM

if you have experienced ANY UNUSUAL URGES AND/OR BEHAVIOURS (such as
excessive gambling o

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Roteq 0,25 mg Film-coated tablets
Roteq 0,5 mg Film-coated tablets
Roteq 1 mg Film-coated tablets
Roteq 2 mg Film-coated tablets
Roteq 3 mg Film-coated tablets
Roteq 4 mg Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Roteq 0,25 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 0,25 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
107.215 mg lactose monohydrate.
Roteq 0.5 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 0,5 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
106.93 mg lactose monohydrate.
Roteq 1 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 1 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
106.36 mg lactose monohydrate.
Roteq 2 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 2 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
105.22 mg lactose monohydrate.
Roteq 3 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 3 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
104.08 mg lactose monohydrate.
Roteq 4 mg film-coated tablets:
One film-coated tablet contains Ropinirole hydrochloride, equivalent
to 4 mg of Ropinirole.
Excipient(s) with known effect: each film-coated tablet contains
102.94 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Roteq 0,25 mg film-coated tablets:
White to off white coloured, round, biconvex film-coated tablets,
plain on both sides.
Roteq 0,5 mg film-coated tablets:
Pale yellow coloured, round, biconvex film-coated tablets, plain on
both sides.
1
Roteq 1 mg film-coated tablets:
Greenish yellow coloured, round, biconvex film-coat