ROTEQ 0.5MG FILM COATED TABLETS

Country: Կիպրոս

language: հունարեն

source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

active_ingredient:

ROPINIROLE HYDROCHLORIDE

MAH:

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

ATC_code:

N04BC04

INN:

ROPINIROLE

dosage:

0.5MG

pharmaceutical_form:

FILM COATED TABLETS

composition:

ROPINIROLE HYDROCHLORIDE (8000002043) 0,57MG

administration_route:

ORAL USE

prescription_type:

Εθνική Διαδικασία

therapeutic_area:

ROPINIROLE

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) ALU/ALU (310014316) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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
The active ingredient of 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.
ROTEQ IS 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.

TO TREAT THE SYMPTOMS OF MODERATE-TO-SEVERE RESTLESS LEGS SYNDROME

Restless Legs Syndrome (RLS) is also called Ekbom syndrome. People
with Restless Legs
Syndrome have an irresistible urge to move their legs, and sometimes
their arms and other
parts of their bodies. Usually, they have unpleasant sensations in
their limbs – sometimes
described as ‘crawling’ or ‘bubbling’ – which can begin as
soon as they sit or lie down, and
are relieved only by movement. So they often have problems with
sittin

SPC

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