Repinex XL 2mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Ropinirole hydrochloride

Commercializzato da:

Aspire Pharma Ltd

Codice ATC:

N04BC04

INN (Nome Internazionale):

Ropinirole hydrochloride

Dosaggio:

2mg

Forma farmaceutica:

Modified-release tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04090100; GTIN: 5060209730844

Foglio illustrativo

Package Leaflet: Information for the user
REPINEX XL 2MG PROLONGED-RELEASE TABLETS
REPINEX XL 4MG PROLONGED-RELEASE TABLETS
REPINEX XL 8MG PROLONGED-RELEASE 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 Repinex XL is and what it is used for
2. What you need to know before you take Repinex XL
3. How to take Repinex XL
4. Possible side effects
5. How to store Repinex XL
6. Contents of the pack and other information
1. WHAT REPINEX XL IS AND WHAT IT IS USED FOR
The active ingredient in Repinex XL 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.
Repinex XL 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
REPINEX XL
Do not take Repinex XL
•
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 Repinex XL.
Tell your doctor if you or your family/carer notices that you are
developing urges or cravings to behave in ways that are
unusual for you and you cannot res

Scheda tecnica

OBJECT 1
REPINEX XL 2MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 08-Aug-2017 | Aspire Pharma
Ltd
1. Name of the medicinal product
Repinex XL 2 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each tablet contains 2 mg ropinirole (as ropinirole hydrochloride).
Excipients with known effect
Each 2 mg prolonged-release tablet contains 1.8 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
2 mg prolonged-release tablets: pink, round biconvex tablets 6.8 ±
0.1 mm in diameter and 5.5 ± 0.2 mm
in thickness.
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
Posology
_Adults_
Individual dose titration against efficacy and tolerability is
recommended.
_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 undesirable effects that they cannot tolerate, may benefit
from switching to treatment with
ropinirole immediate-release tablets at a lower daily dose, divided
into three equal doses.
_Therapeutic regimen_
Patients should be maintained on the lowest dose of ropinirole
prolonged-release tablets that achieves
symptomatic control.
If sufficient symptomatic control is not achieved or maintained at a
dose of 4 mg once daily of ropini