Trobalt
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
19-11-2018
Charakterystyka produktu
(SPC)
19-11-2018
Sprawozdanie z oceny publicznego
(PAR)
19-11-2018
Składnik aktywny:
retigabine
Dostępny od:
Glaxo Group Limited
Kod ATC:
N03AX21
INN (International Nazwa):
retigabine
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsy
Wskazania:
Trobalt is indicated as adjunctive treatment of drug-resistant partial-onset seizures with or without secondary generalisation in patients aged 18 years or older with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated.
Podsumowanie produktu:
Revision: 12
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-03-27
Ulotka dla pacjenta
109
B. PACKAGE LEAFLET
Medicinal product no longer authorised
110
PACKAGE LEAFLET: INFORMATION FOR THE USER
TROBALT 50 MG FILM-COATED TABLETS
TROBALT 100 MG FILM-COATED TABLETS
TROBALT 200 MG FILM-COATED TABLETS
TROBALT 300 MG FILM-COATED TABLETS
TROBALT 400 MG FILM-COATED TABLETS
Retigabine
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 Trobalt is and what it is used for
2.
What you need to know before you take Trobalt
3.
How to take Trobalt
4.
Possible side effects
5.
How to store Trobalt
6.
Contents of the pack and other information
1.
WHAT TROBALT IS AND WHAT IT IS USED FOR
Trobalt contains the active substance retigabine. Trobalt is one of a
group of medicines called
_antiepileptics_
. It works by preventing the brain overactivity that causes epileptic
seizures (also called
fits).
Trobalt is used to treat seizures that affect one part of the brain
(partial seizure), which may or may not
extend to larger areas on both sides of the brain (secondary
generalisation). It is used together with
other anti-epileptic medicines to treat adults who continue to
experience seizures and where other
combinations of antiepileptic medicines have not worked well.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TROBALT
DO NOT TAKE TROBALT
•
if you are allergic to retigabine or any of the other ingredients of
Trobalt (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Trobalt:
•
if you are 65 years of age or above.
•
if you have kidney or liver problems.
Tell your doctor
i
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Trobalt 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of retigabine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50”
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trobalt is indicated as adjunctive treatment of drug-resistant partial
onset seizures with or without
secondary generalization in patients aged 18 years or older with
epilepsy, where other appropriate
combinations with other medicinal products have proved inadequate or
have not been tolerated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Trobalt must be titrated, according to individual patient response, in
order to optimise the balance
between efficacy and tolerability.
The maximum total daily starting dose is 300 mg (100 mg three times
daily). Thereafter, the total daily
dose is increased by a maximum of 150 mg every week, according to the
individual patient response
and tolerability. An effective maintenance dose is expected to be
between 600 mg/day and
1,200 mg/day.
The maximum total maintenance dose is 1,200 mg/day. The safety and
efficacy of doses higher than
1,200 mg/day have not been established.
If patients miss one dose or more, it is recommended that they take a
single dose as soon as they
remember.
After taking a missed dose, at least 3 hours should be allowed before
the next dose and then the
normal dosing schedule should be resumed.
When withdrawing Trobalt, the dose must be gradually reduced over a
period of at least 3 weeks (see
section 4.4).
_Elderly (65 years of age and above) _
There are only limited data on the safety and efficacy of retigabine
in patients aged 65 years and
above. A reduction in the initial and maintenance dose of Trobalt is
recommended in elderly patients.
Medicinal product no longer authorised
3
Th
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