Trobalt 50mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Retigabine

Fáanlegur frá:

GlaxoSmithKline UK Ltd

ATC númer:

N03AX21

INN (Alþjóðlegt nafn):

Retigabine

Skammtar:

50mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04080100; GTIN: 5000123113767 5000123113774

Upplýsingar fylgiseðill

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
n
ot 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
if any of these applies to you. The doctor may de

Vara einkenni

OBJECT 1
TROBALT
Summary of Product Characteristics Updated 18-May-2016 |
GlaxoSmithKline UK
1. Name of the medicinal product
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
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg of retigabine.
Each film-coated tablet contains 100 mg of retigabine.
Each film-coated tablet contains 200 mg of retigabine.
Each film-coated tablet contains 300 mg of retigabine.
Each film-coated tablet contains 400 mg of retigabine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
50 mg tablets:
Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50“
on one side.
100 mg tablets:
Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100“
on one side.
200 mg tablets:
Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with
“RTG-200“ on one side.
300 mg tablets:
Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with
“RTG-300“ on one side.
400 mg tablets:
Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with
“RTG-400“ 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