Tecfidera 240mg gastro-resistant capsules

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Dimethyl fumarate

Dostopno od:

Biogen Idec Ltd

Koda artikla:

N07XX09

INN (mednarodno ime):

Dimethyl fumarate

Odmerek:

240mg

Farmacevtska oblika:

Gastro-resistant capsule

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 08020400; GTIN: 0646520409000

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TECFIDERA 120 MG GASTRO-RESISTANT HARD CAPSULES
TECFIDERA 240 MG GASTRO-RESISTANT HARD CAPSULES
dimethyl fumarate
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 Tecfidera is and what it is used for
2.
What you need to know before you take Tecfidera
3.
How to take Tecfidera
4.
Possible side effects
5.
How to store Tecfidera
6.
Contents of the pack and other information
1.
WHAT TECFIDERA IS AND WHAT IT IS USED FOR
WHAT TECFIDERA IS
Tecfidera is a medicine that contains the active substance
DIMETHYL FUMARATE
.
WHAT TECFIDERA IS USED FOR
TECFIDERA IS USED TO TREAT RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS)
.
MS is a long-term condition that affects the central nervous system
(CNS), including the brain and the
spinal cord. Relapsing-remitting MS is characterised by repeated
attacks (relapses) of nervous system
symptoms. Symptoms vary from patient to patient but typically include
walking difficulties, feeling
off balance and visual difficulties. These symptoms may disappear
completely when the relapse is
over, but some problems may remain.
HOW TECFIDERA WORKS
Tecfidera seems to work by stopping the body’s defence system from
damaging your brain and spinal
cord. This may also help to delay future worsening of your MS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TECFIDERA
DO NOT TAKE TECFIDERA:
-
IF YOU ARE ALLERGIC TO DIMETHYL FUMARATE
or any of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
2
Tecfidera may affect y

Lastnosti izdelka

OBJECT 1
TECFIDERA 120MG AND 240MG GASTRO-RESISTANT
HARD CAPSULES
Summary of Product Characteristics Updated 10-Apr-2018 | Biogen Idec
Ltd
1. Name of the medicinal product
Tecfidera 120 mg gastro-resistant hard capsules
Tecfidera 240 mg gastro-resistant hard capsules
2. Qualitative and quantitative composition
Tecfidera 120mg capsule
Each capsule contains 120 mg dimethyl fumarate.
Tecfidera 240mg capsule
Each capsule contains 240 mg dimethyl fumarate
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant hard capsule
Tecfidera 120mg capsule
Green and white gastro-resistant hard capsule printed with 'BG-12 120
mg'.
Tecfidera 240mg capsule
Green gastro-resistant hard capsule printed with 'BG-12 240 mg'
4. Clinical particulars
4.1 Therapeutic indications
Tecfidera is indicated for the treatment of adult patients with
relapsing remitting multiple sclerosis (please
refer to section 5.1 for important information on the populations for
which efficacy has been established).
4.2 Posology and method of administration
Treatment should be initiated under supervision of a physician
experienced in the treatment of the
disease.
Posology
The starting dose is 120 mg twice a day. After 7 days, the dose is
increased to the recommended dose of
240 mg twice a day.
Temporary dose reduction to 120 mg twice a day may reduce the
occurrence of flushing and
gastrointestinal adverse reactions. Within 1 month, the recommended
dose of 240 mg twice a day should
be resumed.
Tecfidera should be taken with food (see section 5.2). For those
patients who may experience flushing or
gastrointestinal adverse reactions, taking Tecfidera with food may
improve tolerability (see sections 4.4,
4.5 and 4.8).
_Elderly_
Clinical studies of Tecfidera had limited exposure to patients aged 55
years and above, and did not
include sufficient numbers of patients aged 65 and over to determine
whether they respond differently
than younger patients (see section 5.2). Based on the mode of action
of the a