Golpimec 0.5 mg hard capsules

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Fingolimod

থেকে পাওয়া:

Neuraxpharm Ireland Limited

এটিসি কোড:

L04AA27

INN (আন্তর্জাতিক নাম):

Fingolimod

ডোজ:

0.5 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

থেরাপিউটিক এলাকা:

fingolimod

অনুমোদন তারিখ:

2021-11-19

তথ্য লিফলেট

page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GOLPIMEC 0.5 MG HARD CAPSULES
fingolimod
WHAT IS IN THIS LEAFLET:
1. What Golpimec is and what it is used for
2. What you need to know before you take Golpimec
3. How to take Golpimec
4. Possible side effects
5. How to store Golpimec
6. Contents of the pack and other information
1.
WHAT GOLPIMEC IS AND WHAT IT IS USED FOR
WHAT GOLPIMEC IS
The active substance of Golpimec is fingolimod.
WHAT GOLPIMEC IS USED FOR
Golpimec is used in adults and in children and adolescents (10 years
of age and above) to
treat relapsing-remitting multiple sclerosis (MS), more specifically
in:
-
Patients who have failed to respond despite treatment with an MS
treatment.
or
-
Patients who have rapidly evolving severe MS.
Golpimec does not cure MS, but it helps to reduce the number of
relapses and to slow
down the progression of physical disabilities due to MS.
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.
page 2 of 15
WHAT IS MULTIPLE SCLEROSIS
MS is a long-term condition that affects the central nervous system
(CNS), comprised of
the brain and spinal cord. In MS inflammation destroys the protective
sheath (called
myelin) around the nerves in the CNS and stops the nerves from working
properly. This
is called demyelination.
Relapsing-remitting MS is characterised by repeated attacks (relapses)
of nervous system
symptoms that reflect inflammation within the CNS. Symptoms vary from
patient to
patient but typically involve walking difficulties, numbness, vision
problems or disturbed
balan

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
20 June 2022
CRN00CTQS
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Golpimec 0.5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5
mg fingolimod.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule
Hard capsule with white opaque cap imprinted in black with "FIN 0.5"
and white opaque body
Hard capsule dimensions are:
Length of body: 13.13 – 14.05 mm
Length of cap: 7.60 – 8.54 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Golpimec is indicated as single disease modifying therapy in highly
active relapsing remitting multiple sclerosis for the
following groups of adult patients and paediatric patients aged 10
years and older:
- Patients with highly active disease despite a full and adequate
course of treatment with at least one disease modifying
therapy (for exceptions and information about washout periods see
sections 4.4 and 5.1).
or
- Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more disabling relapses in one
year, and with 1 or more Gadolinium enhancing lesions on brain MRI or
a significant increase in T2 lesion load as compared to
a previous recent MRI.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
POSOLOGY
In adults, the recommended dose of Golpimec is one 0.5 mg hard capsule
taken orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:

Paediatric patients with body weight ≤40 kg: 0.25 mg taken orally
once daily. Golpimec 0.5 mg hard capsules are
not suitable for paediatric patients with body weight ≤ 40 kg. Other
fingolimod-containing medicinal products are
available in a lower strength (as 0.25 mg hard capsule).

Paediatric patients with body weight >40 kg: 0.5 mg taken orally once
daily.
Paediatric p