Nurtec 75mg Oral Lyophilisate

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Rimegepant

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Rimegepant

Unit dalam pakej:

2 Tablets; 8 Tablets

Dikeluarkan oleh:

Catalent UK Swindon Zydis Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
NURTEC
TM
ORAL LYOPHILISATE
Rimegepant sulfate (75 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Nurtec is used for
2.
How Nurtec works
3.
Before you use Nurtec
4.
How to use Nurtec
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Nurtec
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT NURTEC IS USED FOR
Nurtec is used to treat and prevent
migraine attacks in adults.
HOW NURTEC WORKS
Nurtec contains the active ingredient
rimegepant, that stops the activity of a
substance in the body called calcitonin
gene-related peptide (CGRP). People
with migraine may have increased levels
of CGRP. Rimegepant attaches to the
receptor for CGRP, reducing the ability
of CGRP to also attach to the receptor.
This reduces the activity of CGRP and
has two effects:
1) it can stop an active migraine attack,
and
2) it can decrease the number of migraine
attacks that occur when taken
preventively.
BEFORE YOU USE NURTEC
-
_When you must not use it_
Do not take Nurtec
-
if you are allergic to rimegepant or to
any of the other ingredients of the
medicine.
-
if you have severe liver problems.
-
If you have reduced kidney function
or are on kidney dialysis.
Nurtec should not be given to children
and adolescents under 18 years of age
because it has not yet been studied in this
age group.
_Pregnancy and lactation_
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice
before taking this medicine. It is
preferable to avoid the use of Nurtec
during pregnancy as the effects of this
medicine in pregnant women are not
known.
If you are breast-feeding or are planning
to breast-feed, talk to your doctor or
pharmacist before using this medicine.
You and your doctor should decide if you
will use Nurtec while breast-feeding.
-
_Before you start to use it_
Talk to your doctor, pharmacist or
nurse before taking Nurtec:
-
If you have kidney or liver disease.
-
if you e

Ciri produk

1
NURTEC
TM
RIMEGEPANT SULFATE
1.
NAME OF THE MEDICINAL PRODUCT
NURTEC 75 mg oral lyophilisate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral lyophilisate contains rimegepant sulfate, equivalent to 75
mg rimegepant
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral lyophilisate
The oral lyophilisate is white to off-white, circular, diameter 14 mm
and debossed with the
symbol
.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NURTEC is indicated for the

Acute treatment of migraine with or without aura in adults;

Preventive treatment of episodic migraine in adults who have at least
4 migraine attacks
per month.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acute treatment of migraine_
The recommended dose is 75 mg rimegepant, as needed, once daily.
_Prophylaxis of migraine_
The recommended dose is 75 mg rimegepant every other day.
The maximum dose per day is 75 mg rimegepant.
NURTEC can be taken with or without meals.
_Concomitant medicinal products_
Another dose of rimegepant should be avoided within 48 hours when it
is concomitantly
administered with moderate inhibitors of CYP3A4 (see section 4.5).
2
Special populations
_Elderly (aged 65 and over)_
There is limited experience with rimegepant in patients aged 65 years
or older. No dose
adjustment is required as the pharmacokinetics of rimegepant are not
affected by age (see
section 5.2).
_Renal impairment_
No dose adjustment is required in patients with mild, moderate, or
severe renal impairment.
Severe renal impairment resulted in a > 2-fold increase in unbound AUC
but less than a 50%
increase in total AUC (see section 5.2). Caution should be exercised
during frequent use in
patients with severe renal impairment. Rimegepant has not been studied
in patients with end-
stage renal disease and in patients on dialysis. Use of rimegepant in
patients with end-stage
renal disease (CLcr < 15 ml/min) should be avoided.
_Hepatic impairment_
No dose adjustment is required in patients with mild (Child-Pugh A) or
moderate (Child