Selexid 400 mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Pivmecillinam hydrochloride

Boleh didapati daripada:

DKSH MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Pivmecillinam hydrochloride

Unit dalam pakej:

10tablet Tablets

Dikeluarkan oleh:

Recipharm Strabgnas AB

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SELEXID FILM-COATED TABLET®
Pivmecillinam hydrochloride (400mg)
1
WHAT IS IN THIS LEAFLET
1.
What Selexid
®
is used for
2.
How Selexid
®
works
3.
Before you use Selexid
®
4.
How to use Selexid
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Selexid
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SELEXID
® IS USED FOR
Selexid
®
is used to treat:
-Infections of the bladder (cystitis) in
adults.
HOW SELEXID
®
WORKS
Selexid
®
belongs to a group of medicines
called
penicillins.
It
is
a
type
of
antibiotic.
Selexid
®
works
by
killing
germs (bacteria) that cause infections.
BEFORE YOU USE SELEXID
®
-
_When you must not use it_
_ _
Your
doctor
may
have
prescribed
a
different use or dosage than stated in this
information.
Always
follow
your
doctor’s instructions.
Do not take Selexid
®
:
-
if you are allergic (hypersensitive)
to pivmecillinam or any of the other
ingredients of this medicine (listed
in
section
Product
Description
–
Ingredients)
-
if you are allergic (hypersensitive)
to other antibiotics. Such antibiotics
include penicillin or cephalosporins
-
if
you
have
narrowing
of
the
oesophagus
-
if you suffer from a condition which
may
reduce
the
amount
of
a
substance called carnitine in in your
body.
Such
conditions
include
carnitine
transporter
defect,
methylmalonic
aciduria
and
propionic acidaemia.
_Pregnancy, breast-feeding and fertility_
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
taking this medicine.
_Pregnancy _
Selexid
®
can
be
taken
during
pregnancy.
Some
cases
of
false-
positive
newborn
screening
tests
simulating the presence of isovaleric
acidaemia
have
been
reported.
The
intake
of
Selexid
®
shortly
before
delivery
may
affect
the
neonatal
screening for metabolic disorders and
give a false positive result. A “false
positive” means that the test wrongly
indicates
tha

Ciri produk

Selexid
®
400 mg film-coated tablets
Pivmecillinam hydrochloride
1.
NAME OF THE MEDICINAL PRODUCT
Selexid
®
400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg Pivmecillinam
hydrochloride. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
A white capsule-shaped, film-coated tablet, size 8 x 17 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Selexid
®
is indicated for adults in the treatment of acute uncomplicated
cystitis caused by bacteria
sensitive to mecillinam (see section 5.1).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 400 mg, 3 times daily.
Duration of treatment
Recommended treatment duration is 3 - 7 days.
Therapy should be continued for at least three days or at least 48
hours after signs and symptoms of infection
have disappeared.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
_Paediatric population _
Selexid
®
should not be used in children and adolescents below 18 years because
the efficacy and safety
have not yet been established.
_Elderly population _
Renal excretion of mecillinam is delayed in the elderly, but
significant accumulation of the drug is not likely
at the recommended adult dosage of Selexid. Dosage adjustment is not
necessary.
_Renal impairment _
Renal excretion of mecillinam is delayed in patients with reduced
kidney function, but significant
accumulation of the drug is not likely at the recommended adult dosage
of Selexid. Dosage adjustment is
not necessary (see section 5.2).
_Hepatic impairment _
Dosage adjustment is not necessary.
Method of administration
Selexid

must be taken with at least half a glass of liquid. Selexid

may be taken with food.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
•
Hypersensitivity to penicillins