TAPCOM-S ophthalmic solution 15 microgramsml + 5 mgml solution in single-dose container

Country: Malaysia

Language: English

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

Active ingredient:

TIMOLOL MALEATE; Tafluprost

Available from:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (International Name):

TIMOLOL MALEATE; Tafluprost

Units in package:

0.3mL x 30units Units

Manufactured by:

Laboratoire UNITHER

Patient Information leaflet

TAPCOM-S OPHTHALMIC SOLUTION 15MICROGRAMS/ML +
5MG/ML, SOLUTION IN SINGLE-DOSE CONTAINER
Tafluprost + Timolol (as maleate) (15mcg/mL+ 5mg/mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Tapcom-S is used for
2.
How Tapcom-S works
3.
Before you use Tapcom-S
4.
How to use Tapcom-S
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tapcom-S
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TAPCOM-S
IS USED FOR
Tapcom-S
is
used
to
treat
a
type
of
glaucoma
called
open
angle
glaucoma
and also a condition known as ocular
hypertension
in
adults.
Both
of
these
conditions are linked with an increase in
the
pressure
within
your
eye
and
eventually they may affect your eyesight.
HOW TAPCOM-S WORKS
Tapcom-S
ophthalmic
solution
contain
tafluprost
and
timolol.
Tafluprost
belongs to a group of medicines called
prostaglandin
analogues
and
timolol
belongs to a group of medicines called
beta
blockers.
Tafluprost
and
timolol
work together to lower the pressure in
the
eye.
Tapcom-S
is
used
when
the
pressure in the eye is too high.
BEFORE YOU USE TAPCOM-S
-
_When you must not use it _
Do not use Tapcom-S:
•
if
you
are
allergic
to
tafluprost,
timolol, beta blockers or any of the
other ingredients of this medicine
(listed in section “Ingredients”.)
•
if you have now or have had in the
past respiratory problems such as
asthma, severe chronic obstructive
bronchitis
(severe
lung
disease
which
may
cause
wheeziness,
difficulty in breathing and/or long-
standing cough)
•
if you have a slow heartbeat, heart
failure
or
disorders
of
the
heart
rhythm (irregular heartbeats).
•
If you are using an eye drop that
containing omidenepag isopropyl.
_ _
-
_Before you start to use it _
Before you use this medicine, tell your
doctor if you have now or have had in
the past:
_ _
•
coronary
heart
disease
(symptoms
can include chest pain or tightness,
breathlessness
or
choking),
heart
failure, low blood pressure
•
disturbances
of
heart
rate
su

Summary of Product characteristics

_TAPCOM_
_®_
_-S OPHTHALMIC SOLUTION_
1. NAME OF THE MEDICINAL PRODUCT
Tapcom-S ophthalmic solution 15micrograms/ml
+ 5 mg/ml, solution in single-dose container.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
One ml solution contains: tafluprost
15micrograms and timolol (as maleate) 5 mg.
One single-dose container (0.3 ml) of eye drops,
solution, contains 4.5 micrograms of tafluprost
and 1.5 mg of timolol.
One drop (about 30 μl) contains about
0.45micrograms of tafluprost and 0.15 mg of
timolol. For the full list of excipients, see section
6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution in single-dose container (eye
drops).
A clear, colorless solution with a PH of 6.0-6.7
and an osmolality of 290-370 mOsm/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in
adult patients with open angle glaucoma or
ocular hypertension who are insufficiently
responsive to topical monotherapy with beta-
blockers or prostaglandin analogues and require
a combination therapy, and who would benefit
from preservative free eye drops.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended therapy is one eye drop in the
conjunctival sac of the affected eye(s) once
daily.
If one dose is missed, treatment should continue
with the next dose as planned. The dose should
not exceed one drop in the affected eye(s) daily.
Tapcom-S is a preservative free sterile solution
packaged in a single-dose container. For single
use only, one container is sufficient to treat both
eyes. Any unused solution should be discarded
immediately after use.
_Paediatric population_
The safety and efficacy of Tapcom-S in children
and adolescents below the age of 18 years have
not been established. No data are available.
Tapcom-S is not recommended for use in
children and adolescents below the age of 18
years.
_Use in elderly_
No dosage alteration in elderly patients is
necessary.
_Use in renal/hepatic impairment_
Tafluprost and timolol eye drops have not been
studied in patients with renal/hepatic impairment
and Tapco