TAPCOM ophthalmic solution

Country: Malaysia

Language: English

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

Active ingredient:

Tafluprost; TIMOLOL MALEATE

Available from:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (International Name):

Tafluprost; TIMOLOL MALEATE

Units in package:

2.5 ml

Manufactured by:

Santen Pharmaceutical Co., Ltd., Shiga Plant

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TAPCOM OPHTHALMIC SOLUTION
Tafluprost (15 micrograms/ml), Timolol (5mg/ml)
WHAT IS IN THIS LEAFLET
1.
What TAPCOM is used for
2.
How TAPCOM works
3.
Before you use TAPCOM
4.
How to use TAPCOM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TAPCOM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT TAPCOM IS USED FOR
TAPCOM
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 WORKS
TAPCOM ophthalmic solution contains
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 and lower the pressure in
the
eye.
TAPCOM
is
used
when
the
pressure in the eye is too high.
BEFORE YOU USE TAPCOM
-
_When you must not use it _
Do not use TAPCOM:
•
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,
bronchospasm,
severe
chronic
obstructive
pulmonary
disease (severe lung disease which
may cause wheeziness, difficulty in
breathing
and/or
long-standing
cough).
•
if you have a slow heartbeat, heart
failure,
atrioventricular
block
or
cardiogenic shock.
-
_Before you start use it _
Before you use this medicine, tell your
doctor if you have now or have had in
the past:
•
If
you
have
bronchial
asthma/history
of
bronchial
asthma, bronchospasm, chronic
obstructive
pulmonary
disease,
heart failure, sinus bradycardia,
atrioventricular
block,
cardiogenic
shock,
diabetes,
intraocular inflammation (iritis,
uveitis),
or
aphakia/
pseudophakia eyes.
•
If you wear contact lenses.
•
If
you
are
pregnan

Summary of Product characteristics

TAPCOM
® OPHTHALMIC SOLUTION
(Tafluprost 15micrograms/ml + Timolol 5mg/ml)
DESCRIPTION
TAPCOM
®
ophthalmic solution is a clear, colorless, sterile aqueous ophthalmic
solution.
Each mL contains 0.015mg of Tafluprost and 6.83mg of Timolol maleate
(equivalent to
5mg Timolol). It also contains sodium dihydrogen phosphate dihydrate,
Polysorbate 80,
Disodium
edetate
hydrate,
Concentrated
Glycerin,
Benzalkonium
Chloride,
Sodium
Hydroxide, Dilute Hydrochloric acid and Purified Water.
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.
DOSAGE AND ADMINISTRATION
Instill 1 drop in the affected eye(s) once daily.
CONTRAINDICATIONS
1)
Patients with bronchial asthma or a history of bronchial asthma,
bronchospasm, or
severe chronic obstructive pulmonary disease [Asthmatic attack may be
aggravated or
induced due to bronchial smooth muscle contraction caused by
β-receptor blockage].
2)
Patients with poor-controlled cardiac failure, sinus bradycardia,
second- or third-
degree
atrioventricular
block,
or
cardiogenic
shock
[These
symptoms
may
be
aggravated
due
to
negative
chronotropic/inotropic
effects
caused
by
β-receptor
blockage].
3)
Patients with a history of hypersensitivity to any of the ingredients
in this product.
WARNINGS AND PRECAUTIONS
_1._
_ _
_CAREFUL ADMINISTRATION (THIS PRODUCT SHOULD BE ADMINISTERED WITH CARE
TO THE _
_FOLLOWING PATIENTS.) _
1)
Patients with right ventricular failure caused by pulmonary
hypertension [Symptoms
may be aggravated due to negative chronotropic/inotropic effects
caused by β-receptor
blockage.]
2)
Patients with congestive heart failure [Symptoms may be aggravated due
to negative
chronotropic/inotropic effects caused by β-receptor blockage.]
3)
Patients with diabetic ketoacidosis or metabolic acidosis [This
product may enhance the
depression of myocardial contraction caused by acidosis