XALACOM EYE DROP 0.005%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LATANOPROST; TIMOLOL MALEATE

Boleh didapati daripada:

UPJOHN (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

LATANOPROST; TIMOLOL MALEATE

Unit dalam pakej:

5ml mL; 2.5 ml mL

Dikeluarkan oleh:

PFIZER MANUFACTURING BELGIUM NV,

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XALACOM
®
EYE DROPS
Latanoprost/Timolol (50 micrograms/mL and 5 mg/mL)
1
WHAT IS IN THIS LEAFLET
1.
What XALACOM is used for
2.
How XALACOM works
3.
Before you use XALACOM
4.
How to use XALACOM
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
XALACOM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT XALACOM IS USED FOR
Reduction of intraocular pressure (IOP)
in patients with open angle glaucoma and
ocular hypertension who are
insufficiently responsive to topical beta-
blockers.
XALACOM is used to reduce the
pressure in your eye if you have
conditions known as open angle
glaucoma or ocular hypertension. Both
these conditions are linked to an increase
in the pressure within your eye,
eventually affecting your eyesight. Your
doctor will usually prescribe you
XALACOM when other medicines have
not worked adequately.
HOW XALACOM WORKS
XALACOM contains two medicines:
latanoprost and timolol. Latanoprost
belongs to a group of medicines known
as prostaglandin analogues. Timolol
belongs to a group of medicines known
as beta-blockers. Latanoprost works by
increasing the natural outflow of fluid
from the eye into the bloodstream.
Timolol works by slowing the formation
of fluid in the eye.
BEFORE YOU USE XALACOM
XALACOM can be used in adult men
and women (including the elderly), but is
not recommended for use if you are less
than 18 years of age.
_- When you must not use it_
Do not use XALACOM:
- if you are allergic (hypersensitive) to
either of the medicines in
XALACOM (latanoprost or timolol)
or any of the other ingredients of
XALACOM (see Section Product
Description).
- if you have or have had in the past
respiratory problems such as asthma,
severe chronic obstructive
pulmonary disease (severe lung
disease which may cause
wheeziness, difficulty in breathing
and/or long-standing cough).
- if you have serious heart problems or
heart rhythm disorders.
_Pregnancy and lactat

Ciri produk

Pfizer Confidential
1
PFIZER
XALACOM
®
LATANOPROST, TIMOLOL MALEATE
1.
NAME OF THE MEDICINAL PRODUCT
Xalacom eye drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 50 micrograms
latanoprost
and 6.8 mg timolol maleate
equivalent to 5 mg timolol.
Excipients with known effects:
Benzalkonium chloride 0.2 mg/mL.
Disodium
phosphate
(E339ii),
Sodium
dihydrogen
phosphate
monohydrate
(E339i)
(containing total phosphate 6.3 mg/mL).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle
glaucoma and
ocular hypertension who are insufficiently responsive to topical
beta-blockers.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
Recommended therapy is one eye drop in 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.
_Paediatric population_
The safety and efficacy of Xalacom in children and adolescents has not
been
established.
Pfizer Confidential
2
Method of administration
Contact lenses should be removed before instillation of the eye drops
and may be
reinserted after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs
should be
administered at least five minutes apart.
When
using
nasolacrimal
occlusion
or
closing
the
eyelids
for
2
minutes,
the
systemic absorption is reduced. This may result in a decrease in
systemic side effects
and an increase in local activity.
4.3
CONTRAINDICATIONS
Xalacom is contraindicated in patients with:

Reactive airway disease including bronchial asthma or a history of
bronchial asthma,
severe chronic obstructive pulmonary disease.

Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or
third degree
atrioventricular
block
not
controlled
w