Combi-Prost Eye Drops

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

LATANOPROST; TIMOLOL MALEATE

Prieinama:

Aspen Medical Products Malaysia Sdn Bhd

INN (Tarptautinis Pavadinimas):

LATANOPROST; TIMOLOL MALEATE

Vienetai pakuotėje:

2.5ml ml

Pagaminta:

RAFARM S.A.

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
COMBI-PROST EYE DROPS
Latanoprost 50mcg/ml and timolol (as timolol maleate) 5mg/ml
WHAT IS IN THE LEAFLET?
1.
What Combi-Prost is used for
2.
How Combi-Prost works
3.
Before you use Combi-Prost
4.
How to use Combi-Prost
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Combi-Prost
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT COMBI-PROST IS USED FOR
Combi-Prost is used to lower
the
pressure in your eye, if you
have conditions known as
open angle
glaucoma and eye
pressure is high, but does not
works with eye drops which is
contains beta-blockers (e.g.
timolol).
HOW COMBI-PROST WORKS
Combi-Prost contains two
active ingredient called
Latanoprost and timolol(as
timolol maleate).
Latanoprost
allows more fluid
to flow out from
within your
eye. Timolol lowers the
pressure in the eye by reducing
the production of fluid.
Although Combi-Prost helps
control
your glaucoma, it does
not cure it. So
you must keep
using it until your
doctor tells
you to stop.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another
reason.
Combi-Prost is not
recommended for use in
children. The safety and
effectiveness of Combi-Prost
in children have not been
established.
BEFORE YOU USE COMBI-PROST
-
_When you must not use it_
Do not use this medicine if you
have an allergy to:
•
The active ingredients,
Latanoprost and timolol
•
any of the other ingredients
listed at the end of this
leaflet
Do not use Combi-Prost if you
have:
•
asthma or a history of
asthma or other breathing
problems
•
certain heart conditions,
such as a very slow heart
rate, an irregular heart beat
or heart failure
Do not use this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should start using thi

Prekės savybės

1
COMBI-PROST
LATANOPROST & TIMOLOL
NAME OF THE MEDICAL PRODUCT
Combi-Prost Eye Drops
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 50mcg of Latanoprost and 6.8 mg of timolol maleate,
equivalent to 5.0 mg
timolol.
PHARMACEUTICAL FORM
Eye drop solution.
The solution is a clear, colourless liquid.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle
glaucoma and ocular
hypertension who are insufficiently responsive to topical
beta-blockers.
POSOLOGY AND METHOD OF ADMINISTRATION
_Recommended dosage for adults (including the elderly): _
The recommended dose is one eye drop in the affected eye(s), once
daily.
If a dose is missed, treatment should continue with the next dose as
normal. The dose should not
exceed one drop in each affected eye daily.
_Administration: _
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after
15 minutes.
If more than one topical ophthalmic medicinal product is being used,
the medicinal products
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.
_ _
Use in children and adolescents:
The safety and efficacy in children and adolescents have not been
established.
2
CONTRAINDICATIONS
Combi-Prost 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 with pace-maker, overt cardiac
failure, cardiogenic
shock.
−
Hypersensitivity to the active substances or to any of the excipients.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SYSTEMIC EFFECTS
Like other topically applied ophthalmic agents, Combi-Prost is
absorbed systemically. Due to the
beta-adrenergic com