COSOPT 20mg/ml + 5mg/ml eye drops, solution

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Dorzolamide; Timolol

Доступно од:

Santen OY

АТЦ код:

S01ED; S01ED51

INN (Међународно име):

Dorzolamide; Timolol

Дозирање:

20+5 milligram(s)/millilitre

Фармацеутски облик:

Eye drops, solution

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Beta blocking agents1); timolol, combinations

Статус ауторизације:

Marketed

Датум одобрења:

1998-08-14

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSOPT
 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION
dorzolamide / timolol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What COSOPT is and what it is used for
2.
What you need to know before you use COSOPT
3.
How to use COSOPT
4.
Possible side effects
5.
How to store COSOPT
6.
Contents of the pack and other information
1.
WHAT COSOPT IS AND WHAT IT IS USED FOR
COSOPT contains two medicines: dorzolamide and timolol.
•
Dorzolamide belongs to a group of medicines called “carbonic
anhydrase inhibitors”.
•
Timolol belongs to a group of medicines called “beta blockers”.
These medicines lower the pressure in the eye in different ways.
COSOPT is prescribed to lower raised pressure in the eye in the
treatment of glaucoma when
beta-blocker eyedrop medicine used alone is not adequate.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT
DO NOT USE COSOPT
•
if you are allergic to dorzolamide hydrochloride, timolol maleate or
any of the other
ingredients of this medicine (listed in section 6).
•
if you have now or had in the past respiratory problems, such as
asthma or 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 heart
rhythm (irregular
heartbeats).
•
if you have severe kidney disease or problems, or a prior history of
kidney stones.
•
if you have excess acidity of the blood caused by a build up of
chlorid

Карактеристике производа

Health Products Regulatory Authority
03 October 2023
CRN00DDJX
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COSOPT 20mg/ml + 5mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 22.26 mg of dorzolamide hydrochloride corresponding
to 20 mg dorzolamide and 6.83 mg of timolol maleate
corresponding to 5 mg timolol.
Excipient with known effect:
One ml of eye drops solution contains 0.075 mg benzalkonium chloride
and one drop contains about 0.002 mg of
benzalkonium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless to nearly colourless, slightly viscous solution with
a pH between 5.5 and 5.8 and an osmolality of 242–323
mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated in the treatment of elevated intraocular pressure (IOP) in
patients with open-angle glaucoma or pseudoexfoliative
glaucoma when topical beta-blocker monotherapy is not sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of COSOPT in the (conjunctival sac of the)
affected eye(s) two times daily.
If another topical ophthalmic agent is being used, COSOPT and the
other agent should be administered at least ten minutes
apart.
Patients should be instructed to wash their hands before use and avoid
allowing the tip of the container to come into contact
with the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled
improperly, can become contaminated by common bacteria
known to cause ocular infections. Serious damage to the eye and
subsequent loss of vision may result from using
contaminated solutions.
Patients should be informed of the correct handling of the containers.
_ _
Method of administration
1.
Wash your hands
2.
Open the container. Take special care that the tip of the dropper
container does not touch your eye, the skin
around your eye or your fingers.
3.
Tilt your head backwards and hold the container upside down ov