Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops, solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Dorzolamide; Timolol

Boleh didapati daripada:

Accord Healthcare Ireland Ltd.

Kod ATC:

S01ED; S01ED51

INN (Nama Antarabangsa):

Dorzolamide; Timolol

Dos:

20 mg/ml+5 milligram(s)/millilitre

Borang farmaseutikal:

Eye drops, solution

Kawasan terapeutik:

Beta blocking agents1); timolol, combinations

Status kebenaran:

Not marketed

Tarikh kebenaran:

2011-08-12

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE/TIMOLOL 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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dorzolamide/Timolol is and what it is used for
2.
What you need to know before you use Dorzolamide/Timolol
3.
How to use Dorzolamide/Timolol
4.
Possible side effects
5.
How to store Dorzolamide/Timolol
6.
Contents of the pack and other information
1.
WHAT DORZOLAMIDE/TIMOLOL IS AND WHAT IT IS USED FOR
Dorzolamide/Timolol is a combination of 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”.
Dorzolamide/Timolol is prescribed to lower raised pressure within the
eye in the treatment of
glaucoma when beta-blocker eye drops used alone are not adequate.
2.
WHAT YOU NEED TO NOW BEFORE YOU USE DORZOLAMIDE/TIMOLOL
DO NOT USE DORZOLAMIDE/TIMOLOL:
-
if you are allergic to dorzolamide or timolol, beta blockers or any of
the other ingredients of
this medicine (listed in section 6).
-
if you have now or have had in the past respiratory problems such as
asthma, severe chronic
obstructive lung disease (severe lung disease which may cause
wheeziness, difficulty in
breathing and/or long-standing cough),
-
if you have severe kidney problems, or a prior history of kidney
stones,
-
if you have a disturbance in the pH (acid/alkali balance) of your
blood,
-
if you have certain heart problems, including certai

Ciri produk

Health Products Regulatory Authority
15 May 2020
CRN009L1Y
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dorzolamide/Timolol 20 mg/ml + 5 mg/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20 mg dorzolamide (as Dorzolamide hydrochloride) and
5 mg timolol (as timolol maleate).
Excipient with known effect: each ml of eye drops solution contains
0.075 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, slightly viscous, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dorzolamide/Timolol is indicated in the treatment of elevated
intra-ocular pressure (IOP) in patients with open-angle glaucoma
or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy
is not sufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of Dorzolamide/Timolol in the (conjunctival sac
of the) affected eye(s) two times daily.
If another topical ophthalmic medicinal product is being used, the
other agent should be administered at least ten minutes
apart.
_Paediatric population_
Efficacy in paediatric patients has not been established.
Safety in paediatric patients below the age of two years has not been
established. (For information regarding safety in
paediatric patients ≥ 2 and < 6 years of age, see section 5.1).
Method of administation
Patients should be instructed to wash their hands before use and avoid
allowing the tip of the dispensing container to contact
the eye or surrounding structures.
In order to secure correct dosage - the dropper tip should not be
enlarged.
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 ophthalmic
_Dorzolamide/Timolol._
1.
The tamper-pro