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

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Dorzolamide hydrochloride; TIMOLOL MALEATE

Disponible desde:

PharmaSwiss Ceska republika s.r.o.

Código ATC:

S01ED; S01ED51

Designación común internacional (DCI):

Dorzolamide hydrochloride; TIMOLOL MALEATE

Dosis:

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

formulario farmacéutico:

Eye drops, solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Beta blocking agents1); timolol, combinations

Estado de Autorización:

Not marketed

Fecha de autorización:

2016-10-14

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE + TIMOLOL PHARMASWISS 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 PharmaSwiss is and what it is used for
2. What you need to know before you use Dorzolamide + Timolol
PharmaSwiss
3. How to use Dorzolamide + Timolol PharmaSwiss
4. Possible side effects
5. How to store Dorzolamide + Timolol PharmaSwiss
6. Contents of the pack and other information
1. WHAT DORZOLAMIDE + TIMOLOL
PHARMASWISS IS AND WHAT IT IS USED FOR
Dorzolamide + Timolol PharmaSwiss 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 pressure in the eye in different ways.
Dorzolamide + Timolol PharmaSwiss is prescribed to lower raised
pressure in the eye in the
treatment of glaucoma when beta-blocker eyedrop medicine used alone is
not adequate.
Dorzolamide + Timolol PharmaSwiss eye drops solution is a sterile
solution that does not
contain a preservative.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE + TIMOLOL
PHARMASWISS
DO NOT USE DORZOLAMIDE + TIMOLOL PHARMASWISS

if you are allergic to dorzolamide, timolol 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 (sev

Ficha técnica

Health Products Regulatory Authority
13 January 2021
CRN009LGN
Page 1 of 12
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 of dorzolamide (as hydrochloride) and 5 mg of
timolol (as meleate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear, colourless, slightly viscous aqueous solution, with a pH
between 5.0 and 6.0, and an osmolality of _251-289 _mOsM/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 Dorzolamide + Timolol eye drops solution in
the (conjunctival sac of the) affected eye(s) two times
daily.
If another topical ophthalmic agent is being used, Dorzolamide +
Timolol eye drops solution and the other agent should be
administered at least ten minutes apart.
Dorzolamide + Timolol eye drops solution is a sterile solution that
does not contain a preservative.
The solution from the multi-dose container can be used for up to 28
days after first opening for administration to the affected
eye(s).
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 as this could cause injury to
the eye.
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.
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.
INSTRUCTI