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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dorzolamide hydrochloride; Timolol Maleate

Available from:

Bausch + Lomb Ireland Limited

ATC code:

S01ED; S01ED51

INN (International Name):

Dorzolamide hydrochloride; Timolol Maleate

Dosage:

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

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Beta blocking agents1); timolol, combinations

Authorization status:

Marketed

Authorization date:

2016-10-14

Patient Information leaflet

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 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 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 eye drops solution is a sterile solution that
does not contain a
preservative.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE + TIMOLOL
DO NOT USE DORZOLAMIDE + TIMOLOL
•
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 (severe lung disease which may cause
wheeziness,
difficulty in breathing and/or long-standing cough);
•
if you have a slow heartbeat,

Summary of Product characteristics

Health℃Products℃Regulatory℃Authority
26℃June℃2023
CRN00DDJN
Page℃1℃of℃12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dorzolamide℃+℃Timolol℃PharmaSwiss℃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℃and℃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℃and℃Timolol℃eye℃drops℃solution℃and℃the℃other℃agent℃should℃be℃
administered℃at℃least℃ten℃minutes℃apart.℃
Dorzolamide℃and℃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℃b