Dorzolamide PharmaSwiss 20 mg/ml eye drops solution

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Dorzolamide

Διαθέσιμο από:

PharmaSwiss Ceska republika s.r.o.

Φαρμακολογική κατηγορία (ATC):

S01EC; S01EC03

INN (Διεθνής Όνομα):

Dorzolamide

Δοσολογία:

20 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Eye drops, solution

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Carbonic anhydrase inhibitors; dorzolamide

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

2016-11-25

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE PHARMASWISS 20 MG/ML, EYE DROPS SOLUTION
Dorzolamide hydrochloride
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 symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Dorzolamide PharmaSwiss is and what it is used for
2. What you need to know before you use Dorzolamide PharmaSwiss
3. How to use Dorzolamide PharmaSwiss
4. Possible side effects
5. How to store Dorzolamide PharmaSwiss
6. Contents of the pack and other information
1. WHAT DORZOLAMIDE PHARMASWISS IS AND WHAT IT IS USED FOR
Dorzolamide PharmaSwiss contains dorzolamide which belongs to a group
of medicines
called "carbonic anhydrase inhibitors".
This medicine is prescribed to lower raised pressure in the eye and to
treat glaucoma. This
medicine can be used alone or in addition to other medicines which
lower the pressure in the
eye (so called beta-blockers).
Dorzolamide PharmaSwiss eye drops solution is a sterile solution that
does not contain a
preservative.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE USE DORZOLAMIDE PHARMASWISS
DO NOT USE DORZOLAMIDE PHARMASWISS

if you are allergic to dorzolamide hydrochloride or any of the other
ingredients of this
medicine.

if you have severe kidney impairment or problems, or a prior history
of kidney
stones.
If you are not sure whether you should use this medicine, contact your
doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Dorzolamide
PharmaSwiss
Tell your doctor or pharmacist about any medical problems you have now
or have ha

Αρχείο Π.Χ.Π.

Health℃Products℃Regulatory℃Authority
12℃August℃2021
CRN00CD4Z
Page℃1℃of℃8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dorzolamide℃PharmaSwiss℃20℃mg/ml℃eye℃drops℃solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each℃ml℃contains℃20℃mg℃of℃dorzolamide℃(as℃dorzolamide℃hydrochloride)
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℃_270-310
_mOsM/Kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dorzolomide℃PharmaSwiss℃eye℃drops℃solution℃is℃indicated:

as℃adjunctive℃therapy℃to℃beta-blockers,℃

as℃monotherapy℃in℃patients℃unresponsive℃to℃beta-blockers℃or℃in℃whom℃beta-℃blockers℃are℃contraindicated,
in℃the℃treatment℃of℃elevated℃intra-ocular℃pressure℃in:

ocular℃hypertension,

open-angle℃glaucoma,

pseudoexfoliative℃glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
When℃used℃as℃monotherapy,℃the℃dose℃is℃one℃drop℃of℃dorzolamide℃in℃the℃conjunctival℃sac℃of℃the℃affected℃eye(s),℃three℃times℃
daily.
When℃used℃as℃adjunctive℃therapy℃with℃an℃ophthalmic℃beta-blocker,℃the℃dose℃is℃one℃drop℃of℃dorzolamide℃in℃the℃conjunctival℃sac℃
of℃the℃affected℃eye(s)℃two℃times℃daily.
When℃substituting℃dorzolamide℃for℃another℃ophthalmic℃anti-glaucoma℃agent,℃discontinue℃the℃other℃agent℃after℃proper℃dosing℃
on℃one℃day,℃and℃start℃dorzolamide℃on℃the℃next℃day.
If℃more℃than℃one℃topical℃ophthalmic℃drug℃is℃being℃used,℃the℃drugs℃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�