COSOPT

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

DORZOLAMIDE AS HYDROCHLORIDE; TIMOLOL AS MALEATE

Dostupné z:

RAFA LABORATORIES LTD

ATC kód:

S01ED01

Forma lieku:

OPHTHALMIC SOLUTION

Zloženie:

DORZOLAMIDE AS HYDROCHLORIDE 20 MG/ML; TIMOLOL AS MALEATE 5 MG/ML

Spôsob podávania:

OCULAR

Typ predpisu:

Required

Výrobca:

MERCK SHARP & DOHME-CHIBRET, FRANCE

Terapeutické skupiny:

CARBONIC ANHYDRASE INHIBITORS

Terapeutické oblasti:

TIMOLOL

Terapeutické indikácie:

For the treatment of elevated intraocular pressure (IOP ) in patients with ocular hypertension, open-angle glaucoma, or other secondary open-angle glaucoma when concomitant therapy is appropriate.

Dátum Autorizácia:

2014-08-31

Príbalový leták

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
COSOPT
®
OPHTHALMIC SOLUTION
Each ml contains:
Dorzolamide (as hydrochloride) 20 mg/ml
Timolol (as maleate) 5 mg/ml
For a list of inactive ingredients see section 6.1 "What COSOPT
contains". See also section 2.6,
“IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF COSOPT”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about COSOPT. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
medical condition seems similar to yours.
•
This medicine is not intended for use in children and infants.
1. WHAT COSOPT IS INTENDED FOR?
COSOPT is used for the reduction of elevated intraocular pressure and
for the treatment of glaucoma.
THERAPEUTIC GROUP: COSOPT contains two active ingredients:
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.
2. BEFORE YOU USE COSOPT
2.1 DO NOT USE COSOPT IF YOU:
•
are allergic (hypersensitive) to dorzolamide hydrochloride, timolol
maleate or any of the other
ingredients of this medicine (for a list of inactive ingredients, see
section 6.1).
•
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).
•
have a slow heart beat, heart failure or disorders of heart rhythm
(irregular heart beats).
•
have severe kidney disease or problems, or a prior history of kidney
stones.
•
have excess acidity of the blood caused by a build up of chloride in
the blood (hyperchloraemic
acidosis).
If you are not sure whether you should use thi

Súhrn charakteristických

Cosopt-DL-May 2022_ rev 04
PRODUCT INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
COSOPT
®
Ophthalmic 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.
Excipients: Benzalkonium chloride 0.075 mg/ml
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
osmolarity of 242-323 mOsM
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indicated for the treatment of elevated intraocular pressure (IOP) in
patients with ocular hypertension,
open-angle glaucoma, or other secondary open-angle glaucoma when
concomitant therapy is appropriate.
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 bottles.
Method of administration
1. Before using the medication for the first time, be sure the Safety
Strip on the front of the bottle is
unbroken. A gap between the bottle and the cap is normal for an
unopened bottle.
2. First wash your hands, then tear off the Safety Strip to break the
seal.
3. To open the bottle, unscrew the cap by turning as indicated by the
arrows on the top of the