Cosopt 20mg/ml / 5mg/ml eye drops

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Dorzolamide hydrochloride; Timolol maleate

Предлага се от:

Santen UK Ltd

АТС код:

S01ED51

INN (Международно Name):

Dorzolamide hydrochloride; Timolol maleate

дозиране:

20mg/1ml ; 5mg/1ml

Лекарствена форма:

Eye drops

Начин на приложение:

Ocular

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 11060000; GTIN: 5013945165401

Листовка

Profile:
PB00-2_SP11031
Profile Revision:
C
Profile Revision Date:
140111
Dimensions (mm):
160 x 315
Black
Profile
Technical Info
Item No.:
Revision Date & No.:
Pharma Code:
MBS Job No.:
517315Z
010915-1
159
375238
ITEM# and REVISION#
in OCRB font
Horizontal Scale 71%
Size 5 points
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSOPT® 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 side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What COSOPT is and what it is used for
2.
What you need to know before you use COSOPT
3.
How to use COSOPT
4.
Possible side effects
5.
How to store COSOPT
6.
Contents of the pack and other information
1.
WHAT COSOPT IS AND WHAT IT IS USED FOR
COSOPT 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 the pressure in the eye in different ways.
COSOPT is prescribed to lower raised pressure in the eye in the
treatment of glaucoma when beta-blocker eyedrop
medicine used alone is not adequate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COSOPT
DO NOT USE COSOPT
•
if you are allergic to dorzolamide hydrochloride, timolol maleate 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-stan

Данни за продукта

OBJECT 1
COSOPT 20 MG/ML + 5 MG/ML, EYE DROPS,
SOLUTION
Summary of Product Characteristics Updated 18-Sep-2017 | Santen UK
Limited
1. Name of the medicinal product
COSOPT
®
20 mg/ml + 5 mg/ml, eye drops, 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
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 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 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 OCUMETER
PLUS 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