Dorzolamide 20mg/ml eye drops

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Dorzolamide hydrochloride

Disponibil de la:

Viatris UK Healthcare Ltd

Codul ATC:

S01EC03

INN (nume internaţional):

Dorzolamide hydrochloride

Dozare:

20mg/1ml

Forma farmaceutică:

Eye drops

Calea de administrare:

Ocular

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 11060000; GTIN: 5016695003306

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DORZOLAMIDE 20 MG/ML EYE DROPS, SOLUTION
Dorzolamide
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 is and what it is used for
2.
What you need to know before you use Dorzolamide
3.
How to use Dorzolamide
4.
Possible side effects
5.
How to store Dorzolamide
6.
Contents of the pack and other information
1.
WHAT DORZOLAMIDE IS AND WHAT IT IS USED FOR
Dorzolamide is supplied as a sterile eye drop solution. Dorzolamide
contains dorzolamide, a sulfonamide-
related compound, as the active ingredient.
Dorzolamide belongs to a group of medicines called ophthalmic carbonic
anhydrase inhibitors which reduce
high pressure in the eye.
Dorzolamide is used to lower raised pressure in the eye and to treat
glaucoma (open-angle glaucoma, pseudo-
exfoliative glaucoma). Dorzolamide can be used alone or in addition to
other medicines which lower the
pressure in the eye (so-called beta-blockers).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE
DO NOT USE DORZOLAMIDE
if you are allergic to dorzolamide or any of the other ingredients of
this medicine (listed in section 6)
if you have severe kidney problems.
- if you have a disturbance in the pH (acid/alkali balance) of your
blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Dorzolamide if:
-
if you have, or have had, liver problems in the past
-
if you have been told you have a corneal defect
-
if you have had any allergies to any sulfonamide like medicines e.g.
co-trimoxazole
-

Caracteristicilor produsului

OBJECT 1
DORZOLAMIDE/TIMOLOL 20 MG/ML + 5 MG/ML EYE
DROPS, SOLUTION
Summary of Product Characteristics Updated 22-Sep-2017 | Generics UK
T/A Mylan
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 dorzolamide (as dorzolamide hydrochloride) and
5 mg timolol (as timolol
maleate).
Excipients with known effect:
Each ml of eye drops solution contains 0.15 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, slightly viscous, colourless aqueous solution.
4. Clinical particulars
4.1 Therapeutic indications
Dorzolamide/Timolol is indicated in the treatment of elevated
intra-ocular pressure (IOP) in patients with
open-angle glaucoma or pseudo-exfoliative 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 in the conjunctival sac of
the affected eye(s) two times
daily.
If another topical ophthalmic medicinal product is being used, the
other agent should be administered at
least ten minutes apart.
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.
_Paediatric population:_
Efficacy in paediatric patients has not been established.
Safety in paediatric patients below the age of two years has not been
established. (for information
regarding safety in paediatric patients ≥2 and < 6 years of age, see
section 5.1).
Method of administration
For ocular use.
Patients should be instructed to wash their hands before use and avoid
allowing the tip of the dispensing
container to contact the eye or surrounding structures.
In order to secure correct dosage - the dropper tip should not be
enlarged.
Patients should also be instructed that ocular solutions, if handled
improperly, can become contaminated
by com