Trusopt 20mg/ml eye drops

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Dorzolamide hydrochloride

Beschikbaar vanaf:

Santen UK Ltd

ATC-code:

S01EC03

INN (Algemene Internationale Benaming):

Dorzolamide hydrochloride

Dosering:

20mg/1ml

farmaceutische vorm:

Eye drops

Toedieningsweg:

Ocular

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 11060000; GTIN: 5013945165302

Bijsluiter

UK-IE-Trusopt MD-060-20170403
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRUSOPT
® 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 TRUSOPT is and what it is used for
2.
What you need to know before you use TRUSOPT
3.
How to use TRUSOPT
4.
Possible side effects
5.
How to store TRUSOPT
6.
Contents of the pack and other information
1. WHAT TRUSOPT IS AND WHAT IT IS USED FOR
TRUSOPT 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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRUSOPT
DO NOT USE TRUSOPT:
-
if you are allergic to dorzolamide hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have severe kidney impairment or problems, or a prior history
of kidney stones.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using TRUSOPT.
Tell your doctor or pharmacist about any medical problems you have now
or have had in the past,
including eye problems and eye surgeries, and about any allergies to
any medications.
If you develop any eye irritation or any new eye problems such as
redness of the eye or swelling of the
eyelids, contact your doctor immediately.
If you suspect that TRUSOPT is causing an allergic reaction (for
example, skin rash, severe

Productkenmerken

OBJECT 1
TRUSOPT 20 MG/ML EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 25-Apr-2017 | Santen UK
Limited
1. Name of the medicinal product
TRUSOPT
®
20 mg/ml eye drops, solution.
2. Qualitative and quantitative composition
Each ml contains 22.26 mg of dorzolamide hydrochloride equivalent to
20 mg of dorzolamide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, colourless to nearly colourless, slightly viscous, solution.
4. Clinical particulars
4.1 Therapeutic indications
TRUSOPT 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 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 medi