Dorzolamide 20mg/ml / Timolol 5mg/ml eye drops

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Dorzolamide hydrochloride; Timolol maleate

Διαθέσιμο από:

Martindale Pharmaceuticals Ltd

Φαρμακολογική κατηγορία (ATC):

S01ED51

INN (Διεθνής Όνομα):

Dorzolamide hydrochloride; Timolol maleate

Δοσολογία:

20mg/1ml ; 5mg/1ml

Φαρμακοτεχνική μορφή:

Eye drops

Οδός χορήγησης:

Ocular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 11060000; GTIN: 5026468744664

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE / TIMOLOL
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. 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.
WHAT IS IN THIS LEAFLET:
1. What Dorzolamide / Timolol is and what it is used for
2. What you need to know before you use Dorzolamide / Timolol
3. How to use Dorzolamide / Timolol
4. Possible side effects
5. How to store Dorzolamide / Timolol
6. Contents of the pack and other information
1.
WHAT DORZOLAMIDE / TIMOLOL IS AND WHAT IT IS USED FOR
Dorzolamide / Timolol 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.
Dorzolamide / Timolol is prescribed to lower raised pressure in the
eye in the treatment of glaucoma when
beta-blocker eye drop medicine used alone is not adequate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE / TIMOLOL
DO NOT USE DORZOLAMIDE / TIMOLOL

if you are allergic (hypersensitive) to dorzolamide hydrochloride,
timolol maleate or any of the other
ingredients of Dorzolamide / Timolol (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-standing
cough)

if you have a slow heart beat, heart failure or disorders of heart
rhythm (irregular heart beat

Αρχείο Π.Χ.Π.

OBJECT 1
DORZOLAMIDE / TIMOLOL 20 MG/ML + 5 MG/ML EYE
DROPS, SOLUTION
Summary of Product Characteristics Updated 09-Dec-2016 | Martindale
Pharma
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 22.3 mg of dorzolamide hydrochloride corresponding to
20 mg dorzolamide and 6.84
mg of timolol maleate corresponding to 5 mg timolol.
Excipients: benzalkonium chloride 0.075 mg/ml
For a 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 5.3-5.7 and an
osmolality of 260-330 mOsm/kg.
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
The dose is one drop in the conjunctival sac of the affected eye(s)
two times daily.
If another topical ophthalmic agent is being used, Dorzolamide /
Timolol 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.
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 paediatr