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

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Dorzolamide hydrochloride; Timolol maleate

Boleh didapati daripada:

Zentiva Pharma UK Ltd

Kod ATC:

S01ED51

INN (Nama Antarabangsa):

Dorzolamide hydrochloride; Timolol maleate

Dos:

20mg/1ml ; 5mg/1ml

Borang farmaseutikal:

Eye drops

Laluan pentadbiran:

Ocular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 11060000; GTIN: 5000283654537

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
DORZOLAMIDE/TIMOLOL 20MG/ML + 5MG/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
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Dorzolamide/Timolol is and what it is used for
2. What do 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 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 a respiratory disease 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 heartbeat, heart failure or disorders of heart
rhythm (irregular
heartbeats).
•
if you have severe kidney dis

Ciri produk

OBJECT 1
DORZOLAMIDE/TIMOLOL 20MG/ML 5MG/ML EYE DROPS
Summary of Product Characteristics Updated 13-Mar-2018 | Zentiva
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
0.075 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 eye drops, solution is indicated in the treatment
of elevated intraocular 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 eye drops, solution 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.
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 ophthalmic
Dorzolamide/Timolol bottles.
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 the safety
in paediatric patients ≥ 2 and < 6
years of age, see section 5.1).
Method of administration
1. The tamper-proof s