Latanoprost/Timolol Zentiva 50 microgram/ml + 5 mg/ml eye drops solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost; Timolol

Available from:

Zentiva k.s.

ATC code:

S01ED; S01ED51

INN (International Name):

Latanoprost; Timolol

Dosage:

50mcg/ml + 5 milligram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Beta blocking agents1); timolol, combinations

Authorization status:

Not marketed

Authorization date:

2013-05-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST/TIMOLOL ZENTIVA 50 MICROGRAMS/ML + 5 MG/ML EYE DROPS,
SOLUTION
LATANOPROST/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
Latanoprost/Timolol Zentiva is and what it is used for
2.
What you need to know before you use Latanoprost/Timolol Zentiva
3.
How to use Latanoprost/Timolol Zentiva
4.
Possible side effects
5.
How to store Latanoprost/Timolol Zentiva
6.
Contents of the pack and other information
1.
WHAT LATANOPROST/TIMOLOL ZENTIVA IS AND WHAT IT IS USED FOR
Latanoprost/Timolol Zentiva contains two medicines: latanoprost and
timolol. Latanoprost
belongs to a group of medicines known as prostaglandin analogues.
Timolol belongs to a
group of medicines known as beta-blockers. Latanoprost works by
increasing the natural
outflow of fluid from the eye into the bloodstream. Timolol works by
slowing the formation
of fluid in the eye.
Latanoprost/Timolol Zentiva is used to reduce the pressure in your eye
if you have conditions
known as open angle glaucoma or ocular hypertension. Both these
conditions are linked
to an increase in the pressure within your eye, eventually affecting
your eyesight. Your doctor
will usually prescribe you Latanoprost/Timolol Zentiva when other
medicines have not
worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL ZENTIVA
Latanoprost/Timolol Zentiva can be used in adult men and women
(including the elderly), but
is not recommended for use if you are less than 18 years of age.
DO NO

Summary of Product characteristics

Health Products Regulatory Authority
10 June 2022
CRN00CVZ9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost/Timolol Zentiva 50 microgram/ml + 5 mg/ml eye drops
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains latanoprost 50 micrograms and timolol maleate
6.83 mg equivalent to 5 mg timolol.
Excipients with known effect: Benzalkonium chloride solution 50% 0.412
mg/ml, sodium dihydrogen phosphate monohydrate
6.390 mg/ml and disodium phosphate anhydrous 2.890 mg/ml (phosphate
buffers).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear colourless, odourless solution, free from visible particles.
pH 5.5 -6.5.
Osmolality 260-320 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Latanoprost/Timolol Zentiva is indicated in adults (including the
elderly) for the reduction of intraocular pressure (IOP) in
patients with open angle glaucoma and ocular hypertension who are
insufficiently responsive to topical beta-blockers or
prostaglandin analogues.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly)_
Recommended therapy is one eye drop in the affected eye(s) once daily.
If one dose is missed, treatment should continue with the next dose as
planned. The dose should not exceed one drop in the
affected eye(s) daily.
_Paediatric population_
The safety and efficacy of latanoprost/timolol in children and
adolescents have not been established.
Method of administration
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five 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.
4.3 CONTRAINDICATIONS
Latanoprost/Timolol Zentiva is contraindicated in pa