Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Latanoprost; Timolol

Dostopno od:

Accord Healthcare Ireland Ltd.

Koda artikla:

S01ED; S01ED51

INN (mednarodno ime):

Latanoprost; Timolol

Odmerek:

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

Farmacevtska oblika:

Eye drops, solution

Terapevtsko območje:

Beta blocking agents1); timolol, combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2011-08-26

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST/TIMOLOL 50 MICROGRAM/5.0 MG PER 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 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
3.
HOW TO USE LATANOPROST/TIMOLOL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LATANOPROST/TIMOLOL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LATANOPROST/TIMOLOL IS AND WHAT IT IS USED FOR
Latanoprost/Timolol 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 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 when other medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL
Latanoprost/Timolol 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 NOT USE LATANOPROST/TIMOLOL:

if you are allergic (hypersensitive) to latanoprost, timolol,
beta

Lastnosti izdelka

Health Products Regulatory Authority
17 January 2020
CRN009JZT
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost / Timolol 50 microgram/5.0 mg per ml Eye Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 microgram latanoprost and 6.8 mg timolol
maleate equivalent to 5 mg timolol.
Excipient with known effect:
Benzalkonium chloride 0.2 mg/ml (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
The solution is a clear, colourless liquid.
Osmolality: 280~320 mOsmol/kg
pH: 5.0 – 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Latanoprost-Timolol 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
_Recommended dosage for 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 has 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).
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.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five minutes apart.
4.3 CONTRAINDICATIONS
Latanoprost-Timolol is contraindicated in patients with:
- Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1.
- Reactive air