Latanoprost 50micrograms/ml / Timolol 5mg/ml eye drops

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Timolol maleate; Latanoprost

Tilgængelig fra:

Zentiva Pharma UK Ltd

ATC-kode:

S01ED51

INN (International Name):

Timolol maleate; Latanoprost

Dosering:

5mg/1ml ; 50microgram/1ml

Lægemiddelform:

Eye drops

Indgivelsesvej:

Ocular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 11060000; GTIN: 5000283655107

Indlægsseddel

BACK
FRONT
DRAFT: 04
CODE: 777206WTH/1C
CLIENT: TUBILUX
PRODUCT: LEAFLET LATANOPROST/TIMOLOL
MEASURE: 120 X 500 MM (120 X 27 MM)
EXTRA: DECA CODE IXXIXXI VISUAL CODE 8-19-20
COLOURS:
TEXT SIZE: 9 PT
NOTE: CARTA DA 40 G/M
2
Packaging development
Techical Direction
Regulatory
Marketing
DATE: 28/11/2012
www.effe5grafica.it
Tel. [phone]
[e-mail]
Approval
Black
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. EVEN IF YOU
HAVE ALREADY USED LATANOPROST/
TIMOLOL SOLUTION ORASIMILAR
MEDICINE BEFORE, WE ADVISE YOU TO
READ THIS TEXT CAREFULLY. THE
INFORMATION MAY HAVE BEEN CHANGED.
•
Keep this leaflet. You may need to
read it again.
•
If you any have 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 inthis leaflet.
WHAT IS IN THIS LEAFLET:
1. What Latanoprost/Timolol is and what
it is used for
2. What do 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
The name of your medicine is
Latanoprost/Timolol 50 microgram/ml +
5mg/ml Eye Drops, solution (referred to
as Latanoprost/Timolol throughout this
leaflet). Latanoprost/Timolol contains
two medicines: latanoprost and timolol.
Latanoprost belongs toagroup of
medicines known as prostaglandin
analogues. Timolol belongs to a group
ofmedicines known asbeta-blockers.
Latanoprost works by increasing the
natural outflow offluid from the eye into
thebloodstream. Timolol works by
slowing the formation of fluid inthe eye.
Latanoprost/Timolol is used to reduce
the pressure in your eye if you have
conditions k

Produktets egenskaber

OBJECT 1
LATANOPROST/TIMOLOL 50 MCG/ML + 5 MG/ML EYE
DROPS, SOLUTION
Summary of Product Characteristics Updated 07-Aug-2014 | Zentiva
1. Name of the medicinal product
Latanoprost/Timolol 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: contains 0.412 mg/ml of benzalkonium
chloride solution 50%.
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
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
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.
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.
Paediatric population
Safety and effectiveness in children and adolescents has not been
established.
4.3 Contraindications
Latanoprost/Timolol is contraindicated in patients with:
• Reactive airway disease including bronchial asthma or a history of
bronchial asthma, severe chronic
obstructive pulmonary disease.
• Sinus bradycardia, sick sinus syndrome,