Xalacom eye drops

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Timolol maleate; Latanoprost

Հասանելի է:

Viatris UK Healthcare Ltd

ATC կոդը:

S01ED51

INN (Միջազգային անվանումը):

Timolol maleate; Latanoprost

Դոզան:

5mg/1ml ; 50microgram/1ml

Դեղագործական ձեւ:

Eye drops

Կառավարման երթուղին:

Ocular

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 11060000; GTIN: 5012882006419

Տեղեկատվական թերթիկ

Your medicine is known as the above but will be referred to as Xalacom
throughout the following leaflet.
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
section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xalacom is and what it is used for
2.
What you need to know before you use Xalacom
3.
How to use Xalacom
4.
Possible side effects
5.
How to store Xalacom
6.
Contents of the pack and other information
1.
WHAT XALACOM IS AND WHAT IT IS USED FOR
Xalacom 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.
Xalacom 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
Xalacom when other medicines have not worked adequately.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE XALACOM
Xalacom 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 XALACOM EYE DROPS SOLUTION:
•
if you are allergic (hypersensitive) to either of the medicines in
Xalacom
(latanoprost or timolol), beta-blockers, or any of the other
ingredients of
Xalacom (listed in section 6)
�

Ապրանքի հատկությունները

OBJECT 1
XALACOM EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 06-Feb-2018 | Pfizer
Limited
1. Name of the medicinal product
Xalacom 50 micrograms/mL + 5 mg/mL, eye drops, solution.
2. Qualitative and quantitative composition
1 mL solution contains latanoprost 50 micrograms and timolol maleate
6.8 mg equivalent to 5 mg timolol.
Excipient with known effect:
Benzalkonium chloride 200 microgram/mL.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
The solution is a clear, colourless liquid.
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
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 _
Safety and effectiveness 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.
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
Xalacom 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, sino-atrial block, second
or third degree atrioventricular block
not controlled with pace-maker, overt cardiac failure, cardiogenic
shock.
• Hypersens