Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Timolol; Latanoprost

থেকে পাওয়া:

Laboratoires Thea

এটিসি কোড:

S01ED; S01ED51

INN (International Name):

Timolol; Latanoprost

ডোজ:

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

ফার্মাসিউটিকাল ফর্ম:

Eye drops, solution in single-dose container

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents1); timolol, combinations

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2018-06-22

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FIXAPOST 50 MICROGRAMS/ML + 5 MG/ML EYE DROPS, SOLUTION IN SINGLE-DOSE
CONTAINER
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fixapost is and what it is used for
2.
What you need to know before you use Fixapost
3.
How to use Fixapost
4.
Possible side effects
5.
How to store Fixapost
6.
Contents of the pack and other information
1.
WHAT FIXAPOST IS AND WHAT IT IS USED FOR
Fixapost
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.
Fixapost 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 Fixapost
when other medicines have not worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FIXAPOST
Fixapost 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 FIXAPOST:
-
if you are allergic (hypersensitive) to latanoprost, timolol,
beta-blockers, or any of the other
ingredients of this medicine (listed in section 6),
-
if y

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
02 May 2023
CRN00DJYW
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains latanoprost 50 micrograms and timolol maleate
equivalent to 5 mg timolol.
One drop contains approximately 1.5 micrograms of latanoprost and 0.15
mg of timolol.
Excipient with known effect
1 ml eye drops solution contains 50 mg of macrogolglycerol
hydroxystearate (castor oil polyoxyl hydrogenated).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
Slightly yellow and opalescent solution, practically free from
particles.
pH: 5.7 – 6.2
Osmolality: 300-340 mosmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fixapost 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 Fixapost in children and adolescents has
not been established.
Method of administration
Ocular use.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be compressed at the
medial canthus (punctal occlusion) for two minutes. This should be
performed immediately following the instillation of each
drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicine is being used, the
medicinal products should be administe