Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Tafluprost; Timolol

Disponibbli minn:

Santen OY

Kodiċi ATC:

S01ED; S01ED51

INN (Isem Internazzjonali):

Tafluprost; Timolol

Dożaġġ:

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

Għamla farmaċewtika:

Eye drops, solution in single-dose container

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Beta blocking agents1); timolol, combinations

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2014-11-28

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAPTIQOM 15 MICROGRAMS/ML + 5 MG/ML
EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
Tafluprost/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 Taptiqom is and what it is used for
2.
What you need to know before you use Taptiqom
3.
How to use Taptiqom
4.
Possible side effects
5.
How to store Taptiqom
6.
Contents of the pack and other information
1.
WHAT TAPTIQOM IS AND WHAT IT IS USED FOR
WHAT KIND OF MEDICINE IS IT AND HOW DOES IT WORK?
Taptiqom eye drops contain tafluprost and timolol. Tafluprost belongs
to a group of medicines called
prostaglandin analogues and timolol belongs to a group of medicines
called beta blockers. Tafluprost and
timolol work together and lower the pressure in the eye. Taptiqom is
used when the pressure in the eye is too
high.
WHAT IS YOUR MEDICINE FOR?
Taptiqom is used to treat a type of glaucoma called open angle
glaucoma and also a condition known as ocular
hypertension in adults. Both of these conditions are linked with an
increase in the pressure within your eye and
eventually they may affect your eyesight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TAPTIQOM
DO NOT USE TAPTIQOM:

if you are allergic to tafluprost, timolol, beta blockers or any of
the other ingredients of this medicine
(listed in section 6.)

if you have now or have had in the past respiratory problems such as
asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause
wheeziness, difficulty in breath

Karatteristiċi tal-prodott

Health Products Regulatory Authority
21 May 2021
CRN009ZDJ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains: tafluprost 15micrograms and timolol (as
maleate) 5 mg.
One single-dose container (0.3 ml) of eye drops, solution, contains
4.5 micrograms of tafluprost and 1.5 mg of timolol.
One drop (about 30 microl) contains about 0.45 micrograms of
tafluprost and 0.15 mg of timolol.
Excipient with known effect: One ml of eye drops solution contains 1.3
mg phosphates and one drop contains approximately
0.04 mg phosphates.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container (eye drops).
A clear, colourless solution with a pH of 6.0-6.7 and an osmolality of
290-370 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in adult patients with open
angle glaucoma or ocular hypertension who are
insufficiently responsive to topical monotherapy with beta-blockers or
prostaglandin analogues and require a combination
therapy, and who would benefit from preservative free eye drops.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended therapy is one eye drop in the conjunctival sac of 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.
Taptiqom is a preservative free sterile solution packaged in a
single-dose container. For single use only, one container is
sufficient to treat both eyes. Any unused solution should be discarded
immediately after use.
_Paediatric population_
The safety and efficacy of Taptiqom in children and adolescents below
the age of 18 years have not been established. No data
are available.
Taptiqom is not recommended for use in children and adolescents below
the age of 18 years_._
_Use in eld