TAPTIQOM 15 micrograms/ml + 5 mg/ml eye drops, solution.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tafluprost; TIMOLOL MALEATE

Available from:

Santen OY

ATC code:

S01ED51

INN (International Name):

Tafluprost; TIMOLOL MALEATE

Dosage:

15/5 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

timolol, combinations

Authorization status:

Not marketed

Authorization date:

2020-12-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAPTIQOM 15 MICROGRAMS/ML + 5 MG/ML
EYE DROPS, SOLUTION
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 breathing
and/or long-standing co

Summary of Product characteristics

Health Products Regulatory Authority
31 March 2022
CRN00CS4D
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TAPTIQOM 15 micrograms/ml + 5 mg/ml eye drops, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 15 micrograms tafluprost and 5 mg timolol (as
timolol maleate).
One drop (about 0.03 ml) contains about 0.45 micrograms of tafluprost
and 0.15 mg of timolol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
A clear, colourless solution, practically free from visible particles
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.
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
multi-dose container.
_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 elderly_
No dosage alteration in elderly patients is necessary.
_Use in renal/hepatic impairment_
Tafluprost and timolol eye drops have not been studied in patients
with renal/hepatic impairment and TAPTIQOM should
therefore be used with caution in such patients.
Method of administration
OCULAR USE
Patients should be informed of the correct handling of the bottle.
When using for the first time, before delivering a drop to the
eye, the patient should first of all practise using the b