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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TAFLUPROST, TIMOLOL MALEATE

Available from:

Santen Oy Niittyhaankatu 20, 33720 Tampere, Finland

ATC code:

S01ED51

INN (International Name):

TAFLUPROST 15 µg/ml TIMOLOL MALEATE 5 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

TAFLUPROST 15 µg/ml TIMOLOL MALEATE 5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-09-17

Patient Information leaflet

PACKAGE LEAFLET
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,
diffic

Summary of Product characteristics

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 15 micrograms 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 µl) 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 elderly _
No dosage alteration in elderly patients is necessary.
_Use in rena