Taptiqom 15micrograms/ml / 5mg/ml eye drops 0.3ml unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Timolol maleate; Tafluprost

Available from:

Santen UK Ltd

INN (International Name):

Timolol maleate; Tafluprost

Dosage:

5mg/1ml ; 15microgram/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 6419716608396

Patient Information leaflet

1
Taptiqom-uk_ie-[002] 20170824
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

Summary of Product characteristics

OBJECT 1
TAPTIQOM 15 MICROGRAMS/ML + 5 MG/ML EYE
DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
Summary of Product Characteristics Updated 01-Feb-2018 | Santen UK
Limited
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.
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 renal/hepatic