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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Tafluprost; Timolol

Dostopno od:

PCO Manufacturing Ltd.

Koda artikla:

S01ED; S01ED51

INN (mednarodno ime):

Tafluprost; Timolol

Odmerek:

15+5

Farmacevtska oblika:

Eye drops, solution in single-dose container

Terapevtsko območje:

Beta blocking agents1); timolol, combinations

Datum dovoljenje:

2021-06-18

Navodilo za uporabo

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 breathing

Lastnosti izdelka

Health Products Regulatory Authority
21 June 2021
CRN00CCSD
Page 1 of 2
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 microl) contains about 0.45 micrograms of
tafluprost and 0.15 mg of timolol.
Excipient with known effect: 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
As per PA0879/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0879/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Glycerol
Disodium phosphate dodecahydrate
Disodium edetate
Polysorbate 80
Hydrochloric acid and/or sodium hydroxide for pH adjustment
Water for injections
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
After first opening a foil pouch: 28 days.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in a refrigerator (2°C - 8°C).
Health Products Regulatory Authority
21 June 2021
CRN00CCSD
Page 2 of 2
After opening the foil pouch:
- Keep the single-dose containers in the original foil pouch in order
to protect from light
- Do not store above 25°C
- Discard an opened single-dose container with any remaining solution
immediately after use.
6.5 NATURE AND CONTENTS OF CONTAINER
Low-density polyethylene (LDPE) single-dose containers packed in a
foil pouch made of a paper-coated,
aluminium-polyethylene laminate. Each single-dose container has a fill
volume of 0.3 ml and there are 10 containers in each
foil pouch.
Pack of