Artelac Preservative Free Single Dose Unit 3.2 mg/ml Eye Drops Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Hypromellose

Boleh didapati daripada:

IMED Healthcare Ltd.

Kod ATC:

S01XA; S01XA20

INN (Nama Antarabangsa):

Hypromellose

Dos:

3.2 milligram(s)/millilitre

Borang farmaseutikal:

Eye drops, solution in single-dose container

Jenis preskripsi:

Product not subject to medical prescription

Kawasan terapeutik:

Other ophthalmologicals; artificial tears and other indifferent preparations

Status kebenaran:

Authorised

Tarikh kebenaran:

2014-10-17

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARTELAC® PRESERVATIVE FREE SINGLE DOSE UNIT 3.2 MG/ML
EYE DROPS SOLUTION
hypromellose
The name of your medicine is Artelac Preservative Free
Single Dose Unit and it is called Artelac Preservative Free
in this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or
advice.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if
you feel worse.
_ _
_WHAT IS IN THIS LEAFLET _
1. What Artelac Preservative Free is and what it is used
for
2. What you need to know before you use Artelac
Preservative Free
3. How to use Artelac Preservative Free
4. Possible side effects
5. How to store Artelac Preservative Free
6. Contents of the pack and other information
1. WHAT ARTELAC PRESERVATIVE FREE IS
AND WHAT IT IS USED FOR
Artelac contains the active ingredient hypromellose which
acts as a lubricant to treat symptoms of dry eye. It is a
soothing solution that is used as an artificial tear when the
eyes are lacking in tears.
Your eyes will normally produce just enough natural tears
to allow them to move easily and comfortably. If your
eyes do not produce enough tears they can become dry,
red and painful.
Your drops keep the surface of the eye lubricated (moist)
when production of tears is less than normal, and has a
refreshing, cooling action. The hypromellose in these
drops increases the thickness of the solution which has a
moisturising effect and helps the solution to stay in
contact with your eye for a longer period of time.
Artelac Preservative Free can be used by children, adults
and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU
USE ARTELAC P

Ciri produk

Health Products Regulatory Authority
12 April 2022
CRN00CWLN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Artelac Preservative Free Single Dose Unit 3.2 mg/ml Eye Drops
Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 3.2 mg hypromellose equivalent to
hypromellose 0.32 % w/v.
Excipients with known effect
Disodium phosphate dodecahydrate and Sodium dihydrogen phosphate
dihydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container. (Eye Drops, Solution)
_Product imported from France:_
Sterile solution for eye drops, presented in plastic single-dose,
single-use units.
4 CLINICAL PARTICULARS
As per PA23259/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23259/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Sorbitol (E420)
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.
Shelf-life after first opening the container: For single-use only.
Discard immediately after use.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Keep container in the outer carton.
Health Products Regulatory Authority
12 April 2022
CRN00CWLN
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
0.5 ml single-dose unit, composed of LDPE packaged in 60 unit pack
sizes.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Avoid contamination during use. Artelac Preservative Free Single Dose
Unit eye drops are sterile until first opened. For single
use only. Each carton contains a patient insert with instructions for
use.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland