Artelac 3.2 mg/ml Eye Drops, Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Hypromellose

Boleh didapati daripada:

Bausch Health Ireland Limited

Kod ATC:

S01XA; S01XA20

INN (Nama Antarabangsa):

Hypromellose

Dos:

3.2 milligram(s)/millilitre

Borang farmaseutikal:

Eye drops, solution

Kawasan terapeutik:

Other ophthalmologicals; artificial tears and other indifferent preparations

Status kebenaran:

Marketed

Tarikh kebenaran:

1996-07-09

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
Artelac® _3.2 mg/ml Eye Drops, Solution_
Hypromellose
The name of your medicine is Artelac 3.2 mg/ml Eye Drops, Solution and
it is called
Artelac 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 is and what it is used for
2. What you need to know before you use Artelac
3. How to use Artelac
4. Possible side effects
5. How to store Artelac
6. Contents of the pack and other information
1. WHAT ARTELAC 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 can be used by children, adults and the elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARTELAC
DO NOT USE ARTELAC
• If you are allergic to hypromellose or any of the ingredients of
this medicine (listed
in Section 6).
WARNINGS AND PRECAUTIONS
• Talk to your d

Ciri produk

Health Products Regulatory Authority
10 December 2020
CRN009ZXX
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Artelac 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 (0.051 mg phosphates in each drop which
is equivalent to 1.84 mg/ml)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Sterile solution for eye drops.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thismedicinalproductacts as a lubricant and artificial tear inthe
symptomatictreatmentof dehydration of the cornea and
conjunctiva.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Suitable for use in adults and children.
Unless otherwise directed, instill1 drop into the conjunctivalsac
(corner of the eye nearest the nose) 3-5 times per
dayorasrequired, to provide sufficient lubrication.
Methodofadministration
For ocularuse.
Therapyofdryeye syndromerequires an individualdosage regimen.
4.3 CONTRAINDICATIONS
There are no known contra-indications except use in patients
hypersensitive to theactive substance(hypromellose) or to
anyoftheexcipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ifirritationpersists or worsens or new eye signs or symptoms
develop,discontinueuseand consult a doctor. Wearers of
softcontact lenses should remove their lenses before Artelac is
administered and should wait for at least 15 minutes before
they insertthemagain.
Ensure the dropper tip does not touch anysurface including the eye
surface. Wearers of soft contactlensesshouldremovetheir
lenses before Artelac3.2mg/mlEyedropssolutionis administered and
should wait for at least 15 minutes beforetheyinsert
themagain.
Ensure the dropper tip does not touch anysurface including the eye
surface.
Health Products Regulatory Authority
10 December 2020
CRN009ZXX
Page 2 of 3
4.5 INTERACTION WITH OTHER