Artelac 0.32% eye drops

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Hypromellose

Boleh didapati daripada:

Bausch & Lomb UK Ltd

Kod ATC:

S01XA20

INN (Nama Antarabangsa):

Hypromellose

Dos:

3.2mg/1ml

Borang farmaseutikal:

Eye drops

Laluan pentadbiran:

Ocular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 11080100; GTIN: 5027519008933

Risalah maklumat

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
ARTELAC 3.2MG/ML
EYE DROPS SOLUTION
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM/IRELAND
(UK/IE)
Nr wykrojnika
Spec No
93038
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
40728PB188/7-IE/UK
Nr korekty
Proof No
7
Data
Date
21-09-2015
Kod farmaceutyczny
Pharmacode
873
Kod wersji
Valeant version code
P1UKIE01
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 8 PT
Wymiar ulotki
PIL size
120 X 270 MM
Krój czcionki
Font used
Helvetica Neue LT W1G
55 Roman
_56 Italic_
75 Bold
_76 Bold Italic_
Gramatura papieru
Paper weight
- G/M
2
Komentarze Comments (Reason for the change)
- PMR_ICN-15-0626-A
- FACTORY (PACKING SITE): DMP BERLIN
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
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

Ciri produk

OBJECT 1
ARTELAC 10ML HYPROMELLOSE 0.32% WITH
PRESERVATIVE, EYE DROPS SOLUTION
Summary of Product Characteristics Updated 15-Oct-2015 | Bausch & Lomb
U.K Limited
1. Name of the medicinal product
Artelac 3.2 mg/ml Eye Drops Solution
2. Qualitative and quantitative composition
Each ml of solution contains 3.2mg of hypromellose equivalent to
Hypromellose 3.2 mg/ml.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution. Sterile clear solution
4. Clinical particulars
4.1 Therapeutic indications
This medicinal product acts as a lubricant and artificial tear in the
symptomatic treatment of dehydration
of the cornea and conjunctiva due to impaired lacrimal secretion and
functional disorders as a result of
topical or systemic diseases, or caused by deficient or incomplete
eyelid closure. Artelac 3.2 mg/ml Eye
Drops Solution is indicated in adults and children.
4.2 Posology and method of administration
Posology
Suitable for use in adults and children. Unless otherwise directed,
instil 1 drop into the conjunctival sac
(corner of the eye, nearest the nose) 3 to 5 times per day or as
required, to provide sufficient lubrication.
Therapy of dry eye syndrome requires an individual dosage regimen.
Method of administration
For ocular use only.
4.3 Contraindications
Hypersensitivity to the active substance (hypromellose) or to any of
the excipients. Listed in section 6.1.
4.4 Special warnings and precautions for use
Stop treatment and consult a physician if irritation persists or
worsens or new eye signs or symptoms
develop. Wearers of soft contact lenses should remove their lenses
before Artelac 3.2 mg/ml Eye Drops
Solution is administered and should wait for at least 15 minutes
before they insert them again. Ensure the
dropper tip does not touch any surface including the eye surface.
4.5 Interaction with other medicinal products and other forms of
interaction
None.
4.6 Fertility, pregnancy and lactation
Pregnancy
Artelac 3.2 mg/ml Eye Drops Solution can be used during pregnancy.
Breast-feeding
A