Liposic 2 mg/g eye gel

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Beli Sekarang

Selebaran informasi Selebaran informasi (PIL)
03-08-2022
Karakteristik produk Karakteristik produk (SPC)
03-08-2022

Bahan aktif:

Carbomer

Tersedia dari:

Bausch + Lomb Ireland Limited

Kode ATC:

S01XA; S01XA20

INN (Nama Internasional):

Carbomer

Bentuk farmasi:

Eye gel

Area terapi:

Other ophthalmologicals; artificial tears and other indifferent preparations

Status otorisasi:

Marketed

Tanggal Otorisasi:

2002-03-22

Selebaran informasi

                                Package leaflet: Information for the user
Bausch & Lomb
LIPOSIC
®
2 MG/G, EYE GEL
CARBOMER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Liposic
®
2 mg/g Eye Gel is and what it is used for
2. What you need to know before you use Liposic
®
2 mg/g Eye Gel
3. How to use Liposic
®
2 mg/g Eye Gel
4. Possible side effects
5. How to store Liposic
®
2 mg/g Eye Gel
6. Contents of the pack and other information
1. WHAT LIPOSIC
®
2 MG/G EYE GEL IS AND WHAT IT IS USED FOR
Liposic
®
2 mg/g Eye Gel is a whitish highly viscous gel which contains a
lubricant that is used as a substitute for
natural 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. Liposic
®
2 mg/g
Eye Gel, will help keep your eyes comfortable.
Liposic
®
2 mg/g Eye Gel, is a highly viscous gel that forms a protective layer
over the eye, which keeps the
surface of the eye moist.
It is easy and comfortable to use, and is particularly suitable for
the symptomatic treatment of severe dry eye
symptoms. You must talk to a doctor if you do not feel better or if
you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LIPOSIC
®
2 MG/G EYE GEL
DO NOT USE Liposic
®
2 mg/g Eye Gel:
-- if you are allergic to Carbomer or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Liposic
®
2 mg/g E
                                
                                Baca dokumen lengkapnya
                                
                            

Karakteristik produk

                                Health Products Regulatory Authority
29 July 2022
CRN00CTSL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liposic 2 mg/g eye gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of eye gel contains 2mg of carbomer.
For a full the list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye gel
White, turbid, highly viscous, gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of dry eye syndrome.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapy of dry eye conditions requires an individual dosage regimen.
According to the severity and intensity of the symptoms, instill one
drop into the conjunctival sac 3‑5 times daily; and
approximately 30 minutes before going to bed (otherwise there is a
risk of sticky eyelids).
Children and adolescents aged to 18 years
The safety and efficacy ofLiposic ® in children and adolescents at
the posology recommended in adults has been established
by clinical experience, but no clinical trial data are available.
Method of administration
Ocular use.
Generally, an ophthalmologist should be consulted when treating
keratoconjunctivitis sicca, which normally turns out to be
long-term or permanent therapy.
An appropriate drop size is obtained when the tube is held in a
vertical position above the eye during instillation.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contact lenses should be removed prior to administration, and may be
inserted again 30 minutes after Liposic2 mg/g Eye gel
has been instilled. Liposic 2 mg/g Eye gel may prolong the
contact-time of topically applied drugs in ophthalmology.
Concomitant ocular medication should be administered 15 minutes prior
to instillation of Liposic 2 mg/g Eye gel (see section
4.5).
If the symptoms of the dry eye continue or worsen, treatment should be
stopped and an ophthalmologist should be consulted.
Health Products Regulatory Authority
29 July 2022
CRN00C
                                
                                Baca dokumen lengkapnya
                                
                            

Peringatan pencarian terkait dengan produk ini