MINIMS ARTIFICIAL TEARS 0.35% W/W + 0.44% W/W EYE 0.35 + 0.4 %w/w Eye Drops Solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

SODIUM CHLORIDE HYDROXYETHYLCELLULOSE

Boleh didapati daripada:

Chauvin Pharmaceuticals Limited

INN (Nama Antarabangsa):

SODIUM CHLORIDE HYDROXYETHYLCELLULOSE

Dos:

0.35 + 0.4 %w/w

Borang farmaseutikal:

Eye Drops Solution

Jenis preskripsi:

Product not subject to medical prescription

Status kebenaran:

Authorised

Tarikh kebenaran:

0000-00-00

Risalah maklumat

Graphics&Packing  
Technology Section 
ICN POLFA RZESZÓW S.A.
ULOTKA 
PIL
Nazwa produktu 
Product Name
MINIMS ARTIFICIAL TEARS
0.35% W/W & 0.44% W/W
DRP SOL
Kolor nadruku 
Colours
Black
Kraj  
Country (ISO)
UNITED KINGDOM (UK), 
IRLEAND (IE)
Nr wykrojnika  
Spec No
5336
Opracowane przez 
Designed by
ŁUKASZ KOZIOŁ
[e-mail]
PHONE: [phone]
Kod Wytwórcy 
Manufacturer code
76815
Nr korekty 
Proof No
4 Data 
Date
16.07.2014 Kod farmaceutyczny 
Pharmacode
76815 DATA MATRIX
Kod wersji  
Valeant version code
P1UKIE01
Inny kod  
Other code
-
Rozmiar czcionki 
Font size
MINIMUM 6 PT
Wymiar ulotki  
PIL size
80 X 140 MM
Krój czcionki  
Font used
BAUSH&LOMB BOLD
Baush&Lomb Regular
Gramatura papieru  
Paper weight
- G/M
2
Komentarze 
Comments (Reason for the change)
LEAFLET CARTON AND OVERWRAP LABEL SHOULD STATE 0.5G INSTEAD OF 0.5ML
PMR_ICN-14-0143-A
PACKING SITE: B&L AUBENAS FRANCE - NATHALIE CLOT,
[e-mail]
Akceptacja Techniczna 
Technical Approval
Akceptacja Działu ds. Rejestracji 
Regulatory Affairs Dept. Approval
0.35% W/W SODIUM CHLORIDE + 0.44%W/W HYETELLOSE EYE DROPS, SOLUTION
Read all this leaflet carefully before you start using your medicine.
It contains 
a summary of the information available on your medicine. If you have
any 
questions or are not sure about anything, ask your doctor or
pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1. 
What Minims
®
 Artificial Tears eye drops is and what it is used for
2. 
Before you use your eye drops
3. 
How to use your eye drops
4. 
Possible side effects
5. 
How to store your eye drops
6. 
Further information
1. 
WHAT MINIMS® ARTIFICIAL TEARS EYE DROPS IS AND WHAT IT IS USED FOR
Minims
®
 Artificial Tears contains a lubricant. It is used as a substitute
for natural tears.
This medicine is indicated for children, adults and the elderly.
2. 
BEFORE YOU USE YOUR EYE DROPS
There are no special precautions which should be taken bef

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Artificial Tears 0.35% w/w + 0.44% w/w Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyetellose Ph. Eur. 0.44 % w/w and sodium chloride Ph. Eur. 0.35 % w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Sterile, single use eye drops, solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of dry eye syndromes associated with deficient tear secretion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One or two drops instilled into the affected eye three or four times daily, or as often as is required.
4.3 CONTRAINDICATIONS
None known.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If irritation persists or worsens or continued redness occurs, discontinue use and consult a physician or
ophthalmologist.
Keep out of reach of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no evidence of safety of this product in human pregnancy. If therapy with artificial tears is needed in
pregnancy this preparation can be used if recommended by a physician and it is considered that the benefits outweigh
the possible risks.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/08/2012_
_CRN 2119869_
_page number: 1_
clear.
4.8 UNDESIRABLE EFFECTS
May cause transient mild stinging or temporarily blurred vision.
4.9 OVERDOSE
Overdose would not be expected to produce symptoms.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
The�