Minims Artificial Tears 0.35% w/w + 0.44% w/w Eye Drops, Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Hydroxyethylcellulose; Sodium chloride

Dostupné z:

Bausch & Lomb UK Limited

ATC kód:

S01AX; S01AX07

INN (Medzinárodný Name):

Hydroxyethylcellulose; Sodium chloride

Dávkovanie:

0.35% w/w + 0.44 percent weight/weight

Forma lieku:

Eye drops, solution

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Other antiinfectives; sodium borate

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1992-03-23

Príbalový leták

1
BN.
EXP.
X00000
00 0000
Eye drops, solution
Sodium chloride + Hyetellose
Preservative-free. For ocular use
Sterile, Single use only 0.5ml
DISCARD ANY UNUSED SOLUTION
GB237C05-08.15
BAUSCH&LOMB
PA555/16/1 PL03468/0067
MINIMS® ARTIFICIAL TEARS
0.35% W/W + 0.44% W/W
HECL 44
P

Súhrn charakteristických

Health Products Regulatory Authority
27 February 2019
CRN008NXP
Page 1 of 3
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
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
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
INTERACTIONS
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 clear.
4.8 UNDESIRABLE EFFECTS
May cause transient mild stinging or temporarily blurred vision.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected
Health Products Regulatory Authority
27 February 2019
CRN008NXP
Page 2 of 3
adverse reactions via HPRA P