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

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Sodium chloride; Hydroxyethylcellulose

Disponibbli minn:

Bausch Health Ireland Limited

Kodiċi ATC:

S01AX; S01AX07

INN (Isem Internazzjonali):

Sodium chloride; Hydroxyethylcellulose

Dożaġġ:

0.35% w/w + 0.44 percent weight/weight

Għamla farmaċewtika:

Eye drops, solution

Żona terapewtika:

Other antiinfectives; sodium borate

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1992-03-23

Fuljett ta 'informazzjoni

BAUSCH & LOMB
MINIMS® ARTIFICIAL TEARS
0.35% W/W SODIUM CHLORIDE + 0.44%W/W HYETELLOSE EYE DROPS, SOLUTION
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 has 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 Minims
®
Artificial Tears eye drops is and what it is used for
2. What you need to know 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. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU USE YOUR EYE DROPS
There are no special precautions which should be taken before using
this product.
PREGNANCY, BREAST-FEEDING AND FERTILITY
You can use Minims
®
Artificial Tears as it will not harm your baby, and it is safe to use
during breastfeeding.
DRIVING AND USING MACHINES
As with all eye drops, your vision may be blurred after putting the
drops in. Wait until your vision is clear before driving or
using machines.
3. HOW TO USE YOUR EYE DROPS
The drops are in special single use “Minims” units, to treat both
eyes if necessary. Once used, they must be thrown away.
DOSAGE
The amount of solution used should be enough to irrigate the eye
properly.
METHOD OF ADMINISTRATION
If you are putting the eye drops in yourself, then follow these
instructions carefully:
1. Wash your hands.
2. Use a mirror, th

Karatteristiċi tal-prodott

Health Products Regulatory Authority
02 May 2019
CRN008VKZ
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
02 May 2019
CRN008VKZ
Page 2 of 3
adverse reactions via HPRA Pharmacovig