INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CELLUFRESH® Eye Drops

SCHEDULING STATUS
Schedule 0

PROPRIETARY NAME
(and dosage form)

CELLUFRESH® Eye Drops

COMPOSITION
CELLUFRESH
® is an isotonic formulation and contains carboxymethylcellulose sodium 5 mg/mL, sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride and purified water.

PHARMACOLOGICAL CLASSIFICATION
A. 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
Pharmacodynamic properties
CELLUFRESH
® Eye Drops is an isotonic, lubricating, non-preserved formulation similar to normal tears.

INDICATIONS
CELLUFRESH
® Eye Drops are indicated as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

CONTRA-INDICATIONS
Hypersensitivity to carboxymethylcellulose sodium or any other ingredient of CELLUFRESH®.

WARNINGS AND SPECIAL PRECAUTIONS
If irritation, pain, redness or changes in vision occur or if the patient’s condition is worsened, treatment discontinuation should be considered and a new assessment made.
To avoid contamination or possible eye injury, do not touch tip of the vial to any surface and avoid contact with the eye.
Do not use if CELLUFRESH
® packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy.

Effects on ability to drive and use machines
Upon instillation, patients may experience transient blurred vision which may impair the ability to drive or use machinery. If affected, patients should not drive or use machinery until their vision has cleared.

INTERACTIONS
None known.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation have not been established.

DOSAGE AND DIRECTIONS FOR USE
Ensure that the single-dose container is intact before use. Instil 1-2 drops in the affected eye/s 4 times a day as needed. The eye drop solution should be used immediately after opening. Discard any unused solution in opened container, i.e. do not re-use container for subsequent doses. The eye drops can be used with contact lenses.
If CELLUFRESH
® is concomitantly used with other ocular eye medications there must be an interval of at least 15 minutes between the two medications (as displacement of a medication may occur).

SIDE EFFECTS
Eye disorders
Common (>1/100, <1/10): Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance
The following other adverse reactions have reported since CELLUFRESH
® has been marketed (frequency unknown):
Immune System Disorders
Hypersensitivity including eye allergy
Eye disorders
Eye pain, blurred vision, eye discharge, increased lacrimation, ocular hyperaemia
Injury, Poisons and Procedural Complications
Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion.
To avoid contamination or possible eye injury, do not touch the tip of the vial to the eye or any other surface.

IDENTIFICATION
Clear, colourless to slightly yellow solution in low density polyethylene single-use containers.

PRESENTATION
Cardboard cartons containing 30 sterile single-use vials per carton. Each single-use container contains 0,4 mL CELLUFRESH
®.

STORAGE INSTRUCTIONS
Store unopened container in a cool place (at or below 25ºC). Do not store opened single-use container. Discard any unused portion. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
32/15.4/0477

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT
Date of registration: 03 May 1999
Date of revision of the package insert: 14 October 2015

PATIENT INFORMATION LEAFLET

SCHEDULING STATUS
Schedule 0

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
CELLUFRESH
® carboxymethylcellulose sodium 5 mg/mL, eye drops

Read all of this leaflet carefully, because it contains important information for you
CELLUFRESH
® is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use CELLUFRESH® carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Do not share CELLUFRESH® with any other person.
Ask your pharmacist if you need more information or advice.
You must see a doctor if your symptoms worsen, or do not improve.

1. WHAT CELLUFRESH
® CONTAINS
The active substance is carboxymethylcellulose sodium 5 mg/mL
The other ingredients are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride, and purified water.

2. WHAT CELLUFRESH
® IS USED FOR
CELLUFRESH
® is a tear substitute and contains a lubricant called carboxymethylcellulose sodium. It is used to relieve the symptoms of dry eye; such as burning, irritation, dryness, or eye pain.

3. BEFORE YOU USE CELLUFRESH®
Do not use CELLUFRESH®:
If you are hypersensitive (allergic) to carboxymethylcellulose sodium or any of the other ingredients of CELLUFRESH®.

Take special care with CELLUFRESH®:
If you experience eye pain, changes in vision, continued redness, or irritation of the eye, or if your condition worsens, stop using the product. In these cases, consult your doctor or pharmacist.
To avoid contamination or possible eye injury, do not let the open-end of the single-dose container touch your eye or anything else.
Do not use if CELLUFRESH® packaging shows evidence of tampering. Do not use if solution changes colour or becomes cloudy.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist, or other healthcare professional for advice before using CELLUFRESH
®.

Driving and using machinery
CELLUFRESH
® may cause temporary blurred vision. Do not drive or use machinery until the symptoms have cleared.

Using other medicines with CELLUFRESH®
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
If you use CELLUFRESH
® with another eye medicine, leave at least 15 minutes between putting CELLUFRESH® and the other medicine. Use any eye ointment or eye gel last.

4. HOW TO USE CELLUFRESH®
Do not share medicines prescribed for you with any other person.
Always use CELLUFRESH
® exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.
Ensure that the single-dose container is intact before use. The usual dose is 1 to 2 drops of CELLUFRESH
® in each affected eye, 4 times a day, or as needed.
If you have the impression that the effect of CELLUFRESH
® is too strong, or too weak, tell your doctor or pharmacist. You do not need to remove contact lenses before using CELLUFRESH®. Do not swallow.
To avoid contamination, do not let the bottle tip touch your eye or anything else. Always wash your hands before applying eye drops. Apply your eye drops in the following way:
1. Tilt your head back and look at the ceiling. Hold the container/vial tip lowermost over your eye.
2. Gently pull the lower eyelid down until there is a small pocket between the inside of the lower eyelid and the eyeball.
3. Squeeze the upturned container/vial to release a drop into your eye.
Do not re-use the opened container/vial for subsequent doses.

5. POSSIBLE SIDE EFFECTS
CELLUFRESH
® can have side effects.
The following side effects may be seen with CELLUFRESH®:
Frequent: Eye irritation, (including burning and discomfort), eye pain, itchy eyes, visual disturbance
Frequency unknown: Allergic reactions (including eye allergy), eye pain, blurred vision, sticky eye, watery eye, redness of the eye, eye injury to the surface of the eye due to the tip of the vial touching the eye during use
Not all side effects reported for CELLUFRESH
® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using this medicine, please consult your doctor, pharmacist, or other health care professional for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

6. STORING AND DISPOSING OF CELLUFRESH®
Store at or below 25ºC. Do not refrigerate.
Keep the container in the outer carton.
Store all medicines out of reach of children.
Throw away any unused solution in the opened container/vial.
Do not use after the expiry date stated on the container/vial.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

7. PRESENTATION OF CELLUFRESH®
CELLUFRESH
® is available in cardboard cartons containing 30 sterile single-use vials per carton. Each single-use container contains 0,4 mL CELLUFRESH®.

8. IDENTIFICATION OF CELLUFRESH®
CELLUFRESH
® is a clear, colourless to slightly yellow solution.

9. REGISTRATION NUMBER / REFERENCE NUMBER
32/15.4/0477

10. NAME AND ADDRESS OF REGISTRATION HOLDER
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
South Africa

11. DATE OF PUBLICATION
Date of registration: 03 May 1999
Date of revision of the patient information leaflet: 14 October 2015

Updated on this site: October 2015
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2015