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OnTears GelDrops unims™

Carboxymethylcellulose Sodium 1% w/v Carboxymethylcellulose Sodium 1% w/v is indicated as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.
OnTears GelDrops unimsTM
Carboxymethylcellulose Sodium 1% w/v

Only for the use of Registered Medical Practitioner, a Hospital or a Laboratory.
ONTEARSUNIMS (Carboxymethylcellulose Sodium 1% w/v)

COMPOSITION: Each ml contains:
Sodium Carboxymethyl Cellulose  IP 10 mg
Aqueous buffered vehicle  q.s.

EXCIPIENTS: Sodium chloride, Potassium chloride, Boric acid, Calcium chloride, Magnesium chloride, Sodium hydroxide, Water.

DOSAGE FORM:
Eye Drops

INDICATIONS:
Carboxymethylcellulose Sodium 1% w/v is indicated as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

DOSAGE AND METHOD OF ADMINISTRATION:
Use one or two drops as needed.
Carboxymethylcellulose Sodium 1% w/v preservative free unit dose ophthalmic solution is meant for single use only.
Method of administration: See instructions for use.
             
USE IN SPECIAL POPULATIONS:
Pregnant women
There are no adequate and well-controlled studies in pregnant women. Judging by its pharmacokinetic properties and its widespread use in food industry, its potential to cause risk to the fetus appears minimal.

Lactating women
Judging by its pharmacokinetic properties and its widespread use in food industry, its potential to cause risk to the newborn appears minimal.

Paediatric Population
Safety and efficacy in children have not been established. No study data available.

Geriatric Population
Preservative free artificial tear Carboxymethylcellulose Sodium 1% w/v provided a temporary yet significant improvement in the visual acuity of symptomatic dry eye (SDE) and asymptomatic dry eye (ADE) patients.

CONTRAINDICATIONS:
Hypersensitivity to the active substance or to any of the excipients .

WARNINGS AND PRECAUTIONS:
FOR EXTERNAL USE ONLY
NOT FOR INJECTION
• To avoid contamination, be careful not to touch the tip of the vial or let it touch your eye.
• Carboxymethylcellulose Sodium 1% w/v preservative free unit dose ophthalmic solution is meant for single use only.
• Do not use the solution that has changed colour or if cloudy.
• There are no adequate and well-controlled studies in pregnant women. Judging by its pharmacokinetic properties and its widespread use in food industry, its potential to cause risk to the fetus appears minimal.
• Judging by its pharmacokinetic properties and its widespread use in food industry, its potential to cause risk to the newborn and to cause adverse effects on fertility appears minimal.

DRUG  INTERACTIONS:
No interaction study report is available. Sodium Carboxymethyl Cellulose is a physiologically inert substance. The chances of drug interactions on topical administration in eyes are negligible.

UNDESIRABLE  EFFECTS:
Possible adverse effects with the use of Carboxymethylcellulose Sodium 1% w/v include eye pain, irritation, continued redness or vision changes. Use should be discontinued if any of them occurs.
Reflex tearing in the other eye may be induced during instillation of artificial tears in one eye. Also hyperaemia, photophobia, stickiness of eyelashes, discomfort and irritation can occur.

OVERDOSAGE:
Acute overdosage with Carboxymethylcellulose Sodium 1% w/v has not been reported.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Eye lubricants like Carboxymethylcellulose Sodium 1% w/v preservative free eye drops keep the eye moist, help to protect the eye from injury and infection, and decrease symptoms of dry eyes such as burning, itching, and foreign body sensation in the eye.

PHARMACOKINETIC PROPERTIES:
Carboxymethylcellulose Sodium 1% w/v is a physiologically inert substance. On oral administration of CMC in rats, nearly 95% is recovered in faeces.

INCOMPATIBILITIES:
None reported.

SHELF LIFE:
2 years

PACKAGING INFORMATION:
Single use sterile vials . Each vial contains 0.4 ml. 10 vials are packed in a unit carton.

STORAGE AND HANDLING INSTRUCTIONS:
Store between 15°C - 30°C. Do not freeze. Protect from light.

COMMON CAUSES OF DRY EYE:
• Environment factors such as excessive heat and wind
• Computer use
• Smoking
• Prolonged contact lens use
• Certain medications
• Aging

Marketed by: Provis
A division of Promed