For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only
Carboxymethylcellulose Sodium IP…….0.5% w/v
Stabilized Oxychloro Complex ( as preservative)…………0.005% w/v
Ophthalmic solution of Carboxymethylcellulose 0.5%
Carboxymethylcellulose Sodium 0.5% eye drops are used as a lubricant to relieve irritation and discomfort due to dryness of the eyes or due to exposure of the eyes to wind or sun, for the treatment of the symptoms of dry eye and as a protectant against further irritation.
Posology and Method of Administration
Instill one to two drops in the affected eye(s) as needed.
Use with Other Topical Ophthalmic Medications
If carboxymethyl cellulose 0.5% eye drops 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).
The safety and efficacy of carboxymethyl cellulose 0.5% eye drops in children and adolescents have been established by clinical experience, but no clinical trial data are available. The dosage recommended in adults is recommended in the paediatric population.
Hypersensitivity to sodium carboxymethyl cellulose or to any of the excipients.
Special Warnings and Precautions for Use
To avoid contamination do not touch tip of container to any surface. Replace cap after using. If you experience eye pain, changes in vision, continued redness or irritation of the eye and if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. If solution changes colour or becomes cloudy, do not use. Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or consult your physician.
Use in Special Population
Due to the negligible systemic exposure and the lack of pharmacological activity carboxymethyl cellulose 0.5% eye drops can be used during pregnancy.
Due to the negligible systemic exposure and the lack of pharmacological activity carboxymethyl cellulose 0.5% eye drops can be used during breast-feeding.
Effects on Ability to Drive and use Machines
Carboxymethylcellulose Sodium 0.5% eye drops are may cause transient blurring of vision which may impair the ability to drive or operate machines. The patient should wait until their vision has cleared before driving or using machinery.
The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (≥ 1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).
Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.
The following additional adverse reactions have been identified during postmarketing use of sodium carboxymethyl cellulose 0.5% in clinical practice. Because postmarketing reporting of these reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions.
Immune System Disorders:
Hypersensitivity including eye allergy.
Blurred vision, eye discharge, lacrimation increased, ocular hyperemia.
Injury, Poisons and Procedural Complications:
Superficial injury of eye (from the vial tip touching the eye during administration) and/or corneal abrasion.
If you experience any side effects, talk to your doctor or pharmacist or write to email@example.com. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024 or you can report to Cipla Ltd. on 18002677779. By reporting side effects, you can help provide more information on the safety of this product.
Accidental overdose will present no hazard.
Carboxymethylcellulose Sodium has no pharmacological effect. Carboxymethylcellulose Sodium has a high viscosity, resulting in an increased retention time on the eye.
The excipients in Carboxymethylcellulose Sodium 0.5% eye drops were chosen to mimic the electrolyte constitution of tears.
Due to the high molecular weight (approximately 90,000 Daltons), Carboxymethylcellulose Sodium is unlikely to penetrate the cornea.
As on pack.
ADD TEARS Eye Drops: Vial of 10ml
Storage and handling instructions
Do not store above 25ºC.
Mfd. By Cipla Ltd
B-2, Dev Bhoomi Indl. Estate
Puhana Iqbalpur Road,
Roorkee, Haridwar – 247667
Permission number and date of issue: 66/UA/LL/SC/P-2019