COMPOSITION
Carboxymethylcellulose Eye Drops IP 1.0 % w/v
Each ml contains:
Carboxymethylcellulose Sodium IP 10 mg
Oxychlorocomplex (Stabilized) 0.075 mg
(as preservative)
Water for Injections BP q.s
DESCRIPTION
A clear, colorless to slightly pale-yellow colored liquid.
PHARMACODYNAMIC
Pharmacotherapeutic group: Other Ophthalmological.
ATC code: S01XA20
Carboxymethylcellulose sodium has no pharmacological effect. Carboxymethylcellulose sodium has a high viscosity resulting in an increased retention time on the eye.
The excipients in EYECLEAR / EYECLEAR MAX were chosen to mimic the electrolyte constitution of tears.
PHARMACOKINETICS
Due to the high molecular weight (approx. 90,000 Daltons) carboxymethylcellulose sodium is unlikely to penetrate the cornea.
THERAPEUTIC INDICATION
Tear substitute. Treatment of the symptoms of dry eye.
DOSAGE AND ADMINISTRATION
Instill 1-2 drops in the affected eye/s 4 times a day or as needed.
Ensure that the single-dose container is intact before use. The eye drop solution should be used immediately after opening.
To avoid contamination or possible eye injury, do not touch tip of the bottle or vial to any surface and avoid contact with the eye.
If EYECLEAR / EYECLEAR MAX 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 eye drops may be used with contact lenses.
Paediatric population
The safety and efficacy of EYECLEAR / EYECLEAR MAX in children and adolescents have been established by clinical experience, but no clinical trial data are available. The posology recommended in adults is recommended in the paediatric population.
INSTRUCTION FOR USE
Apply EYECLEAR / EYECLEAR MAX Eye Drops in the following way:
- Wash your hands. Tilt your head back and look at the ceiling.
- Gently pull the lower eyelid down until there is a small pocket.
- Turn the bottle upside down and gently press the bottle to release drops into eyes that needs treatment.
- Let go of the lower lid, and close your eye for 30 seconds.
- To avoid contamination, do not let the tip of dropper touch your eye or anything else.
- Replace and tighten the cap straight after use.
OVERDOSE
Accidental overdose will present no hazard.
CONTRAINDICATION
Hypersensitivity to the active substance or to any of the excipients.
WARNING AND PRECAUTIONS
- It is not for injection.
- Do not use the eye drop with contact lenses.
- 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.
PREGNANCY AND LACTATION
Due to the negligible systemic exposure and the lack of pharmacological activity EYECLEAR / EYECLEAR MAX can be used during pregnancy and breast-feeding.
DRUG INTERACTION
Not Known
ADVERSE EFFECTS
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).
Eye disorders:
Common: Eye irritation (including burning and discomfort), eye pain, eye pruritus, visual disturbance.
Post marketing Experience
The following additional adverse reactions have been identified during post marketing use of EYECLEAR / EYECLEAR MAX in clinical practice. Because post marketing 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.
Eye Disorders:
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.
PRESENTATION
EYECLEAR MAX Eye Drops are supplied in 10 ml sterilized opaque plastic container with nozzle and cap.
STORAGE AND OTHER INFORMATION
Store at temperature below 30 °C. Keep this medicine out of the sight and reach of children. Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate the solution. Use the solution within one month after opening the container.
