4.1. Therapeutic indications

Substitute tear fluid for the management of dry eye conditions including keratoconjunctivitis sicca, and for unstable tear film.

4.2. Posology and method of administration

For ocular use.

Adults:

1 drop 3 - 4 times daily or as required, depending upon the severity of the disease

Elderly:

No dosage amendment is necessary in the elderly

Children and adolescents aged to 18 years:

The safety and efficacy of Viscotears SDU in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

Viscotears SDU contains a sterile gel until the original closure is broken. The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye

Viscotears Single Dose Unit should be used immediately after opening and discarded after use.

4.3. Contraindications

Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients.

4.4. Special warnings and precautions for use

• For ocular use only

• If patients experience eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor.

• Although the product contains no preservative, contact lenses should not be worn during instillation of the drug due to the viscosity. After instillation there should be an interval of at least 15 minutes before reinsertion.

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

No clinically relevant interactions have been described.

In case of any additional local ocular treatment (eg glaucoma therapy) there should be an application interval of at least 5 minutes between the two medications, Viscotears Single Dose Unit always should be the last medication instilled.

4.6. Pregnancy and lactation

Pregnancy

There are no data from the use of carbomer in pregnant women. However no effects during pregnancy are anticipated, since the systemic exposure to carbomer is expected to be negligible. Additionally, carbomer is an inactive ingredient that exerts a surface protective effect.

Lactation

It is unknown whether carbomer or any of the components are excreted in human milk.

However no effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to carbomer is expected to be negligible. Additionally, carbomer is an inactive ingredient that exerts a surface protective effect.

Administration during pregnancy and lactation is not recommended, except for compelling reasons.

Fertility

There are no available data on the use of this medicine affecting male or female fertility.

4.7. Effects on ability to drive and use machines

Viscotears has no or negligible influence on the ability to drive and use machines.

Viscotears may temporarily influence the visual acuity. Patients with blurred vision driving a vehicle or operating machines should be alerted to the possibility of impaired reactions.

The patient must wait until the vision clears before driving or using machinery.

4.8. Undesirable effects

Summary of the safety profile

In clinical trials, the most frequently reported adverse reactions were blurred vision occurring in 11% of patients and eyelid margin crusting occurring in 7.79% of patients.

The following adverse reactions have been reported during clinical trials with Carbomer 2mg/g, 3mg/g and are classified according to the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

System Organ Classification

Adverse reactions

Eye disorders

Very common: vision blurred

Common: ocular discomfort, eyelid margin crusting, eye irritation

Uncommon: periorbital oedema, conjunctival oedema, eye pain, eye pruritus, ocular hyperaemia, lacrimation increased

Skin and subcutaneous tissue disorders

Uncommon: dermatitis contact

Additional adverse reactions identified from post-marketing surveillance include the following.

Frequencies cannot be estimated from the available data.

System Organ Classification

Adverse reactions

Immune system disorders

Not known: Hypersensitivity

Reporting of suspected adverse reactions

Reporting of 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 adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

4.9. Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one tube.

Although this is unlikely to occur, should patients experience any untoward symptoms after applying too much Viscotears or accidental ingestion, treatment should be symptomatic.