VISCOTEARS Eye gel Ref.[27756] Active ingredients: Carbomer

• 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.

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.

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.

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.

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.

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

Frequencies cannot be estimated from the available data.

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.

Not applicable.