4.1. Therapeutic indications

Hypromellose is used as artificial tears to prevent damage to the cornea in patients with keratoconjunctivitis sicca accompanying rheumatoid arthritis, xerophthalmias or keratitis or during gonioscopy procedures. It is also used to moisten hard contact lenses and to lubricate artificial eyes.

Hypromellose provides immediate relief of dry eye conditions (including dry eye conditions associated with the use of VDUs and TVs, infrequent blinking, certain medical treatments, atmospheric pollution and drying atmospheres e.g. air-conditioning, central heating, wind and sun)

4.2. Posology and method of administration

Posology:

Adults, children and the elderly

The recommended dosage for adults, children and elderly is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician.

Method of administration:

For ocular use only.

4.3. Contraindications

Hypersensitivity to the active substance, Hypromellose or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

May cause transient mild stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continuous redness occur, patients should discontinue use and consult a physician or pharmacist (see section 4.8).

In order to preserve the sterility, the dropper should not be allowed to touch any part of the eye or any other surface.

This formulation of hypromellose eye drops contains 0.2 mg/ml benzalkonium chloride as preservative which may be deposited in soft contact lenses. Hence, hypromellose should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged us

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

Hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.

4.6. Fertility, pregnancy and lactation

Fertility

Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility.

Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.

Pregnancy

There are no or limited amount of data from the use of ophthalmic hypromellose in pregnant women. Systemic exposure to hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.

Breast-feeding

It is unknown whether topical hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding women to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.

4.7. Effects on ability to drive and use machines

May cause blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

4.8. Undesirable effects

Adverse events which have been associated with Hypromellose are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Event

Eye disorders

Not known

transient mild stinging or vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemia

Reporting of suspected adverse reactions

Reporting 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 Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 bottle.