HIPROVIZ 0.3% W/V EYE DROPS SOLUTION - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Hiproviz 0.3% w/v Eye Drops Solution

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient:     Hypromellose 0.3% w/v

Excipient(s) with known effect: Preservative:          Benzal­konium chloride 0.01% w/v

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye Drops, Solution (Eye Drops)

Clear to slightly opalescent colourless practically free of particles, slightly viscous solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hypromellose is used as artificial tears to prevent damage to the cornea in patients with kerato-conjunctivitis sicca accompanying rheumatoid arthritis, 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. airconditioning, central heating, wind and sun).

4.2 Posology and method of administration

Posology

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

Method of administration

Instil eye drops topically into the eye

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

Method of administration

Instil eye drops topically into the eye

4.3 Contraindications

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

4.4 Special warnings and precautions for use

In order to help preserve sterility the dropper should not be allowed to touch the eyelids or any other surface. (Label warning: do not touch the eyelid with the dropper).

This formulation of Hypromellose Eye Drops Solution contains benzalkonium chloride as a preservative. Benzalkonium chloride may be deposited in soft contact lenses and cause eye irritation and discoloration of the lenses. Hence, avoid contact with soft contact lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.

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

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physician.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

May cause transient mild stinging or temporarily blurred vision.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Not applicable to topical (ophthalmic) preparations. Hypromellose is not systemically absorbed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: viscoelastic substances ATC code: S01KA02

Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages over methylcellulose are that mucilages of hypromellose have greater clarity and fewer undispersed fibres are usually present. It prolongs the action of medicated eye drops and is used as artificial tears to prevent damage to the cornea in dry eye syndromes.

5.2 Pharmacokinetic properties

Not applicable to topical (ophthalmic) preparations. Hypromellose is not systemically absorbed.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

Environmental Risk Assessment (ERA)

Hiprovis 0.3% w/v Eye Drops solution does not represent an environmental risk.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride (Preservative)

Sodium chloride

Potassium chloride

Borax

Boric acid

Purified water

Sodium hydroxide solution (to adjust pH)

Hydrochloric acid (to adjust pH)

6.2 Incompatibilities

The product contains Benzalkonium Chloride and should not be used if soft contact lenses are worn.

6.3 Shelf life

Unopened: 36 months Opened: 28 days

6.4 Special precautions for storage

Keep bottle in the outer carton to protect from light.

Do not store above 25°C.

6.5 Nature and contents of container

White Low density polyethylene (LDPE) bottle with a transparent LDPE dropper and a white HDPE closure capsule containing 10 ml of a clear colourless solution.

6.6 Special precautions for disposal

A slight haziness which may develop in the unopened product is normal and does not adversely affect the product. Discard within four weeks of opening

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Farmigea S.p.A

Via G.B. Oliva, 6/8–56121 PISA

Italy

8 MARKETING AUTHORISATION NUMBER(S)

PL 24653/0002