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FDC International Ltd

Unit 6 Fulcrum1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE
Telephone: +44 (0)1489 565222
Fax: +44 (0)1489 565222
WWW: http://www.fdcindia.com
Medical Information e-mail: fdcil@btconnect.com

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Summary of Product Characteristics last updated on the eMC: 01/08/2012
SPC Hypromellose Eye Drops BP


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1. Name of the medicinal product

Hypromellose Eye Drops BP


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2. Qualitative and quantitative composition

Active Ingredient

Hypromellose Ph Eur 0.3g in 100ml


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3. Pharmaceutical form

Eye Drops


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4. Clinical particulars

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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 eg air-conditioning, central heating, wind and sun.


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4.2 Posology and method of administration

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.


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4.3 Contraindications

Hypersensitivity to any component of the preparation.


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4.4 Special warnings and precautions for use

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

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). The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.


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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.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

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


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4.8 Undesirable effects

May cause transient mild stinging or temporarily blurred vision.


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4.9 Overdose

Not applicable


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

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.


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5.2 Pharmacokinetic properties

Not applicable to topical (ophthalmic) preparations.

Hypromellose is not systemically absorbed.


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5.3 Preclinical safety data

Nothing of relevance which is not included in other sections of the SPC


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6. Pharmaceutical particulars

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6.1 List of excipients

Sodium chloride

Potassium chloride

Borax

Boric acid

Benzalkonium chloride solution

Purified water

Sodium hydroxide solution (to adjust pH)

Hydrochloric acid (to adjust pH)


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6.2 Incompatibilities

The product contains benzalkonium chloride and should not be used if soft contact lenses are worn


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6.3 Shelf life

Unopened: 24 months

Opened: 1 month


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6.4 Special precautions for storage

Protect from light.

Store below 25°C

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.


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6.5 Nature and contents of container

Low density polyethylene bottle with polystyrene spiked cap.

Pack size : 10 ml


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6.6 Special precautions for disposal and other handling

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7. Marketing authorisation holder

FDC International Ltd

Unit 6 Fulcrum 1

Solent Way

Whiteley

Fareham

Hants

PO15 7FE

United Kingdom


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8. Marketing authorisation number(s)

15872/0005


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9. Date of first authorisation/renewal of the authorisation

Not applicable


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10. Date of revision of the text

26 July 2012



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/22705/SPC/


Active Ingredients/Generics