- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Hypromellose Eye Drops BP
2. Qualitative and quantitative composition
Active IngredientHypromellose Ph Eur 0.3g in 100ml
3. Pharmaceutical form
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 eg air-conditioning, central heating, wind and sun.
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.
Hypersensitivity to any component of the preparation.
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.
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 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 hazardous machinery unless vision is clear.
4.8 Undesirable effects
May cause transient mild stinging or temporarily blurred vision.
5. Pharmacological properties
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.
5.2 Pharmacokinetic properties
Not applicable to topical (ophthalmic) preparations.Hypromellose is not systemically absorbed.
5.3 Preclinical safety data
Nothing of relevance which is not included in other sections of the SPC
6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride Potassium chloride Borax Boric acid Benzalkonium chloride solution Purified waterSodium hydroxide solution (to adjust pH)Hydrochloric acid (to adjust pH)
The product contains benzalkonium chloride and should not be used if soft contact lenses are worn
6.3 Shelf life
Unopened: 24 monthsOpened: 1 month
6.4 Special precautions for storage
Protect from light.Store below 25°CA slight haziness which may develop in the unopened product is normal and does not adversely affect the product. Discard within four weeks of opening.
6.5 Nature and contents of container
Low density polyethylene bottle with polystyrene spiked cap.Pack size : 10 ml
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
FDC International LtdUnit 6 Fulcrum 1Solent WayWhiteleyFarehamHantsPO15 7FEUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
26 July 2012
FDC International Ltd
Unit 6 Fulcrum1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE
+44 (0)1489 565222
+44 (0)1489 565222
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