- 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 Fertility, 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
Hypromellose 0.3% w/vFor the full list of excipients, see section 6.1
3. Pharmaceutical form
Eye drops, Solution.Clear to slightly opalescent colourless, 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 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 eg air-conditioning, central heating, wind and sun)
4.2 Posology and method of administration
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.Administration : For ocular use only.
Hypersensitivity to 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 continued 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. (Label warning: Do not touch any part of the eye with the dropper). The product contains benzalkonium chloride and should not be used if soft contact lenses are being worn.Remove contact lenses prior to application and wait at least 15 minutes before reinserting. Benzalkonium chloride is known to discolour soft contact lenses.
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
FertilityStudies 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.
PregnancyThere 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.
LactationIt 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 transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
The following adverse reactions have been reported following administration of Hypromellose. Frequency cannot be estimated from the available data:
Eye disorder:• transient mild stinging or vision blurred, • eye pain, • foreign body sensation in eyes, • eye irritation, • ocular hyperaemia.
Reporting of suspected adverse reactionsReporting 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.
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
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals ATC code: SO1X A20Hypromellose 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 an inert substance. It has no pharmacological activity and not absorbed systemically. Hence, the pharmacokinetic properties have not been studied.
5.3 Preclinical safety data
Hypromellose is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity or to have any effect on reproductive processes.Similarly no specific local ocular toxicity or irritation studies have been conducted; however no adverse effects are anticipated. Indeed, hypromellose ophthalmic solution is used as a control in some ophthalmic drugs studies because of the acknowledged low level of toxicity.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloridePotassium chlorideBoraxBoric acidBenzalkonium chloride solutionPurified waterSodium hydroxide solution (for pH adjustment)Hydrochloric acid ( for pH adjustment)
6.3 Shelf life
Unopened: 24 monthsAfter first opening: 1 month
6.4 Special precautions for storage
Protect from light.Do not store above 25°CA slight haziness which may develop in the unopened product is normal and does not adversely affect the product. Discard after 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
Do not touch dropper tip to any surface as this may contaminate the contents.If the drop of medication is not retained in the eye upon dosing for any reason, instill another drop.
7. Marketing authorisation holder
FDC International Ltd.Unit 6, Fulcrum 1Solent WayWhiteley FarehamHampshirePO15 7FEUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
16th January 1998 / 01st July 2008
10. Date of revision of the text
31 March 2015
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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