1. Name Of The Medicinal Product
Hypromellose Eye Drops BP 0.3%
2. Qualitative And Quantitative Composition
Each ml of solution contains 3mg of hypromellose.
For excipients see 6.1.
3. Pharmaceutical Form
Eye drops, solution
Nominal Viscosity 6.9mPaS
4. Clinical Particulars
4.1 Therapeutic Indications
Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production.
It may also be used as an ocular lubricant for artificial eyes.
4.2 Posology And Method Of Administration
Adults, children and the elderly: The dose depends on the degree of lubrication.
Usually one or two drops instilled into each affected eye several times a day or as prescribed.
Care should be taken not to touch the dispensing tip with the fingers or the conjunctiva when drops are instilled as this may contaminate the contents of the dosage container.
If the drop of medication is not retained in the eye for any reason, another drop should be instilled.
4.3 Contraindications
Hypersensitivity to any component of the product. The product contains benzalkonium chloride and, as with all preparations containing benzalkonium chloride, Hypromellose Eye Drops should not be used when soft contact lenses are worn.
4.4 Special Warnings And Precautions For Use
Hypromellose Eye Drops 0.3% should be used with caution in the presence of inflammation of the eye or conjunctiva.
If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue use and consult a physician.
To preserve sterility do not allow the dropper to touch the eye or any other surface.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
There is insufficient evidence as to the safety in pregnancy and this product should, therefore, only be used in pregnancy if it is considered essential by the physician.
It is not known whether hypromellose is secreted in human milk but because many drugs are excreted in human milk, caution be exercised when Hypromellose Eye Drops are administered to nursing mothers.
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 on instillation.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Hypromellose is an inert substance. It has no pharmacological activity.
Pharmacotherapeutic Group: Ophthalmologicals: Other Ophthalmologicals
ATC Code: SO1X A20
5.2 Pharmacokinetic Properties
Hypromellose is an inert substance. It has no pharmacological activity and, therefore, 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 drug studies because of the acknowledged low level of toxicity.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Borax, boric acid, potassium chloride, sodium chloride, benzalkonium chloride and purified water. May also contain sodium hydroxide and/or hydrochloric acid.
6.2 Incompatibilities
None known.
6.3 Shelf Life
24 months (unopened). One month (after first opening).
6.4 Special Precautions For Storage
Do not store above 25°C.
Keep out of the reach and sight of children.
Keep container tightly closed.
Discard the contents and bottle one month after opening the container for the first time.
6.5 Nature And Contents Of Container
Container: Low density polyethylene dropper bottles and plug containing 10 ml solution.
Cap: Polypropylene.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Cusi (UK) Ltd.,
Pentagon Park,
Boundary Way,
Hemel Hempstead,
Herts., HP2 7UD.
United Kingdom
8. Marketing Authorisation Number(S)
PL No. 16020/0016
9. Date Of First Authorisation/Renewal Of The Authorisation
20/10/2005
10. Date Of Revision Of The Text
20/10/2005
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