Isopto Alkaline

1. Name Of The Medicinal Product

ISOPTO ALKALINE

2. Qualitative And Quantitative Composition

Hypromellose 1.0% w/v

3. Pharmaceutical Form

Eye drops, solution.

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. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).

Also 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 need for lubrication. Usually one to two drops to each eye three times daily or as prescribed.

4.3 Contraindications

Hypersensitivity to any component of the product. The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.

4.4 Special Warnings And Precautions For Use

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 safety in pregnancy and this product should, therefore, only be used in pregnancy if it is 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.

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ophthalmologicals: Other ophthalmologicals

ATC code: SO1X A20

Hypromellose is an inert substance. It has no pharmacological activity.

5.2 Pharmacokinetic Properties

Hypromellose is an inert substance. It has no pharmacological activity and, hence, the pharmacokinetic properties have not been studied.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium citrate dihydrate, Disodium Phosphate anhydrous, Sodium biphosphate, Sodium chloride, Benzalkonium chloride, Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months (unopened), 1 month (after first opening).

6.4 Special Precautions For Storage

Do not store above 25°C. Do not refrigerate.

Keep container tightly closed.

Discard 1 month after opening

.

6.5 Nature And Contents Of Container

10 mL Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug

Polystyrene or Polypropylene cap

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, instil another drop.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD. UK

8. Marketing Authorisation Number(S)

PL 0649/5900R

9. Date Of First Authorisation/Renewal Of The Authorisation

9th October 1990/19th December 1996

10. Date Of Revision Of The Text

February 2002