Artelac 10ml hypromellose 0.32% with preservative, Eye drops solution: Clinical Particulars

1. Name of the medicinal product

Artelac 3.2 mg/ml Eye Drops Solution

2. Qualitative and quantitative composition

Each ml of solution contains 3.2mg of hypromellose equivalent to Hypromellose 3.2 mg/ml.

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Eye drops, solution. Sterile clear solution

4. Clinical particulars

4.1 Therapeutic indications

This medicinal product acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systemic diseases, or caused by deficient or incomplete eyelid closure. Artelac 3.2 mg/ml Eye Drops Solution is indicated in adults and children.

4.2 Posology and method of administration

Posology

Suitable for use in adults and children. Unless otherwise directed, instil 1 drop into the conjunctival sac (corner of the eye, nearest the nose) 3 to 5 times per day or as required, to provide sufficient lubrication. Therapy of dry eye syndrome requires an individual dosage regimen.

Method of administration

For ocular use only.

4.3 Contraindications

Hypersensitivity to the active substance (hypromellose) or to any of the excipients. Listed in section 6.1.

4.4 Special warnings and precautions for use

Stop treatment and consult a physician if irritation persists or worsens or new eye signs or symptoms develop. Wearers of soft contact lenses should remove their lenses before Artelac 3.2 mg/ml Eye Drops Solution is administered and should wait for at least 15 minutes before they insert them again. Ensure the dropper tip does not touch any surface including the eye surface.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Fertility, pregnancy and lactation

Pregnancy

Artelac 3.2 mg/ml Eye Drops Solution can be used during pregnancy.

Breast-feeding

Artelac 3.2 mg/ml Eye Drops Solution can be used during and lactation.

Fertility

Artelac 3.2 mg/ml Eye Drops Solution is not expected to have any effect on fertility.

4.7 Effects on ability to drive and use machines

Artelac 3.2 mg/ml Eye Drops Solution on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.

4.8 Undesirable effects

The following adverse reactions have been reported following administration of Artelac 3.2 mg/ml Eye Drops Solution.

Eye disorder:

Very rare (<1/10,000):

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Not known: Brief blurred vision or a slight stinging sensation on instilling Artelac 3.2 mg/ml Eye Drops Solution.

Reporting of suspected adverse reactions:

Reporting 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; Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No case of overdose has been reported.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals

ATC code: S01X A20

Hypromellose prolongs adhesion, enhances moistening of the cornea and conjunctiva and allows for a smoother movement of the conjunctiva over the cornea.

5.2 Pharmacokinetic properties

Hypromellose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.

5.3 Preclinical safety data

Hypromellose has proved to be very well tolerated in local toxicity studies.

6. Pharmaceutical particulars

6.1 List of excipients

Cetrimide

Disodium Phosphate Dodecahydrate

Sodium Dihydrogen Phosphate Dihydrate

Disodium Edetate

Sorbitol

Water for Injections in Bulk

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years. Discard within 28 days of first opening.

6.4 Special precautions for storage

Protect from light. Store below 25°C. Sterile until opened. Avoid contamination during use.

6.5 Nature and contents of container

10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).

6.6 Special precautions for disposal and other handling

Avoid contamination during use. Hypromellose SDU eye drops are sterile until first opened. For single use only. Each carton contains a patient insert with instructions for use.

7. Marketing authorisation holder

Bausch & Lomb (UK) Ltd

Bausch &Lomb House

106 London Road

Kingston-Upon-Thames

Surrey KT2 6TN

UK

8. Marketing authorisation number

PL 03468/0032

9. Date of first authorisation/renewal of the authorisation

02/09/2009

10. Date of revision of the text

15/05/2020