This information is intended for use by health professionals

1. Name of the medicinal product

Tears Naturale

2. Qualitative and quantitative composition

Dextran 70 0.1% w/v

Hypromellose 0.3% w/v

3. Pharmaceutical form

Eye drops, solution.

4. Clinical particulars
4.1 Therapeutic indications

As a lubricant and artificial tear in dry eye and other ocular irritation syndromes associated with deficient tear or mucous secretion.

4.2 Posology and method of administration

Adults, children and the elderly:

One or two drops as required or directed instilled into the conjunctival sac.

Method of administration

For ocular use

Patients must not use this product if the solution becomes cloudy or changes colour. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

After cap is removed, if tamper evident snap collar is loose, remove before using product.

4.3 Contraindications

Hypersensitivity to dextran 70, hypromellose or to any of the excipients.

4.4 Special warnings and precautions for use

• For ocular use only. Not for injection or ingestion.

• Tears Naturale contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided. Patients should be advised to remove their contact lenses prior to the application of Tears Natural and wait at least 15 minutes before reinsertion.

• If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness, or if the condition worsens or persists for more than 3 days, they are to discontinue use and consult their doctor.

4.5 Interaction with other medicinal products and other forms of interaction

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

4.6 Fertility, pregnancy and lactation

Fertility

There is no adequate data regarding the impact of Tears Naturale on fertility. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating. Therefore, no effects on fertility are anticipated.

Pregnancy

There is no adequate data from the use of Tears Naturale in pregnant women. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating; therefore, no adverse effects during pregnancy are anticipated. These components are not expected to be absorbed systemically, to demonstrate any systemic toxicity or to have any effect on reproduction or embryofetal development. Tears Naturale can be used during pregnancy.

Breast-feeding

There is no adequate data regarding the impact of Tears Naturale Eye drops, Solution on lactation. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating therefore, no adverse effects during breast-feeding are anticipated. It is unknown whether dextran 70, hypromellose or any of the components are excreted in human milk. Nonetheless, discontinuation of product use during breast-feeding is not considered necessary.

4.7 Effects on ability to drive and use machines

Tears Naturale has no or negligible influence on the ability to drive or use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

4.8 Undesirable effects

a. Summary of the safety profile

The most frequently occurring adverse reaction during clinical trials was vision blurred.

b. Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post marketing spontaneous reports.

System Organ Classification

MedDRA Preferred Term (v.19.0)

Immune system disorders

Not known: hypersensitivity

Nervous system disorders

Uncommon: headache

Eye disorders

Very common: vision blurred

Common: dry eye (residual), eyelid disorder, abnormal sensation in eye, foreign body sensation in eyes, ocular discomfort.

Uncommon: photophobia, hypoaesthesia eye, eye pruritus, eye irritation, ocular hyperaemia.

Not known: erythema of eyelid, eye swelling, eye pain, eye discharge, eyelid margin crusting, lacrimation increased.

General disorders and administration site conditions

Uncommon: discomfort (skin)

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

• No case of overdose has been reported.

• An overdose of Tears Naturale can easily be washed out of the eye with lukewarm tap water.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Artificial Tears

ATC Code: S01X A20.

The combination of Dextran 70 and hypromellose in an aqueous presentation provides a soothing lubricant preparation for the relief of dry eye syndrome associated with deficient tear secretion or deficient mucous.

5.2 Pharmacokinetic properties

Not applicable.

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

Benzalkonium chloride

Disodium edetate

Sodium chloride

Potassium chloride

Sodium hydroxide and/or Hydrochloric acid

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years (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 one month after opening.

6.5 Nature and contents of container

15 ml Drop-Tainer – Low density polyethylene dropper bottle with white polypropylene cap and LDPE tip.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

Alcon Eye Care UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

8. Marketing authorisation number(s)

PL 41809/0005

9. Date of first authorisation/renewal of the authorisation

6th July 1979 / 12th September 1995

10. Date of revision of the text

25 September 2018

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