- 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 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
2. Qualitative and quantitative composition
Dextran 70 0.1% w/vHypromellose 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.
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 Pregnancy and lactation
PregnancyThere are no or limited amount of data from the use of Tears Naturale in pregnant women. However, the components dextran 70 and hypromellose exert a surface protective effect and are not pharmacologically active. 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.
LactationIt 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. Tears Naturale can be used during breast-feeding.
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 profileThe most frequently occurring adverse reaction during clinical trials was vision blurred.b. Tabulated list of adverse reactionsThe 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.12.0)|
|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)|
• 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 TearsATC Code: S01X AThe 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
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 chlorideDisodium edetateSodium chloridePotassium chlorideSodium hydroxide and/or Hydrochloric acidPurified water
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
7. Marketing authorisation holder
Alcon Laboratories (UK) Ltd.Frimley Business Park,Frimley, Camberley,Surrey, GU16 7SRUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
6th July 1979 / 12th September 1995
10. Date of revision of the text
29th July 2013
Alcon Laboratories (U.K) Limited
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
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