Tears Naturale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TEARS NATURALE SINGLE DOSE eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of TEARS NATURALE SINGLE DOSE contains:
Dextran 70 1.0 mg
Hypromellose 3.0 mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution Clear, colourless solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Tears substitute for the symptomatic treatment of moderate to severe dry eye, including keratoconjunctivitis sicca.
4.2 Posology and method of administration
Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) as needed, up to once every 1-2 hours or as prescribed by the physician.
Adults, children, and the elderly
These drops may be used by both adults and children.
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
• If patients experience headaches, eye pain, changes in vision, persistent redness or irritation of the eyes, or if the condition worsens or persists for more than 3 days, they are to discontinue use and consult a 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
Pregnancy
There are no or limited amount of data from the use of TEARS NATURALE SINGLE DOSE 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 SINGLE DOSE can be used during pregnancy.
Lactation
It is unknown whether dextran 70, hypromellose or any of the components are excreted in human milk. Nonetheless, discontinuation of product use during breastfeeding is not considered necessary. TEARS NATURALE SINGLE DOSE can be used during breast-feeding.
4.7 Effects on ability to drive and use machines
TEARS NATURALE SINGLE DOSE 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 not drive or use machinery until the vision is completely cleared.
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.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) |
Reporting of side effects
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 SINGLE DOSE can easily be washed out of the eye with lukewarm tap water.
5
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code S01X A20
TEARS NATURALE SINGLE DOSE is an unpreserved physiological tear product that exerts a physical, not a pharmacologic action, and it contains the ionic components of the human tear: calcium, magnesium, sodium, potassium, zinc, bicarbonate and chloride ions. TEARS NATURALE SINGLE DOSE also contains the DUASORB system, which consists of two water-soluble polymers: Dextran 70 and hypromellose. The system provides a lubricant and emollient effect to the cornea. The surface tension and viscosity of TEARS NATURALE SINGLE DOSE are similar to those of natural tears.
An animal model study demonstrated that a tear solution with physiologic electrolyte composition, including bicarbonate, can provide an environment for the cornea which is conducive to recovery from epithelial damage. This suggests that artificial tears containing bicarbonate may also be of benefit in the treatment of the compromised ocular surface epithelium of dry eye patients. An open-label, non-randomized, parallel group study was conducted in which 14 patients with keratoconjunctivitis sicca received treatment with TEARS NATURALE SINGLE DOSE. This study demonstrated that TEARS NATURALE SINGLE DOSE provided objective improvement in ocular surface desiccation, cell pathology and symptomatic complaints as compared with a control formulation without bicarbonate. Although statistical comparisons were not conducted between or within treatments, results were considered clinically significant.
5.2 Pharmacokinetic properties
The pharmacokinetics of Dextran 70 and hypromellose have not been studied in this product. Due to the high molecular weights of these polymers, penetration into the cornea and conjunctiva is expected to be low.
5.3 Preclinical safety data
The preclinical safety of TEARS NATURALE SINGLE DOSE was demonstrated in an exaggerated treatment regimen with 12 applications of the product to rabbits’ eyes over a 5.5-hour period. Prior to instillation, the test samples had been opened, stored at room temperature for 10 days, followed by storage at 45o C for 50 hours, in order to increase the pH to approximately 8.8. Under this exaggerated treatment regimen, the product was found to be well tolerated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Potassium chloride Calcium chloride (dihydrate) Magnesium chloride (hexahydrate) Zinc chloride
Sodium hydrogen carbonate Carbon dioxide (to adjust pH) Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
Discard four days after first opening the aluminum overwrap.
After opening, the contents of a single-dose container should be used immediately.
6.4 Special precautions for storage
Do not store above 25 °C.
Do not freeze.
Keep in original container
6.5 Nature and contents of container
28 x 0.4 ml single-dose LDPE containers.
The carton contains seven aluminium overwraps, each of which contains four singledose containers.
6.6 Special precautions for disposal
Ensure that the single-dose container is intact before use.
Separate one container. To open, completely TWIST off tab; do not PULL off.
Do not touch the tip of the container to any surface in order to avoid contamination of the contents.
The solution should not be used if it changes colour or becomes cloudy. Single use only. Discard the open container after use.
7 MARKETING AUTHORISATION HOLDER
Alcon Laboratories (UK) Ltd Frimley Business Park,
Frimley, Camberley,
Surrey, GU16 7SR,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00649/0170
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/10/2005
10 DATE OF REVISION OF THE TEXT
03/08/2015