Tears Naturale II

Tears Naturale II

Manufacturer:

Alcon

Distributor:

Zuellig
Full Prescribing Info
Contents
Dextran 70, hypromellose.
Description
Each mL contains: Active: Dextran 70 0.1% and Hydroxy-propyl Methylcellulose 0.3%.
Preservative: Polyquaternium-1 0.011 mg.
Inactives: Sodium Borate, Potassium Chloride, Sodium Chloride, Purified Water.
May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
Indications/Uses
For the temporary relief of burning and irritation due to dryness of the eye and for use as a protectant against further irritation. For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.
Dosage/Direction for Use
Instill 1 or 2 drops in the affected eye(s) as needed.
Overdosage
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.
Contraindications
Hypersensitivity to any component of the product.
Warnings
If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists for more than 72 hours, they are to discontinue use and consult a doctor. If solution changes color or becomes cloudy, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Dextran 70/Hypromellose (Tears Naturale II) contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of Dextran 70/Hypromellose (Tears Naturale II) and wait at least the 15 minutes before reinsertion.
Special Precautions
Effects on Ability to Drive and Use Machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery.
Use In Pregnancy & Lactation
Fertility: There are no known effects of Dextran 70/Hypromellose (Tears Naturale II) on male or female fertility. Dextran 70 and Hypromellose are pharmacologically inert compounds and would not be expected to have any effect on fertility. There is no adequate data regarding the impact of Dextran 70/Hypromellose (Tears Naturale II) Lubricant Eye Drops. All of the components are pharmacologically inert compounds or generally classified as non-toxic and non-irritating. Therefore, no effects on fertility are anticipated.
Use in Pregnancy: No effects during pregnancy are anticipated, since the systemic exposure to dextran 70 and hypromellose following topical ocular administration is negligible. Additionally, dextran 70 and hypromellose are pharmacologically inert. Dextran 70/Hypromellose (Tears Naturale II) can be used during pregnancy. There is no adequate data from the use of Dextran 70/Hypromellose (Tears Naturale II) Lubricant Eye Drops in pregnant women. All of the components are pharmacologically inert compounds or generally classified as non-toxic and non-irritating; therefore, no adverse effects during pregnancy are anticipated. Dextran 70/Hypromellose (Tears Naturale II) can be used during pregnancy.
Use in Lactation: No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to dextran 70 and hypromellose is negligible. Additionally, both compounds are pharmacologically inert. Dextran 70/Hypromellose (Tears Naturale II) can be used during breast-feeding. There is no adequate data regarding the impact of Dextran 70/ Hypromellose (Tears Naturale II) Lubricant Eye Drops on lactation. All of the components are pharmacologically inert compounds or generally classified as non-toxic and non-irritating; therefore, no adverse effects during breast-feeding are anticipated. Dextran 70/Hypromellose (Tears Naturale II) can be used during breast-feeding.
Adverse Reactions
 The following adverse reactions have been reported during clinical studies with Dextran 70/Hypromellose (Tears Naturale II) and are classified according to the subsequent 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) and very rare (< 1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 1.)

Click on icon to see table/diagram/image

Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data. (See Table 2.)

Click on icon to see table/diagram/image
Drug Interactions
Although no interaction studies have been performed, clinically relevant interactions are not expected.
Storage
Store at temperatures not exceeding 30°C.
Discard 28 days after opening.
Patient Counseling Information
Three easy steps to use TEARS NATURALE II Lubricant Eye Drops: 1. Tilt your head back.
2. Place a finger under your eye, and gently pull down until a "V" pocket is formed between your eye and lower lid.
3. Squeeze one or two drops in the "V" pocket. Try to avoid touching your eye with the dropper tip.
ATC Classification
S01XA20 - artificial tears and other indifferent preparations ; Belongs to the class of other ophthalmologicals.
Presentation/Packing
Eye drops 15 mL x 1's.
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