DURATEARS* ointment contains white petrolatum, anhydrous liquid lanolin and mineral oil. DURATEARS* ointment, because it was specially designed for use in the eye, is ideal for keeping the eye lubricated and comfortable during the night time hours when it is impractical to instill artificial tear drops.

There is no medication in DURATEARS* ointment, only a smooth, comfortable ointment base that quickly melts and prevents drying and discomfort. No prescription is required.

Dry Eyes
Dry eyes are caused by changes in the quantity or the quality of the natural tears that the tear glands produce. Because the tears are imperfect, they have a tendency to prematurely break up into dry spots on the front surface of the eye instead of forming a smooth, continuous lubricating layer. These dry spots are very sensitive and uncomfortable. There are several different causes of dry eyes. The most common is aging. As we get older, tear production naturally diminishes, so the eyes have an increased tendency to become "dry" through lack of sufficient tears. Other causes, regardless of age, can include allergies, vitamin deficiencies, and hot, arid climatic conditions.

What are the symptoms of dry eyes?
Because of the many causes of dry eyes, symptoms may vary. However, the most common symptoms include burning, itching, a sandy or gritty sensation, tiredness and redness. In some cases, discomfort may cause an overabundance of tears but, because they lack certain components, these excess tears cannot properly wet the eye, so they become an annoyance.

Relief for dry eyes
The most satisfactory answer to the problem of dry eyes is the use of artificial tear solutions and, if necessary, special lubricating ointments. Ointments are usually used at night time to provide lubrication during sleep.

Posology
Apply a small amount in the eye(s) as needed or as directed by a physician.

Use in children
The safety and efficacy of DURATEARS*eye ointment in children have not been established. However, no dosage modifications are expected to be required for use in this population.

Use in patients with hepatic or renal impairment
The safety and efficacy of DURATEARS*eye ointment in subjects with hepatic or renal disease have not been established. However, no dosage modifications are expected to be required for use in this population.

Method of administration
For ocular use.

Remove contact lenses before using.

To prevent contamination of the tube tip and ointment, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the tube tip. Keep the tube tightly closed when not in use.

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

Instructions for use:
1. Tilt your head back.
2. Place a finger on your cheek just under your eye and gently pull down until a “V” pocket is formed between your eyeball and your lower eyelid.
3. Apply a small amount (about 1 cm) in the “V” pocket. Do not let the tube tip touch the eye.

- For topical ocular use only.
- 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 their doctor.
- Remove contact lenses before using DURATEARS ointment. This product is not to be used with contact lenses.
- This product contains anhydrous liquid lanolin, which may cause local skin
reactions (e.g. contact dermatitis).

No clinically relevant interactions have been described.

Pregnancy
There are no or limited amount of data from the use of DURATEARS* ointment in pregnant women. All of the components are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (see section 5.3). Therefore, no adverse effects during pregnancy are anticipated.

DURATEARS* ointment can be used during pregnancy.

Breast-feeding
It is unknown whether white petrolatum, anhydrous liquid lanolin or mineral oil are excreted in human milk. However, no effects on the breast-fed newborn or infant are anticipated since the systemic exposure of the breast-feeding woman to the product is expected to be negligible. All of the components from DURATEARS* ointment are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (see section 5.3). Therefore, no adverse effects during breast-feeding are anticipated.

DURATEARS* ointment can be used during breast-feeding.

Fertility
There are no adequate data regarding the impact of DURATEARS* ointment on male or female fertility. All of the components are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (see section 5.3). Therefore, no effects on fertility are anticipated.

DURATEARS* ointment has no or negligible influence on the ability to drive and use machines. However, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines after application of the ointment. If blurred vision occurs after application, the patient must wait until the vision clears before driving or using machinery.

The following adverse reactions have been reported. Frequency cannot be estimated from the available data (data from post-marketing surveillance).

To report any side effect(s):
      - Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
O Fax: +966-11-205-7662
O Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
O Toll free phone: 8002490000
O E-mail: npc.drug@sfda.gov.sa
O Website: www.sfda.gov.sa/npc
       - Other GCC States:
- Please contact the relevant competent authority

An ocular overdose of DURATEARS* ocular lubricant ointment may be flushed from the eye(s) with lukewarm water.

Due to the characteristics of this preparation, no toxic effects are to be expected with a topical ophthalmic overdose of this product, nor in the event of accidental ingestion of the contents of one tube.

Pharmacotherapeutic group: artificial tears and other indifferent preparations. ATC code: S01XA20.

DURATEARS* ointment is a sterile mixture of white petrolatum, anhydrous liquid lanolin and mineral oil and has no pharmacological active ingredient. It has a physical action as an ocular lubricant. It leaves a smooth, softening and durable film protecting the eye at night.

Pharmacodynamic studies with DURATEARS*eye ointment have not been performed. Therefore, no pharmacodynamics data are available.

DURATEARS* eye ointment are ophthalmic emollients and neither of them have pharmacological activity. Therefore, no pharmacokinetic data are available. Following oral feeding of anhydrous liquid lanolin to cats indicate anhydrous liquid lanolin is not absorbed from the intestine..

Non-clinical data reveal no special hazard for topical ocular use in humans based on conventional studies or risk assessments of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development.

White petrolatum, anhydrous liquid lanolin, mineral oil.

Not applicable.

Store below 25 °C
Discard 4 weeks after opening.
Do not use this medicine after the expiry date which is stated on the
packaging. Keep this medicine out of the sight and reach of children.

Epoxy-phenolic lined aluminum ointment tube contains 3.5 g ointment.

No special requirements.