Dexydrop

Dexydrop  3 mg/ml + 1 mg/ml, eye drops, solution

INTERNATIONAL NONPROPRIETARY NAME

Hypromellose/Dextran

PHARMACEUTICAL FORM

Eye drops, solution

Clear, colourless solution.

COMPOSITION

Each ml of Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution contains 3 mg Hypromellose and 1 mg Dextran 70.

 List of excipients

Glycerol

Boric acid

Sodium tetraborate

Potassium chloride

Sodium chloride

Disodium edetate

Benzalkonium chloride

Sodium hydroxide and/or Hydrochloric acid (for pH-adjustment)

Purified water

PHARMACEUTICAL GROUP AND ATC CODE

Pharmacotherapeutic group: Artificial Tears, ATC code: S01XA20

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution is an physiological tear product that exerts a physical, not a pharmacologic action, and it contains the ionic components of the human tear:, , sodium, potassium and chloride ions. It also consists of two water-soluble polymers: Dextran 70 and hypromellose. The polymers provides a lubricant and emollient effect to the cornea. The surface tension and viscosity of artificial tears are similar to those of natural tears. The combination of Dextran 70 and Hypromellose in an aqueous presentation that provides a soothing lubricant preparation for the relief of dry eye syndrome associated with deficient tear secretion or deficient mucous.

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.

THERAPEUTIC INDICATIONS

Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution is indicated in adults, children and elderly as a lubricant and artificial tear in dry eye and other ocular irritation syndromes associated with deficient tear or mucous secretion.

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

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.

Remove the loose collar from the cap when the bottle is first opened to avoid eye injury.

CONTRAINDICATIONS

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

UNDESIRABLE EFFECTS

Summary of the safety profile

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

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)

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 national reporting system.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

• For ocular use only. Not for injection or ingestion.
• Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution 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 Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution 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 a doctor.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution 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.

FERTILITY, PREGNANCY AND LACTATION

Pregnancy

There is no adequate data from the use of Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution

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.

Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution can be used during pregnancy.

Breast-feeding

There is no adequate data regarding the impact of Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution

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. Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution can be used during breast-feeding.

Fertility

There is no adequate data regarding the impact of Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution

on fertility. All of the components are pharmacologically inert compounds or generally classified as

non-toxic and non-irritating. Therefore, no effects on fertility are anticipated.

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.

OVERDOSE

No case of overdose has been reported.

An overdose of Dexydrop 3 mg/ml + 1 mg/ml, eye drops, solution can easily be washed out of the eye with lukewarm tap water.

SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

INCOMPATIBILITIES

None known.

NATURE AND CONTENTS OF CONTAINER

Polyethylene dropper bottle with a dropper insert and a screw cap sealed with safety ring which ensure tightness, and inserted in a carton.

Pack size: 1 x 15 ml.

SPECIAL PRECAUTIONS FOR STORAGE

Store below 25°C in the original package.

SHELF LIFE

3 years.

NAME AND ADDRESS OF MANUFACTURER

S.C. Rompharm Company S.R.L.

Eroilor Street, no. 1A, Otopeni, Ilfov County, 075100, Romania

MARKETING AUTHORISATION HOLDER

Nextra Group Ltd

18 I.Evdoshvili street, zip code 0154, Tbilisi, Georgia.