VIT A N - PACKAGE LEAFLET - LEAFLETS

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Vit A N - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable Effects Shelf Life and Storage

Active ingredients: Retinol (Retinol acetate)

VIT A N "25.000UI / 100 g ophthalmic ointment" tube of 5 g

Indications Why is Vit A N used? What is it for?

Pharmacotherapeutic group: Epithelial eutrophic. Antixerophthalmic.

Indications

Blepharitis, lymphatic keratoconjunctivitis, xerophthalmia, keratitis, corneal ulcers.

Contraindications When Vit A N should not be used

Hypersensitivity to any component of the preparation.

Precautions for use What you need to know before taking Vit A N

None

Interactions Which drugs or foods can modify the effect of Vit A N

None

Warnings It is important to know that:

Keep this medicine out of the reach of children

Dose, Method and Time of Administration How to use Vit A N: Dosage

2-3 applications per day in the conjunctival sac, unless otherwise prescribed.

Side Effects What are the side effects of Vit A N

In some cases, a slight and transient sense of ocular burning may be felt.

Expiry and Retention

Warning: do not use the medicine after the expiry date indicated on the package.

The patient is invited to inform the doctor or pharmacist of any undesirable effects not described in this package leaflet.

Packaging: 5 g tube.

Composition

100 g contain: Retinol (as acetate) 25,000 I.U.

Excipients: p.Methyl hydroxybenzoate; p. Propyl hydroxybenzoate; Liquid paraffin; White petroleum jelly

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Vit A N can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on the ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical data of 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 HOLDER OF THE ALL AUTHORIZATION "PLACING ON MARKETING 08.0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF PR IMA AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VITAN

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 g contain: Retinol (as acetate) 25,000 I.U.

03.0 PHARMACEUTICAL FORM

"25.000UI / 100 g ophthalmic ointment" tube of 5 g

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Blepharitis. Lymphatic keratoconjunctivitis. Xerophthalmia. Keratitis. Corneal ulcers.

04.2 Posology and method of administration

2-3 applications per day in the conjunctival sac, unless otherwise prescribed.

04.3 Contraindications

Known individual hypersensitivity to any component of the product.

04.4 Special warnings and appropriate precautions for use

None.

Keep this medicine out of the reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

None.

04.6 Pregnancy and breastfeeding

There are no known contraindications.

04.7 Effects on ability to drive and use machines

No effects are described.

04.8 Undesirable effects

In some cases, a slight and transient sense of ocular burning may be felt.

04.9 Overdose

No overdose reactions have ever been reported.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Vitamin A is necessary for the growth and normal differentiation of epithelial cells. Its deficiency leads to a decrease in the number of cells and keratinization in all epithelia, including the corneal ones. In particular in this last district, alongside the typical dry eye (xerophthalmia), the lack of Vitamin A can cause serious alterations in the corneal parenchyma such as keratomalacia and corneal ulcers.

05.2 "Pharmacokinetic properties

Retinol administered topically in the rabbit's eye is metabolised to retinoic acid, an active part of the Vitamin A molecule.

05.3 Preclinical safety data

Vitamin A toxicity is very low, or virtually none. In man, the first signs of toxicity, following acute oral or parenteral administration, are observed for doses 10,000 times higher (15 g) than those constituting the normal daily requirement (5000 IU). signs of toxicity for doses 1000 times higher (5,000,000 IU) than necessary daily in physiological conditions. No toxic phenomena have been described in animal or clinical pharmacology following prolonged local administration of Vitamin A