ALMUS 2% Protein Silver

Drops

Composition:

Almus Children 0.5% Protein Silver Nasal and Ear Drops, solution 100 g of solution contain: Active ingredient: 0.5 g Protein Silver Almus Adults 1% Protein Silver Nasal and Ear Drops solution 100 g of solution contain: Active ingredient: silver proteinate g 1 Silver proteinate Almus Adults 2% nasal and ear drops, solution 100 g of solution contain: Active ingredient: silver proteinate g 2 For the full list of excipients see section 6.1

Excipients

Dibasic sodium phosphate dodecahydrate, monobasic potassium phosphate, 2 – bromine – 2 – nitropropan – 1,3 – diol, purified water.

Therapeutic indications

Decongestant and antiseptic of the nasal mucosa and antiseptic of the ear canal.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Dosage

Adults and children Administer 1-2 drops into each nostril or into the ear canal 2-3 times a day.

Warnings and Precautions

Avoid concomitant use with papain products (see section 4.5). Follow the recommended doses and methods of use. Proteinated silver, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena (see section 4.9).

Interactions

The Proteinated Silver Solution can interact with papain products. Papain is a proteolytic enzyme, belonging to the class of hydrolases, which is extracted from the immature fruit of the papaya (Carica papaya). The concomitant use of silver proteinate and papain could inhibit the enzymatic action of papain.

Side effects

The following are the side effects of silver proteinated, organized according to the MedDRA system organ classification. Insufficient data are available to establish the frequency of the individual effects listed. Skin and subcutaneous tissue disorders Dermatitis Rash Burns Skin irritation Skin discoloration Hypersensitivity reactions Argyria (see section 4.9)

Pregnancy and breastfeeding

Pregnancy There are no adequate data from the use of silver protein in pregnant women. Protein silver should not be used during pregnancy unless absolutely necessary. Lactation There are no adequate data regarding the use of silver proteinated in lactation. Proteinated silver should not be used during breastfeeding unless absolutely necessary.