Preparation H - Package Leaflet

Active ingredients: Saccharomyces Cerevisiae Cell Extract

Preparation H ointment in tubes of 25 g and 50 g
Preparation H ointment in 6 single-dose tubes of 5 g each
Preparation H suppositories in cartons of 6 and 12 units

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.

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 interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 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 primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL 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

PREPARATION H

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ointment: 100 g of ointment contain: Saccharomyces Cerevisiae Cell Extract 1.08 g.

Suppositories: each suppository contains: Saccharomyces Cerevisiae Cell Extract 23 mg.

03.0 PHARMACEUTICAL FORM

- Ointment in tubes of 25 g and 50 g

- Ointment in 6 single-dose tubes of 5 g each.

- Suppositories in boxes of 6 and 12 units

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Uncomplicated external and internal hemorrhoids and anal fissures.

04.2 Posology and method of administration

OIL (tube): apply the ointment up to 2-3 times a day, whenever possible, after each bowel movement. For rectal use, remove the cap, lubricate the applicator and screw it onto the tube. Squeeze until the applicator is full. Insert into the rectum, squeeze the tube again until a sufficient quantity of product is introduced. Apply the ointment also on the external area.

After use, clean the applicator and cover it with the cap.

OIL (single dose): apply the entire content up to 2-3 times a day, whenever possible, after each bowel movement.

Remove the cap, insert the applicator into the rectum, squeeze the entire contents of the single-dose tube.

SUPPOSITORIES: remove the protective wrapping and introduce in the rectum up to 2-3 suppositories a day, whenever possible, after each evacuation.

DO NOT EXCEED THE RECOMMENDED DOSE.

04.3 Contraindications

Hypersensitivity to the components or to other closely related substances from a chemical point of view.

04.4 Special warnings and appropriate precautions for use

After a short period of treatment without appreciable results, consult your doctor.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy, after consulting the Doctor. In case of bleeding or persistence of the disorder, consult your doctor.

DO NOT USE FOR TREATMENTS.

04.5 Interactions with other medicinal products and other forms of interaction

Problems related to the interaction with other drugs have never been highlighted.

04.6 Pregnancy and lactation

There are no contraindications if the product is used following the suggested methods and precautions.

04.7 Effects on ability to drive and use machines

No effects on ability to drive and use machines have been reported after use of Preparation H.

04.8 Undesirable effects

No undesirable effects have been reported due to the use of Preparation H.

04.9 Overdose

No overdose phenomena have been reported with the use of Preparation H.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

The application of Saccharomices Cerevisiae extract on injured tissues increases the rate of oxygen consumption at the tissue level and accelerates the resolution of the disease.

05.2 Pharmacokinetic properties

The activity of Preparation H, containing Saccharomices Cerevisiae extract, is measured in biological units. Each suppository contains at least 162 units of biological activity, while the ointment contains at least 67 units / gram of biological activity. One "unit of biological activity corresponds to the concentration of Saccharomices Cerevisiae extract in the Warburg flask (expressed in mg / ml) required to increase the oxygen consumption of 1 mg of dry mouse abdominal skin by 1% at the end of the period of 1 now according to Warburg's essay.

05.3 Preclinical safety data

The cell extract of Saccharomices Cerevisiae contains low molecular weight cellular metabolites such as amino acids and peptides with a molecular weight between 6000 and 12000 d, mostly composed of glutamic acid. Together with these there are also carbohydrates, mainly composed of trehalose and glucose It has been found that some of these components are naturally synthesized by epithelial cells when they are subjected to injury of mechanical or physiological origin.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

UNGUENTO: shark liver oil; white petroleum jelly; anhydrous lanolin; wool wax; light mineral oil; NF red thyme oil (40-45% phenols); glycerol; methyl-p-hydroxybenzoate; propyl-p-hydroxybenzoate.

SUPPOSITORIES: shark liver oil, Witepsol W35, cocoa butter, paracera, polyethylene glycol 600 dilaurate, glycerol.