Preparation H 1.08% ointment 25g

INDICATIONS

Uncomplicated external and internal hemorrhoids and anal fissures.

ACTIVE INGREDIENTS

10.8 mg/g ointment 100 g of ointment contain: Active ingredient: Saccharomyces Cerevisiae cell extract 1.08 g. Excipients with known effects: lanolin, butylated hydroxytoluene (BHT), methyl parahydroxybenzoate, propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 23 mg suppositories Each suppository contains: Active ingredient: Saccharomyces Cerevisiae cell extract 23 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

OINTMENT: shark liver oil; white petrolatum; light mineral oil; Argobase L2 (liquid paraffin, wool wax, petrolatum, anhydrous lanolin, ozokerite, butylated hydroxytoluene (BHT)); lanolin; glycerol; methyl-p-hydroxybenzoate; propyl-p-hydroxybenzoate; red thyme oil. SUPPOSITORY: shark liver oil, Witepsol W35, cocoa butter, parawax, polyethylene glycol dilaurate 600, glycerol.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active ingredient or to closely chemically related substances, or to any of the excipients listed in paragraph 6.1.

DOSAGE

OINTMENT (tube): apply the ointment up to 2-3 times a day, when 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 filled. 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. OINTMENT (single dose): apply the entire contents up to 2-3 times a day, when possible, after each bowel movement. Remove the cap, insert the applicator into the rectum, squeeze the entire contents of the single-dose tube. SUPPOSITORY: remove the protective cover and introduce up to 2-3 suppositories a day into the rectum, when possible, after each bowel movement. DO NOT EXCEED THE RECOMMENDED DOSES.

CONSERVATION

Ointment: Store at temperatures not exceeding 25°C. Suppositories: Store at temperatures not exceeding 30°C.

WARNINGS

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 treatment and institute suitable therapy, after consulting your doctor. In case of bleeding or the persistence of the disorder, consult your doctor. DO NOT USE FOR PROTRACT TREATMENTS. Preparation H ointment contains lanolin, which can cause local skin reactions (e.g. contact dermatitis).Preparation H ointment contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. Preparation H ointment contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which can cause allergic reactions (even delayed).

INTERACTIONS

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

SIDE EFFECTS

No side effects have been reported due to the use of Preparation H. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

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

PREGNANCY AND BREASTFEEDING

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

EFFECTS ON DRIVING ABILITY

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