ANUSOL SOOTHING RELIEF

Posology Adults 18 years and over To be applied sparingly to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. Use for a maximum period of one week. Elderly (over 65 years) As for adults.

Children and adolescents under 18 years Not recommended. Method of administration Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap.

Clean the nozzle after each use. After each use, gently wipe off excess ointment from the external thread of the tube.

No Adverse Drug Reactions (ADRs) have been identified from the analysis of post- marketing data for fixed combinations of Peru balsam, bismuth oxide and zinc oxide. ADRs identified during Post-Marketing experience with zinc oxide (topical use) are included in the Table below.

The frequencies are provided according to the following convention:

Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

4) Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Peru balsam have been reported in published literature. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

For topical administration only. Not to be taken orally. Patients with rectal bleeding or blood in the stool should talk to their doctor before using this product as these conditions may be the symptom of a more serious underlying disorder.

The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind.

Prolonged or excessive use may produce systemic corticosteroid effects. Do not use for more than 7 days unless under the direction of a doctor. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

66 g benzyl benzoate in each 100 g. Benzyl benzoate may cause local irritation. Peru balsam contains benzyl alcohol (approximately 131 mg in each 100 g of ointment), benzyl benzoate and benzyl cinnamate. It may cause allergic reactions, mild local irritation and/or skin reactions.

g. contact dermatitis which is a local irritation at the site of use. g. contact dermatitis) or irritation to the eyes and mucous membranes.

1. Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Do not use in pregnancy or breastfeeding.