ANUSOL

Posology Children and adolescents under 18 years of age Not Recommended. Adults 18 years and over Apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Elderly As for adults Method of administration Thoroughly cleanse the affected area, dry and apply cream.

Anusol Cream is prepared in a vanishing cream base and may be gently smoothed on to the affected area without the need to apply a gauze dressing. For internal conditions, use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use.

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’.

System Organ Class (SOC) Frequency Adverse Drug Reaction (Preferred Term) Immune System Disorders Rare Hypersensitivity General Disorders and Administration site conditions Not known Application site reactions (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Urticaria) 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.

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. If symptoms persist or worsen, patients should be instructed to stop use and consult a physician.

This medicine contains 8000 mg propylene glycol in each 100 g. Propylene glycol may cause skin irritation. Peru balsam may cause skin reactions. - This medicine contains approximately 126 mg benzyl alcohol in each 100 g. Benzyl alcohol may cause allergic reactions and/or mild local irritation.

- This medicine contains approximately 1350 mg benzyl benzoate in each 100 g. Benzyl benzoate may cause local irritation. - Benzyl cinnamate may cause allergic reactions.

1.