ANUSOL

Topical.

Adults and Elderly (over 65 years):

Apply to the affected area at night, in the morning and after each evacuation until the condition is controlled. Thoroughly cleanse the affected area, dry and apply ointment. Anusol Ointment should be applied on a gauze dressing. For internal conditions use rectal nozzle provided and clean it after each use.

Not to be taken orally.

Children:

Not recommended

No Adverse Drug Reactions (ADRs) have been identified from the analysis of post-marketing data for fixed combinations of Balsam Peru, 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 Balsam Peru 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.

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.

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