ANUSOL HC

Anal application. ADULTS Apply ointment to the affected area at night, in the morning and after each evacuation up to a maximum of 4 applications a day. 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. Use for a maximum period of one week. Not to be taken orally. ELDERLY (OVER 65 YEARS) As for adults. 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’.

4) 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 s u s p e c t e d 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.

Following symptomatic relief, definitive diagnosis should be established. 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.

As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. If symptoms persist or worsen patients should be instructed to stop use and consult a physician. 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 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.

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