ANUSOL PLUS HC

Anal insertion Adults (over 18 years) Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week. Not to be taken orally Elderly (over 65 years) As for adults Children (under 18 years) 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 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. 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 and use for periods longer than seven days is not recommended. Do not use for more than 7 days unless under the direction of a doctor. 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.

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.