4.1. Therapeutic indications

Symptomatic relief of uncomplicated internal and external haemorrhoids, pruritus ani, proctitis and fissures. Also indicated post operatively in ano- rectal surgical procedures and after incision of thrombosed or sclerosed ano- rectal veins.

Anusol Ointment provides antiseptic, astringent and emollient properties which help to relieve discomfort associated with minor ano-rectal conditions.

4.2. Posology and method of administration

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. Remove the nozzle cap. Clean the nozzle after each use. Not to be taken orally.

Children: Not recommended

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

4.4. Special warnings and precautions for use

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.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Fertility, pregnancy and lactation

Whilst formal studies on the effect of this product during pregnancy have not been conducted, there is no epidemiological evidence of adverse effects either to the pregnant mother or foetus.

This product should not be used during pregnancy and lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant.

4.7. Effects on ability to drive and use machines

None known.

4.8. Undesirable effects

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

No overdose related adverse drug reactions have been identified from the post- marketing data analysis of Balsam Peru, bismuth oxide, and zinc oxide.

The ingestion of topical zinc oxide can potentiate gastrointestinal symptoms like stomach pain, nausea, vomiting, and diarrhoea.

Symptoms of acute oral overdose of bismuth-containing preparations may include nausea, vomiting, renal failure and rarely liver damage. Encephalopathy and discolouration of mucous membranes may occur with chronic overdose.

No cases of Balsam Peru overdose have been identified in the medical literature.

Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary, apply oxygen and give general supportive measures.