SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Anusol Soothing Relief Ointment

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 100 g of ointment contains the following active ingredients:

Hydrocortisone acetate    0.25 g

Benzyl benzoate    1.25 g

Bismuth subgallate    2.25 g

Bismuth oxide    0.875 g

Balsam peru    1.875 g

Zinc oxide    10.75 g

For full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Ointment.

A smooth, homogeneous buff coloured ointment with the characteristic odour of Balsam Peru.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Symptomatic treatment of uncomplicated internal and external haemorrhoids and pruritus ani.

4.2    Posology and method of administration

Topical administration.

ADULTS (over 18 years)

To be applied sparingly 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 (under 18 years)

Not recommended.

4.3    Contraindications

Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Do not use in pregnancy or breast-feeding.

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.

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. 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.

4.5    Interaction with other medicinal products and other forms of interaction

Concurrent use with other corticosteroid preparations, either topically or orally may increase the likelihood of systemic effects.

4.6    Fertility, pregnancy and lactation

There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. There is evidence of harmful effects in animals.

Do not use in pregnancy or breastfeeding.

4.7    Effects on ability to drive and use machines

No effects have been reported on ability to drive or use machinery.

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 postmarketing data analysis of Balsam Peru, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide.

If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion.

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.

Hydrocortisone normally does not produce toxic effects in an acute single overdose.

Prolonged use of topical corticosteroids may increase potential for local adverse effects, including steroid atrophy (thinning of the skin), striae (stretch marks), and Telangiectasia (visible blood vessels). Systemic availability after rectal administration is very low; however, excessive administration of corticosteroids may increase the potential for systemic effects, such as hypothalamic-pituitary axis suppression.

Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary oxygen and general supportive measures should be given. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05A A01

This product provides antiseptic, astringent, emollient and decongestant properties. In addition hydrocortisone exerts anti-inflammatory actions.

Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties.

Balsam Peru has protective properties and a very mild antiseptic action by virtue of its contents of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells.

Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.

Hydrocortisone acetate has the general properties of hydrocortisone and this anti-inflammatory action is of primary interest of this product.

ATC code: D07B, corticosteroids, combinations with antiseptics.

5.2 Pharmacokinetic properties

Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half-life is approximately 100 minutes and it is 90% bound to plasma protein.

The other active ingredients in this product exert their therapeutic effect without being absorbed into the systemic circulation. These are supported by evidence from various studies and reviews.

5.3 Preclinical safety data

The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented.

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Kaolin light Magnesium stearate Castor oil Cocoa butter Lanolin anhydrous Petroleum jelly white Calcium hydrogen phosphate

6.2    Incompatibilities

No incompatibilities have been reported.

6.3    Shelf life

3 years.

6.4    Special precautions for storage

Do not store above 25°C.

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5    Nature and contents of container

Externally printed aluminium tube with wadded plastic cap, containing 15g of ointment. A plastic nozzle with cap is also provided for internal application. Not all pack sizes may be marketed.

6.6    Special precautions for disposal and other handling

No Special Requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7    MARKETING AUTHORISATION HOLDER

McNeil Products Limited

Foundation Park Roxborough Way Maidenhead Berkshire SL6 3UG United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 15513/0372

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/11/2013

10 DATE OF REVISION OF THE TEXT

19/04/2016