This information is intended for use by health professionals

1. Name of the medicinal product

Anusol Suppositories

2. Qualitative and quantitative composition

Each suppository contains:

Zinc oxide

296 mg

Bismuth subgallate

59 mg

Balsam peru

49 mg

Bismuth oxide

24 mg

For full list of excipients, see section 6.1

3. Pharmaceutical form

Suppository

4. Clinical particulars
4.1 Therapeutic indications

For the relief of internal haemorrhoids and other related ano-rectal conditions.

4.2 Posology and method of administration

Anal insertion

Adults

Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation. Not to be taken orally.

Elderly (over 65 years)

As for adults

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 human pregnancy have not been conducted, there is no epidemiological evidence of adverse effect, 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, give oxygen and general supportive measures.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other agents for treatment of haemorrhoids and anal fissures for topical use, ATC code: C05AX

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

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 content of Cinnamic and Benzoic Acids. It is believed to promote the growth of epithelial cells.

5.2 Pharmacokinetic properties

The active ingredients in Anusol Suppositories exert their therapeutic effect without being absorbed into the systemic circulation. These observations 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.

6. Pharmaceutical particulars
6.1 List of excipients

Hard Fat (Suppocire BS2)

Kaolin light

Titanium Dioxide

Miglyol 812

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store at a temperature not exceeding 25°C.

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

6.5 Nature and contents of container

12 and 24 pack printed strip pack consisting of white opaque PVC/polyethylene laminated film.

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.

Administrative Data

7. Marketing authorisation holder

Church & Dwight UK Limited

Premier House, Shearway Business Park

Pent Road,

Folkestone, Kent,

CT19 4RJ

United Kingdom

8. Marketing authorisation number(s)

PL 00203/0233

9. Date of first authorisation/renewal of the authorisation

15th September 1997 / 19th July 2001

10. Date of revision of the text

30 June 2017