Summary of Product Characteristics (SmPC) - Anusol HC suppositories
1 NAME OF THE MEDICINAL PRODUCT
ANUSOL HC SUPPOSITORIES
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains:
Hydrocortisone acetate 10mg
Bismuth subgallate 59mg
Bismuth oxide 24mg
Balsam Peru 49mg
Benzyl benzoate 33mg
Zinc oxide 296mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
White/off white suppository
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Anusol-HC Suppositories are indicated for the symptomatic relief of internal haemorrhoids and pruritus ani.
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 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
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
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.
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.
Co-treatment with CYP3A inhibitors, including cobicistat containing products, is expected to increase the risk of systemic effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-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 HPA 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
Not applicable.
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 Disorder s | Rare | Hypersensitivity |
General Disorders and Administratio n site conditions | Not known | Application site reactions (including Burn, erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Urticaria) |
| Eye Disorders | Not known | Vision, blurred (see also section 4.4) |
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. 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, 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, give oxygen and general supportive measures. 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 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 content 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 the anti-inflammatory action is of primary interest in this product.
5.2 Pharmacokinetic properties
It is well known that topically applied corticosteroids can be absorbed percutaneously. This appears to be more likely upon repeated or prolonged use.
The other active ingredients in Anusol HC 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
Pre-clinical safety data do not add anything of further significance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Each suppository contains:
Kaolin light
Suppocire BS2 pastilles (Hard fat)
6.2 Incompatibilities
None applicable.
6.3 Shelf life
36 months
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
Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Boxes of 12 and 24 suppositories.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
Not applicable.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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 00203/0239
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 14/08/1998
Date of latest renewal: 10/01/2007
10 DATE OF REVISION OF THE TEXT
30/06/2017