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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316
Summary of Product Characteristics last updated on medicines.ie: 15/06/2017
SPC Anusol HC Ointment

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-May-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Added text has been highlighted and underlined:

4.4       Special warnings and special 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 with suppression of adrenocortical function and toxicity.  Use for periods longer than seven days is not recommended 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, worsen, or if rectal bleeding occurs.

 

Continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation.

 

 

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 medicaments 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.

4.8       Undesirable effects

            
                            [...]

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)

Eye Disorders

Not known

Vision, blurred (see also section 4.4)






Updated on 22/06/2016 and displayed until 15/06/2017
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Jun-2016
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Changes to the text have been highlighted in red - text that has been removed has been struck through:

4.3       Contraindications

 

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

 

Tubercular, fungal, bacterial and viral lesions including herpes simplex, vaccinia and varicella.

 

History of sensitivity to any of the constituents.



4.4       Special warnings and special 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 with suppression of adrenocortical function and toxicity.  Use for periods longer than seven days is not recommended 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, worsen,  or if rectal bleeding occurs.

 

Continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation.


4.6       Fertility,  Pregnancy & Lactation

 

Should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risk to the developing foetus or nursing infant. considered essential by the physician.

 

There are no adequate and well-controlled clinical studies of fixed combinations of balsam peru, benzyl benzoate, bismuth oxide, bismuth subgallate, zinc oxide and hydrocortisone acetate in pregnant or breast-feeding women. There is inadequate evidence of safety in human pregnancy and tThere 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.



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, benzyl benzoate, bismuth oxide, bismuth subgallate, hydrocortisone acetate and zinc oxide.

 

ADRs identified during Post-Marketing experience with Zinc Oxide (topical use) are listed below by System Organ Class (SOC).

 

The frequencies are defined in accordance with current guidance, as:

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 (such as rash)

General Disorders

and

Administration site conditions

Not known

Application site reactions

(including Burn*, Erythema, Exfoliation, Irritation, Pain, Pruritus, Rash and Urticaria)


* Transient ADR especially if the anoderm is not intact.                                       

 

Other adverse reactions include: Skin sensitisation reactions and systemic contact dermatitis, attributed directly to Balsam Peru have been reported in published literature. Rarely, sensitivity reactions. Patients may occasionally experience transient burning on application, especially if the anoderm is not intact.

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.

The ingestion of topical zinc oxide can potentiate gastrointestinal symptoms. 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.

 

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

 

Hydrocortisone does not normally 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 overdosage 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 methylene bluemethylthioninium chloride.

6.6       Special precautions for disposalSpecial precautions for disposal of

a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

No special requirements.

 

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

10.              Date of (partial) revision of the text 

 

                        13 June 2016

Updated on 07/08/2015 and displayed until 22/06/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   30-Jun-2015
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Added to 4.8:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Updated on 02/07/2010 and displayed until 07/08/2015
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   25-Jun-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 2. Details of excipients added.

Renewal date and date of revision o text updated follwoing renewal
Updated on 01/05/2008 and displayed until 02/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   01/2008
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Change from Pfizer Consumer Healthcare, Pottery Road ,Dun Laoghaire, Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.

Updated on 21/12/2005 and displayed until 01/05/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Updated on 18/08/2003 and displayed until 21/12/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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