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Takeda Products Ireland Ltd

First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
Medical Information Direct Line: 1800 937970
Medical Information e-mail: DSO-UK@takeda.com
Medical Information Facsimile: +44 (0)1628 526 617


Summary of Product Characteristics last updated on medicines.ie: 12/01/2018
SPC Condyline Cutaneous Solution 0.5 % w/v


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1. NAME OF THE MEDICINAL PRODUCT

Condyline 0.5 % w/v Cutaneous Solution


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Condyline Solution contains 0.5% w/v podophyllotoxin in bottles of 3.5 ml.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Cutaneous Solution.

Each pack of Condyline Solution consists of a 3.5 ml clear, colourless, alcoholic cutaneous solution of 0.5% w/v podophyllotoxin.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the topical treatment of condylomata acuminata (warts) affecting the penis or the female external genitalia.


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4.2 Posology and method of administration

By topical administration.

Adults and the elderly

Apply twice daily for three days directly to the warts. Allow to dry after treatment.

Use the applicator provided, applying not more than 50 applicators-full for each treatment. This three day treatment may be repeated, if necessary, at weekly intervals for a maximum of five weeks of treatment. Only a small area or number of warts should be treated at any one time.

Children

Not recommended in children under 12 years of age.


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4.3 Contraindications

Podophyllotoxin is contraindicated in patients with the following conditions/diseases:

- known or suspected hypersensitivity to podophyllotoxin or to any of the other ingredients (see section 6.1);

- inflamed or bleeding lesions;

- open wounds following surgical procedures;

- in combination with other podophyllin containing preparations;

- pregnant or breast-feeding women (see section 4.6);

- children under 12 years of age.


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4.4 Special warnings and precautions for use

Avoid contact with healthy skin as well as the eyes and face because of severe irritation.

Lesions in the female and lesions greater than 4 cm2 in the male should be treated under direct medical supervision.

The risk of toxicity is increased during simultaneous treatment with other podophyllin containing preparations since these also contain podophyllotoxin and should therefore be avoided.

The risk of systemic toxicity after topical application is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding or recently removed warts, and by inadvertent application to normal skin or mucous membranes.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


4.6 Fertility, pregnancy and lactation

Studies in animals have shown reproductive toxicity (see section 5.3).

Condyline Solution should not be used during pregnancy or during breast feeding.


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4.7 Effects on ability to drive and use machines

Condyline Solution does not interfere with the ability to drive or use machines.


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4.8 Undesirable effects

Disorders of the reproductive system and breast

• Podophyllotoxin may induce balanoposthitis.

Skin and subcutaneous tissue disorders

• Podophyllotoxin may provoke local irritations (of the mucous membranes) usually mild and include itching, burning, pain, erythema or epithelial ulceration.

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.


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4.9 Overdose

Symptoms

The risk of systemic toxicity after topical application is increased by the treatment of large areas with excessive amounts for prolonged periods, by the treatment of friable, bleeding, or recently removed warts, and by inadvertent application to normal skin or mucous membranes. Symptoms include nausea, vomiting, abdominal pain and diarrhoea; thrombocytopenia, leukopenia, hepatotoxicity or renal failure may occur. CNS-related adverse events are delayed in onset and prolonged in duration and include acute psychotic reactions, hallucinations, confusion, dizziness, stupor, ataxia, hypotonia, seizures and coma. Peripheral and autonomic neuropathies develop later and may result in paraesthesias, reduced reflexes, muscle weakness, tachycardia, apnoea, orthostatic hypotension, paralytic ileus and urinary retention.

Treatment

In topical overdosage, wash well with soap and water; if the eyes are involved, bathe thoroughly with water or if available, with an appropriate eye-cleaning solution. If accidentally ingested, give stomach washout and monitor electrolyte balance, blood gases, liver function and blood picture.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Podophyllotoxin is an anti-mitotic agent, with a topical action against genital warts. It is applied locally to the lesion (e.g. wart) and causes destruction of the tissues locally.

Podophyllotoxin and its derivatives have a special affinity for the microtubule protein of the mitotic spindle and thus arrest mitosis in metaphase leading to epithelial cell death. It is also caustic to normal skin if applied to it and can be absorbed into the systemic circulation with resultant toxic effects, in particular nausea, vomiting and thrombocytopenia.


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5.2 Pharmacokinetic properties

Absorption

After topical application, podophyllotoxin is absorbed through the skin or mucous membranes. The extent of absorption depends on the concentration used.

Topical application of 0.1 ml of 5 mg/ml podophyllotoxin on an area of 4 cm2 resulted in maximum plasma concentrations of 5 ng/ml after 1-2 hours. After topical application of 0.1- 0.15 ml on extreme large lesions the maximum plasma concentrations was 1-17 ng/ml.

Distribution

Owing to its high lipid solubility, it is distributed through the body including the CNS.

Metabolism

No data are available on the metabolism of podophyllotoxin.

Elimination

The serum half-life varies between 1 to 4.5 hours.


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5.3 Preclinical safety data

The LD50 of podofilox in mice is 33 mg.kg-1 and in rats is 15 mg.kg-1. In both species, therapy produced an acute leukopenia. As a cytotoxic agent it has teratogenic potential and has been associated with intrauterine deaths in mice and rats.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Lactic Acid

Sodium Lactate 60% Solution

Ethanol 96%


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6.2 Incompatibilities

None stated.


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6.3 Shelf life

2 years.

Shelf-life after opening the immediate container: 6 weeks.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

Each pack of Condyline Solution consists of an amber glass bottle fitted with a child resistant polypropylene closure, containing 3.5 ml. The pack is supplied with 30 disposable plastic applicators which have a small hole in one end that holds the solution.


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6.6 Special precautions for disposal and other handling

Condyline Solution is flammable and should be kept away from naked flames.

A patient information leaflet is provided with the product giving details on the use and handling of the product.


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7. MARKETING AUTHORISATION HOLDER

Takeda Products Ireland Ltd.

First Floor,

3013 Lake Drive,

Citywest Business Campus,

Dublin 24


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8. MARKETING AUTHORISATION NUMBER(S)

PA 2229/006/001


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11 April 1988

Date of latest renewal: 11 April 2008


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10. DATE OF REVISION OF THE TEXT

5 January 2018



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Active Ingredients

 
   Podophyllotoxin