Active ingredients: Podophyllotoxin
Condyline 0.5% cutaneous solution
Indications Why is Condyline used? What is it for?
Condyline contains the active ingredient podophyllotoxin, an extract that comes from a plant and belongs to a group of medicines called "antivirals".
Condyline is a topical medicine indicated for the treatment of certain types of warts that form on the external skin in the genital area (external sharp warts).
Talk to your doctor if you do not feel better or if you feel worse after the planned treatment period.
Contraindications When Condyline should not be used
Do not use Condyline
- if you are allergic to podophyllotoxin or any of the other ingredients of this medicine (listed in section 6)
- in children
- if you are pregnant (see section "Pregnancy and breastfeeding")
- if you are breast-feeding (see section "Pregnancy and breast-feeding")
- if you are taking other medicines containing podophyllin.
Precautions for use What you need to know before taking Condyline
Talk to your doctor or pharmacist before using Condyline.
- Avoid contact of the Condyline solution with the mucous membrane or healthy skin near or at the base of the warts, as this may cause local irritation and / or damage to the mucous membrane or healthy skin. To avoid accidental contact of the healthy area with the Condyline solution before starting the treatment, you can protect the healthy area by applying a neutral ointment or cream, based on petroleum jelly or zinc oxide.
- Avoid contact of this medicine with your eyes, as it may cause serious irritation. If this happens accidentally, immediately rinse your eyes with water for a long time and consult your doctor.
- Avoid applying this medicine over large areas as this may cause side effects affecting various organs in the body.
- If you are a woman and the use of this medicine is difficult because the wound is inaccessible to self-medicate, ask your doctor about the application of Condyline.
- If the effect of this medicine is not evident after the prescribed treatment period, your doctor will consider alternative therapies.
Children
Condyline is not for use in children.
Interactions Which drugs or foods can modify the effect of Condyline
Other medicines and Condyline
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any other medicines containing podophyllin, as in this case you cannot use this medicine (see section "Do not use Condyline").
Warnings It is important to know that:
Pregnancy and breastfeeding
Do not use Condyline if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving and using machines
This medicine does not affect the ability to drive and use machines.
Dose, Method and Time of Administration How to use Condyline: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is one application twice a day, morning and evening.
Duration of treatment
Apply this medicine, morning and evening, for 3 consecutive days. The treatment scheme can be repeated weekly up to a maximum of 5 consecutive weeks, leaving an interval of 4 days between one week and the other without treatment. The product should be used for short periods and under medical supervision.
Instructions for correct use
- The bottle has a "child resistant" safety closure. To open the bottle, press on the cap and unscrew at the same time in the direction indicated by the arrow (as shown in the figure).
- Apply the solution to the area of skin to be treated using one of the applicators contained in the package, avoiding contact with healthy skin (see paragraph "Warnings and precautions).
- After application, allow the solution to air dry to prevent the solution from coming into contact with healthy areas, particularly when warts are located on the foreskin (fold of skin covering the tip of the penis in men).
- After application, throw away the used applicator and wash your hands carefully.
- After use, close the cap. The bottle is closed child resistant if you hear a click when you unscrew the cap without pressing it.
Overdose What to do if you have taken too much Condyline
If you use more Condyline than you should
There have been no reported side effects from using too much Condyline. However, if you accidentally use more Condyline than you should and you experience any side effects, contact your doctor or the nearest hospital immediately. Your doctor will take it. adequate supportive care.
If you forget to use Condyline
Do not use a double dose to make up for a forgotten dose.
If you stop using Condyline
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Condyline
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local side effects mostly occur on the second or third day of treatment when wart death begins. Generally side effects are mild and are well tolerated.
The frequency for the following side effects is not known.
Undesirable effects affecting the skin and mucous membranes
- erythema (skin irritation) with mild pain and / or superficial skin lesions in the treated area. In this case, the application of Condyline can be painful
- edema (swelling) and balanoposthitis (infection of the extremity of the penis). This effect occurs in the case of large warts in the cavity of the foreskin
In case of incorrect application of the product, the following may also occur:
- stomach and intestinal disorders
- leukopenia (reduction in the number of white blood cells)
- thrombocytopenia (reduction in the number of platelets in the blood)
- changes in liver function
- changes in kidney function
- peripheral neuropathies (peripheral nervous system disease)
- usually modest sensory disturbances (mild mental confusion), these effects can progress and become complicated with more serious pictures affecting the central nervous system.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
Contents of the pack and other information
- the active ingredient is: podophyllotoxin (1 ml of solution contains 5 mg of podophyllotoxin)
- the other ingredients are: lactic acid, sodium lactate, anhydrous ethanol, water.
Description of what Condyline looks like and contents of the pack
Condyline is presented in solution for local use, packaged in a bottle of 3.5 ml of solution.
The box contains two packs of 15 applicators required for therapy.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
CONDYLINE® 0.5% SKIN SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: podophyllotoxin 5 mg.
03.0 PHARMACEUTICAL FORM
Skin solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Topical treatment of external acuminate warts.
04.2 Posology and method of administration
Apply the solution on the warts using one of the applicators contained in the package, avoiding contact with healthy skin.
The application must be carried out twice a day, morning and evening, for 3 consecutive days. This treatment scheme can be repeated weekly up to a maximum of 5 consecutive weeks, leaving a 4-day interval without treatment between one week and the other.
After applying the solution, allow it to dry well in the air to prevent it from spreading to areas not affected by the disease; in particular when the warts are localized to the foreskin.
After application, discard the used applicator and wash your hands carefully.
04.3 Contraindications
Known hypersensitivity to the components.
The use of Condyline is contraindicated in children and in women during pregnancy and breastfeeding. The use is also contraindicated in conjunction with products based on podophyllin.
04.4 Special warnings and appropriate precautions for use
The product should be used for short periods and under medical supervision.
The application of the preparation on relatively large mucous surfaces can give rise to systemic reactions and must therefore be avoided.
The Condyline must not come into contact with the eyes as it could give rise to severe irritative manifestations. If this happens accidentally, immediately rinse your eyes with water for a long time and consult your doctor.
Keep out of the reach and sight of children.
In the case of female patients for whom the lesion is inaccessible for self-medication, the treatment must take place under direct medical supervision.
Local irritative manifestations and / or ulcerations of the mucous membrane or of the healthy skin near or at the base of the warts, inadvertently caused by contact with the Condyline solution, can be avoided by protecting the healthy area with a neutral ointment or cream, based on petroleum jelly or zinc oxide, to be applied before treatment with Condyline.
If the efficacy of the preparation is not evident after the planned treatment period, alternative therapies should be considered.
04.5 Interactions with other medicinal products and other forms of interaction
Do not use Condyline during therapy with products containing podophyllin.
04.6 Pregnancy and lactation
Do not use Condyline during pregnancy and breastfeeding.
04.7 Effects on ability to drive and use machines
The product does not compromise the ability to drive and use machines.
04.8 Undesirable effects
Local secondary reactions occur mainly in conjunction with the optimal therapeutic effect, mostly on the second or third day of treatment when warts necrosis begins. These secondary reactions usually occur mildly and are well tolerated by patients if they are warned by the doctor before starting the therapy. It is foreseeable, in the treated area, the appearance of erythema with slight tenderness and / or superficial ulceration of the epithelium and therefore the application of Condyline can be painful.
Edema and balanoposthitis have been observed in some patients with large warts in the foreskin cavity.
Incorrect application of the product can give rise to manifestations of systemic absorption such as gastrointestinal disorders, leukopenia, thrombocytopenia, hepatic or renal functional alterations, peripheral neuropathies, generally modest sensory disturbances (mild mental confusion) but which can progress and complicate with more serious cases affecting the CNS.
04.9 Overdose
No undesirable effects resulting from podophyllotoxin overdose are reported. Such effects should not be expected with the correct use of Condyline in consideration of the large safety margin of the preparation.
However, should systemic effects of overdose occur, implement therapeutic measures similar to those envisaged in the event of an overdose of podophyllin, aimed at controlling the symptoms (vomiting and convulsions); pressure and diuresis must be kept under close observation, bearing in mind that, in acute podophyllin poisoning, fluid restoration and haemoperfusion may be indicated.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Podophyllotoxin, the active ingredient of Condyline, chemically belongs to the group of lignans.
ATC code: D06BB04.
It is the main therapeutic component of podophyllin from which it is obtained through a particular extraction process that ensures a high degree of purity and standardization of the product. Podophyllotoxin has a marked antimitotic and cytolytic activity that rapidly induces necrosis of acuminate warts. The activity of podophyllotoxin is performed more quickly and effectively than that of podophyllin due to its high degree of purity and standardization. This allows the administration of appropriate doses with lower risk of side effects and makes it possible to treat the patient at home with high cure rates.
05.2 "Pharmacokinetic properties
Acute toxicity
Acute toxicity studies have shown that oral administration of a single dose of podophyllotoxin of less than 25 mg / kg, in rats and mice, is non-toxic.
The acute toxicity of podophyllotoxin has been studied in numerous animal species and by various routes of administration.
The LD50 in mice is 40 mg / kg (oral route), 19 to 33 mg / kg intravenously, 31 mg / kg subcutaneously and 4.6 mg / kg intravenously; in the rat it is 14 mg / kg subcutaneously, 3 mg / kg intramuscularly and 15 mg / kg intraoperitoneally; in rabbits 5 mg / kg intravenously; in the dog subcutaneously from 10 to 30 mg depending on body weight.
Acute toxicity studies for prolonged epicutaneous application for 24 hours (limit tests) of Condyline at a dose of 2 ml / kg of body weight (corresponding to podophyllotoxin 10 mg / kg), on the shaved back of mice and rats (in the latter below occlusion), have shown that the product does not exhibit systemic toxicity.
Subacute or chronic toxicity studies
Following the epicutaneous application in mice, twice a week for 74 weeks, of a solution of 2.5% podophyllotoxin in polyethylene glycol, on a 2.5 cm2 dorsal area, it was found that, after 29 weeks of treatment , the number of deaths was 0/25, after 50 weeks it was 5/25 and after 74 weeks it rose to 12/25 (48%).
The dosage employed was 50 mcl, equivalent to approximately 1.25 mg per mouse.
Considering the body weight of 20 g, the topical dose used is equivalent to 62.5 mg / kg.
In humans, Condyline 0.5% has been applied in doses of about 10-100 mcl, equivalent to 0.0007-0.007 mg / Kg.
Since Condyline is a topical product, the Magnusson-Klingman "maximization test" was performed on guinea pigs using 0.5% podophyllotoxin in propylene glycol and 0.01% to 0.5% solutions in the induction phase. trigger phase.
The provocation test with concentrations 0.1% and 0.5% induced a non-allergic irritative reaction.
There were no allergic reactions in any of the experiments.
The topical irritative effect after repeated applications (2 times a day for 10 days) of 0.01%, 0.05%, 0.1% and 0.5% solutions of podophyllotoxin in 70% ethanol was studied in rabbits (versus a control group treated with 70% ethanol only), both by measuring the thickness of the skin fold and by visually evaluating parameters such as erythema, exudation and presence of crusts.
The results showed a linear correlation between the increase in the concentration of podophyllotoxin and the increase in the thickness of the fold as well as an exponential relationship between the increase in drug concentration and the skin response.
Podophyllotoxin is embryotoxic while it does not exhibit carcinogenic or mutagenic activity.
05.3 Preclinical safety data
Pharmacokinetic studies with labeled podophyllotoxin were performed in healthy and tumor-bearing mice. After 4 hours of subcutaneous administration, most of the radioactivity was equally distributed between intestine and urine while only traces were present in the liver, gallbladder and kidneys as well as in the brain, adrenal cortex and testes. In mice carrying sarcoma 180 most of the radioactivity was found in the urine.
Elimination of podophyllotoxin was much more rapid in these latter animals. The tumor did not contain a significant amount of radioactivity. The levels of radioactivity recovered from the urine were much lower in mice carrying Ehrlich's ascites carcinoma. In all animals. treated a relatively high concentration of radioactivity was found in the bile which, with the renal emunctorium, appears to be the most important route of excretion of podophyllotoxin and its metabolites.
In percutaneous absorption studies in patients treated with 0.5% podophyllotoxin applied at a dose of 0.01-0.05 ml for 3 days, it was not possible to detect the drug in serum in the ½-1 hour after the day. application.
Using doses of 0.1 ml (on warts with total area> 4 cm2), the serum levels of podophyllotoxin were
With a dose of 0.15 ml, the serum levels were approximately equal, while in 5 patients, 12 hours after application they were ≤ 1 ng / ml.
In patients treated with 0.1-1.5 mL for very extensive lesions, maximum levels after 1-12 hours were 1-17 ng / mL. However, it has been shown that solution quantities greater than 0.1 ml are rarely required in clinical practice. A relatively long clearance after the application, twice a day, of 0.1 ml of 0.5% solution may indicate that distribution occurs according to a 2-compartment model. From the studies carried out, a serum half-life from 1 to 1 can be extrapolated. 4½ hours No accumulation of podophyllotoxin was observed.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactic acid, sodium lactate, anhydrous ethanol, water.
06.2 Incompatibility
They are not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store below 25 ° C
06.5 Nature of the immediate packaging and contents of the package
Carton with 3.5 ml bottle with safety lock.
06.6 Instructions for use and handling
Not relevant.
07.0 MARKETING AUTHORIZATION HOLDER
Astellas Pharma S.p.A. - Via delle Industrie 1 - 20061 Carugate (Milan)
08.0 MARKETING AUTHORIZATION NUMBER
027136011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Registration May 2, 1990 - Renewal of authorization June 1, 2010
10.0 DATE OF REVISION OF THE TEXT
September 2011
