País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Podophyllotoxin
Phoenix Labs
D06BB; D06BB04
Podophyllotoxin
0.15 percent weight/weight
Cream
Product subject to prescription which may be renewed (B)
Antivirals; podophyllotoxin
Marketed
1996-09-25
June 2020 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ WARTICON ® 0.15% W/W CREAM Podophyllotoxin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. _ _ WHAT IS IN THIS LEAFLET 1. What Warticon Cream is and what it is used for 2. What you need to know before you use Warticon Cream 3. How to use Warticon Cream 4. Possible side effects 5. How to store Warticon Cream 6. Contents of the pack and other information 1. WHAT WARTICON CREAM IS AND WHAT IT IS USED FOR Warticon Cream contains a medicine called podophyllotoxin. This is a plant extract which belongs to a group of medicines called ‘antivirals’. Warticon Cream is used to treat genital warts. It is used for warts on the penis in men or external warts on the vagina in women. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE WARTICON CREAM DO NOT USE WARTICON CREAM IF: you are ALLERGIC ( _hypersensitive_ ) to podophyllotoxin or any of the other ingredients of Warticon Cream (listed in section 6) your warts are on areas of broken/damaged or bleeding skin you are already using another medicine containing podophyllotoxin. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using this medicine if: your warts cover an area bigger than 4 centimetres (approximately the size of a postage stamp). You may need to have this medicine applied by a nurse/doctor in a clinic. WARTICON CREAM IS ONLY TO BE USED ON THE AFFECTED SKIN. Do not take Warticon Cream by mouth. DO NOT APPLY WARTICON CREAM TO WARTS ON THE INSIDE OF THE PENIS, VAGINA OR RECTUM. Warticon Cream shoul Leer el documento completo
Health Products Regulatory Authority 29 May 2020 CRN009JPJ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warticon 0.15% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Podophyllotoxin 1.5 mg/g (0.15% w/w). Excipients with known effect: Methyl parahydroxybenzoate (E218) 0.100 %w/w Propyl parahydroxybenzoate (E216) 0.030 %w/w Sorbic acid 0.120 %w/w Stearyl alcohol 2.000 %w/w Cetyl alcohol 2.000 %w/w Butyl hydroxyanisole (BHA) (E320) 0.015 %w/w FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 3 PHARMACEUTICAL FORM Topical cream A homogenous white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ROUTE OF ADMINISTRATION:_ _TOPICAL_ For the topical treatment of condylomata acuminata affecting the penis or the external female genitalia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The affected area should be thoroughly washed with soap and water, and dried prior to application. Using a fingertip, the cream should be applied twice daily morning and evening (every 12 hours) for 3 consecutive days using only enough cream to just cover each wart. The cream should then be withheld for the next 4 consecutive days. Application to the surrounding normal tissue should be avoided. Residual warts should be treated with further courses of twice daily applications for three days at weekly intervals, if necessary for a total of 4 weeks of treatment. Hands should be washed thoroughly after application. _Paediatric population_ The safety and efficacy of topical podophyllotoxin have not been established in children under the age of 18. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 29 May 2020 CRN009JPJ Page 2 of 5 HYPERSENSITIVITY TO THE ACTIVE SUBSTANCE OR TO ANY OF THE EXCIPIENTS LISTED IN SECTION 6.1. Open or bleeding wounds. Concomitant use with other podophyllotoxin containing preparations. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Where the area of treatment is greater than 4 cm 2 , it is recommended that treatment takes place under the direct supervision of a healthcare Leer el documento completo