País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Podophyllotoxin
Phoenix Labs Ltd
D06BB04
Podophyllotoxin
5mg/1ml
Cutaneous solution
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13070000; GTIN: 5011091102387
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ WARTICON ® podophyllotoxin 0.5% w/v solution 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 only. 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 of 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 is and what it is used for 2. What you need to know before you use Warticon 3. How to use Warticon 4. Possible side effects 5. How to store Warticon 6. Contents of the pack and other information 1. WHAT WARTICON IS AND WHAT IT IS USED FOR Warticon contains a medicine called podophyllotoxin. This is a plant extract which belongs to a group of medicines called ‘antivirals’. Warticon is used to treat genital warts. It is used for warts on the foreskin of the penis in men or external warts on the vagina in females. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE WARTICON DO NOT USE WARTICON IF: • you are allergic to podophyllotoxin or any of the other ingredients of this medicine (listed in Section 6) • your warts are on areas of broken/damaged or bleeding skin • you are already using another medicine containing podophyllotoxin. Do not use Warticon if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor before using this Warticon if: • your warts cover an area larger than a 4 centimetre area (approximately the size of a postage stamp). You may need to have this medicine applied by your doctor or nurse in a clinic. WARTICON SOLUTION IS ONLY TO BE USED ON THE AFFECTED SKIN. Don’t take Warticon Solution by mouth. DON’T APPLY Llegiu el document complet
OBJECT 1 WARTICON SOLUTION Summary of Product Characteristics Updated 21-Jan-2014 | Stiefel 1. Name of the medicinal product Warticon ® 2. Qualitative and quantitative composition Podophyllotoxin 5 mg/ml (0.5% w/v). The quality of podophyllotoxin fulfills in-house specification. 3. Pharmaceutical form Topical solution 4. Clinical particulars 4.1 Therapeutic indications 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. Warticon should be applied twice daily, morning and evening (every 12 hours) for 3 consecutive days. The treatment should then be withheld for the next 4 consecutive days. Application to the surrounding normal tissue should be avoided. If residual warts persist, this 3-day treatment may be repeated weekly until there is no visible wart tissue or for a total of 4 weeks of treatment. Warticon solution should be applied to the warts with the applicator supplied with the solution. Due to the flammable nature of Warticon solution, patients should avoid smoking or being near an open flame during application and immediately after use. The solution should be allowed to dry before opposing skin surfaces are returned to their normal position. _Paediatric population_ The safety and efficacy of topical podophyllotoxin have not been established in children under the age of 18. 4.3 Contraindications Hypersensitivity to the active substance or 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 professional. Avoid applying the solution to warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). Avoid applying Llegiu el document complet