Catephen 10% Ointment - 15g

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is up to 0.5 cm of ointment strand (corresponding to 250 mg) for all warts together, applied three times daily (in the morning, at mid-day and in the evening).

• Wash hands before and after applying the ointment.

• Apply a small amount of Catephen to each wart using the fingers, dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Do not apply the ointment internally (into the anus, urethra or into the vagina).

• Do not cover the treated area with bandages after you have applied the ointment.

• It is not necessary to wash off the ointment from the treated area prior to the next application. When you wash the treatment area or bathe, apply the ointment afterwards.

• Apply Catephen three times per day (in the morning, at mid-day and in the evening).

• New warts may develop during treatment, which need to be treated in the same way.

• Genital warts are a sexually transmitted disease; therefore, you may infect your partner by sexual activity. Condoms should be used until complete clearance of all warts. The use of condoms prevents reinfection as well.

• Catephen may weaken condoms and vaginal diaphragms. Before sexual activity, wash off the ointment carefully with warm water and mild soap and apply a condom thereafter. Ask your doctor for additional methods of contraception.

• Female patients during menstruation using tampons: insert the tampon before applying the ointment. If you need to change your tampon while the ointment is on your skin, avoid getting the ointment into the vagina. In case of accidental application immediately wash-off the ointment with warm water and mild soap.

• Duration of treatment with Catephen should be continued until complete clearance of all warts, however no longer than 16 weeks, even if new warts develop during the treatment period. If the warts do not go away or if they come back after treatment, please consult your doctor.

Use in children and adolescents (below the age of 18 years) Catephen is not approved for use in children and adolescents below the age of 18 years. Older people There is limited experience for the use of Catephen in older people. Hepatic impairment You should not use Catephen if your liver function is impaired (e.g., abnormal accumulation of fluid in the abdomen, yellow skin due to liver problems). If you use more Catephen than you should You may experience more intense local reactions (see sections ‘2. What you need to know before you use Catephen’ and ‘4. Possible side effects’). Wash off the extra ointment with mild soap and water. If you have accidentally swallowed the ointment, you should contact your doctor. If you forget to use Catephen Continue next dose when it's due. Do not use a double dose to make up for a forgotten dose. If you stop using Catephen Clearance of warts may not be achieved. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects of Catephen are due to its local action on the skin and occur on or around the treated wart area. Many patients experience redness, itching, irritation, pain or swelling. Mild reactions are expected and should ease after the first weeks of treatment. If, however, the intensity of local skin reactions is affecting your daily activities or if blisters occur, please consult your doctor. It may be necessary to interrupt treatment. Treatment can be resumed after the skin reaction has subsided. In case of vesicular local reactions please consult your doctor. If you experience severe local reaction causing unacceptable discomfort e.g., local inflammation/infection, open sore, swelling of lymph nodes or any other serious reaction (e.g., constriction of foreskin or urethra, difficulty passing urine or severe pain) you should stop treatment, wash off the ointment with warm water and mild soap and consult your doctor straight away. Very common:

• Local skin reactions at the wart site where you have applied Catephen including: redness, itching, irritation/burning, pain, swelling, open sores, hardening of the skin, and blisters.

Common:

• Local skin reactions like flakiness, discharge, bleeding, swelling
• Swelling of lymph nodes (in the groin)
• Constriction of the foreskin of the penis

Uncommon:

• Local scarring, fissure, skin dryness, discomfort, erosion, increase or loss of sensation, nodule, papules, inflammation of the skin, and changes in skin colour at the application site, local necrosis, eczema
• Pustules at the application site, infections at the application site, genital herpes infection, staphylococcal infection, fungal infection of the vagina, inflammation of the urethra or of the vulva and vagina
• Pain, high frequency or urgency in urinating
• Inflammation of the foreskin and head of the penis, painful sexual intercourse
• Rash, hypersensitivity

Adverse reactions that were observed with a higher strength (Catephen 15%) ointment only:

• Bacterial skin infections (pyoderma), inflammation of vulva
• Constriction of the urethra/difficulty passing urine, vaginal discharge