Label: information for the user

Wartec 1.5 mg/g cream

Podofilotoxin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Wartec cream contains the active ingredient podofilotoxin. Podofilotoxin is an extract obtained from a plant and belongs to a group of medicines called antivirals.

Wartec cream is used to treat genital warts on the penis in men or external warts on the vagina in women.

Do not use Wartec cream:

• if you are allergic to podofilotoxin or any of the other components of this medication (listed in section 6)
• if your warts are in areas of the skin with cuts/ damaged or bleeding skin
• if you are already using another medication that contains podofilotoxin.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Wartec cream if:

• your warts cover a skin surface of more than 4 centimeters (approximately the size of a postage stamp). In this case, you may need your doctor or nurse to apply this medication for you.

Wartec cream should only be applied to the affected skin.Do not ingest Wartec cream.

Do not apply Wartec cream to warts that are located inside the penis, vagina, or rectum.Wartec cream should only be applied to warts that are located on the surface of the skin (external).

Avoid applying Wartec cream to healthy skinthat surrounds the wart.

Avoid Wartec cream from coming into contact with the eyes, as it may cause irritation.If Wartec cream accidentally comes into contact with the eyes, rinse immediatelywith plenty of water and consult your doctor.

Do not apply a bandage (a dressing)over the surface of the area treated with Wartec cream.

• Consult your doctorif any of the above situations occur.

What to avoid while using Wartec cream

• It is recommendedto avoid sexual intercourseduring treatment with Wartec cream. You should wait until the warts have disappeared and your skin has healed.
• Genital warts are contagious.You may infect your partner or contract the infection from them.

• If you have sexual intercourse during treatment, use a condom to help prevent the spread of genital warts and to protect your partner from contact with podofilotoxin (which is irritating).

Use of Wartec cream with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications purchased without a prescription.

Children

Wartec cream is not recommended for use in children under 18 years of age, as its use has not been established in these age groups.

Pregnancy and breastfeeding

Wartec cream is not recommended during pregnancy or breastfeeding.

• Inform your doctorif you are pregnant
• Use a reliable contraceptive methodto prevent pregnancy while using Wartec cream.
• If you become pregnant during treatmentwith Wartec cream, inform your doctor.

Breastfeeding is not recommendedduring treatment with Wartec cream. Consult your doctor about the advisability of continuing breastfeeding or using podofilotoxin.

Important information about some of the components of Wartec cream

This medication may cause local skin reactions (such as contact dermatitis) because it contains sorbic acid (E-200), stearic alcohol, and cetyl alcohol.

This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxyanisole (E-320).

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Wartec Cream Application

• Apply Wartec cream 2 times a day, in the morning and at night (every 12 hours), for 3 days.
• Do not apply the cream during the 4 days that follow. This completes a treatment cycle.
• When applying Wartec cream, after 2 or 3 days of treatment, you may notice a mild irritation in the treated areas. This indicates that Wartec cream has begun to take effect. However, Wartec cream may cause serious skin reactions.If this occurs, stop using Wartec cream and seek medical attention. If you need more information, read “possible side effects” in section 4.
• If, after 7 days of starting treatment, you still have warts, repeat the treatment cycle (2 times a day, for 3 days followed by 4 days without applying the cream).
• A maximum of 4 treatment cycles may be applied.
• If, after 4 treatment cycles, the warts persist, consult your doctor.

How to Apply Wartec Cream

1. Wash the affected areas with water and soap. Dry the area gently with a clean towel.
2. Using the tip of your finger, apply Wartec cream to each wart, using only the amount of cream necessary to cover it.
3. Massage the cream into the wart. Be careful not to let the cream come into contact with healthy skin. If this occurs, rinse the area with water and soap to remove the cream.
4. Wash your hands thoroughly.
5. Ensure the cap is tightly closed.

If Wartec Cream Comes into Contact with the Eyes or is Swallowed

• If Wartec cream comes into contact with the eyes, rinse them with plenty of water and consult your doctor.
• If Wartec cream accidentally comes into contact with the mouth, rinse immediately with water.
• If you accidentally ingest some cream, go to your doctor or go to the hospital directly. Bring the cream tube with you so the doctor knows what you ingested.

If You Use More Wartec Cream Than You Should

If you accidentally use too much cream, immediately rinse the cream from the treated area and consult your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Use Wartec Cream

Apply Wartec cream as soon as you remember. If it is almost time for the next application, wait until then.

Do Not Apply a Double Doseto compensate for missed doses.

Like all medications, Wartec cream may cause adverse effects, although not everyone will experience them.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

If you have any of the severe adverse effects listed below, stop using Wartec cream and see your doctor:

• Severe burning, itching, pain, bleeding, prickling, or inflammation in the treated area.

If you have these symptoms, wash the cream off your skin with water and soap immediately.

• Contact your doctor as soon as possible

Very Common Adverse Effects

May affectmore than 1 in 10 people:

• Loss of the skin's surface layers, irritation at the application site, including redness, itching, and a burning sensation.

Other adverse effects whose frequencies cannot be estimated with the available data are:

• Allergic reaction, pain, inflammation, bleeding
• Damage or loss of the skin's surface layers, suppurating wounds
• Ulcers on the skin, crusts, skin discoloration, dry skin, blisters.

These adverse effects may occur in areas of the skin where you have applied the cream.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep out of sight and reach of children .
• Do not use Wartec cream after the expiration date indicated on the packaging and tube. The expiration date is the last day of the month indicated.
• No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Wartec cream

• The active ingredient is podofilotoxin. Each gram of cream contains 1.5 mg of podofilotoxin (0.15% w/w).

• The other components are: purified water, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sorbic acid (E-200), phosphoric acid, stearic alcohol, cetyl alcohol, isopropyl myristate, liquid paraffin, medium-chain triglycerides, butylhydroxyanisole (E-320), macrogol - 7 stearate, macrogol - 10 stearate.

Appearance of the product and contents of the container

Wartec cream is presented in tubes containing 5 grams or 10 grams of cream.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Phoenix Labs

Suite 12, Bunkilla Plaza,

Bracetown Business Park,

Clonee, County Meath,

Ireland

[email protected]

Local Representative:

Euromed Pharma Spain, S.L.

C/ Eduard Maristany, 430-432

08918 Badalona

Barcelona-Spain

Tel.: +34 932 684 208

Responsible for manufacturing:

Delpharm Bladel BV

Industrieweg 1

5531 AD Bladel

Netherlands

O

Phoenix Healthcare Limited

Unit 31, 2ndAvenue,

Cookstown Industrial Estate,

Dublin 24, D24 TP60,

Ireland

O

LABORATORI FUNDACIÓ DAU

Pol. Ind. Consorci Zona Franca. c/ C, 12-14

08040 Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Ireland: Warticon 0.15% w/w Cream

Spain: Wartec cream

Netherlands: Wartec, crème 1,5% mg/g

United Kingdom: Warticon 0,15% w/w Cream

Date of the last review of this leaflet:August 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es