WARTEC 1.5 mg/g CREAM

Introduction

Leaflet: Information for the user

Wartec 1.5 mg/g cream

Podophyllotoxin

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What is Wartec cream and what is it used for
2. What you need to know before using Wartec cream
3. How to use Wartec cream
4. Possible side effects
5. Storage of Wartec cream
6. Package contents and additional information

1. What is Wartec cream and what is it used for

Wartec cream contains the active ingredient podophyllotoxin. Podophyllotoxin is an extract obtained from a plant and belongs to the group of antiviral medicines.

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

2. What you need to know before using Wartec cream

Do not use Wartec cream:

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

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, your doctor or nurse may need to apply this medicine.

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

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

Avoid applying Wartec cream to healthy skinsurrounding the wart.

Avoid getting Wartec cream in your eyes, as it may cause irritation. If Wartec cream accidentally gets in your eyes, rinse immediatelywith plenty of water and consult your doctor.

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

• Consult your doctorif any of the above situations occur.

What to avoid while using Wartec cream

• It is recommended to 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 them from your partner.

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

Using Wartec cream with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine. This includes medicines obtained without a prescription.

Children

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

Pregnancy and breastfeeding

Wartec cream is not recommended during pregnancy or breastfeeding.

• Tell your doctor if you are pregnantor plan to become 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 convenience of continuing breastfeeding or using podophyllotoxin.

Important information about some of the components of Wartec cream

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

This medicine may cause local reactions on the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole (E-320).

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to use Wartec cream

Follow your doctor's instructions for using this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Application of Wartec cream

• 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 following 4 days. This completes a treatment cycle.
• When applying Wartec cream, after two or three days of treatment, you may notice mild irritation in the treated areas. This indicates that Wartec cream has started to take effect. However, Wartec cream can cause severe skin reactions.If this happens, stop using Wartec cream and seek medical attention. If you need more information, read “Possible side effects” in section 4.
• If after 7 days from starting treatment you still have warts, repeat the treatment cycle (2 times a day, for 3 consecutive days followed by 4 days without applying the cream).
• A maximum of 4 treatment cycles can 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. Gently dry the area with a clean towel.
2. Using the tip of your finger, apply Wartec cream to each wart, using only enough cream to cover it.
3. Rub the cream into the wart. Be careful not to get the cream on healthy skin. If this happens, rinse the area with water and soap to remove the cream.
4. Wash your hands thoroughly.
5. Make sure you have closed the cap tightly.

If Wartec cream comes into contact with your eyes or is ingested

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

If you use more Wartec cream than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 make up for forgotten doses.

4. Possible side effects

Like all medicines, Wartec cream can cause side effects, although not everyone gets them.

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

If you have any of the serious side effects listed below, stop using Wartec cream and consult your doctor:

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

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

• Contact your doctor as soon as possible

Very common side effects

May affect more than 1 in 10 people:

• loss of the superficial layers of the skin, irritation at the application site including redness, itching, burning sensation.

Other side effects whose frequencies cannot be estimated from the available data are:

• allergic reaction, pain, inflammation, bleeding
• damage or loss of the superficial layers of the skin, suppurating wounds
• skin ulcer, crusts, skin discoloration, dry skin, blisters.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wartec cream

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

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Wartec cream

• The active ingredient is podophyllotoxin. Each gram of cream contains 1.5 mg of podophyllotoxin (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 package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Phoenix Healthcare Limited

Unit 31, 2nd Avenue,

Cookstown Industrial Estate,

Dublin 24, D24 TP60,

Ireland

Or

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 under the following names:

Ireland: Warticon 0.15% w/w Cream

Spain: Wartec cream

Netherlands: Wartec, cream 1.5% mg/g

United Kingdom: Warticon 0.15% w/w Cream

Date of the last revision of this leaflet:August 2022

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