Wartec 1.5 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Wartec 1.5 mg/g cream

Podophyllotoxin

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Wartec cream is and what it is used for
2. What you need to know before using Wartec cream
3. How to use Wartec cream
4. Possible adverse effects
5. How to store Wartec cream
6. Contents of the pack and other information

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

Wartec cream contains the active ingredient podofilox. Podofilox is a plant-derived extract 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 in 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 to any of the other ingredients of this medicine (listed in section 6)
• if your warts are located on wounded, damaged, or bleeding skin
• if you are already using another medicine containing podophyllotoxin.

Warnings and precautions

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

• your warts cover a skin surface area larger than 4 centimeters (approximately the size of a postage stamp). In this case, you may require your doctor or nurse to administer this medicine.

Wartec cream must only be applied to affected skin. Do not swallow Wartec cream.

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

Avoid applying Wartec cream to healthy skin surrounding the wart.

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

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

• Consult your doctor if any of the above situations apply to you.

What to avoid while using Wartec cream

• It is recommended to avoid sexual intercourse during treatment with Wartec cream. You should wait until the warts have disappeared and your skin has healed.

• Genital warts are contagious. You may transmit them to, or acquire them from, your sexual partner.

• If you have sexual intercourse during treatment, you should use a condom to help prevent the spread of genital warts and to protect your partner from exposure to 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 need to use any other medicines. This includes medicines obtained without a prescription.

Children

The use of Wartec cream is not recommended in children under 18 years of age, as its use has not been established in this age group.

Pregnancy and breastfeeding

The use of Wartec cream is not recommended during pregnancy or breastfeeding.

• Inform your doctor if you are pregnant or plan to become pregnant.
• Use a reliable method of contraception to prevent pregnancy while using Wartec cream.
• If you become pregnant during treatment with Wartec cream, inform your doctor immediately.

Breastfeeding is not recommended during treatment with Wartec cream. Consult your doctor about whether to continue breastfeeding or to use podophyllotoxin.

Important information about some of the ingredients of Wartec cream

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

This medicine may cause local skin reactions (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 methylparahydroxybenzoate (E-218) and propylparahydroxybenzoate (E-216).

3. How to use Wartec cream

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Application of Wartec cream

• Apply Wartec cream twice daily, in the morning and at night (every 12 hours), for 3 days.
• Do not apply the cream for the following 4 days. This completes one 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 work. However, Wartec cream may cause serious skin reactions. If this occurs, stop using Wartec cream and seek medical attention. For further information, read "Possible side effects" in section 4.
• If after 7 days from starting treatment you still have warts, repeat the treatment cycle (twice daily for 3 consecutive days, followed by 4 days without applying the cream).
• A maximum of 4 treatment cycles may be applied.
• If warts persist after 4 treatment cycles, 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 fingertip, apply Wartec cream to each wart, using only enough cream to cover it.
3. Rub the cream into the wart. Take care to avoid contact of the cream with healthy skin. If this occurs, wash the area with water and soap to remove the cream.
4. Wash your hands thoroughly.
5. Make sure 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 thoroughly 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 swallow some of the cream, go to your doctor or to the hospital immediately. Take the tube of cream with you so the doctor knows what has been swallowed.

If you use more Wartec cream than you should

If you accidentally use too much cream, immediately wash the cream off the treated area and contact your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 your next dose, wait until then.

Do not apply a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, Wartec cream may cause adverse effects, although not everybody experiences them.

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

If you have any of the following serious adverse effects, stop using Wartec cream and contact your doctor immediately:

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

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

• Contact your doctor as soon as possible

Very common adverse 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, and burning sensation.

Other adverse effects whose frequency cannot be estimated from the available data are:

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Wartec Cream Storage

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Wartec cream

• The active substance is podophyllotoxin. Each gram of cream contains 1.5 mg of podophyllotoxine (0.15% w/w).

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

Appearance of the product and contents of the pack

Wartec cream is supplied 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:

LABORATORI FUNDACIÓ DAU

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

08040 Barcelona

Spain

This medicinal product is authorized in the European Economic Area member states under 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 most recent review of this leaflet: August 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es