WARTEC 5 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Wartec 5 mg/ml Cutaneous Solution

Podophyllotoxin

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

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Wartec solution and what is it used for
2. What you need to know before you start using Wartec solution
3. How to use Wartec solution
4. Possible side effects
5. Storage of Wartec solution
6. Contents of the pack and further information

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

This medicine contains podophyllotoxin, which belongs to a group of medicines called antivirals, for topical administration.

Wartec solution 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 you start using Wartec solution

Do not use Wartec solution:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Wartec solution 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 healthcare professional may need to apply this medicine for you.

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

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

Avoid applying Wartec solution to healthy skinsurrounding the wart.

Avoid getting Wartec solution in your eyes,as it may cause irritation. If Wartec solution accidentally gets into your eyes, rinse immediately with plenty of water and consult your doctor.

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

What to avoid while using Wartec solution

• If severe local reactions occur on the skin (bleeding, inflammation, excessive pain, burning sensation, itching), wash the treated area immediately with water and mild soap. Stop treatment and consult a doctor if necessary, see also the section How to use Wartec solutionbelow.
• Sexual intercourse should be avoidedduring treatment with Wartec solution. You should wait until the warts have disappeared and your skin has healed.
• Genital warts are contagious.You may give them to your partner or get them from your partner.

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 podophyllotoxin (as it is irritating).

This medicine is flammable,see the section How to use Wartec solutionbelow.

Children

Wartec solution is not recommended for use in children under 12 years of age, as its use in these ages has not been established.

Using Wartec solution with other medicines

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

Pregnancy and breastfeeding

Wartec solution is not recommended during pregnancy or breastfeeding.

• Tell your doctor if you are pregnant or planning to become pregnant.
• Use a reliable contraceptive methodto prevent pregnancy while using Wartec solution.
• If you become pregnant during treatment with Wartec solution, tell your doctor.

Breastfeeding is not recommendedduring treatment with Wartec solution. Consult your doctor about whether to continue breastfeeding or use podophyllotoxin.

3. How to use Wartec solution

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

Administration: cutaneous use. For external use only.

Application of Wartec solution

• Apply Wartec solution 2 times a day, in the morning and at night (every 12 hours), for 3 days.
• Do not apply the solution during the following 4 days. This completes a treatment cycle.
• When applying Wartec solution, after 2 or 3 days of treatment, you may notice mild irritation in the treated areas. This indicates that Wartec solution has started to work. However, Wartec solution can cause severe skin reactions. If this happens, stop using Wartec solution and consult a doctor. If you need more information, read “Possible side effects” in section 4below.
• If after 7 days from the start of treatment you still have warts, repeat the treatment cycle (2 times a day, for 3 days followed by 4 days when you do not need to apply the solution).
• A maximum of 4 treatment cycles can be applied.
• If after 4 treatment cycles the warts persist, consult your doctor.

Due to the flammable nature of Wartec solution, you should avoid smoking or being near fire during application and immediately after use.

How to apply Wartec solution

1. Wash the affected areas with water and soap. Gently dry the area with a clean towel.
2. Use a new applicator each time you apply Wartec solution.
3. Insert the loop of the applicator into the solution. If your wart is large or you have many warts in a small area, insert the end with the larger loop (spatula) into the solution.
4. Apply the solution to the wart until it is covered and let the solution dry. Be careful not to get the solution on healthy skin. If this happens, wash the area with water and soap.
5. Repeat this process until you have applied the solution to all warts. Let the solution dry before allowing healthy skin areas to come into contact with the treated area.
6. Wash your hands well after using Wartec solution.

If Wartec solution comes into contact with the eyes or is ingested

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

If you use more Wartec solution than you should

If you accidentally use too much solution, wash the treated area immediately with water 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 solution

Apply Wartec solution 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, this medicine can cause side effects, although not everybody gets them.

If you have any of the following serious side effects, stop using Wartec solution and consult your doctor:

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

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

Contact your doctor as soon as possible.

Very common side effects(may affect up to 1 in 10 people)

• erosion of the skin, irritation at the application site including redness, itching, burning sensation.

Rare side effects(may affect up to 1 in 10,000 people)

The following side effects have been reported at the application site:

• allergic reactions, pain, inflammation, bleeding, caustic lesions, damage or loss of the superficial skin layer, wound secretion (suppuration), skin ulcers, crusts, skin discoloration, dry skin, blisters.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Wartec solution

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use Wartec solution after the expiry date stated on the packaging. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Wartec solution

• The active ingredient is podophyllotoxin. Each ml of solution contains 5 mg of podophyllotoxin.
• The other ingredients are: concentrated phosphoric acid, 96% ethanol, patent blue V (E-131), and purified water.

Appearance of the product and pack contents

Wartec solution is a blue solution.

It is presented in type III amber glass bottles containing 3 ml of solution, equipped with a child-resistant closure made of polypropylene.

Each pack includes 24 plastic applicators with a double loop.

Further information

This medicine is flammable. Keep away from heat and flames. Keep the container tightly closed when not in use.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Phoenix Labs

Suite 12, Bunkilla Plaza,

Bracetown Business Park,

Clonee, County Meath,

Ireland

Manufacturer

Stiefel Laboratories (Ireland), Ltd.

Finisklin Industrial Estate

Sligo (Ireland)

or

Delpharm Bladel B.V

Industrieweg, 1

5531 AD BLADEL

Netherlands

Local representative:

EUROMED PHARMA SPAIN S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: + 34 932 684 208

Date of last revision of this package leaflet:May 2020

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