Label: information for the patient

Wartec 5 mg/ml topical solution

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 doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Label contents

1. What Wartec solution is and for what it is used
2. What you need to know before starting to use Wartec solution
3. How to use Wartec solution
4. Possible adverse effects
5. Storage of Wartec solution
6. Contents of the package and additional information

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

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

Do not use Wartec solution:

• if you are allergic to podophyllotoxin 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 podophyllotoxin.

Warnings and precautions

Consult 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, you may need your doctor or healthcare professional to apply this medication.

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

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

Avoid applying Wartec solution to healthy skinaround the wart.

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

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

?Consult your doctor if any of the above situations occur.

What to avoid while using Wartec solution

• If severe local skin reactions occur (bleeding, inflammation, excessive pain, burning sensation, itching), the treated area should be rinsed immediately with water and mild soap. Treatment should be discontinued and a doctor consulted if necessary, see the sectionHow to use Wartec solution.
• It is recommendedto avoid sexual intercourseduring treatment with Wartec solution. 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 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 (which is irritating).

?This medication is flammable,see the sectionHow to use Wartec solution.

Children

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

Use of Wartec solution 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.

Pregnancy and breastfeeding

Wartec solution is not recommended during pregnancy or breastfeeding.

• Inform your doctor if you are pregnant or plan to become pregnant.
• Use a reliable contraceptive methodto prevent pregnancy while using Wartec solution.
• If you become pregnant during treatment with Wartecsolution, inform your doctor.

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

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

Administration: topical use. For external use only.

Wartec Solution Application

• 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 4 days that follow. This completes a treatment cycle.
• When applying Wartec solution, after 2 or 3 days of treatment, you may notice a mild irritation in the treated areas. This indicates that Wartec solution has started to take effect. However, Wartec solution may cause severe skin reactions. If this happens, stop using Wartec solution and consult a doctor. If you need more information, read “Possible Adverse 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 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 approaching fire during application and immediately after use.

How to Apply Wartec Solution

1. Wash the affected areas with water and soap. Dry the area gently with a clean towel.
2. Use a new applicator each time you apply Wartec solution.
3. Insert the handle 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 handle (spatula) into the solution.
4. Apply the solution over the wart until it is covered and let the solution dry. Be careful not to let the solution come into contact with 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 to come into contact with the treated area.
6. Wash your hands thoroughly after using Wartec solution.

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

• If Wartec solution comes into contact with the eyes, rinse them with plenty of water and consult a 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 the hospital immediately. Bring the solution with you so the doctor knows what you have ingested.

If You Use More Wartec Solution than You Should

If you accidentally use too much solution, rinse the solution off the treated area immediately and go to your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call theToxicology Information Service, phone: 91 562 04 20, indicating the medication 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 Missed Doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If you experience any of the severe adverse effects listed below, stop using Wartec solution and consult your doctor:solutionand consult your doctor:

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

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

?Contact your doctor as soon as possible.

Very Common Adverse Effects(may affect up to 1 in 10 people)

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

Rare Adverse Effects(may affect up to 1 in 10,000 people)

The following adverse effects have been reported at theapplication site:

• Allergic reactions, pain, inflammation, bleeding, caustic injury, damage or loss of the skin's surface layer, wound discharge (suppuration), skin ulcer, crusts, skin discoloration, dry skin, blisters.

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 theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication 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 expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.By doing so, you will help protect the environment.

Composition of Wartec solution

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

Appearance of the product and contents of the packaging

Wartec solution is a blue solution.

It is presented in amber type III glass bottles containing 3 ml of solution equipped with a safety closure for children made of polypropylene.

Each package includes 24 plastic applicators with a double handle.

Additional information

This medication is flammable. Keep away from heat and flames. Keep the packaging perfectly closed when not in use.

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

Responsible for manufacturing

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 the last review of this leaflet: May 2020

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS http://www.aemps.gob.es