War Tec 5 mg/ml cutaneous solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Wartec 5 mg/ml cutaneous solution

Podophyllotoxin

Read the entire 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

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

Wartex 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 using Wartec solution

Do not use Wartec solution:

• 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 areas
• if you are already using another medicine containing podophyllotoxin.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Wartec solution if:

• Your warts cover a skin surface larger than 4 centimeters (approximately the size of a postage stamp). In this case, you may need your doctor or healthcare professional to apply this medicine.

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

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

Avoid applying Wartec solution to healthy skin surrounding the wart.

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

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

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

What to avoid while using Wartec solution

• If severe local skin reactions occur (bleeding, swelling, excessive pain, burning sensation, itching), wash the treated area immediately with water and mild soap. Discontinue treatment and consult a doctor if necessary. See the section How to use Wartec solution for further details.
• It is recommended to avoid sexual intercourse during treatment with Wartec solution. 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).

? This medicine is flammable, see section How to use Wartec solution.

Children

The use of Wartec solution is not recommended in children under 12 years of age, as its use has not been established in this age group.

Use of Wartec solution with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription.

Pregnancy and breastfeeding

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

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

Breastfeeding is not recommended during treatment with Wartec solution. Consult your doctor about whether you should continue breastfeeding or use podophyllotoxin.

3. How to use Wartec solution

Follow exactly the administration instructions for this medicine given 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 twice daily, in the morning and at night (every 12 hours), for 3 days.
• Do not apply the solution for the following 4 days. This completes one treatment cycle.
• When applying Wartec solution, after two or three days of treatment, you may notice mild irritation in the treated areas. This indicates that Wartec solution has started to work. However, Wartec solution may cause serious skin reactions. If this happens, stop using Wartec solution and consult a doctor. For more information, see "Possible adverse effects" in section 4.
• If after 7 days from starting treatment you still have warts, repeat the treatment cycle (twice daily for 3 days, followed by 4 days without applying the solution).
• A maximum of 4 treatment cycles may be applied.
• If warts persist after 4 treatment cycles, consult your doctor.

Due to the flammable nature of Wartec solution, you must avoid smoking or going near open flames during and immediately after application.

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. Dip the loop of the applicator into the solution. If your wart is large or you have multiple warts close together, use the end with the larger handle (spatula) and dip it into the solution.
4. Apply the solution directly onto the wart until it is covered, and allow the solution to dry. Be careful to avoid contact with healthy skin. If this occurs, wash the area immediately with water and soap.
5. Repeat this process to treat all warts. Allow the solution to dry before allowing untreated skin areas 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 thoroughly 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 any solution, go to your doctor or hospital immediately. Take the solution with you so the doctor knows what has been swallowed.

If you use more Wartec solution than you should

If you accidentally use too much solution, immediately rinse 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 solution

Apply Wartec solution 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, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious adverse effects, stop using Wartec solution and contact your doctor:

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

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

?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, and burning sensation.

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Wartec solution

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

Nature of the product and pack contents

Wartec solution is a blue-colored solution.

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

Each package contains 24 double-handled plastic applicators.

Additional information

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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
The 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 most recent review of this leaflet: May 2020

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