Argenpal 42.5 mg transdermal patch

Patient Information Leaflet

Introduction

Patient Information Leaflet

ARGENPAL 42.5 mg cutaneous stick

Silver nitrate

Package leaflet:

1. What Argenpal is and what it is used for

2. What you need to know before using Argenpal

3. How to use Argenpal

4. Possible side effects

5. Storage of Argenpal

6. Contents of the pack and other information

1. What Argenpal is and what it is used for

Argenpal belongs to a group of medicines called antiseptics and disinfectants. It is used in the following cases:

• Treatment of warts and granulomas (inflammatory nodules) of the skin,
• Treatment of oral aphthae (ulcers or sores in the mouth),
• Treatment of nasal bleeding originating in the anterior part of the nasal septum (anterior epistaxis).

2. What you need to know before using Argenpal

Do not use Argenpal:

• If you are allergic (hypersensitive) to silver nitrate or any of the other components of this medicine (listed in section 6).
• If you have injured, infected, irritated, or reddened skin.
• If you have moles, birthmarks, or other pigmented skin lesions, genital warts, or warts on the face or mucous membranes. Healthcare professionals will not apply Argenpal to the anogenital region or over extensive areas.

Warnings and precautions

Silver nitrate is a corrosive substance and must be applied only to the affected area, thus avoiding unnecessary skin staining.

Treatment with silver nitrate causes a black stain on the skin, which fades over time. Healthcare professionals must not repeatedly apply silver nitrate to the same spot, as the stain may become permanent.

When treating anterior nosebleeds (epistaxis), healthcare professionals must take care not to apply the medicine to the same location on both sides of the nasal septum, to avoid possible septal perforation.

If any adverse events occur, treatment will be discontinued.

Other medicines and Argenpal

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Argenpal must not be used concomitantly with other medicines on the same site.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the risk-benefit balance of using Argenpal, as the efficacy and safety of silver nitrate in pregnant women and its potential effect on reproductive capacity are unknown.

Driving and use of machines

There is no evidence of effects on the ability to drive vehicles or operate machinery.

3. How to use Argenpal

Argenpal must be administered by a healthcare professional on the skin (cutaneous use).

Each Argenpal cutaneous stick is for single use and single application.

After previously moistening the Argenpal cutaneous stick in water for a few seconds, the affected area should be painted with the stick for a few seconds, taking care to limit its application to the affected area in order to avoid unnecessary black stains on the skin.

It is advisable to protect the surrounding healthy skin with an ointment or oily cream, for example petroleum jelly.

Finally, the treated area should be covered with a bandage or similar dressing.

Application must be performed exclusively by a physician and for a short period of time, depending on the desired degree of effect.

If you use more Argenpal than you should

Due to its topical application on the skin, Argenpal applicators are not toxic when used appropriately, as silver nitrate is normally not absorbed. However, silver nitrate poisoning may occur and can be either acute or chronic.

Chronic silver nitrate poisoning develops slowly and results from the continuous absorption and penetration of silver compounds into the mucous membranes. It is characterized by the appearance of a grayish-blue discoloration of the skin (argyria).

Accidental or intentional ingestion of silver nitrate may cause throat and stomach pain, acute gastroenteritis, nausea, vomiting, diarrhea, dizziness, thread-like pulse (weak and rapid), shallow breathing, and convulsions.

For the treatment of poisoning, your doctor will administer sodium chloride, followed by gastric lavage or emetic drugs (which induce vomiting), or copious amounts of milk or other demulcents (substances that mimic the protective action of mucous membranes). For pain and nervous irritability, sodium pentobarbital (a hypnotic) will be given intravenously at a dose of 0.2 g; if necessary, cardiac stimulants (medications that increase heart rate) should be used, and artificial respiration should be applied to maintain vital functions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed:

Skin and subcutaneous tissue disorders:

Common (may affect up to 1 in 10 people):

Argenpal may be irritating, causing skin inflammation (dermatitis), redness, burning, skin discoloration, or a blue-gray skin coloration (argyria) that fades over time. After prolonged exposure, skin discoloration or spots may become permanent.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Argenpal

Keep out of the sight and reach of children.

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

Do not use Argenpal after the expiry date stated on the container. The expiry date is the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Argenpal

The active substance is silver nitrate. Each cutaneous stick contains 42.5 mg of silver nitrate.

The other components are: potassium nitrate.

Appearance of the medicinal product and content of the container

Cutaneous stick.

Plastic rod of approximately 2.4 mm diameter and 9.5 cm length, with a tip of the product at one end, white or greyish white in colour.

It is presented in an amber-coloured plastic tube containing 10 sticks.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Medical, S.A.

Ronda de los Olivares, Parcela II, Poligono Industrial Los Olivares

23009-Jaén

This summary of product characteristics was approved in February 2015

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