Leaflet: information for the user

ARGENPAL 42.5 mg cutaneous bar

Silver nitrate

6. Contents of the pack and additional information

Argenpalbelongs to the group of medications known as antiseptics and disinfectants. It is used in the following cases:

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

Do not use Argenpal:

• If you are allergic (hypersensitive) to silver nitrate or any of the other components of this medication (listed in section 6).
• If you have injured, infected, irritated, or inflamed skin,
• If you have moles, birthmarks, or other skin marks, genital warts, facial warts, or mucosal warts. The healthcare staff will not apply Argenpal to the anogenital region or extensive areas.

Warning and precautions

Silver nitrate is a corrosive substance that should be applied only to the damaged area, avoiding unnecessary stains on the skin.

The treatment with silver nitrate produces a black stain on the skin that disappears over time. The healthcare staff will not apply it repeatedly to the same point, as the stain may become permanent.

In the treatment of anterior nasal bleeding (epistaxis), the healthcare staff will take precautions not to apply the medication to the same place on both sides of the nasal septum, to avoid possible perforations.

In case of any problem, administration will be interrupted.

Other medications and Argenpal

Inform your doctor or pharmacist if you are using or have used, recently taken, or may need to use any other medication.

Do not use it with other medications in the same area.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machines

No evidence of effects on the ability to drive vehicles or operate machines

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

Each cutaneous bar of Argenpal is for single use and application.

With the cutaneous bar of Argenpal previously moistened in water for a few seconds, the affected area should be patted with the bar for a few seconds, limiting the application to the affected area to avoid unnecessary black spots on the skin.

It is recommended to protect the healthy skin around the lesion with a moisturizing cream or ointment, for example, vaseline.

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

The application should be performed exclusively by the doctor and for a brief period of time, which will depend on the desired degree of action..

If you use more Argenpal than you should

Due to its application on the skin, Argenpal bars are not toxic if used properly, as silver nitrate is normally not absorbed. In case of absorption, silver nitrate poisoning can be acute or chronic.

Chronic silver nitrate poisoning develops slowly and is due to the continuous absorption and penetration of silver compounds into the mucous membranes. It is characterized by the appearance of a bluish-gray discoloration of the skin (argyria).

Accidental or voluntary ingestion of silver nitrate may cause throat and stomach pain, acute gastroenteritis, nausea, vomiting, diarrhea, dizziness, weak and rapid pulse, shallow breathing, and convulsions.

To treat poisoning, your doctor will use sodium chloride, followed by stomach lavage or emetics (induce vomiting) or abundant milk or other demulcents (substances that imitate the protective action of mucous membranes). For pain and nervous irritability, pentobarbital sodium (hypnotic) will be administered at a dose of0.2 gintravenously and, if necessary, cardiotonics (medicines that increase heart rate) and artificial respiration to maintain vital constants.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:91 562 04 20, indicating the medication and the amount ingested.

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

The following adverse effects have been observed:

Dermatological and Subcutaneous Tissue Disorders:

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

Argenpal may cause skin irritation leading to inflammation (dermatitis), redness, burns, skin discoloration, or a bluish-gray skin discoloration (argyria) that disappears over time. Prolonged exposure may result in permanent skin discoloration or skin marks.

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

Keep out of sight and reach of children.

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

Do not use Argenpal after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Argenpal

The active ingredient is silver nitrate. Each skin bar contains 42.5 mg of silver nitrate.

The other components are: potassium nitrate.

Appearance of the product and content of the packaging

Skin bar.

Plastic rod approximately 2.4 mm in diameter and 9.5 cm in length with a product head at the end of white or light gray color.

It is presented in a topaz-colored plastic tube containing 10 bars.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

B. Braun Medical, S.A.

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

23009-Jaén

This prospectus was approved in February 2015

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es.