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ARGENPAL 42.5 mg CUTANEOUS BAR

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About the medicine

How to use ARGENPAL 42.5 mg CUTANEOUS BAR

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

ARGENPAL 42.5 mg skin stick

Silver nitrate

Read all of this leaflet carefully before you start using this medicine

  • Keep this leaflet, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Argenpal and what is it 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 mouth ulcers (aphthous ulcers),
  • Treatment of nasal bleeding originating from the anterior part of the nasal septum (anterior epistaxis).
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2. What you need to know before you use 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 wounded, infected, irritated, or reddened skin,
  • If you have moles, birthmarks, or other skin spots, genital warts, facial warts, or mucosal warts. Healthcare personnel will not apply Argenpal to the anogenital area or to extensive areas.

Warnings and precautions

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

Treatment with silver nitrate produces a black stain on the skin that disappears over time. Healthcare personnel will not repeatedly apply silver nitrate to the same spot, as the stain may become permanent.

In the treatment of nasal bleeding (anterior epistaxis), healthcare personnel will be careful not to apply the medicine to the same place on both sides of the nasal septum, to avoid possible perforation of the septum.

If any problems occur, administration will be interrupted.

Other medicines and Argenpal

Tell your doctor or pharmacist if you are using or have recently used any other medicines.

It should not be used in conjunction with other medicines in the same area.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess the risk-benefit ratio of using Argenpal, as the efficacy and safety of using silver nitrate in pregnant women are unknown and may affect reproductive capacity.

Driving and using machines

There is no evidence of effects on the ability to drive vehicles or use machines.

Medicine questions

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3. How to use Argenpal

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

Each Argenpal skin stick is for single use and application.

With the Argenpal skin stick previously moistened in water for a few seconds, the area to be treated should be brushed for a few seconds, trying to limit its application to the affected area, to avoid the appearance of unnecessary black stains on the skin.

It is recommended to protect the surrounding healthy skin with an oily ointment or cream, such as petroleum jelly.

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, which will depend on the degree of action desired.

If you use more Argenpal than you should

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

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

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

For the treatment of poisoning, your doctor will use sodium chloride, followed by stomach lavage or emetic medications (which induce vomiting) or milk or other demulcents (substances that mimic the protective action of mucous membranes) in abundance. For pain and nervous irritability, pentobarbital sodium (a hypnotic) will be administered at a dose of 0.2 g intravenously, and if necessary, cardiotonics (medications that increase heart rate) will be used, and artificial respiration will be applied to maintain vital signs.

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

Disorders of the skin and subcutaneous tissue:

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

Argenpal may be irritating, causing skin inflammation (dermatitis), redness, burns, skin discoloration, or bluish-gray skin discoloration (argyria) that disappears over time. After prolonged exposure, skin discoloration or stains may become permanent.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE Circular symbol with a black cross in the center and a curved arrow indicating clockwise rotation collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Argenpal

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

The other ingredients are: potassium nitrate.

Appearance of the product and packaging contents

Skin stick.

Plastic rod approximately 2.4 mm in diameter and 9.5 cm in length with a product head at the end, white or grayish-white in color.

It is presented in a topaz-colored plastic tube containing 10 skin 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 leaflet was approved in February 2015

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

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Frequently Asked Questions

Is a prescription required for ARGENPAL 42.5 mg CUTANEOUS BAR?
ARGENPAL 42.5 mg CUTANEOUS BAR requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ARGENPAL 42.5 mg CUTANEOUS BAR?
The active ingredient in ARGENPAL 42.5 mg CUTANEOUS BAR is silver nitrate. This information helps identify medicines with the same composition but different brand names.
Who manufactures ARGENPAL 42.5 mg CUTANEOUS BAR?
ARGENPAL 42.5 mg CUTANEOUS BAR is manufactured by B Braun Medical S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ARGENPAL 42.5 mg CUTANEOUS BAR online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ARGENPAL 42.5 mg CUTANEOUS BAR is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ARGENPAL 42.5 mg CUTANEOUS BAR?
Other medicines with the same active substance (silver nitrate) include HYDROGEN PEROXIDE CUVE 30 mg/ml CUTANEOUS SOLUTION AND CONCENTRATE FOR ORAL SOLUTION, AGUA OXIGENADA FORET 3% cutaneous solution and concentrate for oral solution, ALCOMON REFORZADO 70º SKIN SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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