SOR VIRGINIA MEDICATED ADHESIVE DRESSING, RECTANGULAR

Introduction

Package Leaflet: Information for the User

Sor Virginia Medicinal Adhesive Patch, Rectangular

Extract of Capsicum frutescens

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What Sor Virginia is and what it is used for
2. What you need to know before using Sor Virginia
3. How to use Sor Virginia
4. Possible side effects
5. Storage of Sor Virginia
6. Package Contents and Additional Information

1. What Sor Virginia, Medicinal Adhesive Patch, Rectangular is and what it is used for

Sor Virginia is a medicinal adhesive patch that belongs to the group of medicines "Preparations with capsicum and similar agents", which produce a sensation of heat and reduce the sensation of pain in the area of application.

This medicine is indicated for the local treatment of muscle pain, such as lumbalgia.

2. What you need to know before starting to use Sor Virginia

Do not use Sor Virginia:

• If you are allergic (hypersensitive) to the soft extract of cayenne pepper, other sources of capsaicinoids, or any of the other components of the patch.
• Do not apply the patch to damaged skin and open wounds.
• Do not apply the patch near the eyes or on mucous membranes.

Warnings and Precautions

• Consult your doctor before using the patch if the pain is accompanied by redness of the skin, swelling, or heat in the joints, permanent joint discomfort, severe back pain that radiates to the legs, with or without numbness and tingling.
• It is recommended not to scratch the area of application to avoid skin lesions.
• Avoid applying other heat sources (such as heating pads) during treatment. The treatment should be interrupted if excessive heat is felt.

Children

• Its use is not recommended in children under 12 years of age.

Using Sor Virginia with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Do not use Sor Virginia in conjunction with other products in the same area of application.

The previous application of other products for pain relief in the same area of application may cause changes in the effect of this patch.

Interactions with other products applied to the same treatment area may occur even several hours after removing the patch. Allow at least 12 hours to pass before using any other product in the same place where the patch was applied.

Pregnancy and Breastfeeding

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.

Driving and Using Machines

No effects have been described that affect driving and using machines.

3. How to use Sor Virginia

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is 1 patch per day.

Route and Method of Administration

Sor Virginia is a medicinal adhesive patch for cutaneous use. It is applied directly to the painful area, adhering to dry, unbroken skin. The patch cover is removed and it is placed with the adhesive face towards the skin, in the painful area where it should remain for at least 4 hours and up to a maximum of 8 hours.

To remove the patch, lift a corner and carefully pull it off.

If necessary, if the pain continues, new patches can be applied, allowing a minimum interval of 12 hours before using a new patch.

Duration of Treatment

It will be used as a maximum of 1 patch per day, for a maximum duration of treatment of 7 days.

If symptoms persist, as well as if any other reaction not described in this package leaflet is observed, consult your doctor or pharmacist.

If you use more Sor Virginia than you should:

Overdose is unlikely.

If you have used more Sor Virginia than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

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

The active principle of the patch usually causes an increase in blood flow with pronounced redness of the skin, which in turn is part of the pharmacological action of the medicine and generally disappears shortly after removing the patch.

During the first days of treatment, itching, stinging sensations, or tingling may occur. If these symptoms seem excessive to you, you should interrupt the treatment.

Rare side effects (may affect up to 1 in 1000 people): appearance of cutaneous allergic reactions (such as hives or blistering), in these cases, the treatment should be interrupted.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package 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 contribute to providing more information on the safety of this medicine.

5. Storage of Sor Virginia

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Sor Virginia

• The active ingredient is 86.4 mg of cayenne pepper extract (Capsicum frutescens), which corresponds to 1.9 mg of capsaicin per patch.
• The other components are: essential oil of rosemary, essential oil of lavender, sweet almond oil, acrylic/acrilonitrile ester copolymer, and vinyl pyrrolidone copolymer. The support material is a polyester and cellulose fabric, and the cover is a silicone paper.

Appearance of the Product and Package Contents

Sor Virginia medicinal adhesive patch, rectangular, is an adhesive patch with a surface area of 120 cm2 (10 cm x 12 cm), manufactured on a fabric support, with a silicone paper cover, and presented in a hermetically sealed paper/polyethylene/aluminum/polyethylene envelope.

Marketing Authorization Holder and Manufacturer

Laboratorios HARTMANN, S.A.

Carrasco i Formiguera, 48

08302 Mataró (Barcelona)

Date of the Last Revision of this Package Leaflet: March 2014

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