Label: information for the user

Sor Virginia Adhesive Medicament, arriñonada

Extract ofCapsicum frutescens

Read this label carefully before starting to use this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

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

1. What is Sor Virginia and for what it is used

2. What you need to know before using Sor Virginia

3. How to use Sor Virginia

4. Possible adverse effects

5. Conservation of Sor Virginia

6. Contents of the package and additional information

Sor Virginia is an adhesive medicated plaster that belongs to the group of medications “Preparations with capsaicin and similar agents”, which produce a sensation of heat and reduce the sensation of pain in the area of application.

This medication is indicated for local treatment of muscle pain, such as lower back pain.

Do not use Sor Virginia:

• If you are allergic (hypersensitive) to capsaicinoid extract or any other component of the patch.
• Do not apply the patch on injured or open skin.
• Do not apply the patch near the eyes or mucous membranes.

Warnings and precautions

• Consult your doctor before using the patch if the pain is accompanied by skin redness, swelling, or heat in the joints, persistent joint discomfort, severe back pain that radiates to the legs, associated or not with numbness and tingling sensation.
• It is recommended not to scratch the area of application to avoid skin injuries.
• Avoid applying other heat sources (such as heating pads) during treatment. Treatment should be interrupted if excessive heat is felt.

Children

• It is not recommended for use in children under 12 years old.

Use of Sor Virginia with other medications

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

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

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

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

Pregnancy and breastfeeding

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

Driving and operating machines

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 medicated adhesive patch for topical use. It is applied directly to the painful area, adhering to dry and unbroken skin. Remove the backing from the patch and place it on the skin with the adhesive side facing the skin, in the painful area where it should be kept for at least 4 hours and up to a maximum of 8 hours.

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

In case of need, if the pain continues, new patches can be applied, leaving a minimum interval of 12 hours before using a new patch.

Treatment duration

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

If symptoms persist, as well as if any other reaction not described in this 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 Toxicological Information Service, phone 91 562 04 20.

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

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

The active ingredient of the dressing usually causes an increase in blood flow with pronounced redness of the skin, which is part of the pharmacological action of the medication and generally disappears shortly after the dressing is removed.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear 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.

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

Composition of Sor Virginia

• The active principle is 236.9 mg of cayenne pepper extract (Capsicum frutescens), which corresponds to 5.2 mg of capsaicin per patch.
• The other components are: sweet almond oil, lavender essential oil, romero essential oil, acrylic/acrilonitrile 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 contents of the packaging

Sor Virginia medicated adhesive patch, arriñonada is a medicated adhesive patch with a surface area of 329 cm2(12.8 cm x 15.0 cm x 25.5 cm), manufactured on a fabric support, with a silicone paper cover, and packaged in a hermetically sealed paper/polyethylene/aluminum/polyethylene envelope.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios HARTMANN, S.A.

Carrasco i Formiguera, 48

08302 Mataró (Barcelona)

Last review date of this leaflet: March 2014

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