Sor Virginia Aposito medicated adhesive patch, rectangular

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sor Virginia Medicinal Adhesive Patch, Rectangular

Extract of Capsicum frutescens

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for using this medicine contained in this leaflet or those provided by your doctor or pharmacist.

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

Contents of the 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 adverse effects
5. Storage of Sor Virginia
6. Contents of the pack and other information

1. What Sor Virginia medicated adhesive patch, rectangular, is and what it is used for

Sor Virginia is a medicated adhesive patch belonging to the group of medicines called "Capsicum and similar agents", which produce a warming sensation and reduce the feeling of pain in the area of application.

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

2. What you need to know before using Sor Virginia

Do not use Sor Virginia:

• If you are allergic (hypersensitive) to the soft extract of cayenne pepper, other sources of capsaicinoids, or to any of the other components of the patch.
• Do not apply the patch to damaged skin or 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 pain is accompanied by redness of the skin, swelling or warmth in the joints, persistent joint discomfort, severe back pain radiating to the legs, with or without numbness and tingling sensations.
• It is recommended not to scratch the application area to avoid skin injury.
• Avoid applying other heat sources (such as heating pads) during treatment. Treatment should be discontinued if excessive heat is felt.

Children

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

Use of Sor Virginia with other medicines

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

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

Prior application of other pain-relief products to the same area may alter the effect of this patch.

Interactions with other products applied to the same treatment area may occur even several hours after removing the patch. Wait at least 12 hours before using any other product on the same site 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 use of machines

No effects on driving and use of machines have been reported.

3. How to use Sor Virginia

Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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 cutaneous use. It is applied directly to the painful area, adhering it to dry, intact skin. Remove the protective liner and apply the patch with the adhesive side in contact with the skin, on 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 one corner and carefully peel it off.

If necessary, and if pain persists, new patches may be applied, leaving a minimum interval of 12 hours before using a new patch.

Duration of treatment

Use a maximum of 1 patch per day, for up to 7 days.

If symptoms persist or if you notice any adverse reaction not described in this leaflet, 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 or pharmacist, or call the Toxicology Information Service at 91 562 04 20.

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

4. Possible adverse effects

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

The active ingredient in the patch usually causes increased blood flow with marked skin reddening, which is part of the medicine's pharmacological action and generally disappears shortly after removing the patch.

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

Rare adverse effects (may affect up to 1 in 1,000 people): occurrence of skin allergic reactions (such as hives or blistering); in these cases, treatment must be discontinued.

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 through 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 Sor Virginia

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Sor Virginia

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

Appearance of the medicinal product and contents of the pack

Sor Virginia medicated adhesive patch, rectangular, is an adhesive patch with a surface area of 120 cm² (10 cm x 12 cm). It is manufactured on a fabric support, with a silicone paper cover, and is supplied in a sealed pouch made of paper/polyethylene/aluminum/polyethylene.

Marketing Authorization Holder and Manufacturer

Laboratorios HARTMANN, S.A.

Carrasco i Formiguera, 48

08302 Mataró (Barcelona)

Date of the most recent review of this leaflet: March 2014

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/