Sor Virginia is a medicated adhesive dressing that belongs to the group of drugs "Prepared 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 in the local treatment of muscle pain, such as low back pain.

Do not use Sr. Virginia:

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

Warnings and cautions

• Consult your doctor before using the dressing if the pain is accompanied by redness of the skin, swelling or warmth in the joints, permanent discomfort of the joints, severe back pain that spreads to the legs, associated or not with numbness and Tingling sensation.
• It is recommended not to scratch in the area of application, to avoid skin injuries.
• Avoid applying other heat sources (such as heating pads) during treatment. Treatment should be stopped if excessively hot is felt.

Children

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

Using Sor Virginia with other medications

Tell your doctor or pharmacist if you are using, have recently used or might take any other medicine.

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

Previous application of other pain relief products to the same area of application may cause changes in the effect of this dressing.

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

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning 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 the use of machines.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is 1 dressing per day.

Route and method of administration

Sor Virginia is a medicated adhesive dressing for skin use. It is applied directly to the painful region, adhering it to dry and non-injured skin. The dressing cover is detached and placed with the adhesive side towards the skin, in the painful area where it must be kept for at least 4 hours and up to a maximum of 8 hours.

To remove the dressing, lift one corner and carefully pull the dressing.

If necessary, if the pain continues, new dressings can be applied, allowing a minimum interval of 12 hours before the use of a new dressing.

Treatment duration

A maximum of 1 dressing per day will be used, up to a maximum of 7 days of treatment duration.

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

If you use more Sister Virginia than you should:

Overdose is unlikely.

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

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

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

The active substance in the dressing usually causes increased blood flow with pronounced redness of the skin, which in turn is part of the pharmacological action of the medicine and usually disappears within a short time after the dressing is removed.

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

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

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: www.notificaRAM.es . By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

It does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Sr. Virginia

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

What the product looks like and contents of the pack

Sister Virginia medicated adhesive dressing, rectangular is an adhesive dressing that has a surface area of 120 cm 2 (10 cm x 12 cm), is manufactured on a cloth backing, covered with silicone paper and is packaged in an airtight envelope paper / polyethylene / aluminum / polyethylene.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios HARTMANN , SA

Carrasco i Formiguera, 48

08302 Mataró (Barcelona)

Date of last revision of this leaflet: March 2014

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