Label: information for the user

Sensedol 0.075% cream

Extract ofCapsicum annuumL. (equivalent to 0.075% capsaicin)

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

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Sensedolcontains capsaicin oil resinfrom Capsicum annuum L.a local anesthetic active principle.

It is indicated for the relief of moderate to severe pain in diabetic painful neuropathy that interferes with daily activities and has not responded to other treatment in adults.

No use Sensedol

If you are allergic to the oleoresin ofCapsicum annuumL.or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Sensedol.

This treatment must be initiated and supervised by the specialist treating the diabetic patient. This medication is for exclusive external use. Do not apply it to irritated skin or wounds. The product is highly irritating. Avoid contact with the eyes and mucous membranes. To do this, it is recommended to wash your hands thoroughly with cold water and soap immediately after each application, and unless your doctor explicitly indicates otherwise, avoid applying the cream near the eyes or in mucous membranes (such as the mouth). Contact with the eyes or other mucous membranes may cause a burning sensation. In case of occurrence, the area will be washed with plenty of cold water.

If the treated area is the hands, patients should not wash them for at least 30 minutes after application. During this time, accidental contact with sensitive areas should be monitored.

If the pain persists or worsens after the first 2 weeks of treatment, or if it disappears and returns a few days later, or if excessive irritation appears, interrupt treatment and consult your doctor.

Do not apply heat or tight bandages to the area. Do not use for a prolonged period or in extensive areas.

Children and Adolescents

Not recommended.

Other Medications and Sensedol

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

The possible interactions of this medication with other topical medications are unknown.

Given that this is a topical product, no interactions with other systemic medications are expected.

Pregnancy and Breastfeeding

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

If you are pregnant, your doctor will determine whether it is advisable to start this treatment.

Similarly, if you are breastfeeding, it will also be your doctor who determines whether it is advisable to start treatment with this medication.

Driving and Operating Machines

The use of this medication does not affect the ability to drive and operate machines.

Sensedol contains cetomacrogol, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), and propylene glycol (E-1520)

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol.

This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219) and propyl parahydroxybenzoate, sodium salt (E‑217).

This medication contains 50 mg of propylene glycol in each gram of cream.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Use in adults and elderly patients

The recommended dose is three or four applications per day for 8 weeks, after which your doctor will determine whether to suspend or continue treatment.

Use in children and adolescents

Not recommended.

Sensedol is a topical medication for external use only. It will be applied to the painful skin areas.

Instructions for correct administration

The tube must be pierced before its first use. Pierce the tube and apply following the instructions below:

Follow these instructions unless your doctor has given you different instructions.

Apply the minimum amount of cream necessary to cover the affected skin area.

Spread the cream with a gentle massage until it is fully absorbed, avoiding any residue, as indicated in Figure 6 of Section 3.

It is essential to make daily applications.

The treatment duration will be 8 weeks, after which your doctor will determine whether to suspend or continue treatment.

Your doctor will inform you of the duration of your treatment with Sensedol.

If you use more Sensedol than you should

Acute poisoning is almost impossible with the proper use of this medication.

In case of overdose or accidental ingestion, or eye contact, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to useSensedol

Do not make a double application to compensate for the missed doses.

Continue treatment with the recommended dosage.

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

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

During the first few days of treatment, a burning or stinging sensation on the skin at the application site may occur in approximately 50% of cases. This known reaction is a consequence of the pharmacological action of capsaicin, which releases substance P from peripheral nerve endings and accumulates in the synapse, and usually disappears or decreases over time as treatment continues at the recommended dose, without the need to interrupt it. Its duration and intensity are variable but may be prolonged ifSensedolis applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible adverse effects on the skin may be irritative erythema and dry skin at the application site.

During treatment, other adverse effects such as sneezing, tearing, or coughing (less than 2%) may also appear, as a result of inhaling dry cream residues. Therefore, it is essential to apply the minimum amount of cream necessary and avoid leaving any residue on the skin, as well as washing hands with cold water and soap after use.

Reporting 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 prospectus. You can also report them directly through theSpanish 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 this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment..

Composition of Sensedol

• The active principle is the oleoresin ofCapsicum annuumL. Each 100 grams of Sensedol 0.075% cream contains312 - 625 mg ofoleoresin ofCapsicum annuumL. equivalent to 75 mg of capsaicin.
• The other components (excipients) are:stearic acid; cetyl alcohol; oleic alcohol; isopropyl myristate; glyceryl monostearate; polyethylene glycol monostearate; methyl parahydroxybenzoate, sodium salt (E-219); propyl parahydroxybenzoate, sodium salt (E-217); propylene glycol (E-1520); purified water.

Appearance of the product and contents of the packaging

Sensedolis a cream of white-yellowish color.

This medication is available in packaging of 30 and 50 grams.

Holder of the marketing authorization and responsible for manufacturing

Centrum Pharmaceutical Specialties, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Asacpharma Group

Last review date of this leaflet:March 2019.

Other sources of information

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