Sensedol 0.075% cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sensedol 0.075% cream
Oleoresin of Capsicum annuum L. (equivalent to capsaicin 0.075%)
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Sensedol is and what it is used for
- What you need to know before using Sensedol
- How to use Sensedol
- Possible adverse effects
- How to store Sensedol
- Contents of the pack and other information
1. What Sensedol is and what it is used for
Sensedol contains oleoresin of Capsicum annuum L., which is a locally acting anesthetic active substance.
It is indicated for the relief of moderate to severe pain in painful diabetic neuropathy that interferes with daily activities and has not responded to other treatments in adults.
2. What you need to know before using Sensedol
Do not use Sensedol
If you are allergic to the oleoresin of Capsicum annuum L. or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Sensedol.
This treatment should be initiated and supervised by the specialist managing the diabetic patient. This medicine is for external cutaneous use only. Do not apply on irritated skin or open wounds. The product is highly irritating. Avoid contact with eyes and mucous membranes. For this reason, it is recommended to always wash your hands thoroughly with cold water and soap immediately after each application. Unless specifically directed by your doctor, avoid applying the cream near the eyes or on mucous membranes (for example, the mouth). Contact with the eyes or other mucous membranes may cause a burning sensation. If this occurs, rinse the affected area thoroughly with abundant cold water.
When treating the hands, patients should not wash them for at least 30 minutes after application. During this time, care must be taken to avoid accidental contact with sensitive areas.
If pain persists or worsens after the first 2 weeks of treatment, or if pain disappears and reappears after a few days, or if excessive irritation occurs, discontinue treatment and consult your doctor.
Do not apply heat or tight bandages to the treated area. Do not use for prolonged periods or over large areas.
Children and adolescents
Not recommended.
Other medicines and Sensedol
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Possible interactions of this medicine with other topical medicines are not known.
As this is a topical product, interactions with systemic medicines are not expected.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
If you are pregnant, your doctor will decide whether or not it is appropriate to start this treatment.
Likewise, if you are breastfeeding, your doctor will also decide whether or not it is appropriate to start treatment with this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Sensedol contains cetyl alcohol, methylparahydroxybenzoate, sodium salt (E-219), propylparahydroxybenzoate, sodium salt (E-217), and propylene glycol (E-1520)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medicine may cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate, sodium salt (E-219) and propylparahydroxybenzoate, sodium salt (E-217).
This medicine contains 50 mg of propylene glycol in each gram of cream.
3. How to use Sensedol
Follow exactly the administration instructions for this medicine as given by your doctor. If in 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 the doctor will determine whether to discontinue or continue treatment.
Use in children and adolescents
Not recommended.
Sensedol is a cutaneous medicine for external use only. It should be applied to the painful areas of the skin.
Instructions for correct administration
The tube must be pierced before first use. Pierce the tube and apply as per the following instructions:
Follow these instructions unless your doctor has given you different ones.
Apply the minimum amount of cream necessary to cover the affected area of skin.
Spread the cream with a gentle massage until completely absorbed, ensuring no residue remains, as shown in figure 6 of section 3.
It is important to apply the cream daily.
The duration of treatment will be 8 weeks, after which the doctor will determine whether to discontinue or continue treatment.
Your doctor will advise you on the duration of your treatment with Sensedol.
If you use more Sensedol than you should
Acute intoxication is practically impossible with proper use of this medicine.
In case of overdose or accidental ingestion, or contact with the eyes, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Sensedol
Do not apply a double dose to make up for missed doses.
Continue your treatment with the recommended dosage.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
During the first days of treatment, a sensation of burning or stinging on the skin at the application site may occur in approximately 50% of cases. This known reaction is due to the pharmacological action of capsaicin, which releases substance P from peripheral nerve endings and leads to its accumulation at the synapse. This sensation usually diminishes or disappears over time as treatment continues at the recommended dose, without the need to discontinue treatment. Its duration and intensity are variable but may be prolonged if Sensedol is applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible cutaneous adverse effects may include irritative erythema and dryness of the skin at the application site.
During treatment, sneezing, lacrimation, or cough (less than 2%) may also occur, but much less frequently, as a result of inhaling dried cream residues. Therefore, it is important to apply the smallest necessary amount of cream, avoid leaving any residue on the skin, and wash hands with cold water and soap after use.
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 via 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 Sensedol
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sensedol
- The active substance is oleoresin from Capsicum annuum L. Each 100 grams of Sensedol 0,075% cream contains 312 - 625 mg of oleoresin from Capsicum annuum L., equivalent to 75 mg of capsaicin.
- The other components (excipients) are: stearic acid; cetostearyl alcohol; oleic alcohol; isopropyl myristate; glycerol monostearate; polyethylene glycol monostearate; methylparahydroxybenzoate, sodium salt (E-219); propylparahydroxybenzoate, sodium salt (E-217); propylene glycol (E-1520); purified water.
Appearance of the product and contents of the pack
Sensedol is a yellowish-white cream.
This medicine is available in packs of 30 and 50 grams.
Marketing Authorization Holder and Manufacturer
Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario, 14
03006 Alicante (Spain)
Grupo Asacpharma
Date of the most recent revision of this leaflet: March 2019.
Other sources of information
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/