Alacapsin 0.075% cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Alacapsin 0.075% Cream
Oleoresin of Capsicum annuum L (equivalent to 0.075% capsaicin)
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Alacapsin cream is and what it is used for
- What you need to know before using Alacapsin cream
- How to use Alacapsin cream
- Possible side effects
- How to store Alacapsin cream
- Contents of the pack and other information
1. What Alacapsin cream is and what it is used for
Alacapsin cream contains Capsicum annuum oleoresin, 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.
2. What you need to know before using Alacapsin cream
Do not use Alacapsin cream
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 Alacapsin.
This treatment should be initiated and supervised by the specialist managing the diabetic patient. This preparation is for external use only. Do not apply on irritated skin or 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 instructed by your doctor, avoid applying the cream near the eyes or on mucous membranes (e.g. mouth). Contact with the eyes or other mucous membranes may cause a burning sensation. If this occurs, rinse the affected area thoroughly with plenty of 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 it disappears and reappears a few days later, 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.
Other medicines and Alacapsin cream
Possible interactions of this product with other topical medicines are unknown.
As this is a topical product, interactions with systemic medicines are not expected.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 to start this treatment.
Likewise, if you are breastfeeding, your doctor will also determine whether or not it is appropriate to start treatment with this medicine.
Driving and use of machines
Alacapsin cream has no influence on the ability to drive or operate machinery.
Alacapsin cream contains cetyl alcohol, sodium methyl p-hydroxybenzoate (E-219), sodium propyl p-hydroxybenzoate (E-217), and propylene glycol (E-1520)
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol. It may also cause allergic reactions (possibly delayed) because it contains sodium methyl p-hydroxybenzoate (E-219) and sodium propyl p-hydroxybenzoate (E-217).
This medicine contains 5 mg of propylene glycol in each 100 mg.
3. How to use Alacapsin cream
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Alacapsin cream is a medicine for topical use, exclusively for external application. It should be applied to the painful areas of the skin.
Adults and elderly
The usual dose is three or four applications per day for 8 weeks, after which your doctor will decide whether to discontinue or continue treatment.
Use in children
Not recommended.
Follow these instructions unless your doctor has given you different ones.
Apply the smallest amount of cream necessary to cover the affected area of skin.
Spread the cream gently with a light massage until completely absorbed, taking care to avoid leaving any residue.
It is important to apply the cream daily.
The duration of treatment will be 8 weeks, after which your doctor will determine whether to discontinue or continue treatment.
Your doctor will indicate the duration of your treatment with Alacapsin cream.
If you use more Alacapsin than you should
Acute intoxication is practically impossible with proper use of the product.
In case of overdose or accidental ingestion, or contact with the eyes, contact 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 Alacapsin cream
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 will experience them.
During the first 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 due to the pharmacological action of capsaicin, which releases substance P from peripheral nerve endings and causes its accumulation at the synapse. This sensation usually diminishes or disappears over time as treatment continues at the recommended dose, without the need to interrupt treatment. Its duration and intensity may vary and may persist if Alacapsin cream is applied fewer than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible cutaneous adverse effects may include irritant erythema and dryness of the skin at the application site.
During treatment, sneezing, lacrimation, or cough (less than 2%) may also occur much less frequently, as a result of inhaling residues of dried cream.
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 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 Alacapsin cream
Keep this medicine out of the sight and reach of children.
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.
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 Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the package and other information
Composition of Alacapsin cream
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The active substance is oleoresin of Capsicum annuum L. Each 100 grams of cream contains Capsicum annuum L oleoresin (312–625) mg equivalent to 75 mg of capsaicin.
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The other components (excipients) are: polyethylene glycol monostearate, glyceryl monostearate, isopropyl myristate, propylene glycol (E-1520), oleyl alcohol, stearic acid, cetostearyl alcohol, sodium methyl p-hydroxybenzoate (E-219), sodium propyl p-hydroxybenzoate (E-217), purified water.
Appearance of the medicinal product and contents of the pack
Alacapsin cream is a yellowish-white cream. The pack contains 30 or 50 grams.
Marketing Authorization Holder
Alfasigma España, S.L.
C/ Aribau 195, 4º
08021 Barcelona. Spain
Manufacturer
Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario, 14
03006 – Alicante - Spain
Date of the most recent revision of this leaflet: April 2021
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/