Ipsodol 0.075% cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ipsodol 0.075% cream
Oleoresin of Capsicum annuum L. (equivalent to 0.075% capsaicin)
Read this entire leaflet carefully before you start using this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ipsodol cream is and what it is used for
- What you need to know before using Ipsodol cream
- How to use Ipsodol cream
- Possible adverse effects
- How to store Ipsodol cream
- Contents of the pack and other information
1. What Ipsodol cream is and what it is used for
Ipsodol cream contains oleoresin from Capsicum annuum L., which is a locally acting anesthetic active substance.
It is used 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 Ipsodol cream
Do not use Ipsodol 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 Ipsodol cream.
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. This medicine 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 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.
Use of Ipsodol with other medicines
Possible interactions of this product with other topical medicines are unknown.
As this is a topical medicine, interactions with systemic medicines are not expected.
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use 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 it is appropriate to start this treatment.
Likewise, if you are breastfeeding, your doctor will determine whether it is appropriate to start treatment with this medicine.
Driving and use of machines
This medicine does not affect the ability to drive or operate machinery.
Ipsodol contains propylene glycol (E-1520), cetyl alcohol, sodium methylparahydroxybenzoate (E-219), and sodium propylparahydroxybenzoate (E-217).
This medicine contains 5 g of propylene glycol (E-1520) per 100 g of cream. Propylene glycol may cause skin irritation.
It may cause allergic reactions (possibly delayed) due to the presence of sodium methylparahydroxybenzoate (E-219) and sodium propylparahydroxybenzoate (E-217).
This medicine may cause local skin reactions (such as contact dermatitis) due to the presence of cetyl alcohol.
3. How to use Ipsodol cream
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Ipsodol cream is a medicine for external cutaneous use only. It should be applied to the painful areas of the skin.
Use in adults and elderly patients:
The usual dose is three or four applications per day for 8 weeks, after which your doctor will determine whether to discontinue or continue treatment.
Use in children:
Not recommended.
Follow these instructions unless your doctor has given you different advice.
Apply the smallest amount of cream necessary to cover the affected area of skin.
Spread the cream with a gentle massage until completely absorbed, avoiding 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 advise you on the duration of your treatment with Ipsodol cream.
If you use more Ipsodol cream than you should
Acute intoxication is practically impossible with proper use of the medicine.
In case of overdose or accidental ingestion, or contact with 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 Ipsodol cream
Do not apply a double dose to make up for missed doses.
Continue 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, Ipsodol cream 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 accumulates at the synapse. This sensation usually diminishes or disappears over time as treatment continues at the recommended dose, without the need to discontinue therapy. Its duration and intensity may vary and may persist if Ipsodol cream 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 irritant 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 residue on the skin, and wash hands thoroughly with cold water and soap after use.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ipsodol cream
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Package contents and additional information
Composition of Ipsodol 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, cetyl alcohol, methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), purified water.
Appearance of Ipsodol and package contents
Yellowish-white cream.
Package contents: 30 and 50 grams.
Marketing Authorization Holder
ANGELINI PHARMA ESPAÑA, S.L.
C/ Antonio Machado, 78-80
3rd floor, module A - Edificio Australia
08840 Viladecans, Barcelona (Spain)
Manufacturer
Especialidades Farmacéuticas Centrum, S.A.
C/ Sagitario, nº 14
03006 – Alicante (Spain)
Date of the most recent review of this leaflet: August 2013
Detailed and up-to-date 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