Label: information for the user

Ipsodol 0.075% cream

Oleoresin ofCapsicum annuumL.(equivalent to capsaicin 0.075%)

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

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they 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.

1. What isIpsodolcream and for what it is used

2. What you need to know before starting to useIpsodolcream

3. How to useIpsodolcream

4. Possible adverse effects

5. Storage ofIpsodolcream

6. Contents of the package and additional information

Ipsodol creamcontains capsaicin resin fromCapsicum annuumL., which is a local anesthetic active principle.

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

Do not use Ipsodol cream

If you are allergic to the oleoresin ofCapsicum annuum L.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 Ipsodol cream.

This treatment must be initiated and supervised by the specialist treating the diabetic patient. This preparation is for exclusive external use. Do not apply it to irritated skin or wounds. This medication 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 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 disappears and reappears a few days later, or 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.

Use of Ipsodol with other medications

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

Given that it is a topical medication, no interactions with other systemic medications are expected.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 machinery

The use of the medication does not alter the ability to drive and operate machinery.

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

This medication 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) because it contains methyl parahydroxybenzoate, sodium salt (E-219) and propyl parahydroxybenzoate, sodium salt (E-217).

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

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

Ipsodol creamis a medication for external use only on the skin. It will be applied to painful skin areas.

Use in adults and elderly people:

The usual 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:

Not recommended.

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.

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 Ipsodol cream.

If you use more Ipsodol cream than you should

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

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

If you forgot to use Ipsodol cream

Do not apply a double dose 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, Ipsodol creammay cause adverse effects, although not everyone will experience them.

During the first few days of treatment, you may experience a sensation of burning or itching on the skin at the application site in approximately 50% of cases. This reaction, known as, 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 if Ipsodol creamis 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, you may also experience, in much smaller proportions, sneezing, tearing, or coughing (less than 2%), as a consequence 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 your hands with cold water and soap after use.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 use this medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Composition of Ipsodol cream

• The active ingredient is the oleoresin ofCapsicum annuumL. Each100 gramsof cream containsOleoresin ofCapsicum annuumL.(312-625 mg) equivalent to 75 mg of capsaicin.

• The other components (excipients) are: monoestearate of polyethylene glycol, monoestearate of glyceryl, isopropyl myristate, propylene glycol (E-1520), oleic alcohol, stearic acid, cetyl alcohol, methyl parahydroxybenzoate, sodium salt (E-219), propyl parahydroxybenzoate, sodium salt (E-217), purified water.

Appearance of Ipsodol and content of the packaging

White-yellowish cream.

The content of the packaging is 30 and50 grams.

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, nº 14

03006 – Alicante (Spain)

Last review date of this leaflet:August 2013

The 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.gob.es