IPSODOL 0.075% CREAM

Introduction

Package Leaflet: Information for the User

Ipsodol 0.075% Cream

Oleoresin of Capsicum annuumL.(equivalent to 0.075% capsaicin)

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

• Keep this package leaflet, as you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ipsodol cream and what is it used for
2. What you need to know before using Ipsodol cream
3. How to use Ipsodol cream
4. Possible side effects
5. Storage of Ipsodol cream
6. Contents of the pack and further information

1. What is Ipsodol cream and what is it used for

Ipsodol cream contains oleoresin of Capsicum annuumL., which is a local anesthetic active ingredient.

It is used for the relief of moderate to severe pain in diabetic neuropathic pain 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 oleoresin of Capsicum annuum L.or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ipsodol cream.

This treatment should be initiated and supervised by the specialist who treats the diabetic patient. This preparation is for external use only. Do not apply to irritated skin or wounds. This medicine is highly irritating. Avoid contact with eyes and mucous membranes. To do this, it is recommended to always wash your hands well with cold water and soap immediately after each application, and unless indicated by the doctor, application of the cream near the eyes or on mucous membranes (e.g., the mouth) should be avoided. Contact with the eyes or other mucous membranes can cause a burning sensation. If this occurs, the area should be washed with plenty of cold water.

When 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 after a few days, or excessive irritation appears, treatment should be discontinued and the doctor consulted.

Do not apply heat or tight bandages to the area. Do not use for prolonged periods or on large areas.

Using Ipsodol with other medicines

Possible interactions of this specialty with other topical medicines are not known.

As it is a medicine for cutaneous use, interactions with other systemic medicines are not expected.

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Pregnancy and Breastfeeding

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

If you are pregnant, your doctor will determine the suitability of starting this treatment.

Similarly, if you are breastfeeding, your doctor will determine the suitability of starting treatment with this medicine.

Driving and Using Machines

The use of the medicine does not alter the ability to drive and use machines.

Ipsodol contains propylene glycol (E-1520), cetyl alcohol, methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (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) because it contains methyl parahydroxybenzoate, sodium salt (E-219), and propyl parahydroxybenzoate, sodium salt (E-217).

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

3. How to use Ipsodol cream

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

Ipsodol cream is a medicine for external cutaneous use only. It will be applied to the painful areas of the skin.

Use in adults and elderly:

The normal dose is three or four applications per day for 8 weeks, after which the 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 important to make daily applications.

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

Your doctor will indicate 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 the eyes, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 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 forgotten 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 side effects

Like all medicines, Ipsodol cream can cause side effects, although not everybody gets them.

During the first few days of treatment, a burning or itching sensation may appear in the application area in approximately 50% of cases. This reaction, which is known, is a consequence of the pharmacological action of capsaicin, releasing substance P from peripheral nerve endings and accumulating 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 cream is applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion may intensify this sensation. Other possible side effects at the skin level may be irritative erythema and dryness of the skin at the application site.

During treatment, estornudos, lacrimation, or cough (less than 2%) may also appear, as a consequence of inhaling dry cream residues. Therefore, it is important to apply the minimum amount of cream necessary and avoid leaving residues on the skin, as well as washing hands with cold water and soap after use.

If you consider that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es.

By reporting side 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 expiration date stated on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ipsodol cream

• The active ingredient is oleoresin of Capsicum annuumL. Each 100 grams of cream contains oleoresin of Capsicum annuumL. (312-625 mg) equivalent to 75 mg of capsaicin.

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

Appearance of Ipsodol and contents of the pack

White-yellowish cream.

The pack contains 30 and 50 grams.

Marketing authorization holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, nº 14

03006 – Alicante (Spain)

Date of the last revision of this package leaflet:August 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es