DOLBAN 0.75 mg/g cream

Introduction

Package Leaflet: Information for the User

DOLBAN 0.75mg/g Cream

Oleoresin of Capsicum annuumL (equivalent to Capsaicin 0.75mg/g)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What DOLBAN is and what it is used for
2. What you need to know before you use DOLBAN
3. How to use DOLBAN
4. Possible side effects
5. Storing DOLBAN
6. Contents of the pack and other information

1. What DOLBAN is and what it is used for

DOLBAN contains oleoresin of Capsicum annuum, which is a local anesthetic active ingredient.

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 you use DOLBAN

Do not use DOLBAN

If you are allergic to oleoresin of Capsicum annuum L or to any of the other ingredients of this medicine.

Be cautious with DOLBAN:

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. The product 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 the doctor explicitly indicates otherwise, 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 rinsed 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 returns after a few days, or excessive irritation appears, discontinue treatment and consult your doctor.

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

Using other medicines:

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

As it is a topical product, interactions with other systemic medicines are not expected.

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Similarly, if you are breastfeeding, your doctor will determine the convenience 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.

Important information about some of the ingredients of DOLBAN:

As it contains propylene glycol, it may cause skin irritation.

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

3. How to use DOLBAN

Follow the administration instructions of DOLBANindicated by your doctor. Consult your doctor or pharmacist if you have doubts.

DOLBANis for cutaneous use only (to be applied only to the skin). It will be applied to the painful areas of the skin.

The normal dose is:

Adults and elderly:

Three or four daily applications for 8 weeks, after which the doctor will determine whether to suspend or continue treatment.

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 leaving 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 DOLBAN.

If you use more DOLBAN than you should:

Acute intoxication is practically impossible with the proper use of the specialty.

In case of overdose or accidental ingestion, or eye contact, 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 DOLBAN:

Do not apply a double dose to make up for forgotten doses.

Continue with the treatment according to the recommended posology.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, DOLBANcan cause side effects, although not everybody gets them.

During the first days of treatment, a burning or itching sensation may appear in the application area in a proportion close to 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 DOLBANis applied less than 3 or 4 times a day. Hot water, excessive sweating, or occlusion can intensify this sensation. Other possible side effects at the cutaneous level may be irritative erythema and dryness of the skin at the application site.

During treatment, sneezing, tearing, or coughing (less than 2%) may also appear as a consequence of inhaling dry cream residue. Therefore, it is important to apply the minimum amount of cream necessary and avoid leaving residue 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 leaflet, inform your doctor or pharmacist.

5. Storing DOLBAN

Keep out of the reach and sight of children.

Do not use DOLBANafter 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. Deposit the packaging and medicines you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of DOLBAN

• The active ingredient is oleoresin of Capsicum annuum L.

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, glycerol monostearate, isopropyl myristate, propylene glycol, oleic acid, stearic acid, cetyl alcohol, methylparaben sodium, propylparaben sodium, purified water.

Appearance of the product and contents of the pack

DOLBANis a cream with a yellowish-white color. The pack contains 30 and 50 grams.

Marketing authorization holder

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6 - 10

Pol. Ind. Del Henares 19180 Marchamalo. Guadalajara (Spain)

Manufacturer

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, nº 14

03006 – Alicante (Spain)

This leaflet was approved in May 2011

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.es/