PATIENT INFORMATION LEAFLET

Difur 120 mg Hard Capsules

Dried extract ofPolypodium leucotomos L.

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not described in this leaflet.

You should consult a doctor if you get worse, or if you do not improve after 14 days of treatment.

Difur is a traditional herbal medicinal product for the relief of symptoms associated with mild to moderate skin inflammatory processes, based exclusively on its traditional use.

Do not take Difur 120 mg hard capsules

If you are allergic (hypersensitive) to the extract ofPolypodium leucotomosL. or to any of the other components of the medication.

Warnings and precautions

Consult your doctor or pharmacist before using any medication.

In case of fever, infectious diseases, hypertension, or heart failure, consult your doctor before taking the medication.

Use in children

The use of the medication is not recommended in children under 6 years old due to the lack of sufficient clinical information to validate its safe and effective use.

Children aged 6 to 12 years: Consult your doctor before starting treatment to assess the clinical situation.

Use of Difur 120 mg hard capsules with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Difur 120 mg hard capsules with food and beverages

Difur should be taken 30 minutes before meals, avoiding the ingestion of foods or medications that reduce stomach acidity or alcoholic beverages at the same time, as they may reduce its effect.

Pregnancy and breastfeeding

The safety during pregnancy and breastfeeding has not been established. As a precaution, its administration is not recommended in women during pregnancy or breastfeeding.

Driving and operating machines

The effect of Difur on the ability to drive and operate machines is negligible or insignificant.

Important information about some of the components of Difur 120 mg hard capsules

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This is an oral medication.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Dosage

Use in adults and adolescents:The recommended dose is 1 capsule (120 mg)/3 times a day, which is equivalent to 360 mg of Polypodium leucotomos extract per day.

If necessary, an additional capsule may be administered, preferably at night.

The recommended treatment duration is 4 weeks. After this period, consult your doctor about the convenience of continuing treatment.

Use in children aged 6 to 12 years:

The recommended dose is 120 mg (1 capsule)/2 times a day, which is equivalent to 240 mg of Polypodium leucotomos extract per day.

If symptoms persist or worsen two weeks after starting treatment, consult your doctor.

Administration form

Difur is administered orally.

Take the capsules 30 minutes before each of the main meals, whole, with the help of some liquid.

If you take more Difur 120 mg hard capsules than you should

If you have taken more Difur 120 mg hard capsules than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Difur 120 mg hard capsules

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Difur may cause adverse effects, although not all people will experience them.

With a very rare frequency (affecting less than 1 in 10,000 patients) may appear stomach discomfort, skin rash, and itching.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

No requires special conditions for conservation.

Keep out of sight and reach of children.

Do not use Difur 120 mg Hard Capsules after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Difur 120 mg Hard Capsules

• The active ingredient is the extract of Polypodium leucotomos L. . Each hard capsule contains 120 mg of dried rhizome extract of Polypodium leucotomos L (DER native 4-6:1) corresponding to 2.5-6.25 mg of quinic acid. Extraction solvent: Ethanol 12.5% V/V.

The other components are: Capule content : cornstarch, anhydrous lactose, and magnesium stearate (E-572). Capule coating : gelatin, erythrosine (E-127), quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance of the product and contents of the package

Difur is presented in the form of hard gelatin capsules with an orange-colored cap and a white-colored body, packaged in PVC-aluminum blisters, in containers containing 24 or 96 capsules.

Holder of the marketing authorization:

Industrial Farmacéutica Cantabria, S.A

Barrio Solia 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for manufacturing:

Toll Manufacturing Services, S.L.

Aragoneses nº 2 ,

28108 Alcobendas (Madrid) - Spain

or

Industrial Farmacéutica Cantabria, S.A

C/Pirita, 9. - Torrejón de Ardoz

28850 (Madrid)

Spain

This leaflet was approved in March 2022

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