DIFUR 120 mg HARD CAPSULES

Introduction

PATIENT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS

Difur 120 mg hard capsules

Dry extract of Polypodium leucotomos L.

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

This medication can be obtained without a prescription. Nevertheless, to achieve the best results, it should be used properly.

Follow the administration instructions for the medication contained in this summary or as indicated by your doctor or pharmacist.

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

You should consult a doctor if your condition worsens or does not improve after 14 days of treatment.

Contents of the summary:

1. What Difur 120 mg hard capsules are and what they are used for
2. What you need to know before taking Difur 120 mg hard capsules
3. How to take Difur 120 mg hard capsules
4. Possible side effects
5. Storage of Difur 120 mg hard capsules
6. Package contents and additional information

1. What Difur 120 mg hard capsules are and what they are used for

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

2. Before taking Difur 120 mg hard capsules

Do not take Difur 120 mg hard capsules

If you are allergic (hypersensitive) to the extract of Polypodium 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 of age due to the lack of sufficient clinical information to support its safe and effective use.

Children from 6 to 12 years: Consult your doctor before starting treatment so that they can 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 obtained 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 food or medications that reduce stomach acidity or alcoholic beverages at the same time, as they may decrease its effect.

Pregnancy and breastfeeding

Safety during pregnancy and breastfeeding has not been established. As a precautionary measure, its administration is not recommended to women during pregnancy or breastfeeding.

Driving and using machines

The effect of Difur on the ability to drive and use machines is nil 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.

3. How to take Difur 120 mg hard capsules

It is a medication for oral use.

Follow the administration instructions for the medication contained in this summary or as 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 leucotomosextract 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 it.

Use in children from 6 to 12 years:

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

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

Method of administration

Difur is administered orally.

Take the capsules 30 minutes before each main meal, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Difur 120 mg hard capsules

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

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

4. Possible side effects

Like all medications, Difur can cause side effects, although not all people experience them.

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

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not described in this summary.

5. Storage of Difur 120 mg hard capsules

No special storage conditions are required.

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.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Difur 120 mg hard capsules

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

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

Appearance of the product and package contents

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

Marketing authorization holder:

Industrial Farmacéutica Cantabria, S.A.

Barrio Solia 30

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer:

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 summary was approved in March 2022

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