Difur 120 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Difur 120 mg hard capsules
Dried extract of Polypodium leucotomos L.
Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.
This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.
Follow exactly the instructions for use provided in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
You should consult a doctor if you get worse, or if you do not improve after 14 days of treatment.
Leaflet contents:
- What Difur 120 mg hard capsules are and what they are used for
- What you need to know before taking Difur 120 mg hard capsules
- How to take Difur 120 mg hard capsules
- Possible adverse effects
- Storage of Difur 120 mg hard capsules
- Contents of the container and additional information
1. What Difur 120 mg hard capsules is and what it is used for
Difur is a traditional herbal medicinal product for the relief of symptoms associated with mild to moderate inflammatory skin conditions, 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 Polypodium leucotomos L. extract or to any of the other components of the medicine.
Warnings and precautions
Consult your doctor or pharmacist before taking any medicine.
If you have fever, infectious diseases, hypertension, or heart failure, consult your doctor before taking this medicine.
Use in children
The use of this medicine is not recommended in children under 6 years of age, as there is insufficient clinical information to support its safe and effective use.
Children aged 6 to 12 years: Consult your doctor before starting treatment so that your clinical condition can be evaluated.
Taking Difur 120 mg hard capsules with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Taking Difur 120 mg hard capsules with food and drinks
Difur should be taken 30 minutes before meals. Avoid ingesting food or medications that reduce stomach acidity or alcoholic beverages at the same time, as they may reduce its effectiveness.
Pregnancy and breastfeeding
The safety of this medicine during pregnancy and breastfeeding has not been established. As a precautionary measure, administration to women during pregnancy or breastfeeding is not recommended.
Driving and using machines
The effect of Difur on the ability to drive and use machines is none or negligible.
Important information about some of the components of Difur 120 mg hard capsules
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Difur 120 mg hard capsules
It is an oral medicine.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dosage
Use in adults and adolescents: The recommended dose is 1 capsule (120 mg) three times daily, equivalent to 360 mg of Polypodium leucotomos extract per day.
If necessary, an additional capsule may be taken, preferably at night.
The recommended duration of treatment is 4 weeks. After this period, consult your doctor regarding the convenience of continuing treatment.
Use in children aged 6 to 12 years:
The recommended dose is 120 mg (1 capsule) twice daily, equivalent to 240 mg of Polypodium leucotomos extract 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 whole, 30 minutes before each of the main meals, with a drink.
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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Difur may cause adverse effects, although not everyone experiences them.
Very rare side effects (affecting less than 1 in 10,000 patients) may include stomach discomfort, skin rash, and itching.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
5. Storage of Difur 120 mg hard capsules
No special storage conditions are required.
Keep out of the sight and reach of children.
Do not use Difur 120 mg hard capsules after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Additional Information
Composition of Difur 120 mg hard capsules
- The active substance is Polypodium leucotomos L. extract. Each hard capsule contains 120 mg of dried rhizome extract of Polypodium leucotomos L. (native DER 4-6:1), equivalent to 2.5–6.25 mg of quinic acid. Extraction solvent: ethanol 12.5% V/V.
The other components are: Capsule contents: corn starch, 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 contents of the pack
Difur is presented as hard gelatin capsules, with an orange cap and a white body, packed 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 leaflet was approved in March 2022
"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"