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FEPARIL 10mg/g + 50mg/g GEL

FEPARIL 10mg/g + 50mg/g GEL

Ask a doctor about a prescription for FEPARIL 10mg/g + 50mg/g GEL

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use FEPARIL 10mg/g + 50mg/g GEL

Introduction

Package Leaflet: Information for the User

Feparil 10mg/g + 50mg/g Gel

escin / diethylamine salicylate

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

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

  • Keep this package leaflet, as you may need to read it again.
  • If you need advice or more information, consult your pharmacist.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
  • You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

  1. What is Feparil and what is it used for
  2. What you need to know before using Feparil
  3. How to use Feparil
  4. Possible side effects
  5. Storage of Feparil
  6. Package Contents and Additional Information

1. What is Feparil and what is it used for

This medication is indicated for the local symptomatic relief of superficial venous disorders, such as heaviness and tightness of the legs with varices in adults.

Also for the symptomatic relief of pain and superficial bruising caused by blows, bruises, sprains, and mild strains as a result of a twist in adults and children over 12 years of age.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before using Feparil

Do not use Feparil

  • If you are allergic to escin, diethylamine salicylate, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other components of this medication (listed in section 6).
  • In skin conditions, such as dermatitis, eczema, or hives.
  • On mucous membranes, or on irritated, wounded, or radiated skin areas.

Warnings and Precautions

For external use only.

Use only on intact skin.

Avoid contact with the eyes.

Do not apply simultaneously to the same area as other topical medications.

Do not use for a prolonged period without medical supervision.

Children and Adolescents

Do not use in children under 12 years of age.

Other Medications and Feparil

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

No interactions with other medications are known. However, avoid simultaneous application with another topical preparation to avoid possible interference between active ingredients.

Using Feparil with Food, Drinks, and Alcohol

No effect has been described between the use of this medication and the consumption of food and drinks.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and Using Machines

No effects of this medication on the ability to drive and use machines are expected.

Feparil contains fragrances with d-limonene, linalool, and farnesol.

D-limonene, linalool, and farnesol may cause allergic reactions.

3. How to Use Feparil

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use exclusively on intact skin.

Adults and children over 12 years of age.

Apply a thin layer of gel one to three times a day to the affected area, performing a small massage to favor the absorption of the product. The use of an occlusive dressing is not recommended, but if necessary, it can be covered with a gauze.

The maximum daily dose is 20 g of gel, which is equivalent to approximately 1,000 mg of diethylamine salicylate.

Do not use the medication on large areas of skin.

If symptoms worsen or persist after 5 days, you should consult a doctor.

Wash your hands after each application to avoid unintentional contact with eyes and mucous membranes.

If You Use More Feparil Than You Should

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If You Forget to Use Feparil

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

Wait for the next application and continue with the usual routine.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the period of use of the combination of escin and diethylamine salicylate in gel, the following side effects have been observed, whose frequency could not be established with precision:

They are generally mild and infrequent.

Disorders of the skin and subcutaneous tissue: erythema (redness of the skin) may appear in the application area due to local irritation or because contact dermatitis has occurred. Both disappear completely when treatment is stopped.

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 Pharmacovigilance System for Human Use Medications: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Feparil

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date (EXP.) that appears on the box and tube. 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. Package Contents and Additional Information

Composition of Feparil

  • The active ingredients are escin and diethylamine salicylate.
  • The other components are polyacrylic acid, macrogol-6-glycerol caprylocaprate, disodium edetate, tromethamine, isopropyl alcohol, purified water, lavender oil, and orange blossom oil.

Appearance of the Product and Package Contents

Feparil is a clear, colorless to light yellow gel with a lavender scent, presented in aluminum tubes containing a total of 40 or 100 g of gel.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Manufacturer

Madaus GmbH

Lutticher Strasse, 5

53842 Troisdorf

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Date of the Last Revision of this Package Leaflet:January 2024

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

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