Leaflet: information for the user

Feparil 10mg/g + 50mg/g gel

escin / salicylate of diethanolamine

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the administration instructions for 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 or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

1. What isFepariland for what it is used

2. What you need to know before starting to useFeparil

3. How to useFeparil

4. Possible side effects

5. Storage ofFeparil

6. Contents of the package and additional information

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

It is also for the symptomatic relief of pain and superficial bruises produced by blows, contusions, strains, and minor sprains as a result of a twist in adults and children over 12 years old.

Consult a doctor if it worsens or does not improve after 5 days.

Do not use Feparil

• If you are allergic to escin, diethylamino salicylate, acetylsalicylic acid, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other components of this medication (listed in section 6).
• In skin conditions, such as dermatitis, eczema, or urticaria.
• On mucous membranes, or areas of the skin that are irritated, injured, or exposed to radiation therapy.

Warnings and precautions

External use.

Use only on intact skin.

Avoid contact with the eyes.

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

Do not use for an extended period without medical supervision.

Children and adolescents

Do not use in children under 12 years old.

Other medications and Feparil

Inform your doctor or pharmacist if you are using, have used recently, 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.

Use of Feparil with food, drinks, and alcohol

No effects have 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

No effects of this medication are expected on the ability to drive and operate machinery.

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

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

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

Exclusively for use on intact skin.

Adults and children over 12 years old.

Apply a thin layer of gel one to three times a day on the affected area, making a small massage to favor the absorption of the product..Do not recommend the use of an occlusive dressing (waterproof dressing), 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 salicylate of diethanolamine.

Do not use the medication on large skin areas.

If symptoms worsen or persist after 5 days, you must consult the doctor.

Wash your hands after each application to avoid accidental 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 Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If you forgot to use Feparil

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of the combination of escin and salicylate of diethanolamine in gel, the following adverse effects have been observed, whose frequency has not been established with exactness:

They are generally mild and infrequent.

Dermatological and subcutaneous tissue disorders: erythema (skin redness) may appear in the application area due to local irritation or contact dermatitis. Both resolve completely upon cessation of treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 (CAD. or EXP.) that appears on the box and in the tube. 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 containers and medications that you no longer need. In this way, you will help protect the environment..

Composition of Feparil

• The active principles are escin and diethylamino salicylate.
• The other components are polyacrylic acid, caprilocaprato of macrogol-6-glycerol, disodium edetate, trometamol, isopropyl alcohol, purified water, lavender oil, and orange blossom oil.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

Madaus GmbH

Lutticher Strasse, 5

53842 Troisdorf

Germany

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

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona

Spain

Last review date of this leaflet:January2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)