Feparil 10 mg/g + 50 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Feparil 10mg/g + 50mg/g gel
aescin / diethylamine salicylate
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You must consult a doctor if your condition worsens or does not improve after 5 days.
Contents of the leaflet
- What Feparil is and what it is used for
- What you need to know before using Feparil
- How to use Feparil
- Possible adverse effects
- Storage of Feparil
- Contents of the pack and other information
1. What Feparil is and what it is used for
This medicine 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 indicated for the symptomatic relief of pain and superficial bruising caused by blows, contusions, strains, and mild sprains resulting from twisting injuries in adults and children over 12 years of age.
You should consult a doctor if symptoms worsen or do 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, other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other components of this medicine (listed in section 6).
- In skin conditions such as dermatitis, eczema, or urticaria.
- On mucous membranes, or on irritated, wounded, or irradiated skin areas.
Warnings and precautions
For external use only.
Use only on intact skin.
Avoid contact with the eyes.
Do not apply simultaneously on the same area as other topical medications.
Do not use for prolonged periods without medical supervision.
Children and adolescents
Do not use in children under 12 years of age.
Other medicines and Feparil
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions with other medicines are known. However, avoid simultaneous application with other topical preparations to prevent possible interactions between active substances.
Use of Feparil with food, drinks, and alcohol
No interaction between this medicine and food or drink has been reported.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
Driving and using machines
Effects of this medicine on the ability to drive or operate machinery are unlikely.
Feparil contains fragrances with d-limonene, linalool, and farnesol.
D-limonene, linalool, and farnesol may cause allergic reactions.
3. How to use Feparil
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.
For external use only on intact skin.
Adults and children over 12 years of age.
Apply a thin layer of gel one to three times daily to the affected area, gently massaging to enhance product absorption. The use of an occlusive dressing (impermeable dressing) is not recommended, but if necessary, the area may be covered with gauze.
The maximum daily dose is 20 g of gel, equivalent to approximately 1,000 mg of diethylamine salicylate.
Do not use the medicine over large areas of skin.
If symptoms worsen or persist beyond 5 days, consult your doctor.
Hands should be washed after each application to avoid inadvertent 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 contact the Toxicology Information Service at telephone number 915 62 04 20, indicating the medicine and the amount ingested.
If you forget to use Feparil
Do not apply a double dose to make up for missed doses.
Wait until the next scheduled application and continue with the usual dosing regimen.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
During the period of use of the combination of aescine and diethylamine salicylate in gel, the following adverse effects have been observed, although their frequency could not be precisely determined:
In general, they are mild and infrequent.
Skin and subcutaneous tissue disorders: erythema (redness of the skin) may occur at the application site due to local irritation or the occurrence of contact dermatitis. Both resolve completely upon discontinuation of treatment.
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Feparil Storage
This medicine does not require special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (CAD. or EXP.) stated on the carton and tube. The expiry date refers to 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 that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Feparil
- The active substances are escin and diethylamine salicylate.
- The other components are polyacrylic acid, macrogol-6-glycerol caprylocaprate, disodium edetate, tromethamine, isopropyl alcohol, purified water, lavender oil, orange blossom oil.
Appearance of the product and contents of the pack
Feparil is a transparent, colourless to pale yellow gel with a lavender scent, supplied in aluminium tubes containing a total of 40 g or 100 g of gel.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60,
1112 AX Diemen,
The Netherlands
Manufacturer
Madaus GmbH
Lutticher Strasse, 5
53842 Troisdorf
Germany
For more information about this medicine, you may contact the local representative of the Marketing Authorisation Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 – Barcelona
Spain
Date of the most recent review of this leaflet: January 2024
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)