VENOSMIL 20 mg/g GEL
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How to use VENOSMIL 20 mg/g GEL
Introduction
Package Leaflet: Information for the User
VENOSMIL 20 mg/g gel
Hydrosmine
Read the 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 not listed in this package leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 5 or 6 days.
Contents of the Package Leaflet:
- What is Venosmil gel and what is it used for
- What you need to know before using Venosmil gel
- How to use Venosmil gel
- Possible side effects
- Storage of Venosmil gel
- Package contents and additional information
1. What is Venosmil gel and what is it used for
Venosmil is a venotonic medication: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).
Venosmil is indicated in adults for the relief of symptoms related to mild venous insufficiency of the lower limbs, such as pain, feeling of heaviness, tightness, tingling, and itching in legs with varices or swollen legs.
You should consult a doctor if your condition worsens or does not improve after 5 or 6 days.
2. What you need to know before using Venosmil gel
Do not use Venosmil gel
- if you are allergic to hydrosmine 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 on irritated or wounded skin areas.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Venosmil gel.
- use only on intact skin.
- avoid contact with eyes and mucous membranes, ears, and mouth.
- 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
- it should not be used in children and adolescents unless indicated by a doctor.
Using Venosmil gel with other medications
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.
No interactions with food or other medications are known; in any case, never use another medication on your own initiative without your doctor's recommendation.
Do not apply simultaneously to the same area as other topical medications.
Pregnancy and breastfeeding
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.
No clinical data are available on the use of Venosmil in pregnant women. As a precautionary measure, the use of Venosmil is not recommended during pregnancy, unless your doctor considers that the potential benefits outweigh the possible risks.
No clinical data are available on the use of hydrosmine in breastfeeding women. It is not known whether hydrosmine is excreted in breast milk; therefore, its use is not recommended during breastfeeding.
Driving and using machines
Venosmil has no or negligible influence on the ability to drive and use machines.
Venosmil gel contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medication may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216) (see section 4, "Possible side effects").
3. How to use Venosmil gel
Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
If the symptoms do not improve within 5-6 days, you should discontinue treatment and consult a doctor.
Adults
The recommended dose is: 3-4 centimeters of gel, 2 or 3 times a day, if necessary.
Instructions for the correct administration of the preparation
Exclusive cutaneous use on intact skin
- Remove the cap from the tube and, with the back of the cap, sufficiently pierce the metal mouth.
- Apply to the affected area, approximately 3-4 cm of gel, as needed, 2 or 3 times a day, performing a small massage to favor the absorption of the product.
Wash your hands after each application to avoid unintentional contact with eyes and mucous membranes.
If your condition worsens, does not improve, or irritation occurs in the treated area, you should consult a doctor.
Children and adolescents
It should not be used in children and adolescents unless indicated by a doctor.
If you use more Venosmil gel than you should:
No intoxications with this medication have been reported, even in cases of accidental overdose.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forget to use Venosmil gel
Do not apply a double dose to make up for forgotten doses. Apply it as soon as you remember and continue with the usual schedule.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
During the use of Venosmil gel, some side effects have occurred, whose frequency could not be determined exactly:
- Allergic reactions (hypersensitivity) to hydrosmine or any of the excipients (see section 2, "What you need to know before using Venosmil gel").
- Rash and itching on the skin in the application area.
These reactions disappear when treatment is discontinued.
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 Medication Surveillance System for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Venosmil gel
Keep out of sight and reach of children.
Store below 30°C.
Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, 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 Venosmil gel
- The active ingredient is hydrosmine. Each gram of gel contains 20 mg of hydrosmine.
- The other components (excipients) are carbomer, triethanolamine, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and distilled water.
Appearance of the product and package contents
Venosmil gel is presented in a 60g aluminum tube containing a transparent, yellowish gel.
Marketing authorization holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer and batch release responsible
Faes Farma Portugal, S.A.
Rua Elias Garcia, 28
2700-327 Amadora, Lisbon
Portugal
Date of the last revision of this package leaflet:July 2016
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- CompositionMETILPARABENO (E 218) (0,1 g mg), PROPILPARABENO (E 216) (0,05 g mg)
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to VENOSMIL 20 mg/g GELDosage form: CAPSULE, 200 mgActive substance: hidrosminManufacturer: Faes Farma S.A.Prescription requiredDosage form: CAPSULE, 200 mgActive substance: hidrosminManufacturer: Faes Farma S.A.Prescription not requiredDosage form: TABLET, 500 mgActive substance: diosmin, combinationsManufacturer: Laboratorios Servier S.L.Prescription not required
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