Package Insert: Information for the User

VENOSMIL 20 mg/g gel

Hidrosmina

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 or 6 days.

1. Contents of the package and additional information

Venosmil is a venotonic medication: it increases the tone of the veins and the resistance of capillaries (small blood vessels).

Venosmil is indicated in adults for the alleviation of symptoms related to mild lower limb venous insufficiency, such as pain, heaviness, tightness, tingling, and itching in legs with varicose veins or swollen legs.

Consult a doctor if symptoms worsen or do not improve after 5 or 6 days.

Do not use Venosmil gel

• if you are allergicto hydrosamine or to any of the other components of this medication (listed in section 6).
• on skin conditions, such as dermatitis, eczemas, or urticarias.
• 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 the eyes and mucous membranes, the ear and the mouth.
• 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 and adolescents unless your doctor advises it.

Use of Venosmil gel with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

No interactions with food or other medications are known, howeverdo not use another medication on your own initiative without your doctor's recommendation.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

No clinical data are available on the use of hydrosamine in pregnant women. As a precaution, the use of Venosmil during pregnancy is not recommended, unless your doctor considers that the potential benefits of its administration outweigh the possible risks.

No clinical data are available on the use of hydrosamine in breastfeeding women. It is unknown whether hydrosamine is excreted in breast milk, so its use during breastfeeding is not recommended.

Driving and operating machinery

The influence of Venosmil on the ability to drive and operate machinery is negligible or insignificant.

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 adverse effects”).

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

If symptoms do not improve in 5-6 days, discontinue treatment and visit your doctor.

Adults

The recommended dose is: 3 -4 centimeters of gel 2 or 3 times a day if necessary.

Instructions for correct administration of the preparation

Exclusively topical use on intact skin

1. Remove the cap from the tube and with the back of the cap perforate the metal nozzle sufficiently.

2.Apply to the affected area, approximately 3-4 cmof gel, as needed, 2 or 3 times a day, performing a small massage to facilitate the absorption of the product.

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

If it worsens, does not improve, or irritation occurs in the treated area, you should consult your doctor.

Children and adolescents

Do not use in children and adolescents unless your doctor advises it.

If you use more Venosmil gel than you should:

Up to now, no cases of poisoning with this medication have been reported, not even in cases of accidental overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or visit a medical center, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Venosmil gel

Do not apply a double dose to compensate for the missed doses. Apply it as soon as you remember and continue with the usual schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

During the period of use of Venosmil gel, some adverse effects have occurred whose frequency has not been determined with exactness:

• Reactions of hypersensitivity (allergic) to hydrosamine or to any of the excipients (see section 2 “What you need to know before starting to use Venosmil gel”).

• Rash and itching on the skin in the application area.

These reactions disappear when treatment is interrupted.

Reporting of Adverse Effects:

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

Keep out of sight and reach of children.

Store below30°C.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you no longer need at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Venosmil gel

• The active ingredient is hyaluronidase.Each gram of gel contains 20 mg of hyaluronidase.
• The other components (excipients) arecarbomer, triethanolamine, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and distilled water.

Appearance of the product and contents of the packaging

Venosmil gelis presented in an aluminum tube of60 gcontaining a transparent yellowish gel.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing and batch release

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700-327 Amadora, Lisbon

Portugal

Date of the last review of this leaflet:july 2016

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