MENAVEN 1000 IU/G GEL

Introduction

Package Leaflet: Information for the User

Menaven 1000 IU/g Gel

Sodium Heparin

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 it is a side effect 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 Menaven and what is it used for
2. What you need to know before using Menaven
3. How to use Menaven
4. Possible side effects
5. Storage of Menaven
6. Package Contents and Additional Information

1. What is Menaven and what is it used for

This medicine is a gel for skin use that contains sodium heparin as the active ingredient.

Menaven is indicated for the local symptomatic relief in adults of superficial venous disorders, such as heaviness and tightness of the legs with varices, and superficial hematomas caused by blows.

2. What you need to know before using Menaven

Do not use Menaven:

• if you are allergic to sodium heparin or any of the other components of this medicine (listed in section 6).
• on mucous membranes, ulcers, and open or infected wounds

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Menaven.

• Avoid contact with the eyes.
• Use only on intact skin
• In case of venous problems of thrombotic origin (such as thromboembolism), it is recommended to apply the product gently and without massage.
• Do not use for a long time or on very large areas of the skin. In prolonged treatments, sensitization phenomena may appear.
• Caution is required in patients with hemorrhagic manifestations or significant alterations of the mechanisms to stop a hemorrhage (hemostasis), or even, at the doctor's discretion, its use should be avoided in these cases.
• Evaluate the clinical situation if the patient suffers from any other condition, is allergic, or is using any other medicine.

• Due to the low absorption of the drug locally, it is unlikely that the adverse reactions typical of the systemic effect (inside the body) of the drug will be observed; however, caution is required in patients with severe hypertension, gastroduodenal ulcer, and hemorrhagic disorders, congenital or acquired, such as hemophilia, thrombocytopenia, and some vascular purpuras, since the risk of hemorrhage is greater.
• The use during menstruation increases the risk of hemorrhage.

Children and Adolescents

Its use is not recommended in children and adolescents as its efficacy and safety have not been established in these populations.

Other Medicines and Menaven

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

Although with Menaven it is not foreseeable the risk of interaction given the low absorption of the active ingredient in the administration route of the medicine, it is described in the bibliography that drugs that affect platelet function such as non-steroidal anti-inflammatory drugs (NSAIDs), dextran, dipyridamole, etc. should be administered with caution in patients who receive heparin as they may interact pharmacologically increasing the risk of hemorrhages.

In turn, other medicines such as nitroglycerin and cardiac glycosides (for heart diseases), nicotine, quinine (for heart arrhythmias), and tetracyclines (antibiotics) may interfere with the anticoagulant effect of heparin.

For heparin by topical route, there are no data on interference with laboratory tests.

It is not recommended to apply other skin preparations to the same area without consulting your doctor.

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 medicine.

Heparin does not cross the placenta or distribute in breast milk. Nevertheless, since studies on the administration of heparin during pregnancy and breastfeeding have not been conducted, Menaven should only be administered in these cases when strictly necessary and after consulting your doctor.

Driving and Using Machines

The influence of Menaven on the ability to drive and use machines is nil or insignificant.

Menaven 1000 IU/g Gel contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E216), lavender essence, and alcohol (ethanol).

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E216).

This medicine contains lavender essence with amylcinnamaldehyde, citral, eugenol, hydroxycitronellal, coumarin, geraniol, farnesol, linalool, citronellol, D-limonene, which may cause allergic reactions.

This medicine contains 227.3 mg of alcohol (ethanol) in each gram of gel.

It may cause a burning sensation on damaged skin.

3. How to Use Menaven

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Topical use (on the skin).

The recommended dose is one to three applications a day on the affected area, applying 3 to 10 cm of gel depending on the area to be treated, followed by a gentle massage.

After application, wash your hands unless they are the treatment area.

If symptoms persist for more than 5 days, or irritation or worsening occurs, you should consult a doctor.

If you use more Menaven than you should

Since this medicine is for topical use, it is unlikely that intoxication will occur. It is unlikely that overdose cases will occur due to the low systemic absorption of sodium heparin applied topically.

In the event of overdosing by topical route, signs of skin irritation or local reactions on the skin may appear.

In cases of overdose or accidental ingestion of large amounts of Menaven, 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 medicine and the amount ingested.

Accidental ingestion of large amounts of Menaven, due to its ethanol content, may cause symptoms of acute alcohol intoxication.

If you forget to use Menaven

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

You should continue treatment normally without taking any particular action.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The adverse reactions most frequently presented with Menaven are: contact dermatitis, local irritation, local allergic phenomena, and itching (pruritus).

Less frequently, the appearance of skin redness (erythema), dryness of the skin, burning sensation, feeling of cold, and skin rashes (urticaria) has been described.

Very rarely, the possibility of necrosis in the application area has been described.

Due to the low absorption of the active ingredient of Menaven by topical route, it is not expected that the adverse reactions typical of the systemic effect of the drug will occur.

Although it is not expected to have an effect of the drug at the internal level (systemic), maintain special caution when administering it to patients at risk of hemorrhages (see section 2).

Reporting of 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 Medicines and Health Products Agency: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Menaven

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at your pharmacy. If in doubt, consult your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Menaven 1000 IU/g Gel

• The active ingredient is sodium heparin. Each gram of gel contains 1000 IU of sodium heparin (equivalent to 5.56 mg)
• The other components (excipients) are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), carbomer, ethanol 96%, tromethamine, lavender essence, and purified water.

Appearance of the Product and Package Contents

Menaven 1000 IU/g Gel is a transparent gel with a lavender odor.

It is presented in aluminum tubes of 60 g of gel.

Marketing Authorization Holder and Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona) Spain

• +34 934 628 800

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

Menarini Consumer Healthcare, S.A.U.

Guifré, 724 – 08918 Badalona (Barcelona) Spain

Date of the Last Revision of this Package Leaflet:June 2020.

Other Sources of Information

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