Package Insert: Information for the User

Menaven 1000 UI/g gel

Sodium Heparin

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

Follow exactly the medication administration instructions 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 days.

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

Menaven is indicated for local symptomatic relief in adults of superficial venous disorders, such as heaviness and tightness of the legs with varicose veins, and superficial hematomas produced by trauma.

Do not use Menaven:

• If you are allergic to sodium heparin or any of the other components of this medication (listed in section 6).
• On mucous membranes, ulcers, or 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 cases of thrombotic venous disorders (such as thromboembolism), it is recommended to apply the product gently and without massaging.
• Do not use for a prolonged period or on large areas of the skin. In prolonged treatments, sensitization phenomena may appear.
• Exercise caution in patients with hemorrhagic manifestations or significant alterations in the mechanisms for stopping bleeding (hemostasis), or even at the doctor's discretion, avoid its use in these cases.
• Evaluate the clinical situation if the patient suffers from another illness, is allergic, or is using another medication.

• Due to the low absorption of the drug locally, it is unlikely to observe adverse reactions typical of the systemic effect (inside the body) of the drug; however, caution is required in patients with severe hypertension, gastric ulcer, and bleeding disorders, congenital or acquired, such as hemophilia, thrombocytopenia, and some vascular purpuras (purple spots on the skin), as the risk of bleeding is higher.
• Use during menstruation increases the risk of bleeding.

Children and adolescents

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

Other medications and Menaven

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

Although with Menaven, the risk of interaction is not predictable due to the low absorption of the active ingredient in the administration route of the medication, it has been described in the literature that drugs that affect platelet function, such as non-steroidal anti-inflammatory drugs (NSAIDs), dextran, dipiridamol, etc., should be administered with caution in patients receiving heparin, as they may interact pharmacologically, increasing the risk of bleeding.

At the same time, the anticoagulant effect of heparin may be interfered with by other medications such as nitroglycerin and cardiac glycosides (for heart disease), nicotine, quinine (for arrhythmias of the heart), and tetracyclines (antibiotics).

No data are available on the interference of topical heparin with laboratory tests.

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

Pregnancy and breastfeeding

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

Heparin does not cross the placenta or distribute in breast milk. However, since no studies have been conducted on the administration of heparin during pregnancy and breastfeeding, Menaven should only be administered in these cases when strictly necessary and after consulting with your doctor.

Driving and operating machinery

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

Menaven 1000 UI/g gel contains parahydroxybenzoic acid methyl ester (E 218), parahydroxybenzoic acid propyl ester (E216), lavender essence, and ethanol.

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

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

This medication contains 242 mg of ethanol in each gram of gel.

It may cause a burning sensation on injured skin.

Follow exactly the medication administration instructions contained in this leaflet or those 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 per 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, hands should be washed unless they are the treatment site.

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

If you use more Menaven than you should

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

In the event of topical overdose, skin irritation signs may appear or local skin reactions may occur.

In cases of overdose or accidental ingestion of large quantities of Menaven, consult your doctor or pharmacist immediately, or go to a medical center or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to use Menaven

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

You should continue treatment normally without taking any particular action.

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 everyone will experience them.

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

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

Very rarely, the possibility of skin 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 systemic reactions will occur.

Although it is not expected that the drug will have an internal effect (systemic), special caution should be exercised when administering it to patients at risk of bleeding (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging and the tube after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

any unused medication at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medication. By doing so, you will help protect the environment.

Composition of Menaven 1000 UI/ g gel

• The active principle is sodium heparin. Each g of gel contains 1000 UI of sodium heparin (equivalent to 5.56 mg)
• The other components (excipients) are methylparaben (E218), propylparaben (E216), carbomer, ethanol at 96%, trometamol, lavender essence, and purified water.

Appearance of the product and contents of the packaging

Menaven 1000 UI/ g gel is a transparent gel with a lavender scent.

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – E-08918 Badalona (Barcelona)

T. +34 934 628 800

E-mail: [email protected]

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

Menarini Consumer Healthcare, S.A.U.

Guifré, 724 – 08918 Badalona (Barcelona) Spain

Last review date of this leaflet:June 2020.

Other sources of information

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