MENAVEN 1000 IU/G GEL

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Menaven 1000 IU/g gel

Sodium heparin

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of the leaflet

1. What Menaven is and what it is used for
2. What you need to know before using Menaven
3. How to use Menaven
4. Possible side effects
5. How to store Menaven
6. Contents of the pack and other information

1. What Menaven is and what it is used for

This medicine is a topical gel containing sodium heparin as the active substance.

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

2. What you need to know before using Menaven

Do not use Menaven:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Menaven.

• Avoid contact with the eyes.

• Use only on intact skin.

• In venous disorders of thrombotic origin (e.g., thromboembolism), it is recommended to apply the product gently without massage.

• Do not use for prolonged periods or over extensive areas of skin. With prolonged treatment, sensitization reactions may occur.

• Caution is required in patients with hemorrhagic manifestations or significant disorders in the mechanisms controlling bleeding (hemostasis); in some cases, use should be avoided at the physician's discretion.

• Consider the patient's clinical condition if they suffer from any other illness, have allergies, or are taking other medications.

• Due to the low local absorption of the drug, adverse reactions related to the systemic (inside the body) effects of the drug are unlikely; however, caution is advised in patients with severe hypertension, gastroduodenal ulcer, or congenital or acquired bleeding disorders such as hemophilia, thrombocytopenia, and certain vascular purpuras (purple skin spots), as the risk of bleeding is higher.

• Use during menstruation increases the risk of bleeding.

Children and adolescents

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

Other medicines and Menaven

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

Although drug interactions are unlikely with Menaven due to the low absorption of the active ingredient via the route of administration, the literature describes that drugs affecting platelet function, such as non-steroidal anti-inflammatory drugs (NSAIDs), dextran, dipyridamole, etc., should be administered with caution in patients receiving heparin, as they may interact pharmacologically and increase the risk of bleeding.

In addition, other medications 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 topical heparin, there are no available data on interference with laboratory tests.

It is not recommended to apply other topical 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Heparin does not cross the placenta nor is it distributed into breast milk. Nevertheless, because adequate studies on heparin administration during pregnancy and lactation have not been conducted, Menaven should only be used in these cases when strictly necessary and after consulting with your doctor.

Driving and using machines

The influence of Menaven on the ability to drive and operate machinery is none or negligible.

Menaven 1000 IU/g gel contains methylparaben (E 218), propylparaben (E 216), lavender essence, and alcohol (ethanol).

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E 218) and propylparaben (E 216).

This medicine contains lavender essence with amyl cinnamaldehyde, 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 dosage instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For 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 size of the area to be treated, followed by gentle massage.

After application, hands should be washed unless they are the area being treated.

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

If you use more Menaven than you should

Because this medicine is for topical use, intoxication is unlikely. Overdose is unlikely due to the low systemic absorption of topically applied sodium heparin.

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

In cases of overdose or accidental ingestion of large amounts of Menaven, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone: 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 missed doses.

Continue treatment as usual, without needing to take any special action.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

Less frequently, skin redness (erythema), skin dryness, burning sensation, cold sensation, and skin hives (urticaria) have been reported.

Very rarely, skin necrosis at the application site has been reported.

Due to the low absorption of the active substance of Menaven following topical administration, adverse reactions related to the systemic effects of the drug are not expected.

Although a systemic (internal) effect of the drug is not expected, special caution should be maintained when administering it to patients at risk of hemorrhage (see section 2).

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. Storage of Menaven

Keep this medicine out of 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Menaven 1000 IU/g gel

• The active substance 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, 96% ethanol, tromethamine, lavender essence, and purified water.

Nature of the product and pack contents

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

It is supplied in 60 g aluminium tubes.

Marketing Authorization Holder and Manufacturer

LABORATORIOS MENARINI, S.A.

Alfons XII, 587 – 08918 Badalona (Barcelona), Spain

• +34 934 628 800

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Menarini Consumer Healthcare, S.A.U.

Guifré, 724 – 08918 Badalona (Barcelona), Spain

Date of the most recent review of this leaflet: June 2020.

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/