TANTUM 30 mg/g OINTMENT

Introduction

Package Leaflet: Information for the User

Tantum 30 mg/g Ointment

Bencidamine Hydrochloride

Read the entire 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 exactly.

• 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 side effects not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet:

1. What Tantum is and what it is used for
2. What you need to know before starting to use Tantum
3. How to use Tantum

1. Possible side effects
2. Storage of Tantum

1. Contents of the pack and further information

1. What Tantum is and what it is used for

Tantum contains the active ingredient bencidamine hydrochloride, which belongs to the group of non-steroidal anti-inflammatory medications.

It is a medication for external use with analgesic activity.

It is used for the local symptomatic relief of muscle and joint pain caused by: bruises, blows, sprains, strains, contractures, sprains, and lumbago, in adults and adolescents over 12 years of age.

If symptoms worsen or last more than 7 days or irritation occurs, treatment should be discontinued and a doctor consulted.

2. What you need to know before starting to use

• If you are allergic to bencidamine or any of the other components of this medication (listed in section 6).

Warnings and Precautions

• Use only on intact skin, never on wounds, mucous membranes, or irritated or eczematous skin.
• Avoid contact with the eyes.

• Avoid applying heat, tight bandages, or those that do not allow ventilation of the area to be treated.
• Avoid using it for a prolonged period or on extensive areas.

• Avoid applying other external use medications simultaneously in the same area.
• The treated areas should not be exposed to the sun (even when cloudy) or to ultraviolet (UVA) lamps.
• In patients who have suffered or suffer from bronchial asthma, it can cause bronchospasm (sudden feeling of suffocation), so these patients should not use this medication.

Children

• Do not use in children under 12 years of age.

Other medications and Tantum

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

No interactions have been described, but it should not be used with other analgesics or anti-inflammatories in the same area without consulting your doctor first.

Using Tantum with food, drink, and alcohol

Food and drink do not affect the use of this medication.

Pregnancy, breastfeeding, and fertility

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

Do not use Tantum during pregnancy unless clearly necessary and advised by your doctor. If treatment is needed, use the lowest dose for the shortest possible time.

Driving and using machines

No effect on the ability to drive vehicles and use machinery has been described for cutaneous use on the skin.

Tantum contains propylene glycol (E1520) and cetyl alcohol

This medication contains 100 mg of propylene glycol (E1520) per gram of ointment. Propylene glycol may cause skin irritation.

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

3. How to use Tantum

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

The recommended dose is:

Adults and adolescents over 12 years of age: apply a thin layer of ointment to the painful area 3 or 4 times a day.

Method of administration:

For exclusive external cutaneous use, on the skin.

The ointment should be applied with a gentle massage to facilitate penetration and absorption. Wash your hands after each application.

If symptoms worsen, last more than 7 days, or irritation occurs, discontinue treatment and consult a doctor.

Use in children

Do not use in children under 12 years of age.

If you use more Tantum than you should

Due to its external use, it is unlikely that intoxication will occur. In case of overdose or accidental ingestion, go immediately to a medical center or consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are uncommon (may affect 1 in 100 people) and disappear when treatment is discontinued:

• Sensitivity of the skin to sunlight,
• Redness,
• Skin inflammation (dermatitis),

• Local irritation,
• Itching in the application area.

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 Tantum

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after the abbreviation 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 unused medications at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

• The active ingredient is bencidamine hydrochloride, each gram of ointment contains 30 mg of bencidamine hydrochloride.
• The other components (excipients) are: cetyl alcohol, vaseline, sorbitan stearate, polysorbate 60, propylene glycol (E1520), and purified water.

Appearance of the product and contents of the pack

Tantum is a white ointment with a characteristic aroma. It is presented in aluminum tubes of 50 grams with a white polypropylene screw cap.

Marketing authorization holder

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Australia Building

08840 Viladecans, Barcelona (Spain)

Manufacturer

A.C.R.A.F. S.p.A.,

Via Vecchia del Pinocchio, 22

60131 - Ancona, Italy

Date of the last revision of this package leaflet:September 2025

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/