Label: information for the user

Tantum 30 mg/g ointment

Bencidamine hydrochloride

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

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

• Keep this label, 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 label.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. Possible adverse effects
2. Tantum storage

1. Contents of the package and additional information

Tantum contains the active ingredient hydrochloride of bencidamina which belongs to the group of non-steroidal anti-inflammatory drugs.

It is an external medication with analgesic activity.

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

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

Warnings and precautions

• Use it 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 air circulation to the treated area.
• Avoid using it for a prolonged period or on extensive areas.

• Avoid applying it simultaneously in the same area as other external medications.
• Treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet lamps (UVA).
• In patients who have suffered or suffer from bronchial asthma, it may cause bronchospasm (sudden sensation of choking), so these patients should not use this medication.

Children

- Do not use in children under 12 years old.

Other medications and Tantum

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

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

Use of Tantum with food, drink, and alcohol

Foods and beverages do not affect the use of this medication.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

No effects have been described on the ability to drive vehicles and use machinery in the use of topical skin application.

Tantum contains propylene glycol (E1520) and cetomacrogol

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 cetomacrogol.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

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

Administration form:

For external use only on the skin.

The ointment should be applied by gently massaging it in to facilitate penetration and absorption. Wash your hands after each application.

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

Use in children

It should not be used in children under 12 years old.

Using more Tantum than you should

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

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

Adverse effects are infrequent (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 at the application site.

Reporting 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 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.

This product does not require special preservation conditions.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

ANGELINI PHARMA ESPAÑA, S.L.

c/ Antonio Machado, 78-80

3rd floor, module A-Edificio Australia

08840 Viladecans, Barcelona (Spain)

Responsible for manufacturing

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

Via Vecchia del Pinocchio,22

60131 - Ancona, Italy

Date of the last review of this leaflet:August 2021

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/