Leaflet: information for the user

Tantum 50 mg/g cream

Bencidamine hydrochloride

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if you get worse or do not improve after 7 days.

1. What is Tantum and what it is used for

2.What you need to knowbefore starting to use Tantum

3. How to use Tantum

4. Possible side effects

5. Storage of Tantum

6.Contents of the pack and additional information

Tantum containsthe active ingredienthydrochloride 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 discontinued and a doctor consulted.

Do not use Tantum

- If you are allergic tobenzocaine or any of the other components of this medication (listed in section 6).

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.

The 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.

Other medications and Tantum

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use anyother 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, drinks and alcohol

Foods and drinks do not affect when using this medication.

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery

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

Tantumcontains propylene glycol (E1520),methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), bergamot oil and fragrances containing allergens.

This medication contains 50 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

It may increase sensitivity to UV light (natural or artificial light) because it contains bergamot oil.

This medication contains fragrances with 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, d-limonene and linalol, which may cause allergic reactions.

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

The recommended dose is:

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

Administration form:

For external use only on the skin.

The cream 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.

If you use 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 all people will experience them.

Adverse effects are infrequent (may affect up to 1 in 100 people) and disappear when treatment is suspended:

• 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 about possible adverse effects that do not appear 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.

No special preservation conditions are required.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after the CAD abbreviation. 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 packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tantum

• The active ingredient is hydrochloride of bencidamina. Each gram of cream contains 50 mg of hydrochloride of bencidamina.
• The other components (excipients) are: glyceryl palmito-stearate and polyoxiethylene glycol, ethoxylated saturated glycerides, decyl oleate, liquid silicone, propylene glycol (E1520), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), perfume Crematest (contains benzyl benzoate, bergamot oil, and fragrances with allergens 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-ona, benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, d-limonene, and linalol) and purified water.

Appearance of the product and content of the packaging

Tantum is a white cream with a characteristic aroma. It is presented in aluminum tubes of 30 and 50 grams and 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

Last review date of this leaflet: September 2021

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