Tantum 30 mg/g ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Tantum 30 mg/g ointment
Benzidamine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
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You should consult a doctor if you worsen or do not improve after 7 days.
Leaflet contents:
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What Tantum is and what it is used for
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What you need to know before using Tantum
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How to use Tantum
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Possible adverse effects
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How to store Tantum
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Contents of the pack and other information
1. What Tantum is and what it is used for
Tantum contains the active substance benzidamine hydrochloride, which belongs to the group of non-steroidal anti-inflammatory drugs.
It is an externally used medication with analgesic activity.
It is used for the local symptomatic relief of muscular and joint pain caused by bruises, blows, sprains, strains, cramps, sprains, and lumbago, in adults and adolescents over 12 years of age.
If symptoms worsen or last longer than 7 days, or if irritation occurs, treatment must be discontinued and a doctor should be consulted.
2. What you need to know before starting to use it
- If you are allergic to bendizethine or any of the other components of this medicine (listed in section 6).
Warnings and precautions
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Use only on intact skin; never on wounds, mucous membranes, or irritated or eczematous skin.
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Avoid contact with the eyes.
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Avoid applying heat, tight bandages, or occlusive dressings that prevent aeration of the treated area.
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Avoid prolonged use or application over large areas.
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Avoid simultaneously applying other topical medicines to the same area.
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Treated areas must not be exposed to sunlight (even when cloudy) or to ultraviolet (UVA) lamps.
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In patients who have suffered or suffer from bronchial asthma, it may cause bronchospasm (sudden sensation of suffocation); therefore, these patients should not use this medicine.
Children
- Do not use in children under 12 years of age.
Other medicines and Tantum
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
No interactions have been reported; however, it should not be used together with other analgesics or anti-inflammatory medicines on the same area without first consulting your doctor.
Use of Tantum with food, drink and alcohol
Food and drink do not affect the use of this medicine.
Pregnancy, breastfeeding and fertility
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.
Tantum should not be used during pregnancy unless clearly necessary and advised by your doctor. If treatment is needed, the lowest dose for the shortest possible time should be used.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported with cutaneous use on the skin.
Tantum contains propylene glycol (E1520) and cetyl alcohol
This medicine contains 100 mg of propylene glycol (E1520) per gram of ointment. Propylene glycol may cause skin irritation.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
3. How to use Tantum
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, 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 affected area 3 or 4 times a day.
Method of administration:
For external cutaneous use only, on the skin.
The ointment should be applied with a gentle massage to facilitate penetration and absorption. Wash hands after each application.
If symptoms worsen, persist for more than 7 days, or irritation occurs, discontinue treatment and consult your doctor.
Use in children
This medicine must not be used in children under 12 years of age.
If you use more Tantum than you should
Due to its external use, intoxication is unlikely. In case of overdose or accidental ingestion, seek immediate medical attention at a healthcare center or contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The adverse effects are uncommon (may affect 1 in 100 people) and disappear when treatment is stopped:
- Skin sensitivity to sunlight,
- Redness,
- Skin inflammation (dermatitis),
- Local irritation,
- Itching at the application site.
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 Tantum
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
- The active substance is benzydamine hydrochloride; each gram of ointment contains 30 mg of benzydamine hydrochloride.
- The other components (excipients) are: cetostearyl alcohol, white soft paraffin, 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 odour. It is supplied in 50-gram aluminium tubes with a white polypropylene screw cap.
Marketing Authorisation Holder
ANGELINI PHARMA ESPAÑA, S.L.
C/ Antonio Machado, 78-80
3rd floor, module A - Edificio Australia
08840 Viladecans, Barcelona (Spain)
Manufacturer
A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 - Ancona, Italy
Date of the most recent revision of this summary: September 2025
Detailed and up-to-date 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/