Package leaflet: Information for the user
TANTUM VERDE SPRAY, 1.5 mg/ml
TANTUM VERDE SPRAY FORTE, 3 mg/ml
benzydamini hydrochloridum
oral spray
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
What is in this leaflet
1.
What Tantum Verde Spray and Tantum Verde Spray Forte is and what it is used for
2.
What you need to know before you use Tantum Verde Spray and Tantum Verde Spray Forte
3.
How to use Tantum Verde Spray and Tantum Verde Spray Forte
4.
Possible side effects
5.
How to store Tantum Verde Spray and Tantum Verde Spray Forte
6.
Contents of the pack and other information
1.
What Tantum Verde Spray and Tantum Verde Spray Forte is and what it is used for
The active ingredient of this preparation is benzydamine hydrochloride, a substance with anti-inflammatory,
pain suppressing, mild local anaesthetic and disinfecting effects.
The product is indicated for treatment of signs of inflammation in oral cavity and throat associated with pain
(such as aphthae, inflammation of the nasopharynx, inflammation of mucosa in mouth cavity, inflammation
of gums). Further it is used for supportive therapy after dental interventions and surgery in oral cavity or
throat, in those indications if recommended by a doctor.
Tantum Verde Spray is due to the pharmaceutical form suitable for adults, adolescents and children over 6
years, only for those capable of to cooperate (to hold breath during application).
Tantum Verde Spray Forte is intended for adult patients.
The product is particularly suitable for those patients who have difficulties with gargling.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.
2.
What you need to know before you use Tantum Verde Spray and Tantum Verde Spray Forte
Do not use Tantum Verde Spray and Tantum Verde Spray Forte:
if you are allergic to active substance or any of the other ingredients of this medicine (listed in section
6).
Warnings and precautions
Long-term use of the product may lead to development of hypersensitivity and it is thus recommended that
the product be used only as long as needed for treatment. In case of hypersensitivity, interrupt the treatment.
Inflammation of gums may be a symptom of dental disorder and thus a visit at a dentist may be useful in
case of the product ineffectiveness.
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Other medicines and Tantum Verde Spray and Tantum Verde Spray Forte
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
It is not known that the product would affect effectiveness of other medicines.
Tantum Verde Spray and Tantum Verde Spray Forte with food
Apply the product after meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
The product can be used during pregnancy only after consultation with a doctor.
Penetration of benzydamin-hydrochloride to breast-milk cannot be excluded, thus the product should not be
used during breast-feeding.
Driving and using machines
It is not probable that after application of the product the attention when driving or operating machines
could be decreased.
Tantum Verde Spray and Tantum Verde Spray Forte contain methylparaben.
Methylparaben can cause allergic reactions (likely late).
3.
How to use Tantum Verde Spray and Tantum Verde Spray Forte
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Tantum Verde Spray
Adults and children over 12 years: 4 - 8 doses 2 - 6 times a day.
Paediatric use: children over 6 and below 12: 1 - 3 doses 2 - 6 times a day.
Tantum Verde Spray Forte
Adults: 2 - 4 doses 2 - 6 times a day.
The product in this concentration is not intended for use in children.
The product should be applied with intervals 1.5 - 3 hours between applications.
Instructions for use:
1. Turn the cannula (white tube) to be vertical to the bottle.
2. Insert the cannula at your mouth and aim at the inflamed place in your mouth or throat.
3. Press strongly the dosing pump on the top of the bottle as many times as prescribed doses.
One press means one dose. Hold your breath during application.
Before the first use, spray several times into the air to assure equal doses application.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days, or if a fewer or other
signs appear.
Do not use the product longer than 14 days without consulting your doctor.
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If you use more Tantum Verde Spray and Tantum Verde Spray Forte than you should
No cases of overdose are known and due to the application form they are very unlikely.
If an overdose yet occurs, symptoms as sleep disturbances, agitation, optical hallucinations (black spots in
front of the eyes, coloured or white spots) or skin reactions (rush or photo sensibility) can be expressed.
These symptoms are reversible and subside spontaneously.
In case of overdose, it is recommended to cause vomiting. Swallowing of a smaller amount of the product is
harmless.
In case of ingestion of bigger amount of the product (particularly at children), contact a doctor.
If you forget to use Tantum Verde Spray and Tantum Verde Spray Forte
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely burning or decreased sensitivity in mouth can occur. The events can be caused by ethyl alcohol
contained in the product.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly to the address:
Státní ústav pro kontrolu léčiv
Šrobárova 48
100 41 Praha 10
Web page: http://www.sukl.cz/nahlasit-nezadouci-ucinek
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Tantum Verde Spray and Tantum Verde Spray Forte
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packing after Expiry. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Tantum Verde Spray and Tantum Verde Spray Forte contain
Tantum Verde Spray
The active substance is benzydamini hydrochloridum 0.15 g in 100 ml of solution (1 dose means 0.17
ml of solution)
The other excipients are glycerol, ethanol 96%, saccharine, sodium hydrogencarbonate,
methylparaben (E218), mint flavour, polysorbate 20, purified water.
Tantum Verde Spray Forte
The active substance is benzydamini hydrochloridum 0.30 g in 100 ml of solution (1 dose means 0.17
ml of solution)
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The other excipients are glycerol 85%, ethanol 96%, saccharine sodium salt, methylparaben (E218),
glyceromacrogol-hydroxystearate, mint flavour, purified water.
What Tantum Verde Spray and Tantum Verde Spray Forte looks like and contents of the pack
Product description: colourless clear solution with mint taste and flavour.
Packing: HDPE bottle with a mechanic dosing pump with PE cannula, box.
Pack size: Tantum Verde Spray 30 ml, Tantum Verde Spray Forte 15 ml.
Marketing Authorisation Holder
Medicom International s.r.o.
Páteřní 7, 635 00 Brno, Czech Republic
Manufacturer
Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A.
Via Vecchia del Pinocchio 22, 60131 Ancona, Italy
This leaflet was last revised
2.7.2014
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