TANTUM VERDE spray 0.15% 30ml
Leaflet: user information
TANTUM VERDE 0.15% spray for oral mucosa, solution
benzydamine hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your doctor or
- a pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 7 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What is TANTUM VERDE spray and what is it used for
2. What you should know before using TANTUM VERDE spray
3. How to use TANTUM VERDE spray
4. Possible side effects
5. How to store TANTUM VERDE spray
6. Contents of the package and additional information
1. What is TANTUM VERDE spray and what is it used for
TANTUM VERDE spray contains the active substance benzydamine hydrochloride. Benzydamine has pronounced anti-inflammatory and pain-relieving properties. Based on the rapid penetration and the local accumulation in the inflamed tissue, the pains and complaints on swallowing are quickly alleviated.
TANTUM VERDE spray is used for painful inflammations of the oral cavity, gums and throat, as well as for infections of the mucous membrane of the oral cavity and throat, especially for colds.
It is applied before and after tooth extraction.
2. What you should know before using TANTUM VERDE spray
Do not use TANTUM VERDE spray
- if you or your child are allergic to benzydamine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If complaints persist or if the expected effect does not appear, seek medical advice as soon as possible.
Inadvertent ingestion of small amounts of the drug is safe. If large quantities are accidentally swallowed (e.g. by children), seek immediate medical attention. Induction of vomiting is recommended as a first aid measure.
Other medicines and TANTUM VERDE spray
You should tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
There are no known interactions with other drugs.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
When used as intended, it is possible to use this medicine during pregnancy and breastfeeding.
Driving and using machines
TANTUM VERDE spray does not affect concentration when driving and operating machinery.
TANTUM VERDE spray contains ethanol, methyl parahydroxybenzoate, mint flavor and sodium
This medicine contains 13.6 mg of alcohol (ethanol) in each administered dose of 0.17 ml, which is equivalent to 0.34 ml of beer or 0.14 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Methyl parahydroxybenzoate may cause allergic reactions (probably of the delayed type).
This medicine contains less than 1 mmol sodium (23 mg) per administered dose, i.e. it can be said to be practically sodium-free.
This medication contains fragrance with benzyl alcohol, cinnamyl alcohol, citral, citronellol, geraniol, isoeugenol, linalool, eugenol, and d-limonene, which may cause allergic reactions.
3. How to use TANTUM VERDE spray
TANTUM VERDE spray is intended for injection into the oral cavity and throat.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
What quantity
Adults and adolescents
4-8 sprays, 2-6 times a day (each spray is equivalent to 0.17 ml of the solution).
Use in children
Children (6-12 years old): 4 injections, 2-6 times a day.
Infants and children (under 6 years): 1 spray per 4 kg of body weight, up to a maximum of 4 sprays, 2-6 times daily.
Caution: Do not exceed the recommended dose without consulting your doctor first.
For how long
Use TANTUM VERDE only for short periods of time. If necessary or you or your child does not feel better after 3 days, ask your doctor.
If you notice a change in symptoms or they get worse, ask your doctor.
How
Instructions for use
1. Lift the pump nozzle.
2. Place the nozzle in the mouth and aim at the affected area. Press the pump button with your index finger.
Important: Before the first use of TANTUM VERDE spray, you must press the pump button several times until an aerosol cloud appears.
If you have used more than the required dose of TANTUM VERDE spray
If you accidentally swallow some of your medicine, contact your doctor or pharmacist immediately for advice.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adverse reactions with an unknown frequency:
- Allergic reactions (hypersensitivity);
- Serious allergic reactions (anaphylactic shock), signs of which may include difficulty breathing, chest pain or tightness and/or feeling dizzy/fainting, severe itchy skin or raised lumps/bumps on the skin, swelling of the face, lips, tongue and/or throat, which can be potentially life-threatening.
A tingling sensation may occur in the mouth and throat immediately after use. This effect is due to the mode of action of the medicinal product and subsides after a short time.
In very rare cases, slight burning of the mucous membrane of the oral cavity, malaise or vomiting may occur after using TANTUM VERDE spray.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system: Medicines Executive Agency, 8 Damyan Gruev Street, 1303 Sofia, Tel.: +359 2 8903417, website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store TANTUM VERDE spray
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What TANTUM VERDE spray contains
100 ml of solution contain:
Active substance: benzydamine hydrochloride 0.15 g.
Other ingredients: ethanol 96%, glycerol, methyl parahydroxybenzoate, mint flavor, saccharin, sodium hydrogen carbonate, polysorbate 20, purified water.
What TANTUM VERDE spray looks like and what the package contains
TANTUM VERDE spray is available in a polyethylene bottle containing 30 ml of solution, placed in a cardboard box with an attached patient leaflet.
License holder
Angelini Pharma Bulgaria Ltd
10 Asen Yordanov Blvd
Sofia 1592, Bulgaria
Tel.: + 359 2 975 13 95
Fax: + 359 2 971 57 45
Manufacturers
ACRAFSpA, Via Vecchia del Pinocchio 22, 60131 Ancona, Italy
Famar Nederland BV, Industrieweg 1, 5531 Ad Bladel, The Netherlands
For further information about this medicine, please contact the Marketing Authorization Holder.
Leaflet last revised date 05/2021.
