TANTUM VERDE Forte spray 0.3% 15ml
Leaflet: user information
TANTUM VERDE FORTE 0.30% 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 pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This 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 TANTUM VERDE FORTE spray is and what it is used for
2. What you need to know before using TANTUM VERDE FORTE spray
3. How to use TANTUM VERDE FORTE spray
4. Possible side effects
5. How to store TANTUM VERDE FORTE spray
6. Contents of the package and additional information
1. What TANTUM VERDE FORTE spray is and what it is used for
TANTUM VERDE FORTE spray contains the active substance benzydamine hydrochloride. Benzydamine is a non-steroidal anti-inflammatory agent and has pronounced anti-inflammatory and analgesic properties. Based on the rapid penetration and the local enrichment of the inflamed tissue, the pains and complaints when swallowing are quickly alleviated.
TANTUM VERDE FORTE spray is used as an anti-inflammatory and pain reliever for inflammatory conditions of the throat, oral cavity and gums.
It can be used in dental practice, as an aid after tooth extraction, in laryngitis and in disorders after radiation therapy.
2. What you need to know before using TANTUM VERDE FORTE spray
Do not use TANTUM VERDE FORTE spray
- if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in point 6).
Warnings and precautions
Before treatment with TANTUM VERDE FORTE spray, pay attention if you have problems controlling your swallowing.
If a short-term treatment with benzydamine does not achieve the desired result, you should immediately consult a doctor. TANTUM VERDE FORTE spray is indicated for patients who have difficulty gargling.
Other medicines and TANTUM VERDE FORTE spray
It is possible to use TANTUM VERDE FORTE spray and other medicinal products, as there is no evidence of adverse drug reactions.
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.
As there are no data on contraindications for local use of benzydamine during pregnancy or breastfeeding, TANTUM VERDE FORTE spray can be used for short-term treatment and under medical supervision.
Driving and using machines
Local use of TANTUM VERDE FORTE spray in recommended doses does not affect the ability to drive and operate machinery.
TANTUM VERDE FORTE spray contains ethanol, methyl parahydroxybenzoate, polyoxyl 40 hydrogenated castor oil, mint flavor and sodium
This medicine contains 13.6 mg of alcohol (ethanol) in each administered single 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).
Polyoxyl 40 hydrogenated castor oil may cause stomach upset and diarrhea.
This medication contains fragrance with benzyl alcohol, citronellol, D-limonene, geraniol, linalool, and eugenol, which may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per administered dose, i.e. it can be said to be practically sodium-free.
3. How to use TANTUM VERDE FORTE spray
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: 2-4 sprays, 2-6 times a day (each spray is equivalent to 0.17 ml of the solution).
Caution: Do not exceed the recommended dose without consulting your doctor first.
Instructions for use
If you notice a change in symptoms or they get worse, ask your doctor.
Caution: use only for short periods of time.
1. Turn the nozzle of the dosing pump.
2. Place the nozzle in the mouth and direct the stream to the inflamed areas or the throat if the pharynx is inflamed.
Press the dosing pump button firmly.
Important: Before the first use of TANTUM VERDE FORTE 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 FORTE spray
There have been no reports of overdose with benzydamine applied topically.
Accidental ingestion of small amounts is safe.
If you accidentally swallow some of your medicine, contact your doctor or pharmacist immediately for advice.
If you forget to use TANTUM VERDE FORTE spray
Do not take a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 (with a frequency lower than 1 in 10,000 people), the following side effects have been observed after using TANTUM VERDE FORTE spray:
· burning sensation of the mucous membrane of the oral cavity;
· nausea or vomiting;
· allergic reactions.
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.
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.
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 side effects directly through the national reporting system:
Executive Agency for Medicines, 8 Damyan Gruev St., 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 FORTE spray
Keep out of the reach of children.
Keep out of sunlight; the medicine should be stored in the outer packaging.
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 FORTE spray contains
100 ml of solution contain:
Active substance: benzydamine hydrochloride 0.30 g.
Other ingredients: ethanol 96%, glycerol, polyoxyl 40 hydrogenated castor oil, mint flavor, methyl parahydroxybenzoate, saccharin, purified water.
One injection equals 0.17 ml of solution.
What TANTUM VERDE FORTE spray looks like and what it contains
TANTUM VERDE FORTE spray is supplied in a 15 ml bottle with a dosing pump, placed in a cardboard box with an attached patient leaflet.
License holder
Angelini Pharma Bulgaria Ltd
Bul. Asen Yordanov 10
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
For further information about this medicine, please contact the Marketing Authorization Holder.
Leaflet last revised date 10/2020
