Active ingredients: Flurbiprofen
TANTUM VERDE THROAT 0.25% mouthwash
TANTUM VERDE THROAT 0.25% solution for oral mucosa
Why is Tantum Verde Gola used? What is it for?
WHAT IS THAT
Tantum Verde Gola is a non-steroidal anti-inflammatory drug with pain relieving properties for local oral treatment.
WHY IT IS USED
Tantum Verde Gola is used as a symptomatic treatment of irritative-inflammatory states, also associated with oropharyngeal pain (eg pharyngitis).
Contraindications When Tantum Verde Gorge should not be used
Tantum Verde Gola is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs.
In the third trimester of pregnancy.
Do not use in patients who have a peptic ulcer or have had it in the past.
Precautions for use What you need to know before you take Tantum verde throat
No special precautions for use are necessary.
Interactions Which drugs or foods can modify the effect of Tantum verde throat
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
There are no known interactions with other drugs or otherwise.
Warnings It is important to know that:
At the recommended doses, any occasional swallowing of the Tantum Verde Gola solution does not cause any harm to the patient as these doses are much lower than those commonly used in systemic treatments with flurbiprofen.
When it can be used only after consulting your doctor
After a few days of treatment without noticeable results. In fact, cases of bronchospasm with flurbiprofen have been reported in patients with non-allergic asthma in patients with a history of bronchial asthma.
The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation. In such cases it is necessary to interrupt the treatment and institute, if necessary, a suitable therapy. Do not use for prolonged treatments.
It is also advisable to consult your doctor in cases where these disorders have occurred in the past.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases.
However, administration of flurbiprofen is not recommended in nursing mothers.
Consult your doctor if you suspect you are pregnant or want to plan a maternity leave.
Effects on ability to drive and use machines
Tantum Verde Gola, at recommended doses, does not affect the ability to drive or use machines.
Important information about some of the excipients
Tantum Verde Gola 0.25% mouthwash and 0.25% oral mucosal solution contain ethanol.
For those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations.
NOTES ON HEALTH EDUCATION
In favorable environmental conditions (lowering or sudden changes in temperature, raising the level of humidity, etc.) the upper respiratory tract can be the site of engraftment of pathogenic germs that cause inflammation. The characteristic symptoms of inflammation of the upper respiratory tract (mouth, nose, throat) include sore throat, burning sensation, difficulty in swallowing and can be partially controlled by avoiding exposure to additional irritating factors such as smoke, smog, dry air, crowded places, etc.
Dosage and method of use How to use Tantum verde throat: Dosage
How many
Warning: do not exceed the indicated doses
Mouthwash: The recommended dose is 2-3 gargling a day with 10ml of mouthwash.
Solution for oral mucosa: the recommended dose is 2 sprays 3 times a day addressed directly to the affected part.
Warning: do not exceed the indicated doses without medical advice.
When and for how long
Use the drug as needed, at any time of the day.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Warning: use only for short periods of treatment.
Like
Mouthwash: Pour 10 ml of solution into the measuring cup to be used in pure form, as a gargle.
Solution for oral mucosa: Direct sprays directly on the affected part. Each spray delivers 0.2 ml of solution equivalent to 0.5 mg of active ingredient.
Overdose What to do if you have taken an overdose of Tantum verde Throat
Tantum Verde Gola 0.25% mouthwash should be used for gargling and Tantum Verde Gola 0.25% solution for oral mucosa should be sprayed directly on the affected part; small accidental ingestions of medicines do not cause problems.
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
In the event of this occurrence, appropriate treatments must be adopted; gastric lavage and, if necessary, correction of any imbalances in serum electrolytes are indicated.
In case of accidental ingestion of an excessive dose of Tantum Verde Gola, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Tantum Verde Gola, ask your doctor or pharmacist.
Side Effects What are the side effects of Tantum verde throat
Like all medicines, Tantum Verde Gola can cause side effects, although not everybody gets them.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
The following undesirable effects have been reported, particularly after administration of formulations for systemic use. Insufficient data are available to establish the frequency.
These side effects are usually transient.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to throw away medicines that are no longer used. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Deadline "> Other information
COMPOSITION
Mouthwash
100 ml contain:
- Active ingredient: flurbiprofen 250 mg.
- Excipients: glycerol, ethanol (96 per cent), crystallizable liquid sorbitol, castor oil 40 hydrogenated polyoxyethylenate, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, patent blue V (E131), purified water.
Solution for oral mucosa
100 ml contain:
- Active ingredient: flurbiprofen 250 mg.
- Excipients: glycerol, ethanol (96 per cent), crystallizable liquid sorbitol, polysorbate 20, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, purified water.
HOW IT LOOKS
Tantum Verde Gola 0.25% mouthwash is presented as a mouthwash in a 160 ml dark glass bottle with measuring cup.
Tantum Verde Gola 0.25% solution for oral mucosa is presented as a solution in a 15 ml polyethylene nebulizer bottle.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
TANTUM ACTIV THROAT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml contain, active principle: flurbiprofen 250 mg.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM -
Mouthwash.
Solution for oral mucosa
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Symptomatic treatment of irritative-inflammatory states, also associated with pain in the oropharyngeal cavity (eg pharyngitis, gingivitis, stomatitis), also as a consequence of conservative or extractive dental therapy.
04.2 Posology and method of administration -
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section Special warnings and precautions for use).
Mouthwash
The recommended dose is 2-3 rinses or gargles per day with 10ml of mouthwash.
It can be diluted in water. Pour 10 ml of Tantum Activ Throat 0.25% mouthwash into the measuring cup to be used in pure form, as a gargle, or in diluted form, as an oral rinse, adding water to the cup itself.
Solution for oral mucosa
The recommended dose is 2 sprays 3 times a day addressed directly to the affected area.
Each spray delivers 0.2 ml of solution equivalent to 0.5 mg of active ingredient.
Use the drug as needed, at any time of the day.
Be careful not to exceed the indicated doses.
04.3 Contraindications -
Tantum Activ Gola is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients and to aspirin or other NSAIDs.
In the third trimester of pregnancy.
Do not use in patients who have a peptic ulcer or have had it in the past.
04.4 Special warnings and appropriate precautions for use -
At the recommended doses, any occasional swallowing of Tantum Activ Throat does not cause any harm to the patient as these doses are much lower than those commonly used in systemic treatments with flurbiprofen.
Tantum Activ Gola should be used with caution by patients with non-allergic asthma, as there have been reports of bronchospasm with flurbiprofen in patients with a history of bronchial asthma.
The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation. In such cases it is necessary to interrupt the treatment and institute, if necessary, a suitable therapy. Do not use for prolonged treatments.
For those who carry out sporting activities: the use of medicines containing ethyl alcohol can determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations.
04.5 Interactions with other medicinal products and other forms of interaction -
There are no known interactions with other drugs or otherwise.
04.6 Pregnancy and breastfeeding -
During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases.
However, administration of flurbiprofen is not recommended in nursing mothers.
04.7 Effects on ability to drive and use machines -
It does not affect the ability to drive and use machines.
04.8 Undesirable effects -
The use of Tantum Activ Gola, especially if prolonged, can give rise to sensitization and local irritation phenomena, in which case the treatment must be interrupted and appropriate therapy instituted, if necessary.
These phenomena are generally transient.
The following undesirable effects have been reported, particularly after administration of formulations for systemic use:
Disorders of the blood and lymphatic system
Thrombocytopenia, aplastic anemia and agranulocytosis.
Disorders of the immune system
Anaphylaxis, angioedema, allergic reaction.
Disorders of the nervous system
Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and sleepiness.
Acoustic and labyrinth disturbances
Tinnitus.
Respiratory, thoracic and mediastinal disorders
Respiratory tract reactivity (asthma, bronchospasm and dyspnoea).
Gastrointestinal disorders
The most commonly observed adverse events are gastrointestinal in nature.
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently.
Skin and subcutaneous tissue disorders
Skin disorders including rash, pruritus, urticaria, purpura and very rarely bullous dermatoses (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme).
Kidney and urinary system disorders
Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome.
As with other NSAIDs, rare cases of renal failure have been reported.
04.9 Overdose -
Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur.
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
In the event of this occurrence, appropriate treatments must be adopted; gastric lavage and, if necessary, correction of any imbalances in serum electrolytes are indicated.
There are no specific antidotes to flurbiprofen.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Stomatologicals: other substances for local oral treatment.
ATC: A01AD11
Flurbiprofen is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic properties, due to the inhibition of the cyclooxygenase and lipoxygenase enzymes, with consequent inhibition of the synthesis of prostaglandins and leukotrienes.
The antiprostaglandin activity carried out by flurbiprofen justifies the use of the drug in all those morbid states in which the anti-inflammatory component is a predominant and elective characteristic.
05.2 "Pharmacokinetic properties -
Tantum Activ Throat 0.25% mouthwash and 0.25% solution for oral mucosa, whose use is aimed at obtaining a local effect, has a low systemic absorption. The relative bioavailability of flurbiprofen in mouthwash compared to the oral route is between 5% and 10%.
05.3 Preclinical safety data -
Non-clinical data reveal no risk to humans based on conventional studies of safety pharmacology, repeated dose toxicity and reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Mouthwash
Glycerol, ethanol (96 per cent), crystallizable liquid sorbitol, castor oil 40 hydrogenated polyoxyethylenate, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, patent blue V (E 131), purified water
Solution for oral mucosa
Glycerol, ethanol (96 per cent), crystallizable liquid sorbitol, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, polysorbate 20, purified water.
06.2 Incompatibility "-
There are no known chemical-physical incompatibilities of flurbiprofen with other compounds.
06.3 Period of validity "-
2 years.
06.4 Special precautions for storage -
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
Mouthwash
160 ml dark glass bottle with measuring cup with level mark at 10 ml.
Solution for oral mucosa
15 ml polyethylene nebulizer bottle.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Joint Chemical Companies Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia 70, 00181 Rome
08.0 MARKETING AUTHORIZATION NUMBER -
AIC n. 034015014 - Tantum Activ Throat 0.25% mouthwash, 160 ml bottle
AIC n. 034015026 - Tantum Activ Gola 0.25% solution for oral mucosa, nebulizer bottle 15 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 1 June 2000 Date of renewal of the authorization: 1 June 2005
10.0 DATE OF REVISION OF THE TEXT -
AIFA Determination of March 2009
