TANTUM VERDE THROAT * COLLUT 160ML
Therapeutic indications
Symptomatic treatment of irritative-inflammatory states, also associated with oropharyngeal pain (eg pharyngitis).
Dosage and method of use
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4Special warnings and precautions for use). Mouthwash: The recommended dose is 2-3 gargling a day with 10ml of mouthwash.
Pour 10 ml of Tantum Verde Gola mouthwash into the measuring cup to be used in its pure form, as a gargle. Oromucosal spray, solution: 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.
Contraindications
Tantum Verde Gola is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients listed in section 6.1 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.
Side effects
They have been reported, in particularafter administration of formulations for systemic use, the following undesirable effects, reported according to the MedDRA systemic and organ class. The following scales of values were used: very common (≥1 / 10); common (≥1 / 100,
| MedDRA System Organ Classification | Frequency not known(frequency cannot be estimated from the available data) |
| Disorders of the blood and lymphatic system | Thrombocytopenia, aplastic anemia, agranulocytosis |
| Disorders of the immune system | Anaphylaxis, angioedema, allergic reaction. |
| Psychiatric disorders | Depression, confusion, hallucination |
| Nervous system disorders | Dizziness, haemorrhage and cerebrovascular accident, optic neuritis, migraine, paraesthesia, somnolence. |
| Eye disorders | Visual disturbances |
| Ear and labyrinth disorders | Tinnitus, vertigo |
| Respiratory, thoracic and mediastinal disorders | Asthma, bronchospasm, dyspnoea |
| Gastrointestinal disorders | Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage, colitis and Crohn's disease, gastritis, peptic ulcer, perforation and gastric ulcer with haemorrhage. |
| Skin and subcutaneous tissue disorders | Bullous conditions (including, Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), skin disorders including rash, itching, hives, purpura |
| Renal and urinary disorders | Renal failure, nephrotoxicity in various forms including interstitial nephritis and nephrotic syndrome |
| General disorders and administration site conditions | Discomfort, fatigue |
Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting systemwww.agenziafarmaco.gov.it/it/responsabili.
Special warnings
At the recommended doses, any occasional swallowing of Tantum Verde Gola does not cause any harm to the patient as these doses are much lower than those commonly used in treatments with systemic flurbiprofen. Tantum Verde Gola should be used with caution by patients with non-allergic asthma, in fact 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, treatment should be interrupted and appropriate therapy instituted if necessary. Do not use for prolonged treatments.
Pregnancy and breastfeeding
During the first and second trimester of pregnancy, Tantum Verde Gola should not be administered except in strictly necessary cases. Tantum Verde Gola should not be used from the third trimester of pregnancy. However, administration of flurbiprofen is not recommended in nursing mothers.
Expiration and retention
This medicine does not require any special storage conditions.
Interactions with other drugs
There are no known interactions with other drugs or otherwise.
Overdose
Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur.SymptomsSymptoms of overdose may include nausea, vomiting and irritation of the gastrointestinal tract.TreatmentIn 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.
Active principles
100 ml contain: active ingredient: flurbiprofen 250 mg. For the full list of excipients, see section 6.1.
Excipients
Mouthwash : glycerol, ethanol (96%), crystallizable liquid sorbitol, hydrogenated castor oil 40 polyoxyethylenate, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, patent blue V (E 131), purified water. Oromucosal spray, solution:glycerol, ethanol (96 per cent), crystallizable liquid sorbitol, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavor, polysorbate 20, purified water.
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