Spray to provide relief in case of inflamed or irritated throat.
Indications
Tantum Verde Gola 0.25% is indicated in the symptomatic treatment of irritative-inflammatory conditions, also associated with pain in the oropharyngeal cavity (e.g. pharyngitis).
Flavor: Chamomile and Honey.
Composition
Active ingredients per 100 ml: flurbiprofen 250 mg.
Excipients: Glycerol, ethanol (96 percent), liquid crystallizable sorbitol, potassium bicarbonate, polysorbate 20, sodium saccharin, sodium benzoate, honey flavoring, natural chamomile flower flavoring, purified water, sodium hydroxide.
How to use and Dosage
The recommended dose is 2 sprays 3 times a day directed directly at the affected area.
Each spray delivers 0.2 ml of solution equivalent to 0.5 mg of active ingredient.
Use the medicine as needed, at any time of the day.
Be careful not to exceed the indicated doses.
Warnings
At the recommended doses, 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 systemic flurbiprofen treatments.
Tantum Verde Gola should be used with caution by patients with non-allergic asthma. In fact, cases of bronchospasm with flurbiprofen have been reported in patients with a history of bronchial asthma.
Use of the product, especially if prolonged, may give rise to sensitization or local irritation.
/>In such cases, treatment should be discontinued and appropriate therapy instituted, if necessary.
Do not use for prolonged treatment.
Contraindications
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 suffering from peptic ulcer or who have suffered from it in the past.
Undesirable effects
The following undesirable effects have been reported, particularly after the administration of formulations for systemic use, reported according to the MedDRA systemic and organ classification.
The following value scales have been used:
- Very common (?1/10);
- Common (?1/100, < 1/10);
- Uncommon (? 1/1,000, < 1/100);
- Rare ? 1/10,000, < 1/1,000);
- Very rare (<1/10,000);
- Not known (frequency cannot be estimated from the available data).
| MedDRA system organ class | Frequency not known (frequency cannot be estimated from the available data) |
| Blood and lymphatic system disorders | Thrombocytopenia, aplastic anaemia, agranulocytosis |
| Immune system disorders | Anaphylaxis, angioedema, allergic reaction. |
| Psychiatric disorders | Depression, confusion, hallucination |
| Nervous system disorders | Dizziness, cerebrovascular accident and haemorrhage, 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, diarrhoea, 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, pruritus, urticaria, 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 |
Overdose
Considering the low content of the active ingredient and its local use, overdose situations are unlikely to occur.
Symptoms: Symptoms of overdose may include nausea, vomiting and irritation of the gastrointestinal tract.
Treatment: In this case, appropriate treatment should be adopted; gastric lavage is indicated and, if necessary, correction of any serum electrolyte imbalances. There are no specific antidotes for flurbiprofen.
Pregnancy and Breastfeeding
During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary.
Tantum Verde Gola should not be used from the third trimester of pregnancy.
However, the administration of flurbiprofen is not recommended in breastfeeding mothers.
Format
15 ml spray with nebulizer
Product Code:FRCM136254
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