Tantum activ gola spray 0.25% - sore throat nebulizer 15 ml

Dosage
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section Special warnings and precautions for use).

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.

Active Ingredients
100 ml contain, active ingredient: flurbiprofen 250 mg.

Excipients
Glycerol, ethanol (96 percent), liquid crystallizable sorbitol, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavoring, polysorbate 20, purified water.

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 suffering from peptic ulcers or who have suffered from them in the past.

Warnings
At the recommended doses, occasional swallowing of Tantum Activ 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 Activ Gola should be used with caution in 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 treatments. For those who participate in sports: the use of medicines containing ethyl alcohol may cause a positive result in anti-doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.

Pregnancy
During the first and second trimester of pregnancy, flurbiprofen should not be administered unless strictly necessary. However, the administration of flurbiprofen is not recommended for breastfeeding mothers.

Side Effects
The use of Tantum Activ Gola, especially if prolonged, may give rise to sensitization and local irritation phenomena. In this case, treatment should be discontinued and, if necessary, appropriate therapy instituted.

These phenomena are generally transitory. The following undesirable effects have been reported, particularly after administration of systemic formulations:
- Blood and lymphatic system disorders Thrombocytopenia, aplastic anemia and agranulocytosis.
- Immune system disorders Anaphylaxis, angioedema, allergic reaction.
- Nervous system disorders Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and somnolence.
- Acoustic and labyrinth disorders 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. Less frequently, gastritis, peptic ulcer, perforation, and ulcer haemorrhage have been observed.
- 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).
- Renal and urinary tract disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.

Overdose
Given the low content of the active ingredient and its local use, overdose situations are unlikely to occur. Symptoms of overdose may include nausea, vomiting, and gastrointestinal irritation. In the event of such an occurrence, 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.

Interactions
No interactions with other drugs or other types of drugs are known.

Storage
This medicine does not require any special storage conditions.

Format
15ml spray.