Tantum Verde Gola 0.25% Flurbiprofen Anti-inflammatory Mouthwash 160 ml

Flurbiprofen-based mouthwash for oral mucosa with anti-inflammatory action.

Therapeutic indications

Tantum Verde Gola is a non-steroidal anti-inflammatory drug with pain relieving properties for local oral treatment. It is used as a symptomatic treatment of irritative-inflammatory states, also associated with oropharyngeal pain (eg pharyngitis).

Dosage and posology

Mouthwash: The recommended dose is 2-3 gargling a day with 10ml of mouthwash. Warning: do not exceed the indicated doses without medical advice.

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.

Pour 10 ml of solution into the measuring cup to be used in pure form, as a gargle.

Overdose

Tantum Verde Gola 0.25% mouthwash should be used for gargling. 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 further questions on the use of Tantum Verde Gola, ask your doctor or pharmacist.

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.
• In patients who have or have had a peptic ulcer in the past.

Side effects

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 frequency. Frequency not known (frequency cannot be estimated from the available data):

• System disorders: blood and lymphatic thrombocytopenia, aplastic anemia, agranulocytosis.
• Immune system disorders: 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, 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.

These side effects are usually transient. Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

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.

Special warnings

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 well below those commonly used in systemic treatments with flurbiprofen.

After a few days of treatment without noticeable results. In fact, in patients with non-allergic asthma, cases of bronchospasm with flurbiprofen have been reported 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 discontinued and appropriate therapy instituted if necessary. Do not use for prolonged treatments. It is advisable to consult the doctor even in cases in which these disorders have occurred in the past.

Tantum Verde Gola 0.25% mouthwash contains ethanol. For those who play sports: the use of medicines containing ethyl alcohol can determine a positive anti-doping test in relation to the alcohol concentration limits indicated by some sports federations.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 ml of Tantum Verde Throat 0.25% Mouthwash contain:

Active principle

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.