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ANGELINI PHARMA ITALIA SpA

Tantum Verde throat 250 mg/100 ml 15 ml oral spray

Tantum Verde throat 250 mg/100 ml 15 ml oral spray

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Tantum Verde Gola oral spray 250 mg/100 ml is an over-the-counter medicine indicated for the symptomatic treatment of sore throat and irritation-inflammatory conditions of the oropharyngeal cavity . Based on flurbiprofen , it offers local anti-inflammatory and analgesic action with a targeted spray , practical to use and rapid relief in cases of sore throat, pain and inflammation .

NET WEIGHT OF THE PRODUCT

EAN

034015026

MINSAN

034015026

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Tantum Verde Gola 250 mg/100 ml 15 ml oral spray is a specific solution for the symptomatic treatment of sore throat and irritation-inflammatory conditions of the oral mucosa . Thanks to the presence of flurbiprofen , an active ingredient with anti-inflammatory and analgesic properties, this oral spray acts quickly to relieve localized pain and inflammation in the throat. The spray solution formulation allows for targeted and practical application, ideal for those looking for local and immediate use of the product.

The 15 ml format is perfect to carry with you at all times, ensuring rapid relief at any time of the day. Tantum Verde Gola is an over-the-counter medicine widely used to combat discomfort related to a sore throat, pain and inflammation due to colds, pharyngitis or other inflammatory conditions of the throat. Its effectiveness is recognized for local and targeted treatment , thanks to the possibility of easily measuring the number of sprays needed. Choose Tantum Verde Gola for rapid relief from a sore throat and to take care of your oral health with a reliable and quality product


ACTIVE INGREDIENTS

Active ingredients contained in Tantum Verde gola 250 mg/100 ml 15 ml oral spray - What is the active ingredient of Tantum Verde gola 250 mg/100 ml 15 ml oral spray?

100 ml contain: active ingredient: flurbiprofen 250 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Tantum Verde gola 250 mg/100 ml 15 ml oral spray - What does Tantum Verde gola 250 mg/100 ml 15 ml oral spray contain?

Mouthwash : glycerol, ethanol (96%), liquid crystallizable sorbitol, polyoxyethylene hydrogenated castor oil 40, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavouring, patent blue V (E 131), purified water. Oral mucosa spray, solution : glycerol, ethanol (96%), liquid crystallizable sorbitol, sodium saccharin, potassium bicarbonate, sodium benzoate, mint flavouring, polysorbate 20, purified water.

DIRECTIONS

Therapeutic indications Tantum Verde gola 250 mg/100 ml 15 ml oral spray - Why is Tantum Verde gola 250 mg/100 ml 15 ml oral spray used? What is it used for?

Symptomatic treatment of irritative-inflammatory conditions, also associated with pain in the oropharyngeal cavity (e.g. pharyngitis).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Tantum Verde gola 250 mg/100 ml 15 ml oral spray - When should Tantum Verde gola 250 mg/100 ml 15 ml oral spray 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 listed in paragraph 6.1 and to aspirin or other NSAIDs. In the third trimester of pregnancy. Do not use in patients who suffer from peptic ulcer or who have suffered from it in the past.

DOSAGE

Quantity and method of taking Tantum Verde gola 250 mg/100 ml 15 ml oral spray - How do you take Tantum Verde gola 250 mg/100 ml 15 ml oral spray?

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use ). Mouthwash: The recommended dose is 2-3 gargles per day with 10 ml of mouthwash. Pour 10 ml of Tantum Verde Gola mouthwash into the measuring cup to be used in pure form, as a gargle. Spray for oral mucosa, solution: 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 when needed, at any time of the day. Be careful not to exceed the indicated doses.

CONSERVATION

Storage Tantum Verde gola 250 mg/100 ml 15 ml oral spray - How is Tantum Verde gola 250 mg/100 ml 15 ml oral spray stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Tantum Verde gola 250 mg/100 ml 15 ml oral spray - About Tantum Verde gola 250 mg/100 ml 15 ml oral spray it is important to know that:

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 treatments with systemic flurbiprofen. 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 phenomena. In such cases, treatment should be stopped and, if necessary, appropriate therapy instituted. Do not use for prolonged treatments.

INTERACTIONS

Interactions Tantum Verde gola 250 mg/100 ml 15 ml oral spray - Which medicines or foods can modify the effect of Tantum Verde gola 250 mg/100 ml 15 ml oral spray?

There are no known interactions with other drugs or other types of drugs.

SIDE EFFECTS

Like all medicines, Tantum Verde gola 250 mg/100 ml 15 ml oral spray can cause side effects - What are the side effects of Tantum Verde gola 250 mg/100 ml 15 ml oral spray?

The following undesirable effects have been reported, particularly after administration of systemic formulations , reported according to the MedDRA system organ classification. The following scales of values ​​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 Classification Frequency not known (frequency cannot be estimated from the available data)
Pathologies of the haemolymphopoietic system 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 pathologies Visual disturbances
Ear and labyrinth pathologies Tinnitus, vertigo
Respiratory, thoracic and mediastinal pathologies Asthma, bronchospasm, dyspnea
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
Kidney and urinary disorders Renal failure, nephrotoxicity in various forms including interstitial nephritis and nephrotic syndrome
Systemic disorders and conditions related to the administration site Discomfort, fatigue
Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili .

OVERDOSE

Overdose Tantum Verde gola 250 mg/100 ml 15 ml oral spray - What are the risks of Tantum Verde gola 250 mg/100 ml 15 ml oral spray in case of overdose?

Considering the low content of active ingredient and its local use, it is unlikely that overdose situations may occur. Symptoms Symptoms of overdose may include nausea, vomiting and irritation of the gastrointestinal tract. Treatment In the event of such an 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 for flurbiprofen.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Tantum Verde gola 250 mg/100 ml 15 ml oral spray.

During the first and second trimester of pregnancy, Tantum Verde Gola 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 mothers who are breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Tantum Verde gola 250 mg/100 ml 15 ml oral spray before driving or using machines - Does Tantum Verde gola 250 mg/100 ml 15 ml oral spray affect driving or using machines?

Tantum Verde Gola does not alter the ability to drive vehicles or use machinery.
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