TANTUM VERDE GOLA*NEB 15ML0.25

TANTUM VERDE GOLA 250mg/100ml oral mucosal spray, solution
Flurbiprofen

What it is and what it is used for
Tantum Verde Gola is a non-steroidal anti-inflammatory drug with analgesic properties, i.e. a drug that acts against pain and inflammation of the throat, mouth, and gums.
Tantum Verde Gola is used for the symptomatic treatment of inflammation and irritation of the mouth and throat, also associated with pain (e.g., pharyngitis).

What you need to know before taking the medicine
Do not take Tantum Verde Gola
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are allergic to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are more than 6 months pregnant;
- if you suffer or have suffered in the past from episodes of stomach or duodenal ulcers.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tantum Verde Gola.

Talk to your doctor or pharmacist if you have an infection - refer to the Infections section below.
In particular, inform your doctor if you suffer or have suffered in the past from breathing disorders, such as non-allergic asthma.

The use of Tantum Verde Gola, especially if prolonged, may lead to sensitization phenomena (allergic phenomena) or local irritation (see paragraph 4 Possible side effects).
Consult your doctor even if the disorders listed above have occurred in the past.
Do not use Tantum Verde Gola for prolonged treatments.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects while being treated with Tantum Verde Gola, STOP treatment and contact your doctor immediately:
• allergic phenomena (sensitization phenomena):
- hypersensitivity reactions (allergic reaction)
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
- asthma (an inflammatory disease characterized by a reduction in the caliber of the lower airways)
- bronchospasm (difficulty breathing)
• local irritation phenomena

Furthermore, the following side effects have been reported, particularly after taking systemic formulations, the frequency of which cannot be established from available data.

Effects on the blood
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anemia (reduction in the amount of hemoglobin in the blood, the substance that carries oxygen in the blood)
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood)

Psychiatric effects
- depression
- confusion
- hallucinations (seeing or hearing inexplicable things)

Effects on the nervous system
- dizziness
- hemorrhage and cerebrovascular accident (disease caused by insufficient blood flow to an area of the brain or by the rupture of an artery)
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision up to blindness)
- migraine (chronic disease characterized by recurrent headaches)
- numbness of the limbs or other parts of the body (paresthesia)
- drowsiness

Effects on the eyes
- visual disturbances

Effects on the ear and labyrinth
- ringing in the ears (tinnitus)
- vertigo

Effects on the bronchi and lungs
- dyspnea (shortness of breath)
- asthma (difficulty breathing)
- bronchospasm (constriction of the bronchi)

Effects on the mouth, stomach, and intestines
- nausea
- vomiting
- diarrhea
- gas emission (flatulence)
- constipation
- difficulty digesting
- abdominal pain
- blood in the stool
- blood in the vomit
- lesions inside the mouth
- blood loss from the stomach and intestines
- worsening of inflammatory diseases of the colon and intestines (colitis, Crohn's disease)
- heartburn
- stomach or duodenal ulcer
- blood loss from the stomach and duodenum
- ulcer and perforation of the stomach walls with blood loss

Effects on the skin and underlying tissue
- severe skin rash or exfoliation (including toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
- skin rash
- itching
- urticaria (skin redness accompanied by itching)
- purpura (appearance of purple skin patches of various sizes)

Effects on the kidneys and urinary tract
- renal failure (reduction in kidney function)
- interstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)

General effects and conditions at the administration site
- discomfort
- fatigue

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.