TANTUM VERDE GOLA*SPRAY 15ML W/M

TANTUM VERDE GOLA 0.25% mouth spray, chamomile and honey flavour
Flurbiprofen

What it is and what it is used for
Tantum Verde Gola is a non-steroidal anti-inflammatory drug with analgesic properties, meaning it 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, including those 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 section 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 section 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 during treatment 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

In addition, 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 number of blood cells)
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood)

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

Effects on the nervous system
- dizziness
- hemorrhage and cerebrovascular accident (disease caused by lack of blood flow to an area of the brain or rupture of an artery)
- optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss 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
- vision disturbances

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

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

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

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

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

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

Reporting of side effects
If you get any side effects, including those 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.