TANTUM VERDE GOLA "250 MG/100 ML MOUTHWASH" ​​160 ML BOTTLE

Name
TANTUM VERDE GOLA 250mg/100ml mouthwash
Flurbiprofen


What is it and what is it used for?
Tantum Verde Gola is a nonsteroidal 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, even when 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 nonsteroidal anti-inflammatory drugs (NSAIDs);
- if you have been pregnant for more than 6 months;
- if you suffer or have suffered in the past from episodes of stomach or duodenal ulcer.


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 – see “Infections” below.
In particular, tell your doctor if you suffer or have suffered in the past from breathing problems, such as non-allergic asthma.

The use of Tantum Verde Gola, especially if prolonged, may give rise to sensitization phenomena (allergic phenomena) or local irritation (see paragraph 4 "Possible side effects").
Consult your doctor even if you have had any of the above-mentioned symptoms 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 taking 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 narrowing of the lower airways)
- bronchospasm (difficulty breathing)
• local irritation phenomena

Furthermore, the following side effects may occur, reported in particular after taking systemic formulations, the frequency of which cannot be established on the basis of available data.

Effects affecting 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 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 by the rupture of an artery)
- optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss and even blindness)
- migraine (chronic disease characterized by recurrent headaches)
- numbness of the limbs or other parts of the body (paresthesia)
- drowsiness

Effects affecting the eyes
- vision problems

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

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

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

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

Effects on the kidneys and urinary tract
- renal failure (reduced kidney function)
- interstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli which causes a loss of proteins in the urine)

General effects and conditions related to the site of administration
- nuisance
- fatigue

Reporting of side effects
If you experience 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.