BRONCHENOLO GOLA "0.25% SPRAY FOR ORAL MUCOSA" 15 ML BOTTLE"

Name
BRONCHENOLO GOLA 2.5 mg/ml mouthwash
BRONCHENOLO GOLA 2.5 mg/ml spray for oral mucosa
Flurbiprofen


What it is and what it is used for
Bronchenolo Gola contains flurbiprofen, a medicine that acts against pain (analgesic) and against inflammation (non-steroidal anti-inflammatory drug, NSAID).

BRONCHENOLO GOLA is used in adults and adolescents over 12 years of age in case of burning, redness and/or pain in the mouth and throat, due to mild and transitory inflammation (gingivitis, stomatitis, pharyngitis) or dental procedures (dental treatments such as caries treatment or tooth extraction).


What you need to know before taking the medicine
Do not use BRONCHENOLO GOLA
• if you and/or the child are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you and/or the child are allergic to acetylsalicylic acid (a medicine against inflammation, pain, fever and heart problems) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section "Other medicines and BRONCHENOLO GOLA");
• if you and/or your child have suffered in the past from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you and/or your child suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
• if you and/or your child suffer frequently from peptic ulcer (stomach sore) or bleeding from the stomach or intestine (two or more distinct episodes of ulcer or bleeding);
• if you and/or your child suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe renal failure (reduced kidney function).

Do not take/give BRONCHENOLO GOLA if you are in the last 3 months of pregnancy (see section "Pregnancy and breast-feeding").

Do not give BRONCHENOLO GOLA to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving BRONCHENOLO GOLA to your child.

In particular, tell your doctor if you and/or your child:
• you have suffered from bronchial asthma (a breathing disease) in the past, as this increases the risk that you/your child may develop bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
• you have suffered from allergies in the past;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic failure);
• you suffer from hypertension (high blood pressure);
• you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
• you have suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases in the past as this increases the risk that these diseases may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 "Possible side effects");
• if you are elderly (as you are more likely to experience side effects);
• if you have heart or blood vessel problems, as medicines such as BRONCHENOLO GOLA may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatment; do not exceed the dose of BRONCHENOLO GOLA and do not take it for long periods. Tell your doctor if you have heart problems, a history of stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke);
• have an infection – see “Infections” below.

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, may give rise to allergic or local irritation phenomena (see paragraph 4 "Possible side effects"); in such cases, stop the treatment and consult your doctor who, if necessary, will carry out an appropriate therapy.

If you or your child experience mouth irritation, stop treatment.

After short periods of treatment (3 days) without appreciable results, consult your doctor.

Children and adolescents
Do not give BRONCHENOLO GOLA to children under 12 years of age.


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 BRONCHENOLO GOLA, STOP treatment and contact your doctor immediately :
• allergic phenomena (sensitization phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of heat or tingling in the mouth and throat
• respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
• various skin disorders: various types of skin rashes, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with BRONCHENOLO GOLA, contact your doctor immediately :
- abdominal pain
- peptic ulcer (stomach injury) - perforation and bleeding of the stomach or intestines.
These side effects can be fatal and you and/or your child may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you and/or your child have suffered from stomach and intestinal diseases in the past.

Additionally, you may experience the following side effects:

Effects affecting the blood
- anemia (reduction in the amount of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anemia (reduction in the amount of all types of blood cells, red blood cells, white blood cells, platelets)
- agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood).

Effects on the nervous system
- dizziness
- headache (headache)
- paresthesia (numbness of the limbs or other parts of the body)
- drowsiness
- cerebrovascular accidents (diseases caused by lack of blood flow to an area of ​​the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision and even blindness)
- migraine (chronic disease characterized by recurrent headaches)
- confusion
- dizziness.

Effects on the immune system
- anaphylactic reactions (severe allergic reaction)
- angioedema (inflammatory reaction of the skin)
- hypersensitivity.

Effects affecting the eye
- visual disturbances.

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

Effects on the cardiovascular system
- heart failure
- swelling
- hypertension (high blood pressure)

Effects affecting the bronchi and lungs
- throat irritation
- asthma
- bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
- dyspnea (shortness of breath)
- blisters in the mouth or throat
- numbness of the mouth or throat.

Effects affecting the mouth, stomach and intestines
- diarrhea
- lesions inside the mouth
- nausea
- mouth and throat pain
- sensation of heat or burning, tingling in the mouth
- abdominal distension
- stomach pain
- constipation
- dry mouth
- difficulty digesting
- flatulence (emission of gas from the intestine)
- inflammation of the tongue
- alteration of taste
- vomit
- blood in stool
- blood in vomit
- loss of blood from the stomach and intestines
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- inflammation of the stomach (gastritis)
- gastritis
- peptic ulcer
- gastric perforation
- inflammation of the pancreas (pancreatitis).

Effects affecting the skin and underlying tissue
- skin rashes
- itching
- urticaria (redness of the skin accompanied by itching)
- purpura (appearance of purple skin patches of various sizes)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema multiforme.

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

General and administration site effects
- fever
- pain
- unease
- fatigue
- malaise

Effects affecting the liver
- hepatitis

General and administration site effects
- fever

Effects on the psychiatric sphere
- insomnia
- depression
- hallucination.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.