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 is it and what is it for?
Bronchenolo Gola contains flurbiprofen, a medicine that acts against pain (analgesic) and against inflammation (nonsteroidal 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 transient 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 your child are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you and/or your child are allergic to acetylsalicylic acid (a medicine used to treat 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 frequently suffer from peptic ulcers (stomach sores) or bleeding from the stomach or intestines (two or more distinct episodes of ulcers 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 breastfeeding").

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 experience 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 ulcers (stomach ulcers) and other stomach and intestinal diseases in the past, as this increases the risk of these diseases recurring. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if your peptic ulcer has been complicated by bleeding or perforation of the stomach and intestines (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 like BRONCHENOLO GOLA may be associated with a small increased 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, high cholesterol, or smoke);
• have an infection – see “Infections” below.

Report any unusual abdominal symptoms to your doctor.

Use of this medicine, especially if prolonged, may give rise to allergic reactions or local irritation (see section 4 "Possible side effects"); in such cases, discontinue treatment and consult your doctor who, if necessary, will perform 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 while taking 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: rashes of various types, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the start 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 are especially likely to occur if you are elderly or if you and/or your child have had stomach or intestinal problems 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 number 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 a lack of blood flow to an area of ​​the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss and even blindness)
- migraine (chronic disease characterized by recurrent headaches)
- confusion
- dizziness.

Effects affecting the immune system
- anaphylactic reactions (severe allergic reaction)
- angioedema (inflammatory skin reaction)
- 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 which causes 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
- sore mouth and throat
- sensation of heat or burning, tingling in the mouth
- abdominal distension
- stomach pain
- constipation
- dry mouth
- difficulty digesting
- flatulence (passing of gas from the intestine)
- inflammation of the tongue
- alteration of taste
- vomit
- blood in the 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
- hives (redness of the skin accompanied by itching)
- purpura (appearance of purple skin patches of varying 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 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.