BRONCHENOLO GOLA*ORAL SPRAY 15ML

BRONCHENOLO GOLA 2.5 mg/ml mouthwash
BRONCHENOLO GOLA 2.5 mg/ml oral spray
Flurbiprofen

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

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

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 (medicine for 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 the child have previously suffered from bleeding or perforation of the stomach or intestines related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you and/or the child suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
• if you and/or the child frequently suffer from peptic ulcers (stomach lesions) or bleeding from the stomach or intestines (two or more distinct episodes of ulcer or bleeding);
• if you and/or the child suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney 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 the child:
• have a history of bronchial asthma (a respiratory disease), as there is an increased risk that you/the child may experience bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
• have a history of allergies;
• are taking other Non-Steroidal Anti-inflammatory Drugs (NSAIDs);
• suffer from systemic lupus erythematosus or mixed connective tissue disease;
• suffer from reduced kidney, heart or liver function (kidney, heart or liver failure);
• suffer from hypertension (high blood pressure);
• are taking other analgesics for a long time or not according to the prescribed dosage, as headaches may occur;
• have a history of peptic ulcers (stomach lesions) and other stomach and intestinal diseases, as there is an increased 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 intestines (see section 4 Possible side effects);
• if you are elderly (as you are more likely to experience side effects);
• have heart or blood vessel problems, as medicines like BRONCHENOLO GOLA may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatments; 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 for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or smoke);
• have an infection - refer to the Infections section below.

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see section 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will provide appropriate therapy.

If you or the 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 being treated with BRONCHENOLO GOLA, STOP treatment and contact your doctor immediately:
• allergic reactions (sensitisation phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of warmth or tingling in the mouth and throat
• respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
• various skin disorders: skin 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 beginning of treatment with BRONCHENOLO GOLA, contact your doctor immediately:
- abdominal pain
- peptic ulcer (stomach lesion)
- perforation and bleeding of the stomach or intestine.
These side effects can be fatal and you and/or the child may experience them with or without warning symptoms. These side effects are particularly common if you are elderly or if you and/or the child have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects on the blood
- anaemia (reduction in the number of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anaemia (reduction in 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
- paraesthesia (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 up to blindness)
- migraine (chronic disease characterised by recurrent headaches)
- confusion
- vertigo.

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

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

Effects on the mouth, stomach and intestines
- diarrhoea
- lesions inside the mouth
- nausea
- mouth and throat pain
- sensation of warmth or burning, tingling of the mouth
- abdominal distension
- abdominal pain
- constipation
- dry mouth
- difficulty digesting
- flatulence (gas expulsion from the intestine)
- inflammation of the tongue
- altered taste
- vomiting
- blood in stools
- blood in vomit
- blood loss from the stomach and intestines
- colitis
- worsening of inflammatory bowel diseases (Crohn's disease)
- stomach inflammation (gastritis)
- gastritis
- peptic ulcer
- gastric perforation
- pancreatitis.

Effects on the skin and subcutaneous tissue
- skin rashes
- itching
- urticaria (skin redness accompanied by itching)
- purpura (appearance of purplish skin patches of different sizes)
- bullous dermatoses (severe skin lesions characterised 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 leading to protein loss in the urine)
- renal failure (reduced kidney function).

General effects and effects at the administration site
- fever
- pain
- discomfort
- fatigue
- malaise

Effects on the liver
- hepatitis

General effects and effects at the administration site
- fever

Psychiatric effects
- insomnia
- depression
- hallucination.

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-averse.
By reporting side effects, you can help provide more information on the safety of this medicine.