Bronchenolo Gola

Italy
Brand name Bronchenolo Gola
Form mouthwash
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
A01AD11
Registration number 041515
Manufacturer PERRIGO ITALIA S.R.L.
Bronchenolo Gola mouthwash

Table of Contents

Package leaflet: Information for the patient

BRONCHENOLO GOLA 2.5 mg/ml mouthwash, oral mucosal spray

Flurbiprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use/give the child this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

  • Keep this leaflet. You may need to read it again.
  • If you need more information or advice, consult your pharmacist.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
  • Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

  1. What BRONCHENOLO GOLA is and what it is used for
  2. What you need to know before using BRONCHENOLO GOLA
  3. How to use BRONCHENOLO GOLA
  4. Possible side effects
  5. How to store BRONCHENOLO GOLA
  6. Contents of the pack and other information

1. What BRONCHENOLO GOLA 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 for soreness, redness and/or pain in the mouth and throat due to mild and transient inflammations (gingivitis, stomatitis, pharyngitis) or following dental procedures (dental treatments such as cavity treatment or tooth extraction).

2. What you should know before using BRONCHENOLO GOLA

Do not use BRONCHENOLO GOLA

  • if you and/or the child are allergic to flurbiprofen or to 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 used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and BRONCHENOLO GOLA”);
  • if you and/or the child have previously experienced stomach or intestinal bleeding or perforation related to previous treatment 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 ulcer (stomach lesion) or gastrointestinal bleeding (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), or 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 the child.
In particular, inform your doctor if you and/or the child:

  • have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you/your child may experience bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
  • have previously suffered from 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 (renal, cardiac or hepatic insufficiency);
  • suffer from hypertension (high blood pressure);
  • have been taking other analgesics for a long time or without following the recommended dosage, as this may cause headache;
  • have previously suffered from peptic ulcer (stomach lesion) or other stomach and intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (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 higher doses and prolonged treatment; do not exceed the recommended dose of BRONCHENOLO GOLA and do not take it for long periods. Inform 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, high cholesterol or smoke).
  • have an infection – refer to the section “Infections” below.

Inform your doctor of any unusual abdominal symptoms.
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 start appropriate therapy.
If you or the child experience mouth irritation, stop treatment.
If no significant improvement occurs after short-term treatment (3 days), consult your doctor.
Children and adolescents
Do not give BRONCHENOLO GOLA to children under 12 years of age.
Other medicines and BRONCHENOLO GOLA
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicine.
Inform your doctor if you/the child are taking any of the following medicines:

  • aspirin and medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever and heart conditions), as they may increase side effects;
  • antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as they increase the risk of stomach and intestinal bleeding;
  • anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), as their effect may be enhanced by NSAIDs;
  • selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of stomach and intestinal bleeding;
  • antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive drugs may increase renal toxicity;
  • alcohol, as it may increase the risk of side effects, especially the risk of stomach and intestinal bleeding;
  • cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase glycoside levels in the blood;
  • cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of kidney toxicity;
  • corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach and intestinal ulcers and bleeding;
  • lithium (a medicine used for behavioral disorders), as lithium levels in the blood may increase;
  • methotrexate (a medicine used for psoriasis, arthritis and tumors), as methotrexate levels in the blood may increase;
  • mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
  • quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of seizures;
  • tacrolimus (an immunosuppressive medicine used after organ transplantation), as NSAIDs may
  • increase the risk of kidney toxicity;
  • zidovudine (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
  • Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as this may increase the effect of these medicines and the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use flurbiprofen during the last 3 months of pregnancy as it may harm the fetus or cause
problems during delivery. It may cause kidney and heart problems in the newborn. It may affect your and your baby's tendency to bleed and may cause delayed or prolonged labor.
Do not use/give BRONCHENOLO GOLA during the first 6 months of pregnancy, unless absolutely necessary and under medical advice. If treatment is needed during this period, take the lowest possible dose for the shortest possible time. If taken for more than a few days from the 20th week of pregnancy onwards, flurbiprofen may cause kidney problems in the fetus leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised
by a doctor.
Fertility
Flurbiprofen belongs to a group of medicines that may affect female fertility. This effect is reversible when the medicine is discontinued. Occasional use of this medicine is unlikely to affect the ability to become pregnant. However, consult your doctor if you have fertility problems before taking this medicine.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and pain.
This may delay appropriate treatment of the infection, thereby increasing the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
Driving and using machines
This medicine may affect the ability to drive vehicles and use machinery.
BRONCHENOLO GOLA contains:

  • propyl and methyl parahydroxybenzoates: may cause allergic reactions (including delayed reactions);
  • polyoxyl 40 hydrogenated castor oil: may cause localized skin reactions;
  • mint flavor, which contains linalool. Linalool may cause allergic reactions.

3. How to use BRONCHENOLO GOLA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The lowest effective dose for the shortest necessary duration should be used in order to relieve symptoms. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).

Mouthwash
Perform 2–3 rinses or gargles per day using 10 ml of undiluted mouthwash or diluted in a small amount of water, without swallowing the medicine.

Spray
The recommended dose is 2 sprays, three times a day, directed directly at the affected area.

If you are elderly or you and/or the child have previously suffered from ulcer (stomach lesion)
If you are elderly or you and/or the child have previously had a peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is a higher risk of serious consequences in case of adverse effects, and an increased risk of developing stomach or intestinal ulcers, bleeding, or perforation (see section 4 “Possible side effects”).

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

If you take/give the child more BRONCHENOLO GOLA than you should
If you/the child accidentally ingest/overdose on BRONCHENOLO GOLA, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, symptoms such as nausea, vomiting, irritation of the stomach or intestine, stomach ache, or rarely diarrhoea may occur. Tinnitus, headache, and gastrointestinal bleeding may also occur. In such cases, the doctor will provide appropriate treatment.

If you forget to take/give the child BRONCHENOLO GOLA
Do not take/give a double dose to make up for the missed dose.

If you stop treatment with BRONCHENOLO GOLA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP treatment and contact your doctor immediately if you experience any of the following side effects during treatment with BRONCHENOLO GOLA:

  • Allergic reactions (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 affecting the mouth and throat
  • Respiratory events: Asthma, bronchospasm, breathlessness or shortness of breath
  • Various skin disorders: Skin rashes of different types, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

Contact your doctor immediately if you experience any of the following side effects at the beginning of treatment with BRONCHENOLO GOLA:

  • Abdominal pain
  • Peptic ulcer (stomach lesion)
  • Perforation and bleeding of the stomach or intestine. These side effects can be fatal and may occur with or without warning symptoms in you and/or the child. These side effects are especially likely if you are elderly or if you and/or the child have previously suffered from stomach or intestinal diseases.

In addition, you may experience the following side effects:
Effects related to the blood

  • Anaemia (reduction in the amount 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 cells, in the blood).

Effects related to the nervous system

  • Dizziness
  • Headache
  • Paraesthesia (numbness of limbs or other body parts)
  • Drowsiness
  • Cerebrovascular accidents (diseases caused by inadequate blood flow to an area of the brain)
  • Visual disturbances
  • Optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
  • Migraine (chronic disease characterized by recurrent headaches)
  • Confusion
  • Vertigo.

Effects related to the immune system

  • Anaphylactic reactions (severe allergic reaction)
  • Angioedema (inflammatory skin reaction)
  • Hypersensitivity.

Effects related to the eye

  • Visual disturbances.

Effects related to the ear and labyrinth

  • Tinnitus (ringing in the ears).

Effects related to the cardiovascular system

  • Heart failure
  • Swelling
  • Hypertension (high blood pressure)

Effects related to the bronchi and lungs

  • Throat irritation
  • Asthma
  • Bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
  • Dyspnoea (shortness of breath)
  • Blisters in the mouth or throat
  • Numbness of the mouth or throat.

Effects related to the mouth, stomach and intestine

  • Diarrhoea
  • Mouth lesions
  • Nausea
  • Pain in the mouth and throat
  • Sensation of heat or burning, tingling in the mouth
  • Abdominal distension
  • Abdominal pain
  • Constipation
  • Dry mouth
  • Indigestion
  • Flatulence (passing gas from the intestine)
  • Inflammation of the tongue
  • Taste disturbances
  • Vomiting
  • Blood in the stool
  • Blood in vomit
  • Bleeding from the stomach and intestine
  • Colitis
  • Worsening of inflammatory bowel diseases (Crohn's disease)
  • Inflammation of the stomach (gastritis)
  • Gastritis
  • Peptic ulcer
  • Gastric perforation
  • Inflammation of the pancreas (pancreatitis).

Effects related to the skin and underlying tissue

  • Skin rashes
  • Itching
  • Urticaria (red, itchy skin patches)
  • Purpura (appearance of purple-coloured skin patches of varying sizes)
  • Bullous dermatoses (severe skin lesions characterized by erythema, blistering and areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme.

Effects related to the kidneys and urinary tract

  • Renal toxicity
  • Tubulo-interstitial nephritis (inflammation of the kidneys)
  • Nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
  • Renal failure (reduced kidney function).

General effects and effects at the site of administration

  • Fever
  • Pain
  • Discomfort
  • Fatigue
  • Malaise

Effects related to the liver

  • Hepatitis

General effects and effects at the site of administration

  • Fever

Effects related to psychiatric disorders

  • Insomnia
  • Depression
  • Hallucination.

Reporting of side effects
If you/the child experiences any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BRONCHENOLO GOLA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
No special storage precautions are required.
BRONCHENOLO GOLA mouthwash should be used within 9 weeks of first opening the bottle.
BRONCHENOLO GOLA spray should be used within 21 weeks of first use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BRONCHENOLO GOLA contains
The active substance is flurbiprofen.
100 ml of medicinal product contain: 250 mg of flurbiprofen.
The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, hydrogenated castor oil-40 polyoxylated, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of BRONCHENOLO GOLA and contents of the pack
Mouthwash
160 ml bottle with child-resistant closure and dosing cup.
Spray
15 ml bottle with microdosing pump and spray nozzle.

Marketing Authorization Holder
Perrigo Italia S.r.l., Viale dell’Arte, 25 00144 Roma

Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)