FLOMAX THROAT*SPRAY 15ML

FLUIBRON GOLA 0.25% Mouthwash
FLUIBRON GOLA 0.25% Oral spray
Flurbiprofen

What it is and what it is used for
Flomax Gola is a medicine that contains flurbiprofen, a non-steroidal anti-inflammatory drug that acts against inflammation and pain in the throat, mouth, and gums.

Flomax Gola is used in the treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), also as a result of conservative or extractive dental therapy (e.g., cavity treatment or tooth extraction).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not take Flomax Gola if:
- you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- you have had allergies or asthma after taking other drugs used for pain and inflammation (non-steroidal anti-inflammatory drugs, NSAIDs) such as aspirin;
- in the past, due to taking NSAIDs, you have had bleeding or perforation in the stomach or intestines;
- you have had two or more distinct episodes of peptic ulcer (lesion of the stomach or the first part of the intestine) or bleeding in the stomach or intestines (including blood in vomit or during bowel movements or black and tarry stools);
- you suffer or have suffered from inflammatory diseases of the colon or small intestine (ulcerative colitis and Crohn's disease);
- you suffer from severe reduction in heart function (heart failure);
- you suffer from severe reduction in liver function;
- you suffer from severe reduction in kidney function;
- you are in the last three months of pregnancy (see paragraph Pregnancy and breastfeeding);
- you are under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flomax Gola.

In particular, inform your doctor if:
- you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of developing bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced air passage);
- you have previously suffered from allergies;
- 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 (kidney, heart or liver failure);
- you suffer from hypertension (high blood pressure);
- you are taking other analgesics for a long time or without respecting the dosage, as headache may occur;
- you have previously suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases 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 intestines (see paragraph 4 Possible side effects);
- you are elderly (as you are more likely to experience side effects);
- you have heart or blood vessel problems, as medicines like Flomax Gola may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk of having side effects increases with high doses and prolonged treatments; do not exceed the dose of Flomax 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 or high cholesterol or smoke);
- you have an infection - refer to the Infections section below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain.
This can delay appropriate treatment for the infection, which, in turn, can lead to an increased risk of complications. If you take this medicine during an infection and the symptoms of the infection persist or worsen, contact your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, can give rise to allergic phenomena or local irritation (see paragraph 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will prescribe appropriate therapy.

If you experience mouth irritation, stop treatment.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking Flomax Gola immediately and contact your doctor if you experience severe allergic reactions such as: swelling (angioedema) of the face, eyes, lips, throat; sudden drop in blood pressure (anaphylactic shock).

In addition, the following side effects may occur, reported in particular after taking non-local (systemic) formulations, the frequency of which is not known:

Blood disorders
- reduction in the number of platelets in the blood (thrombocytopenia);
- reduction in the number of red blood cells in the blood (anemia);
- reduction in the number of all types of blood cells (aplastic anemia);
- reduction in the number of granulocytes, a type of white blood cells in the blood (agranulocytosis).

Mental disorders
- depression;
- confused state;
- perception of non-existent things in reality (hallucination).

Nervous system disorders
- dizziness;
- disease caused by lack of blood flow to an area of the brain by an artery (cerebrovascular accidents);
- severe inflammation of the optic nerve, which can lead to reduced vision up to blindness (optic neuritis);
- headache (migraine);
- alteration of the sensitivity of the limbs or other parts of the body consisting of the onset of tingling, prickling, tickling (paresthesia);
- drowsiness.

Eye disorders
- visual disturbances.

Ear disorders
- vertigo;
- ringing in the ears (tinnitus).

Heart and blood vessel disorders
- edema;
- high blood pressure (arterial hypertension);
- reduction in heart function (heart failure).
Clinical studies and epidemiological data suggest that taking some NSAIDs (especially at high doses and in case of long-term treatment) may be associated with an increased risk of blood clot formation in the blood vessels, which reduce blood flow for example to the heart or brain (arterial thrombotic events such as heart attack or stroke).

Respiratory disorders
- difficulty breathing or feeling short of breath (asthma, bronchospasm, dyspnea);
- blisters in the mouth or throat;
- decreased sensitivity or numbness of the oral cavity (oral dysesthesia).

Disorders affecting the mouth, stomach and intestines (gastrointestinal)
- nausea;
- vomiting;
- diarrhea;
- gas emission from the intestines (flatulence);
- difficulty in evacuating (constipation);
- difficulty digesting (dyspepsia);
- sensation of pain/burning on the tongue (glossodynia);
- altered taste (dysgeusia);
- mouth and throat pain;
- dry mouth;
- abdominal bloating;
- abdominal pain;
- black blood in the stool (melena);
- vomiting blood (hematemesis);
- ulcers inside the mouth (ulcerative stomatitis);
- bleeding from the stomach and intestines (gastrointestinal hemorrhage);
- worsening of inflammatory diseases of the colon and small intestine (colitis and Crohn's disease);
- stomach inflammation (gastritis);
- lesion of the stomach and the first part of the intestine (peptic ulcer);
- perforation of the stomach or intestine;
- inflammation of the pancreas (pancreatitis); (very rare).

Disorders affecting the skin and underlying tissue
- skin rash (also localized);
- itching;
- redness with rounded raised areas of the skin accompanied by itching (urticaria);
- appearance of skin patches of different sizes, purple in color (purpura);
- severe skin rashes with redness, blistering and exfoliation (e.g., Steven-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); (very rare).

Disorders affecting the kidneys and urinary tract
- kidney disorders including, kidney inflammation (interstitial nephritis), loss of blood proteins through the kidney (nephrotic syndrome), reduction in kidney function (kidney failure), (rare).

Systemic disorders
- malaise;
- fatigue;
- fever;
- pain.

Liver disorders
- hepatitis.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.