FLOMAX THROAT 0.25% SPRAY FOR ORAL MUCOSA 15 ML BOTTLE

Name
FLOMAX THROAT 0.25% Mouthwash
FLOMAX GOLA 0.25% Spray for oral mucosa
Flurbiprofen


What is it and what is it 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 to treat symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), also following conservative or extractive dental therapy (e.g. caries treatment or tooth extraction).

Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.


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


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

In particular, tell your doctor if:
- have suffered from bronchial asthma (a breathing disease) in the past, as this increases the risk that you may experience bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- has suffered from allergies in the past;
- are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- suffers from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic failure);
- suffer from hypertension (high blood pressure);
- you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
- have suffered from peptic ulcers (stomach ulcers) 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 your peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section "4 Possible side effects");
- is elderly (as he or she is more likely to experience side effects);
- have heart or blood vessel problems, as medicines like Flomax Throat 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 Flomax Throat or 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.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) can hide signs of infection such as fever and pain.

This may delay appropriate treatment of the infection, which, in turn, may increase the 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.
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 prescribe appropriate therapy.

If you experience mouth irritation, discontinue treatment.


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

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

Furthermore, the following side effects may occur, reported in particular after taking formulations for non-local (systemic) use, the frequency of which is unknown:

Disorders affecting the blood
- reduction in the number of platelets in the blood (thrombocytopenia);
- reduction in the amount 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 cell in the blood (agranulocytosis).

Disorders affecting the mind
- depression;
- state of confusion;
- perception of things that do not exist in reality (hallucination).

Disorders affecting the nervous system
- dizziness;
- disease caused by the lack of blood flow to an area of ​​the brain from an artery (cerebrovascular accident);
- severe inflammation of the optic nerve, which can lead to vision loss and even blindness (optic neuritis);
- headache (migraine);
- alteration of sensitivity in the limbs or other parts of the body consisting of the onset of tingling, pricking, tickling (paraesthesia);
- drowsiness.

Disorders affecting the eye
- visual disturbances.

Disorders affecting the ear
- dizziness;
- ringing in the ears (tinnitus).

Disorders affecting the heart and blood vessels
- edema;
- high blood pressure (arterial hypertension);
- reduced 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 clots forming 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 sensation of numbness in the oral cavity (oral dysesthesia).

Disorders affecting the mouth, stomach, and intestines (gastrointestinal)
- nausea;
- vomit;
- diarrhea;
- emission of gas from the intestine (flatulence);
- difficulty in evacuating (constipation);
- difficulty digesting (dyspepsia);
- pain/burning sensation in the tongue (glossodynia);
- alteration of taste (dysgeusia);
- sore mouth and throat;
- dry mouth;
- bloating;
- stomach pain (abdominal pain);
- blood, black in color, in the stool (melena);
- vomiting blood (hematemesis);
- ulcers inside the mouth (ulcerative stomatitis);
- loss of blood from the stomach and intestines (gastrointestinal bleeding);
- worsening of inflammatory diseases of the colon and small intestine (colitis and Crohn's disease);
- inflammation of the stomach (gastritis);
- lesion of the stomach and 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 (even localized);
- itching;
- redness with rounded raised areas of the skin accompanied by itching (hives);
- appearance of purple (purpura) skin patches of various sizes;
- severe skin rashes with redness, blistering and peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme); (very rare).

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

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

Disorders affecting the liver
- hepatitis.

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.