FLURBIPROFEN TE*OS SPRAY 15ML

FLURBIPROFEN TEVA 0.25% mouthwash
FLURBIPROFEN TEVA 0.25% oral mucosa spray

What it is and what it is used for
Flurbiprofen Teva contains the active ingredient flurbiprofen, belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation. This medicine is used in adults and adolescents over 12 years of age for the treatment of symptoms of irritation and/or inflammation of the mouth and pharynx (e.g., gingivitis, stomatitis, pharyngitis), including after dental treatment such as cavity filling or tooth extraction.

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

What you need to know before taking the medicine
Do not use Flurbiprofen Teva
- if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in paragraph 6);
- if you know you are allergic or have suffered from asthma and/or urticaria, rhinitis, bronchospasm or other allergic manifestations after using this medicine or other medicines belonging to the NSAID category, such as aspirin or ibuprofen;
- if you have suffered from bleeding due to lesions in the stomach or intestine (gastrointestinal hemorrhage) or perforations due to treatments with medicines belonging to the NSAID category;
- if you have or have had inflammation of the intestine characterized by lesions (ulcerative colitis);
- if you suffer from Crohn's disease, a chronic inflammatory bowel disease;
- if you have had episodes of lesions or bleeding in the stomach or intestine (recurrent peptic ulcer or gastrointestinal hemorrhage);
- if you suffer from severe heart problems (severe heart failure);
- if you suffer from severe liver or kidney problems (severe hepatic insufficiency and severe renal insufficiency).

Do not take Flurbiprofen Teva if you are in the last three months of pregnancy (see Pregnancy, breastfeeding, and fertility).

Do not give Flurbiprofen Teva to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Flurbiprofen Teva if:
- you suffer from reduced kidney or liver function (in case of severe kidney or liver problems, the use of the medicine is contraindicated);
- you have heart or blood vessel problems, as flurbiprofen may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke (the risk of adverse effects increases with high doses and prolonged treatments) (in case of severe heart problems, the use of the medicine is contraindicated);
- you have a history of stroke or heart attack 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 had respiratory problems (bronchial asthma);
- you have suffered from allergies in the past;
- you have suffered from stomach or intestinal lesions (ulcer) or other stomach and intestinal diseases (perforations, gastrointestinal hemorrhages);
- you are elderly (as you are more likely to experience adverse effects, particularly bleeding and perforation of the digestive tract, which can be life-threatening);
- you are already taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see Other medicines and Flurbiprofen Teva);
- you are in the first or second trimester of pregnancy or if you are breastfeeding (see Pregnancy, breastfeeding, and fertility);
- you suffer from autoimmune diseases such as Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease;
- you regularly take diuretic medicines;
- you are taking any of the medicines listed in the paragraph Other medicines and Flurbiprofen Teva;
- you suffer from hypertension (high blood pressure).
- you have an infection - refer to the Infections paragraph below;

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

During the use of Flurbiprofen Teva
- Report any unusual abdominal symptoms (bleeding) or the appearance or worsening of signs of a bacterial infection or mouth irritation to your doctor;
- Stop the treatment and consult your doctor who can determine an appropriate therapy if you notice the appearance of local irritation, skin or mucous membrane reactions, or any other symptom of hypersensitivity to the medicine.

Do not use this medicine for long periods.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 2).

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

STOP treatment immediately and contact your doctor immediately if you experience any of the following during treatment with this medicine:
- allergic phenomena (sensitization phenomena): allergic reactions;
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:
various types of skin rashes, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes;
- abdominal pain*;
- peptic ulcer (stomach lesion)*;
- perforation and bleeding of the stomach or intestine.
*These side effects can be fatal and you may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you have suffered from stomach and intestinal diseases in the past.

The following side effects have been reported, particularly after the administration of systemic formulations (oral, parenteral):

Common side effects (may affect up to 1 in 10 patients):
- dizziness;
- headache;
- tingling and altered sensitivity in the limbs or other parts of the body (paresthesia);
- throat irritation;
- nausea;
- diarrhea;
- formation of mouth ulcers (aphthous ulcer);
- pain in the mouth and/or throat;
- discomfort in the mouth and/or throat (sensation of heat or burning);
- tingling of the mouth (oral paresthesia).

Uncommon side effects (may affect up to 1 in 100 patients):
- insomnia;
- drowsiness;
- breathing difficulties (asthma, bronchospasm and dyspnea);
- formation of blisters in the mouth and/or throat;
- numbness of the mouth and/or throat (oropharyngeal hypoesthesia);
- abdominal distension;
- vomiting;
- increased intestinal gas (flatulence);
- constipation;
- dry mouth;
- digestive difficulties (dyspepsia);
- abdominal pain;
- burning tongue (glossodynia);
- altered sense of taste (dysgeusia);
- disorders or altered sensitivity of the mouth (oral dysesthesia);
- skin irritation such as rashes;
- itching;
- fever;
- pain.

Rare side effects (may affect up to 1 in 1,000 patients):
- severe allergic reaction (anaphylactic reaction).

Side effects of unknown frequency (frequency cannot be estimated from the available data):
- decrease in the number of platelets (thrombocytopenia);
- decrease in the number and production of red blood cells (anemia and aplastic anemia);
- severe decrease in the number of a type of white blood cells (agranulocytosis);
- swelling of the skin, mucous membranes, and submucosal tissues, especially around the mouth and eyes (angioedema);
- allergic reaction (hypersensitivity);
- depression;
- hallucinations;
- visual disturbances;
- inflammation of the optic nerve (optic neuritis);
- severe headache (migraine);
- confusional state;
- dizziness;
- malaise;
- hearing disorders, such as the perception of sounds in the ear (tinnitus);
- swelling caused by fluid accumulation (edema);
- heart problems (heart failure);
- increased blood pressure (hypertension);
- increased risk of cardiovascular disorders, such as stroke (cerebrovascular accident) and heart attack, especially with high doses and prolonged treatments;
- blood in the stool or dark stools (melena);
- blood clots in vomit (hematemesis);
- gastrointestinal hemorrhage and worsening of colitis and Crohn's disease;
- inflammation of the stomach (gastritis);
- stomach disorders characterized by lesions (peptic ulcer);
- perforation and hemorrhage from ulcer;
- inflammation of the pancreas (pancreatitis);
- urticaria;
- skin disorder that manifests itself through bleeding lesions (purpura);
- skin and mucous membrane inflammations that manifest with the appearance of blisters (bullous dermatoses), which include Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme;
- feeling of discomfort;
- fatigue;
- kidney problems (toxic nephropathy in various forms, including nephrotic syndrome, tubulointerstitial nephritis and renal failure);
- inflammation of the liver (hepatitis).

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