FLURBIPROFENE TE 0.25% SPRAY FOR ORAL MUCOSA 1 GLASS BOTTLE OF 15 ML

Name
TEVA FLURBIPROFENE 0.25% mouthwash
TEVA FLURBIPROFENE 0.25% oral spray


What is it and what is it for?
Flurbiprofen Teva contains the active ingredient flurbiprofen, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation. This medicine is used in adults and adolescents over 12 years of age to treat symptoms of irritation and/or inflammation of the mouth and pharynx (e.g., gingivitis, stomatitis, pharyngitis), including following dental treatment such as tooth decay or tooth extraction.

Talk to 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 substance or to any of the other ingredients of this medicine (listed in section 6);
- if you know that you are allergic or have suffered from asthma and/or urticaria, rhinitis, bronchospasm or other allergic-type manifestations following the use of 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 haemorrhage) or perforations due to treatments with medicines belonging to the NSAID category;
- if you have or have had inflammation of the intestine characterised 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 haemorrhage);
- if you suffer from serious heart problems (severe heart failure);
- if you suffer from severe liver or kidney problems (severe liver failure and severe kidney failure).

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

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


Warnings and precautions
Talk to your doctor or pharmacist before using Flurbiprofen Teva if:
- suffer from reduced kidney or liver function (in case of serious kidney or liver problems, the use of the medicine is contraindicated);
- have heart or blood vessel problems, as flurbiprofen 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) (in case of severe heart problems, the use of the medicine is contraindicated);
- have had a stroke or heart attack before or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or if you smoke);
- had breathing problems (bronchial asthma);
- has suffered from allergies in the past;
- have suffered from lesions in the stomach or intestine (ulcer) or other diseases of the stomach and intestine (perforations, gastrointestinal bleeding);
- you are elderly (as you are more likely to experience side effects, especially bleeding and perforation of the digestive tract, which may 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");
- suffers from autoimmune diseases such as systemic lupus erythematosus (SLE) and mixed connective tissue disease;
- regularly takes diuretic medicines;
- are taking any of the medicines listed in the section "Other medicines and Flurbiprofen Teva";
- suffers from hypertension (high blood pressure).
- have an infection – see “Infections” below;

Infections
Nonsteroidal 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, may increase the risk of complications. If you take this medicine during an infection and the symptoms persist or worsen, contact your doctor or pharmacist immediately.

While using Flurbiprofen Teva
- Report to your doctor any unusual abdominal symptoms (bleeding) or the new or worsening signs of a bacterial infection or mouth irritation;
- Stop treatment and consult your doctor who will be able to define an appropriate therapy if you notice the appearance of local irritation, skin or mucous membrane reactions or any other symptoms of hypersensitivity to the medicine.

Do not use this medicine for long periods.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 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:
- 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 are especially likely if you are elderly or have had stomach or intestinal problems in the past.

The following adverse reactions have been reported, particularly after administration of systemic formulations (oral, parenteral):

Common side effects (may affect up to 1 in 10 patients):
- dizziness;
- heachache;
- tingling and altered sensation in the limbs or other parts of the body (paraesthesia);
- throat irritation;
- nausea;
- diarrhea;
- formation of mouth ulcers (aphthous ulcers);
- sore mouth and/or throat;
- discomfort in the mouth and/or throat (sensation of heat or burning);
- tingling in 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;
- vomit;
- increased intestinal gas (flatulence);
- constipation;
- dry mouth;
- digestive difficulties (dyspepsia);
- abdominal pain;
- burning tongue (glossodynia);
- alteration of the sense of taste (dysgeusia);
- disturbances or alterations in the sensation 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 with unknown frequency (frequency cannot be established on the basis of 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 one type of white blood cell (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);
- state of confusion;
- dizziness;
- state of 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 treatment;
- presence of blood in the stool or dark stools (melena);
- presence of blood clots in vomit (hematemesis);
- gastrointestinal bleeding and worsening of colitis and Crohn's disease;
- inflammation of the stomach (gastritis);
- stomach disorders characterized by lesions (peptic ulcer);
- perforation and bleeding from ulcer;
- inflammation of the pancreas (pancreatitis);
- hives;
- skin disorder manifested by bleeding lesions (purpura);
- inflammation of the skin and mucous membranes manifested by the appearance of blisters (bullous dermatoses), which include Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme;
- feeling of discomfort;
- tiredness;
- 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 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.