FLURBIPROFENE 0.25% Płyn do płukania ust

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1. FLURBIPROFENE TEVA 0,25% mouthwash, oral mucosa spray
   1. What is FLURBIPROFENE TEVA and what it is used for
   2. What you need to know before using FLURBIPROFENE TEVA
   3. How to use FLURBIPROFENE TEVA
   4. Possible side effects
   5. How to store FLURBIPROFENE TEVA
   6. Contents of the pack and other information

FLURBIPROFENE TEVA 0,25% mouthwash, oral mucosa spray

Read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after short periods of treatment.

Contents of this leaflet:

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

1. What is FLURBIPROFENE TEVA and what it is used for

FLURBIPROFENE 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 the age of 12as
treatment of symptoms of irritation and/or inflammation of the mouth and pharynx (for example
gingivitis, stomatitis, pharyngitis), even following dental therapy such as caries treatment or
tooth extraction.
See your doctor if you do not feel better or if you feel worse after short periods of treatment.

2. What you need to know before using FLURBIPROFENE TEVA

Do not use FLURBIPROFENE TEVA

• if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you know you are allergic or have suffered from asthma and/or urticaria, rhinitis, bronchospasm or other allergic-type reactions following the use of this medicine or other medicines belonging to the category of NSAIDs, such as aspirin;
• if you have suffered from bleeding due to lesions of the stomach or intestine (gastrointestinal hemorrhage) or perforations due to treatments with medicines belonging to the category of NSAIDs;
• 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 disease of the intestine;
• 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 failure and severe renal failure); Do not takeFlurbiprofene Teva in the last 3 months of pregnancy (see “Pregnancy and Breastfeeding”). Do not giveFlurbiprofene Teva to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using FLURBIPROFENE TEVA if:

• you suffer from reduced kidney or liver function (if you have severe kidney or liver problems, the use of the medicine is contraindicated);
• if you have heart or blood vessel problems, as flurbiprofen may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke (the risk of adverse effects increases with high doses and prolonged treatments);
• you have had episodes 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 had respiratory problems (bronchial asthma);
• you have suffered in the past from allergies;
• you have suffered from lesions of 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 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 FLURBIPROFENE TEVA”);
• you are in the first or second trimester of pregnancy or if you are breastfeeding (see “Pregnancy and Breastfeeding”);
• 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 section “other medicines and FLURBIPROFENE TEVA”;
• you suffer from hypertension (high blood pressure). During the use of FLURBIPROFENE TEVA
• Tell your doctor about any unusual abdominal symptoms (bleeding) or the appearance or worsening of signs of a bacterial infection or irritation of the mouth;
• Stop treatment and consult your doctor who can define an appropriate therapy if you notice the appearance of phenomena 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.

Adverse effects can be minimized by using the lowest effective dose for the
shortest possible duration of treatment necessary to control the symptoms (see “How
to use FLURBIPROFENE TEVA ”).

Other medicines and FLURBIPROFENE TEVA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.

In particular ifyou are already taking:

• Aspirin and other medicines containing acetylsalicylic acid (medicine against inflammation, pain, fever and heart disorders) as they may increase the adverse effects;
• Antiplatelet agents (make the blood more fluid such as low-dose daily aspirin), as it increases the risk of bleeding from the stomach and intestines;
• Anticoagulant medicines (used for the prevention and treatment of blood clots such as warfarin), as it increases the risk of bleeding from the stomach and intestines;
• Other NSAID anti-inflammatory medicines and selective cyclooxygenase-2 inhibitors called Cox-2 (used for pain and inflammation) as it may increase the effect of these medicines and the risk of adverse effects.
• Selective serotonin reuptake inhibitors (SSRIs) (used against depression), as it increases the risk of bleeding from the stomach and intestines;
• Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists), as NSAIDs may reduce the effect of diuretics or some antihypertensive drugs may increase renal toxicity;
• Cardiac glycosides (medicines that affect heart function), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• Cyclosporine (medicine that prevents rejection after organ transplantation), as it increases the risk of renal toxicity;
• Corticosteroids (used to reduce inflammation/allergies), as it increases the risk of lesions or bleeding in the stomach and intestines;
• Lithium (medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• Methotrexate (medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• Mifepristone (medicine used to terminate a pregnancy): NSAIDs should not be used for 8 - 12 days after taking mifepristone, as they reduce its effect;
• Quinolone antibiotics (medicines used for bacterial infections), as NSAIDs may increase the risk of developing seizures;
• Tacrolimus (immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• Zidovudine (medicine used for AIDS), as NSAIDs increase the risk of blood toxicity.

The adverse effects of FLURBIPROFENE TEVA, especially those affecting the gastrointestinal
tract, may be increased if it is taken at the same time as certain
medicines.

FLURBIPROFENE TEVA with alcohol
Taking alcohol at the same time may increase the risk of adverse effects,
especially the risk of bleeding in the stomach and intestines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use FLURBIPROFENE TEVA in the first six months of pregnancy, unless your doctor considers it strictly necessary. In this case, you will be carefully monitored by your doctor who will prescribe the dose most appropriate to your clinical condition.
FLURBIPROFENE TEVA may have a negative effect on pregnancy and/or fetal development.

Do not use this medicine during the third trimester of pregnancy.

Breastfeeding
Flurbiprofen is excreted in breast milk. The use of this medicine is not recommended if you are
breastfeeding with breast milk.

Fertility
Flurbiprofen belongs to a group of medicines that can affect female fertility.
This effect is reversible when taking the medicine is stopped.
Occasional use of this medicine is unlikely to affect the chances of
becoming pregnant. However, ask your doctor if you have fertility problems before taking
the medicine.

Driving and using machines
This medicine does not interfere with the ability to drive vehicles and use machines.

FLURBIPROFENE TEVAmouthwash and oral mucosa spray contain para-
hydroxybenzoates, hydrogenated castor oil-40 polyoxyethylene and ethanol (alcohol) and the
dye patent blue V

• These medicines contain para-hydroxybenzoates which may cause allergic reactions (even delayed).
• These medicines contain hydrogenated castor oil-40 polyoxyethylene which may cause localized skin reactions.
• These medicines contain small amounts of ethanol (alcohol), less than 100 mg per dose.
• These medicines contain the dye patent blue V (E131), which may cause allergic reactions.

3. How to use FLURBIPROFENE TEVA

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Mouthwash: the recommended dose is two or three rinses or gargles a day with 10 ml of mouthwash (1 measuring cap). It can be used neat or diluted in water.
• Oral mucosal spray: the recommended dose is 2 sprays, three times a day directed directly onto the affected area.

Do not exceed the recommended doses.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment necessary to control the symptoms.
If you are elderly or have previously suffered from a peptic ulcer (stomach lesion), it is recommended to use the lowest recommended dose, as there is a greater risk of serious consequences in case of undesirable effects and the risk of developing an ulcer, bleeding or perforation of the stomach and intestines is greater (see section 4 “Possible side effects”).
Do not give FLURBIPROFENE TEVA to children under 12 years of age.
Method of use of FLURBIPROFENE TEVA 0.25% mouthwash:
rinse or hold in the mouth during gargling for up to 1 minute. Do not ingest.
Method of use of FLURBIPROFENE TEVA 0.25% Oral mucosal spray:
rotate the nozzle to the right or left, without tampering with the applicator.
Direct the applicator towards the affected area (mouth, throat) and spray. Before using the product, press the applicator several times until a regular
spray is achieved.

If you use more FLURBIPROFENE TEVA than you should
In case of ingestion/accidental intake of an excessive dose of FLURBIPROFENE TEVA
immediately notify your doctor or go to the nearest hospital.
In case of overdose, nausea, vomiting, inflammatory disorders of the
stomach and intestines (gastrointestinal irritation), stomach pain, diarrhea, ringing in the
ears (tinnitus) and headache may occur. In cases of severe poisoning, drowsiness, occasionally excitability, convulsions, blurred vision, disorientation or
coma may occur. In case of severe poisoning, a condition called metabolic acidosis may occur, prolonged prothrombin time/INR, kidney and liver damage, worsening
of asthma in asthmatic subjects.

If you forget to use FLURBIPROFENE TEVA
Do not use a double dose to make up for a missed dose.
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 everyone will experience them.

STOPtreatment immediately and contact your doctor immediatelyif you experience the following during treatment with this medicine:

• allergic reactions (hypersensitivity reactions): allergic reaction; 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, shortness of breath or difficulty breathing;
• various skin disorders: skin rashes of various types, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes;
• abdominal pain*
• peptic ulcer (lesion of the stomach)*
• 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 previously suffered from stomach and intestinal diseases. The following side effects have been reported, particularly after administration of systemic formulations (oral, parenteral):

Common side effects (may affect up to 1 in 10 people):

• dizziness;
• headache;
• tingling and altered sensitivity in the limbs or other parts of the body, such as the mouth (paresthesia, oral paresthesia);
• throat irritation;
• nausea;
• diarrhea;
• formation of mouth ulcers (aphthous ulcer);
• pain or discomfort in the mouth and/or throat;
• feeling of warmth or burning, tingling in the mouth. Uncommon side effects (may affect up to 1 in 100 people):
• insomnia;
• drowsiness;
• difficulty breathing (asthma, bronchospasm and dyspnea);
• formation of blisters in the mouth or throat;
• numbness of the mouth and throat (oropharyngeal hypoesthesia);
• abdominal distension;
• vomiting;
• increased intestinal gas (flatulence);
• constipation;
• dry mouth;
• digestive difficulties (dyspepsia);
• abdominal pain;
• burning of the tongue (glossodynia);
• altered sense of taste (dysgeusia);
• disorders or alteration of the sensitivity of the mouth (oral dysesthesia);
• skin irritation such as rash;
• itching;
• fever;
• pain. Rare side effects (may affect up to 1 in 1,000 people):
• severe allergic reaction (anaphylactic reaction).

Side effects with unknown frequency (frequency cannot be estimated on the basis of available data):

• decreased number of platelets (thrombocytopenia);
• decreased production of red blood cells (anemia and aplastic anemia);
• decreased 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;
• cerebral circulation disorders (cerebrovascular accidents);
• visual disturbances and/or inflammation of the optic nerve (optic neuritis);
• severe headache (migraine);
• confusional state;
• vertigo;
• feeling unwell;
• 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 and heart attack, especially with high doses and prolonged treatments;
• 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);
• urticaria;
• skin disorder that manifests through bleeding lesions (purpura);
• inflammations of the skin and mucous membranes that manifest with the appearance of blisters (bullous dermatoses). These include Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme;
• feeling of discomfort;
• fatigue;
• kidney problems, including kidney inflammation (nephrotic syndrome, interstitial nephritis and kidney problems);
• liver inflammation (hepatitis).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
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 FLURBIPROFENE TEVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging.
The expiry date refers to the last day of that month and the medicine correctly
stored.
FLURBIPROFENE TEVA 0.25% mouthwash
Once opened, use within 9 weeks.
FLURBIPROFENE TEVA 0.25% oral mucosal spray
Once opened use within 21 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FLURBIPROFENE TEVA contains
FLURBIPROFENE TEVA 0.25% mouthwash

• The active ingredient is flurbiprofen. 100 ml of solution contains 0.25 g of flurbiprofen.
• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

FLURBIPROFENE TEVA 0.25% oral mucosal spray

• The active ingredient is flurbiprofen. 100 ml of solution contains 0.25 g of flurbiprofen.
• The other ingredients are: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil-40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE TEVA and contents of the pack
FLURBIPROFENE TEVA 0.25% mouthwash
Pack containing a bottle with dosing measuring cup and safety cap of 160 ml.
FLURBIPROFENE TEVA 0.25% oral mucosal spray
Pack containing a bottle, with dosing pump and dispenser of 15 ml.

Marketing Authorisation Holder
TEVA ITALIA S.r.l., Piazzale Luigi Cadorna, 4 – 20123 Milano

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