Flurbiprofen Teva

Patient Information Leaflet

FLURBIPROFEN TEVA 0.25% oral rinse, oral mucosa spray

Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

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

FLURBIPROFENE TEVA contains the active substance flurbiprofene, which belongs 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 procedures such as treatment of dental caries or tooth
extraction.
Consult your doctor if you do not feel better or if you feel worse after short periods of treatment.

2. What you should know before using FLURBIPROFENE TEVA

Do not use FLURBIPROFENE TEVA

• if you are allergic to flurbiprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you know you are allergic or have previously experienced asthma and/or urticaria, rhinitis, bronchospasm, or other allergic-type reactions after taking this medicine or other medicines belonging to the NSAID class, such as aspirin;
• if you have previously experienced gastrointestinal bleeding or perforation due to treatment with NSAIDs;
• if you currently have or have previously had intestinal inflammation with lesions (ulcerative colitis);
• if you suffer from Crohn's disease, a chronic inflammatory bowel disease;
• if you have previously experienced stomach or intestinal ulcers, injuries, or bleeding (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 or severe renal insufficiency);
  Do not take Flurbiprofene Teva during the last 3 months of pregnancy (see "Pregnancy and Breastfeeding").
  Do not give Flurbiprofene Teva to children under 12 years of age.

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

• you have reduced kidney or liver function (in case of severe kidney or liver problems, use of this medicine is contraindicated);
• 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 higher doses and prolonged treatment);
• you have previously had a stroke or believe you may be at risk for such conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke);
• you have respiratory problems (bronchial asthma);
• you have previously suffered from allergies;
• you have previously experienced stomach or intestinal injuries (ulcers) or other gastrointestinal diseases (perforations, gastrointestinal bleeding);
• you are elderly (as you are more likely to experience adverse effects, particularly gastrointestinal bleeding and perforation, which may 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 are breastfeeding (see "Pregnancy and Breastfeeding");
• you suffer from autoimmune diseases such as systemic lupus erythematosus (SLE) or mixed connective tissue disease;
• you regularly take diuretic medicines;
• you are taking any of the medicines listed in section "Other medicines and FLURBIPROFENE TEVA";
• you suffer from hypertension (high blood pressure). During treatment with FLURBIPROFENE TEVA
• Inform your doctor of any unusual abdominal symptoms (bleeding) or the onset or worsening of signs of bacterial infection or mouth irritation;
• Discontinue treatment and consult your doctor if you experience local irritation, skin or mucous membrane reactions, or any other symptoms of hypersensitivity to the medicine. Do not use this medicine for prolonged periods.

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

Other medicines and FLURBIPROFENE TEVA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
In particular, if you are already taking:

• Aspirin and other medicines containing acetylsalicylic acid (used for inflammation, pain, fever, and heart conditions), as they may increase adverse effects;
• Antiplatelet agents (make blood thinner, such as low-dose daily aspirin), as they increase the risk of gastrointestinal bleeding;
• Anticoagulants (used to prevent and treat blood clots, such as warfarin), as they increase the risk of gastrointestinal bleeding;
• Other NSAIDs and selective cyclooxygenase-2 (COX-2) inhibitors (used for pain and inflammation), as they may enhance the effects of these medicines and increase the risk of adverse effects;
• Selective serotonin reuptake inhibitors (SSRIs) (used for depression), as they increase the risk of gastrointestinal bleeding;
• Antihypertensives (diuretics, ACE inhibitors, angiotensin II antagonists), as NSAIDs may reduce the effectiveness of diuretics or certain antihypertensive drugs may increase renal toxicity;
• Cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase blood levels of cardiac glycosides;
• Cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of renal toxicity;
• Corticosteroids (used to reduce inflammation/allergies), as they increase the risk of gastrointestinal injuries or bleeding;
• Lithium (used for behavioral disorders), as blood levels of lithium may increase;
• Methotrexate (used for psoriasis, arthritis, and tumors), as blood levels of methotrexate may increase;
• Mifepristone (used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
• Quinolone antibiotics (used for bacterial infections), as NSAIDs may increase the risk of seizures;
• Tacrolimus (an immunosuppressant used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• Zidovudine (used for AIDS), as NSAIDs increase the risk of blood toxicity.

The adverse effects of FLURBIPROFENE TEVA, particularly those affecting the
gastrointestinal tract, may be increased when taken together with certain
medicines.

FLURBIPROFENE TEVA and alcohol
Concomitant alcohol intake may increase the risk of adverse effects, especially the risk of stomach and intestinal bleeding.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use FLURBIPROFENE TEVA during the first six months of pregnancy unless your doctor considers it strictly necessary. In such cases, you will be closely monitored by your doctor, who will prescribe the most appropriate dose for your clinical condition.
FLURBIPROFENE TEVA may have negative effects on pregnancy and/or embryonic/fetal development.
Do not use this medicine during the third trimester of pregnancy.

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

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

Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

FLURBIPROFENE TEVA mouthwash and oral mucosa spray contain
parahydroxybenzoates, polyoxyl 40 hydrogenated castor oil, ethanol (alcohol), and the
patent blue dye

• These medicines contain parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
• These medicines contain polyoxyl 40 hydrogenated castor oil, which may cause local skin reactions.
• These medicines contain small amounts of ethanol (alcohol), less than 100 mg per dose.
• These medicines contain patent blue V dye (E131), which may cause allergic reactions.

3. How to use FLURBIPROFENE TEVA

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

• Mouthwash: The recommended dose is two or three mouth rinses or gargles per day with 10 ml of mouthwash (1 measuring cup). It may be used undiluted or diluted with water.
• Oral mucosa spray: The recommended dose is 2 sprays, 3 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 duration necessary to control symptoms.
If you are elderly or have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as there is a higher risk of serious consequences in case of adverse effects, and an increased risk of developing stomach or intestinal ulcers, bleeding, or perforation (see section 4 "Possible side effects").
Do not give FLURBIPROFENE TEVA to children under 12 years of age.

Instructions for use of FLURBIPROFENE TEVA 0.25% mouthwash:
Rinse or hold in the mouth during gargling for up to 1 minute. Do not swallow.

Instructions for use of FLURBIPROFENE TEVA 0.25% oral mucosa spray:
Rotate the nozzle to the right or left without tampering with the spray pump.
Direct the nozzle towards the affected area (mouth, throat) and spray. Before first use, press the spray pump several times until a regular spray is obtained.

If you use more FLURBIPROFENE TEVA than you should
If FLURBIPROFENE TEVA is accidentally swallowed or overdosed, contact your doctor immediately or go to the nearest hospital.
In case of overdose, symptoms such as nausea, vomiting, inflammatory disorders of the stomach and intestine (gastrointestinal irritation), stomach pain, diarrhoea, ringing in the ears (tinnitus), and headache may occur. In severe cases of poisoning, drowsiness may occur, occasionally excitability, convulsions, blurred vision, disorientation, or coma. In cases of severe intoxication, a condition called metabolic acidosis may develop, prolonged prothrombin time/INR, kidney and liver damage, and worsening of asthma in asthmatic patients.

If you forget to use FLURBIPROFENE TEVA
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP treatment immediately and contact your doctor immediately if you experience any of the following while being treated 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 warmth or tingling in the mouth and throat;
• Respiratory events: asthma, bronchospasm, shortness of breath or difficulty breathing;
• Various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation 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 previously suffered from stomach or 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 sensation in limbs or other parts of the body, for example the mouth (paraesthesia, oral paraesthesia);
• throat irritation;
• nausea;
• diarrhoea;
• development of mouth ulcers (aphthous ulcer);
• pain or discomfort in the mouth and/or throat;
• sensation of heat or burning, tingling in the mouth.

Uncommon side effects (may affect up to 1 in 100 people):

• insomnia;
• somnolence;
• breathing difficulties (asthma, bronchospasm, and dyspnoea);
• formation of blisters in the mouth or throat;
• numbness of mouth and throat (oropharyngeal hypoaesthesia);
• abdominal distension;
• vomiting;
• increased intestinal gas (flatulence);
• constipation;
• dry mouth;
• digestive difficulties (dyspepsia);
• abdominal pain;
• burning sensation of the tongue (glossodynia);
• altered taste sensation (dysgeusia);
• disturbances or altered sensation in the mouth (oral dysaesthesia);
• 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 from available data):

• decrease in platelet count (thrombocytopenia);
• reduced production of red blood cells (anaemia and aplastic anaemia);
• 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;
• disturbances in brain circulation (cerebrovascular events);
• visual disturbances and/or inflammation of the optic nerve (optic neuritis);
• severe headache (migraine);
• confusion;
• vertigo;
• malaise;
• hearing disturbances, such as ringing in the ears (tinnitus);
• swelling due to fluid retention (oedema);
• 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 treatment;
• presence of blood in stools, or dark stools (melena);
• presence of blood clots in vomit (haematemesis);
• gastrointestinal bleeding and worsening of colitis and Crohn's disease;
• inflammation of the stomach (gastritis);
• stomach disorders characterised by lesions (peptic ulcer);
• ulcer perforation and bleeding;
• inflammation of the pancreas (pancreatitis);
• urticaria;
• skin disorder manifesting as bleeding lesions (purpura);
• skin and mucous membrane inflammations presenting with blister formation (bullous dermatoses), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and Erythema Multiforme;
• feeling of discomfort;
• fatigue;
• kidney problems, including kidney inflammation (nephrotic syndrome, interstitial nephritis, and other kidney problems);
• liver inflammation (hepatitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website:
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 stated on the packaging.
The expiry date refers to the last day of that month and to the medicine stored correctly.
FLURBIPROFENE TEVA 0.25% mouthwash
Once the bottle is opened, use within 9 weeks.
FLURBIPROFENE TEVA 0.25% oral mucosa spray
Once opened, use within 21 weeks.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FLURBIPROFENE TEVA contains
FLURBIPROFENE TEVA 0.25% mouthwash

• The active substance is flurbiprofen. 100 ml of solution contain 0.25 g of flurbiprofen.
• The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

FLURBIPROFENE TEVA 0.25% oral mucosa spray

• The active substance is flurbiprofen. 100 ml of solution contain 0.25 g of flurbiprofen.
• The other components are: glycerol (98%), ethanol, liquid non-crystallizable sorbitol, polyoxyl 40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Description of the appearance of FLURBIPROFENE TEVA and package contents
FLURBIPROFENE TEVA 0.25% mouthwash
Pack containing one bottle with measuring cup and safety cap, 160 ml.
FLURBIPROFENE TEVA 0.25% oral mucosa spray
Pack containing one bottle with dosing pump and applicator, 15 ml.
Marketing Authorization Holder
TEVA ITALIA S.r.l., Piazzale Luigi Cadorna, 4 – 20123 Milano, Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy