FLURBIPROFENE 2,5 mg/ml Mouthwash

Зміст інструкції

1. FLURBIPROFENE COOP 0.25mg/ml mouthwash, oral mucosa spray
   1. What is FLURBIPROFENE COOP and what is it used for
   2. What you need to know before using FLURBIPROFENE COOP
   3. How to use FLURBIPROFENE COOP
   4. Possible side effects
   5. How to store FLURBIPROFENE COOP
   6. Contents of the pack and other information

FLURBIPROFENE COOP 0.25mg/ml mouthwash, oral mucosa spray

Flurbiprofene

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 to do.

• 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 3 days of treatment.

Contents of this leaflet:

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

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

FLURBIPROFENE COOP 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 as symptomatic treatment in case 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.
Consult a doctor if you/the child do not feel better or if you feel worse after 3 days of
treatment (see section 3).

2. What you need to know before using FLURBIPROFENE COOP

Do not use FLURBIPROFENE COOP

• if you and/or the child are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
• if you and/or the child are allergic to acetylsalicylic acid (medicine against inflammation, pain, fever and heart problems) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURBIPROFENE COOP”);
• if you and/or the child have suffered from bleeding or perforation of the stomach or intestine related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
• if you and/or the child suffer from chronic inflammatory diseases of the intestine (ulcerative colitis and Crohn's disease);
• if you and/or the child frequently suffer from peptic ulcer (lesion of the stomach) or bleeding of the stomach or intestine (two or more episodes of ulcer or bleeding);
• if you and/or the child suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function) and severe kidney failure (reduced kidney function).
• if you are in the third trimester of pregnancy. (see section “Pregnancy and breastfeeding”)

Do notgive Flurbiprofene Coop mouthwash and Spray to children under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before using FLURBIPROFENE COOP
In particular, inform your doctor if you and/or the child:

• have suffered from bronchial asthma (a respiratory disease), as this increases the risk that you and/or the child may experience bronchospasm (narrowing of the bronchi which causes severe breathing difficulties due to reduced air passage);
• have suffered from allergies in the past;
• are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• suffer from systemic lupus erythematosus or mixed connective tissue disease;
• suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• suffer from hypertension (high blood pressure);
• are taking other painkillers for a long time or without respecting the dosage, as headache (headache) may occur;
• have suffered in the past from peptic ulcer (lesion of the stomach) and other diseases of the stomach and intestine 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 the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see section 4 “Possible side effects”);
• if you are elderly (because you are more likely to experience side effects);
• have problems with the heart or blood vessels, as medicines like Flurbiprofene COOP may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatments; do not exceed the dose of Flurbiprofene COOP and do not take it for long periods. Inform your doctor if you have heart problems, a history 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).

Report any unusual abdominal symptoms to your doctor.
The use of FLURBIPROFENE COOP 0.25mg/ml mouthwash and FLURBIPROFENE COOP 0.25mg/ml
oral mucosal spray, especially if prolonged, may give rise to allergic or irritation
reactions (see section 4 “Possible side effects”); in these cases it is necessary to interrupt the
treatment and consult the doctor who will be able to define an appropriate therapy.
Do not use this medicine for long periods.
For those who engage in sports, the use of medicines containing ethyl alcohol may result in positive
doping tests in relation to the alcohol concentration limits indicated by some sports
federations.

Children and adolescents
Do not give Flurbiprofene Coop mouthwash and Spray to children under the age of 12 years.

Other medicines and FLURBIPROFENE COOP
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Inform your doctor if you are taking any of the following medicines:

• Aspirinand medicines containing acetylsalicylic acid(medicine against inflammation, pain, fever and heart problems), as they may increase the side effects;
• Antiplatelet agents(medicines that make the blood more fluid), as this increases the risk of bleeding from the stomach and intestines;
• Anticoagulant agents(medicines that slow down or inhibit the blood clotting process, such as warfarin), as their effect may be potentiated by NSAIDs;
• Selective serotonin reuptake inhibitors(medicines used against depression), as this increases the risk of bleeding from the stomach and intestines;
• Antihypertensive medicines(ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive medicines may increase renal toxicity;
• Alcohol, as it may increase the risk of side effects, especially the risk of bleeding in the stomach and intestines;
• 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(medicines used against inflammation/allergies), as this increases the risk of having 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 toxicity in the blood;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as this may increase the effect of these medicines and the risk of side effects.

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

Pregnancy

Do notuse FLURBIPROFENE COOP in the first 6 months of pregnancy, unless it is
strictly necessary.
The use of flurbiprofen in the last 3 months of pregnancyis contraindicated.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and
advised by your doctor.

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

Driving and operating machinery
This medicine does not interfere with the ability to drive vehicles and operate machinery.

FLURBIPROFENE COOP mouthwash and spray for oral mucosa contain para-
hydroxybenzoates, hydrogenated castor oil-40 polyoxyethylene, ethanol (alcohol) and the dye
patent blue
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 patent blue V dye (E131), which may cause allergic
reactions.
FLURBIPROFENE COOP 0.25mg/ml spray for oral mucosa contains less than 1 mmol (23mg) of
sodium per dose, i.e. essentially ‘sodium-free’.
FLURBIPROFENE COOP 0.25mg/ml spray for oral mucosa contains 30 mg of sorbitol per dose.
FLURBIPROFENE COOP 0.25mg/ml spray for oral mucosa contains small amounts of ethanol
(alcohol), less than 100 mg per dose.

3. How to use FLURBIPROFENE COOP

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.

HOW MUCH AND HOW
Undesirable effects can be minimized by using the lowest doses for the shortest duration possible of treatment necessary to control the symptoms.
Caution: do not exceed the indicated doses without your doctor's advice.

Adults and children over 12 years of age

Mouthwash:
The recommended dose is two or three rinses or gargles per day (hold in mouth for up to 1 minute).
You can use the mouthwash:

• Pure (without diluting with water): use 10 ml (1 measuring cap) of mouthwash
• Diluted: pour 10 ml (1 measuring cap) of mouthwash into half a glass of water. At the recommended doses, occasional ingestion does not cause any harm to you and/or the child, although it is advisable not to ingest the product.

Oral mucosa spray:
The recommended dose is 2 sprays, 3 times a day directed directly onto the affected area (mouth, throat).
Each spray corresponds to 0.2 ml of solution, equivalent to 0.5 mg of flurbiprofen.

If you are elderly or you and/or the child have suffered in the past from an ulcer (stomach lesion)
If you are elderly or you and/or the child have suffered in the past 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”).

Duration of treatment
Use FLURBIPROFENE COOP only for short periods of treatment, no longer than 7 days. If no appreciable results are noticed after 3 days of treatment, the cause may be a different pathological condition, therefore consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more FLURBIPROFENE COOP than you should
If you/the child accidentally ingest/take an excessive dose of FLURBIPROFENE COOP, inform your doctor immediately or go to the nearest hospital.
In the event of accidental ingestion of significant quantities of flurbiprofen, you may experience symptoms such as: nausea, vomiting and irritation of the stomach or intestines, stomach pain or rarely diarrhea. In such cases, the doctor will adopt appropriate treatments.

If you forget to take FLURBIPROFENE COOP
Do not take a double dose to make up for a missed dose.

If you stop the treatment with FLURBIPROFENE COOP
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects during treatment with FLURBIPROFENE COOP,

STOPtreatment and contact your doctor immediately:

• allergic reactions (hypersensitivity reactions):
• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• respiratory phenomena:asthma, bronchospasm, wheezing or shortness of breath
• various skin disorders:skin rashes of various types, itching, redness, swelling, skin loss, blisters, scaling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with FLURBIPROFENE COOP, contact your doctor immediately:

• abdominal pain
• peptic ulcer (stomach lesion)
• perforation and bleeding of the stomach or intestine.These side effects can be fatal to you and/or the baby and may occur with or without warning symptoms. These side effects are especially likely to occur if you are elderly or if you and/or the baby have previously suffered from stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects affecting the blood

• anemia (reduction in the number of red blood cells in the blood)
• thrombocytopenia (reduction in the number of platelets in the blood)
• aplastic anemia (reduction in the number of all types of blood cells, red blood cells, white blood cells, platelets)
• agranulocytosis (reduction in the number of granulocytes, a type of white blood cells, in the blood).

Effects affecting the nervous system

• dizziness
• headache
• paresthesia (numbness of the limbs or other parts of the body)
• drowsiness
• cerebrovascular accidents (diseases caused by insufficient blood flow to an area of the brain)
• visual disturbances
• optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss up to blindness)
• migraine (chronic disease characterized by recurrent headaches)
• confusion
• vertigo.

Effects affecting the immune system

• anaphylactic reactions (severe allergic reaction)
• angioedema (inflammatory reaction of the skin)
• hypersensitivity.

Effects affecting the eye

• visual disturbances.

Effects affecting the ear and labyrinth

• tinnitus (ringing in the ears).

Effects affecting the cardiovascular system

• heart failure
• swelling
• hypertension (high blood pressure)

Effects affecting the bronchi and lungs

• throat irritation
• asthma
• bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced air passage)
• dyspnea (shortness of breath)
• blisters in the mouth or throat
• numbness of the mouth or throat.

Effects affecting the mouth, stomach and intestines

• diarrhea
• lesions inside the mouth
• nausea
• pain in the mouth and throat
• a feeling of warmth or burning, tingling of the mouth
• abdominal distension
• abdominal pain
• constipation
• dry mouth
• difficulty digesting
• flatulence (emission of gas from the intestines)
• inflammation of the tongue
• altered taste
• vomiting
• blood in the stool
• blood in the vomit
• bleeding from the stomach and intestines
• colitis
• worsening of inflammatory diseases of the colon and intestines (Crohn's disease)
• inflammation of the stomach (gastritis)
• gastritis
• peptic ulcer
• gastric perforation.

Effects affecting the skin and subcutaneous tissue

• skin rashes
• itching
• urticaria (reddening of the skin accompanied by itching)
• purpura (appearance of patches of skin of various sizes, purple in color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment), including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Erythema multiforme.

Effects affecting the kidneys and urinary tract

• renal toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli which involves a loss of proteins with the urine)
• renal insufficiency (reduction of kidney function).

General effects and at the site of administration

• fever
• pain
• discomfort
• fatigue

Effects affecting the liver

• hepatitis

General effects and at the site of administration

• fever

Effects affecting the psychiatric sphere

• insomnia
• depression
• hallucination.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
report-a-suspected-adverse-reaction.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store FLURBIPROFENE COOP

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 pack after Exp.
The expiry date refers to the last day of that month.
FLURBIPROFENE COOP 0.25mg/ml mouthwash
Once opened, use within 9 weeks.
FLURBIPROFENE COOP 0.25mg/ml oral mucosal spray
Use within 21 weeks once opened.
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 to protect
the environment.

6. Contents of the pack and other information

What FLURBIPROFENE COOP contains
FLURBIPROFENE COOP 0.25mg/ml 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), citric acid, sodium hydroxide, purified water.

FLURBIPROFENE COOP 0.25mg/ml 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), citric acid, sodium hydroxide, purified water.

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

Marketing Authorisation Holder
EPIFARMA S.R.L.
Via San Rocco, 6

• 85033 – Episcopia (PZ)

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