KAVOFLOG 0.25% Płyn do płukania ust

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

KAVOFLOG 0.25% mouthwash, 0.25% oral mucosa spray

Flurbiprofen

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 would like 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.

Contents of this leaflet:

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

1. What is KAVOFLOG and what is it used for

KAVOFLOG 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 cases of irritation and/or inflammation of the mouth and pharynx (e.g.
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 3 days.

2. What you need to know before using KAVOFLOG

Do not use KAVOFLOG

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

Do nottake/give KAVOFLOG in the last 3 months of pregnancy (see section “Pregnancy and
breastfeeding”).

Do notgive KAVOFLOG Spray and Mouthwash to children under 12 years of age.
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Warnings and precautions
Consult your doctor or pharmacist before using KAVOFLOG.
In particular, tell your doctor if:

• you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk that you may experience bronchospasm (narrowing of the bronchi causing severe breathing difficulties due to reduced airflow);
• you have previously suffered from allergies;
• you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease;
• you suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic insufficiency);
• you suffer from hypertension (high blood pressure);
• you are taking other pain relievers for a long time or without respecting the dosage, as headache may occur;
• you have previously suffered from a peptic ulcer (lesion of the stomach) and other diseases of the stomach and intestines 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 intestines (see section 4 “Possible side effects”);
• you are elderly (because you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like KAVOFLOG may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of experiencing side effects increases with high doses and prolonged treatments; do not exceed the dose of KAVOFLOG and do not take it for long periods. Tell 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).
• you have an infection - refer to the section “Infections” below.

Report to your doctor any unusual symptoms at the abdominal level
The use of this medicine, especially if prolonged, can give rise to allergic or irritation phenomena
local (see section 4 “Possible side effects”); in such cases discontinue treatment and
consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, discontinue treatment.
Do not use this medicine for long periods.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections 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
symptoms of the infection persist or worsen, consult your doctor or pharmacist immediately.

Children and adolescents
Do notgive KAVOFLOG Spray and Mouthwash to children under 12 years of age.

Other medicines and KAVOFLOG
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Tell your doctor if you/the child are taking any of the following medicines:
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• medicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart problems), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose aspirin daily), as this increases the risk of bleeding in 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 in 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(a 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(a medicine used for behavioral disorders), as the level of lithium in the blood may increase;
• methotrexate(a medicine used for psoriasis, arthritis and tumors), as the level of methotrexate in the blood may increase;
• mifepristone(a 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(an immunosuppressant medicine used after organ transplantation), as NSAIDs may increase the risk of renal toxicity;
• zidovudine(a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
• Cox-2 inhibitors and other NSAIDs(medicines used against inflammation and pain), as it may increase the effect of these medicines and the risk of side effects.

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 before using this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the unborn child.
It can cause problems with the kidneys or heart of the fetus. It can affect its tendency or that of your
child to bleed and cause labor to be later or longer than expected. If taken for
more than a few days from the twentieth week of pregnancy onwards, flurbiprofen can cause
kidney problems in the fetus which, in turn, can lead to low levels of amniotic fluid
surrounding the fetus (oligo-hydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart
of the child. If treatment continues for more than a few days, the doctor may recommend
further monitoring.
It is not known if the same risk applies to KAVOFLOG.
Do not take KAVOFLOG in the last three months of pregnancy.
Do not take KAVOFLOG in the first 6 months of pregnancy unless absolutely necessary and
as directed by your doctor. If treatment is necessary during this period, you should take the lowest dose
for the shortest possible time.

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

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 have an effect on the chances of getting 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 operate machinery.

KAVOFLOG mouthwash and spray for oral mucosa contain para-hydroxybenzoates, hydrogenated castor oil-40 polyethylene glycol and the blue patent dye
Para-hydroxybenzoates: may cause allergic reactions (even delayed).
Hydrogenated castor oil-40 polyethylene glycol: may cause local skin reactions.
These medicines contain the blue patent V dye (E131) may cause allergic reactions

3. How to use KAVOFLOG

Use this medicine following the instructions of your doctor or pharmacist exactly. 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. It may be diluted in water.
• Oral mucosal spray: the recommended dose is 2 sprays 3 times a day directed directly onto the affected area.

Do not exceed the recommended doses. The minimum effective dose should be used for the shortest time
necessary to relieve symptoms. If you have an infection, consult your doctor or
pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to paragraph
2).
How to use KAVOFLOG 0.25% Oral mucosal spray: rotate the nozzle to the right or
left, without tampering with the applicator.
When using the product for the first time, press the applicator several times until a regular
spray is obtained.

If you use more KAVOFLOG than you should
If you accidentally ingest/take an excessive dose of KAVOFLOG, immediately notify your
doctor or go to the nearest hospital.
In the event of accidental ingestion/intake of significant amounts of flurbiprofen, you may
experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach pain or rarely diarrhea.
Ringing in the ears, headache and bleeding of the stomach or intestines may also occur. In such cases, the
doctor will adopt appropriate treatments.

If you forget to use KAVOFLOG
Do not use a double dose to make up for a missed dose.

If you stop using KAVOFLOG
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with KAVOFLOG, STOPthe
treatment and contact your doctor immediately:

• allergic reactions(hypersensitivity reactions): or allergic reaction or anaphylactic reactions (severe allergic reactions) or angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• respiratory phenomena:asthma, bronchospasm, shortness of breath or difficulty breathing
• 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 KAVOFLOG, contact your doctor

immediately:

• 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 are particularly likely to occur if you are elderly or if you 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.

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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 difficulty breathing due to reduced airflow)
• 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
• abdominal distension
• abdominal pain
• constipation
• dry mouth
• difficulty digesting
• flatulence (emission of gas from the intestine)
• 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 underlying tissue
• skin rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of skin patches of various sizes with a purplish 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 resulting in protein loss in the urine)
• renal failure (reduction of kidney function). Page 6of 8

General effects and at the site of administration

• fever
• pain
• discomfort
• fatigue

Effects affecting the liver

• hepatitis Effects affecting the psychiatric sphere
• insomnia
• depression
• hallucination.

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

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 “Expiry date”. The expiry date refers to the last day of that month.
KAVOFLOG 0.25% mouthwash
Once opened, use within 9 weeks.
KAVOFLOG 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 KAVOFLOG contains
KAVOFLOG 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. KAVOFLOG 0.25% oral mucosa 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, Page 7of 8

paraidrossibenzoato, mint aroma, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide,
purified water.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pool Pharma S.r.l. - Via Basilicata 9 - San Giuliano Milanese (MI), 20098 - Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) - Italy
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