Kavoflog

Italy
Brand name Kavoflog
Form mouthwash
Active substance / Dosage
FLURBIPROFENE
Prescription type Over-the-counter
ATC code
A01AD11
Registration number 041794
Manufacturer POOL PHARMA SRL
Kavoflog mouthwash

Table of Contents

Package leaflet: Information for the user

KAVOFLOG 0.25% mouthwash, 0.25% oral spray

Flurbiprofen
Please read this leaflet carefully before using this medicine because it contains important information for you.
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 any improvement 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 KAVOFLOG is and what it is used for

KAVOFLOG contains the active substance flurbiprofen, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation.
This medicine is used for irritation and/or inflammation of the mouth and pharynx (e.g. gingivitis, stomatitis, pharyngitis), including cases following dental treatment such as filling of caries or tooth extraction.
Consult 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 to any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to acetylsalicylic acid (a medicine used for inflammation, pain, fever and heart conditions) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and KAVOFLOG”);
  • if you have previously experienced gastrointestinal bleeding or perforation related to prior treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
  • if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
  • if you frequently suffer from peptic ulcer (stomach lesion) or gastrointestinal bleeding (two or more distinct episodes of ulcer or bleeding);
  • if you have severe heart failure (reduced heart function), severe liver failure (reduced liver function), or severe kidney failure (reduced kidney function).

Do not take/give KAVOFLOG during the last 3 months of pregnancy (see section “Pregnancy and
breast-feeding”).
Do not give KAVOFLOG Spray and Mouthwash to children under 12 years of age.
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Warnings and precautions
Talk to your doctor or pharmacist before using KAVOFLOG.
In particular, inform 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 airways 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 have reduced kidney, heart, or liver function (renal, cardiac, or hepatic insufficiency);
  • you suffer from hypertension (high blood pressure);
  • you have been taking other analgesics for a long time or without following the prescribed dosage, as this may lead to headache;
  • you have previously suffered from peptic ulcer (stomach lesion) or other stomach and intestinal diseases, as this increases the risk that these conditions may recur. This risk increases especially with high doses of flurbiprofen, if you are elderly, or if the peptic ulcer was complicated by gastrointestinal bleeding or perforation (see section 4 “Possible side effects”);
  • you are elderly (as you are more likely to experience side effects);
  • you have heart or blood vessel problems, as medicines like KAVOFLOG may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with higher doses and prolonged treatment; do not exceed the recommended dose of KAVOFLOG or use 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, high cholesterol, or smoke).
  • you have an infection – refer to the section “Infections” below.

Tell your doctor about any unusual abdominal symptoms.
The use of this medicine, especially if prolonged, may cause allergic reactions or local irritation
(see section 4 “Possible side effects”); in such cases, stop treatment and
consult your doctor, who will prescribe appropriate therapy if necessary.
If you experience mouth irritation, discontinue treatment.
Do not use this medicine for long periods.
Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infection such as fever and
pain. This may delay appropriate treatment of the infection, which, in turn, may lead to
an increased risk of complications. If you take this medicine during an infection and the
infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
Children and adolescents
Do not give 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 might take
any other medicine.
Inform your doctor if you/your child are taking any of the following medicines:
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  • medicines containing acetylsalicylic acid (medicines for inflammation, pain, fever and heart conditions), as they may increase side effects;
  • antiplatelet agents (medicines that make the blood thinner, such as low-dose daily aspirin), as this increases the risk of gastrointestinal bleeding;
  • anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), since their effect may be enhanced by NSAIDs;
  • selective serotonin reuptake inhibitors (medicines used for depression), as this increases the risk of gastrointestinal bleeding;
  • antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), as NSAIDs may reduce the effect of diuretics or some antihypertensive drugs may increase renal toxicity;
  • alcohol, as it may increase the risk of side effects, especially the risk of stomach and intestinal bleeding;
  • cardiac glycosides (medicines affecting heart function), as NSAIDs may worsen heart failure and increase glycoside levels in the blood;
  • cyclosporine (a medicine used to prevent organ transplant rejection), as this increases the risk of renal toxicity;
  • corticosteroids (medicines used for inflammation/allergies), as this increases the risk of stomach and intestinal lesions or bleeding;
  • lithium (a medicine used for behavioral disorders), as blood lithium levels may increase;
  • methotrexate (a medicine used for psoriasis, arthritis, and cancer), as blood methotrexate levels may increase;
  • mifepristone (a medicine used to terminate pregnancy): NSAIDs should not be used for 8–12 days after taking mifepristone, as they reduce its effectiveness;
  • quinolone antibiotics (medicines 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 (a medicine used for AIDS), as NSAIDs increase the risk of blood toxicity;
  • Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), as this may enhance the effect of these medicines and increase the risk of side effects.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding,
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the newborn.
It may cause kidney or heart problems in the fetus. It may affect your or your baby's tendency to bleed and may cause labor to start later or last longer than expected. If taken for more than a few days from the 20th week of pregnancy onwards, flurbiprofen may cause kidney problems in the fetus, which in turn may lead to low levels of amniotic fluid surrounding the fetus (oligo-hydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment lasts more than a few days, your doctor may recommend additional monitoring.
It is not known whether the same risk applies to KAVOFLOG.
Do not take KAVOFLOG during the last three months of pregnancy.
Do not take KAVOFLOG during the first 6 months of pregnancy unless absolutely necessary and on medical advice. If treatment is needed during this period, take the lowest effective dose for the shortest possible time.
Breast-feeding
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The use of flurbiprofen during breast-feeding is not recommended unless strictly necessary and advised by a doctor.
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 the chances of becoming pregnant. However, consult your doctor if you have fertility problems before taking the medicine.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
KAVOFLOG mouthwash and oral spray contain parahydroxybenzoates, hydrogenated castor oil-40 polyoxyl
ethylenated and the dye patent blue
Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
Hydrogenated castor oil-40 polyoxyl ethylenated: may cause local skin reactions.
These medicines contain the dye patent blue V (E131), which may cause allergic reactions.

3. How to use KAVOFLOG

Use this medicine exactly 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 rinses or gargles per day with 10 ml of mouthwash. It may be diluted with water.
  • Oral spray: the recommended dose is 2 sprays, 3 times a day, directed directly onto the affected area.

Do not exceed the recommended doses. The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor or pharmacist immediately if symptoms (such as fever and pain) persist or worsen (refer to section 2).
Instructions for use of KAVOFLOG 0.25% Oral Spray: rotate the nozzle to the right or left without tampering with the dispenser.
At first use, press the dispenser several times until a regular spray is obtained.
If you use more KAVOFLOG than you should
If you accidentally swallow or take too much KAVOFLOG, inform your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of a large amount of flurbiprofen, you may experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach ache, or rarely diarrhea.
Ringing in the ears (tinnitus), headache, and bleeding of the stomach or intestines may also occur. In such cases, the doctor will provide appropriate treatment.
If you forget to use KAVOFLOG
Do not use a double dose to make up for a forgotten dose.
If you stop using KAVOFLOG
If you have any questions 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 everybody gets them.
If you experience any of the following side effects during treatment with KAVOFLOG, STOP
treatment and contact your doctor immediately:

  • Allergic reactions: hypersensitivity reactions, allergic reactions or anaphylactic reactions (severe allergic reactions), or angioedema (sudden swelling of the mouth/throat and mucous membranes)
  • Local irritation
  • Respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
  • Various skin disorders: skin rashes of different types, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

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

  • Abdominal pain
  • Peptic ulcer (stomach lesion)
  • Perforation and bleeding of the stomach or intestine. These side effects can be fatal and may occur with or without warning symptoms. These side effects are more likely if you are elderly or have previously suffered from stomach or intestinal diseases.

In addition, you may experience the following side effects:
Effects related to the blood

  • Anaemia (reduction in the amount of red blood cells in the blood)
  • Thrombocytopenia (reduction in the number of platelets in the blood)
  • Aplastic anaemia (reduction in all types of blood cells: red blood cells, white blood cells, platelets)
  • Agranulocytosis (reduction in the number of granulocytes, a type of white blood cell, in the blood).

Effects related to the nervous system

  • Dizziness
  • Headache
  • Paresthesia (numbness of limbs or other body parts)
  • Drowsiness
  • Cerebrovascular accidents (diseases caused by inadequate blood flow to an area of the brain)
  • Visual disturbances
  • Optic neuritis (severe inflammation of the optic nerve, which may lead to reduced vision or even blindness)
  • Migraine (a chronic condition characterized by recurrent headaches)
  • Confusion
  • Vertigo.

Effects related to the immune system

  • Anaphylactic reactions (severe allergic reactions)
  • Angioedema (inflammatory reaction of the skin)
  • Hypersensitivity.

Effects related to the eye

  • Visual disturbances.

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Effects related to the ear and labyrinth

  • Tinnitus (ringing in the ears).

Effects related to the cardiovascular system

  • Heart failure
  • Swelling
  • Hypertension (high blood pressure)

Effects related to the bronchi and lungs

  • Sore throat
  • Asthma
  • Bronchospasm (narrowing of the bronchi causing severe breathing difficulty due to reduced airflow)
  • Dyspnea (shortness of breath)
  • Blisters in mouth or throat
  • Numbness of mouth or throat.

Effects related to the mouth, stomach and intestine

  • Diarrhea
  • Mouth sores
  • Nausea
  • Mouth and throat pain
  • Abdominal bloating
  • Abdominal pain
  • Constipation
  • Dry mouth
  • Indigestion
  • Flatulence (passing gas from the intestine)
  • Inflammation of the tongue
  • Taste disturbances
  • Vomiting
  • Blood in stool
  • Blood in vomit
  • Bleeding from stomach and intestine
  • Colitis
  • Worsening of inflammatory bowel diseases (Crohn's disease)
  • Inflammation of the stomach (gastritis)
  • Gastritis
  • Peptic ulcer
  • Gastric perforation.

Effects related to the skin and underlying tissue

  • Skin rashes
  • Itching
  • Urticaria (red, itchy skin patches)
  • Purpura (appearance of purple-coloured skin patches of varying sizes)
  • Bullous dermatoses (severe skin lesions characterized by erythema, blistering and areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Erythema Multiforme.

Effects related to the kidneys and urinary tract

  • Renal toxicity
  • Tubulo-interstitial nephritis (inflammation of the kidneys)
  • Nephrotic syndrome (alteration of the kidney glomeruli leading to protein loss in urine)
  • Renal failure (reduced kidney function). Page 6 of 8

General effects and effects at the site of administration

  • Fever
  • Pain
  • Discomfort
  • Fatigue

Effects related to the liver

  • Hepatitis

Effects related to psychiatric disorders

  • Insomnia
  • Depression
  • Hallucinations.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
KAVOFLOG 0.25% mouthwash
Once the bottle has been opened, use within 9 weeks.
KAVOFLOG 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What KAVOFLOG contains
KAVOFLOG 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, polyoxethylated hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

KAVOFLOG 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, polyoxethylated hydrogenated castor oil-40, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, peppermint flavour, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.
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Description of the appearance of KAVOFLOG and contents of the pack
KAVOFLOG 0.25% mouthwash
Pack containing a bottle with measuring cup and child-resistant cap, 160 ml.
KAVOFLOG 0.25% oral mucosa spray
Pack containing a bottle with dosing pump and spray applicator, 15 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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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