FLURACTIVE 0.25 % Płyn do płukania ust

Treść ulotki

1. FLURACTIVE 2,5 mg/ml mouthwash
   1. What is FLURACTIVE and what is it used for
   2. What you need to know before using FLURACTIVE
   3. How to use FLURACTIVE
   4. Possible side effects
   5. How to store FLURACTIVE
   6. Package Contents and Other Information
   7. What is FLURACTIVE and what is it used for
   8. What you need to know before using FLURACTIVE
   9. How to use FLURACTIVE
   10. Possible side effects
   11. How to store FLURACTIVE
   12. Contents of the pack and other information

FLURACTIVE 2,5 mg/ml mouthwash

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.

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

1. What is FLURACTIVE and what is it used for

FLURACTIVE contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine
that acts against inflammation and pain of the throat, mouth and gums.
FLURACTIVE is used in adultsand adolescentsover 12 years of agein the treatment of
symptoms of pain and irritation of the gums, mouth and throat (for example gingivitis,
stomatitis, pharyngitis), even as a result of conservative or extraction dental therapy (e.g. treatment
of cavities or tooth extraction).
See a doctor if you 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 FLURACTIVE

Do not use FLURACTIVE

• 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 (medicine against inflammation, pain, fever and heart disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and FLURACTIVE”);
• if you have previously suffered from bleeding or perforation of the stomach or intestine 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 intestine (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 not use FLURACTIVE if you are in the last 3 months of pregnancy (see section “Pregnancy and
breastfeeding”).

Do notgive FLURACTIVE to children under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before using FLURACTIVE.
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 have been taking other pain relievers for a long time or without respecting the dosage, as headache (headache) may occur;
• you have previously suffered from a 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”);
• you are elderly (as you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like FLURACTIVE 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 FLURACTIVE and do not use 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).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, can give rise to allergic or local irritation phenomena (see section 4 “Possible side effects”); in such cases, discontinue the
treatment and consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, discontinue treatment.

Children and adolescents
Do notgive FLURACTIVE to children under the age of 12 years.

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

• medicines containing acetylsalicylic acid(medicine against inflammation, pain, fever and heart disorders), as they may increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose daily acetylsalicylic acid), as it increases the risk of bleeding from the stomach and intestines;
• anticoagulants(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 it 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 the functioning of the heart), 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 it 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 to the blood;
• 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 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 not use FLURACTIVE if you are 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 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. 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 using machines
This medicine does not interfere with the ability to drive vehicles and use machinery.

FLURACTIVEcontains para-hydroxybenzoates and hydrogenated castor oil-40 polyoxyethylene

Para-hydroxybenzoates:may cause allergic reactions (even delayed).

Hydrogenated castor oil-40 polyoxyethylene: may cause skin reactions localized.

3. How to use FLURACTIVE

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 adolescents over 12 years of age
The recommended dose is 2-3 rinses or gargles per day (hold in mouth for up to 1 minute).
You can use the mouthwash neat (without diluting it with water), using 10 ml (1 measuring cap) of mouthwash
or diluted, pouring 10 ml (1 measuring cap) of mouthwash into half a glass of water.
At the recommended doses, occasional ingestion does not cause any harm, although it is
advisable not to ingest the product.

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

Use in children and adolescents
Do not give FLURACTIVE to children under 12 years of age.

Duration of treatment
Use FLURACTIVE only for short periods of treatment, not exceeding 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 recurs or if you have noticed any recent
change in its characteristics.

If you use more FLURACTIVE than you should
If you accidentally ingest/take an excessive dose of FLURACTIVE, inform
your doctor immediately or go to the nearest hospital.
In the event of accidental ingestion/intake of considerable quantities 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 FLURACTIVE
Do not use a double dose to make up for a missed dose.

If you stop treatment with FLURACTIVE
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 everyone will experience them.
If you experience the following side effects during treatment with FLURACTIVE, STOPthe
treatment and contact your doctor immediately:

• allergic reactions (sensitization reactions):
• allergic reaction
• anaphylactic reactions (severe allergic reactions)
• 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, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with FLURACTIVE, 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 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.

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 reduced vision 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 that causes 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 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)
• gastritis (inflammation of the stomach)
• peptic ulcer
• gastric perforation.

Effects affecting the skin and subcutaneous tissue

• rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of patches of skin of various sizes with a purple 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 failure (reduction of kidney function).

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
contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting
side effects you can help provide more information on the safety of this
medicine.

5. How to store FLURACTIVE

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 after Exp.
The expiry date refers to the last day of that month.
Once the bottle is opened, use within 9 weeks.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What FLURACTIVE contains

• The active ingredient is flurbiprofen. 100 ml of solution contains 250 mg 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 flavour, Patent Blue V (E131), anhydrous citric acid, sodium hydroxide, purified water. Description of the appearance of FLURACTIVE and package contentsPackage containing a bottle with a measuring dropper and a safety cap of 160 ml.

Marketing Authorisation Holder
FG S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

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

FLURACTIVE2.5 mg/ml oral mucosal 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.

• 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 FLURACTIVE is and what it is used for
• 2. What you need to know before using FLURACTIVE
• 3. How to use FLURACTIVE
• 4. Possible side effects
• 5. How to store FLURACTIVE
• 6. Package Contents and Other Information

2. What is FLURACTIVE and what is it used for

FLURACTIVE contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain reliever)
medicine, which acts against inflammation and pain of the throat, mouth and gums.
FLURACTIVE is used in adultsand adolescentsover 12 years of agein the treatment of
symptoms of pain and irritation of the gums, mouth and throat (for example gingivitis,
stomatitis, pharyngitis), even as a result of conservative or extraction dental therapy (e.g. treatment
of cavities or tooth extraction).
See a doctor if you 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 FLURACTIVE

Do not use FLURACTIVE

• 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 FLURACTIVE”);
• if you have previously suffered from bleeding or perforation of the stomach or intestine 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 intestine (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 not use FLURACTIVE if you are in the last 3 months of pregnancy (see section “Pregnancy and
breastfeeding”).

Do notgive FLURACTIVE to children under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before using FLURACTIVE.
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 bronchi which causes 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 have been 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 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”);
• you are elderly (as you are more likely to experience side effects);
• you have problems with the heart or blood vessels, as medicines like FLURACTIVE 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 FLURACTIVE and do not 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 or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, may give rise to allergic or local irritation phenomena (see section 4 “Possible side effects”); in such cases, discontinue the
treatment and consult your doctor who, if necessary, will carry out suitable therapy.
If you experience irritation of the mouth, discontinue treatment.

Children and adolescents
Do notgive FLURACTIVE to children under the age of 12 years.

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

• 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 daily acetylsalicylic acid), as this increases the risk of bleeding in the stomach and intestine;
• anticoagulants(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 intestine;
• antihypertensive medicines(ACE inhibitors, angiotensin II antagonists and diuretics), in

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 bleeding in the stomach and intestine;
• cardiac glycosides(medicines that affect the functioning of the heart), as NSAIDs may worsen heart failure and increase the level of glycosides in the blood;
• cyclosporine(a medicine that prevents organ rejection after transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as it increases the risk of having lesions or bleeding in the stomach and intestine;
• 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 convulsions;
• 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 toxicity to the blood;
• 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 you are pregnant 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 FLURACTIVE if you are in the first 6 months of pregnancy, unless 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 using machines
This medicine does not interfere with the ability to drive vehicles and use machinery.

FLURACTIVEcontains para-hydroxybenzoates and hydrogenated castor oil-40 polyoxyethylene

Para-hydroxybenzoates:may cause allergic reactions (even delayed).

Hydrogenated castor oil-40 polyoxyethylene: may cause skin reactions localized.

3. How to use FLURACTIVE

Use this medicine following exactly as described 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 low doses for the shortest duration possible of treatment necessary to control the symptoms.
Caution: do not exceed the indicated doses without the advice of your doctor.

Adults and adolescents over the age of 12 years
The recommended dose is 2 sprays, 3 times a day.
Spray the solution, directing it directly onto the affected area (mouth, throat).
At the recommended doses, occasional ingestion does not cause any harm, although it is advisable not to ingest the product.

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

Use in children and adolescents
Do not give FLURACTIVE to children under the age of 12 years.

Duration of treatment
Use FLURACTIVE only for short periods of treatment, not exceeding 7 days.
If no appreciable results are observed 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.

Method of administration
Rotate the nozzle to the right or left, without tampering with the dispenser.
At the first use of the product, press the dispenser several times until a regular spray is obtained.

If you use more FLURACTIVE than you should
If you accidentally ingest/take an excessive dose of FLURACTIVE, 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 FLURACTIVE
Do not use a double dose to make up for a missed dose.

If you stop treatment with FLURACTIVE
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 FLURACTIVE, STOPthe
treatment 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, 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 FLURACTIVE, 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 occur especially 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 reduced vision 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 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)
• gastritis (inflammation of the stomach)
• peptic ulcer
• gastric perforation.

Effects affecting the skin and subcutaneous tissue

• rash
• itching
• urticaria (redness of the skin accompanied by itching)
• purpura (appearance of skin patches of various sizes, purple in color)
• bullous dermatoses (severe skin lesions characterized by erythema, blistered 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 failure (reduction in kidney function).

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 get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store FLURACTIVE

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 after Exp.
The expiry date refers to the last day of that month.
Once the bottle is opened, use within 21 weeks.
Do not dispose of any medicine in waste water 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 FLURACTIVE contains

• The active ingredient is flurbiprofen. 100 ml of solution contains 250 mg 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 FLURACTIVE and contents of the packPack containing a bottle with a dosing pump and dispenser of 15 ml.

Marketing Authorisation Holder
FG S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ) - Italy

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