BENACTIV 2,5 MG/ML Mouthwash

Зміст інструкції

1. BENACTIV GOLA 2,5 mg/ml Mouthwash, Oral Mucosa Spray
   1. What is BENACTIV GOLA and what is it used for
   2. What you need to know before taking BENACTIV GOLA
   3. How to take BENACTIV GOLA
   4. Possible side effects
   5. How to store BENACTIV GOLA
   6. Contents of the pack and other information
2. BENACTIV GOLA 8.75 mg Lozenges Lemon and Honey flavour, Sugar-Free Orange flavour
   1. What is BENACTIV GOLA and what is it used for
   2. What you need to know before taking BENACTIV GOLA
   3. How to take BENACTIV GOLA
   4. Possible side effects
   5. How to store BENACTIV GOLA
   6. Contents of the pack and other information

BENACTIV GOLA 2,5 mg/ml Mouthwash, Oral Mucosa Spray

flurbiprofene

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take 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 BENACTIV GOLA is and what it is used for
• 2. What you need to know before you take BENACTIV GOLA
• 3. How to take BENACTIV GOLA
• 4. Possible side effects
• 5. How to store BENACTIV GOLA
• 6. Contents of the pack and other information

1. What is BENACTIV GOLA and what is it used for

BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
BENACTIV GOLA is used in adultsand adolescentsover 12 years of agein the treatment of symptoms
of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), even
following conservative or extractive dental therapy (e.g. cavity treatment 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 taking BENACTIV GOLA

Do not take BENACTIV GOLA

• 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 disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and BENACTIV GOLA”);
• 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 nottake/give BENACTIV GOLA in the last 3 months of pregnancy (see section “Pregnancy, breastfeeding
and fertility”).

Do notgive BENACTIV GOLA Spray and Mouthwash to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking BENACTIV GOLA.
In particular, tell your doctor if you:

• have previously suffered from bronchial asthma (a respiratory disease), as it increases the risk of bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced air passage);
• have previously suffered from allergies;
• 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 previously suffered from peptic ulcer (lesion of the stomach) and other diseases of the stomach and intestine as it 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 (as you are more likely to experience side effects);
• have problems with the heart or blood vessels, as medicines like BENACTIV GOLA 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 BENACTIV GOLA 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);
• have an infection - refer to the “Infections” section below.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infection 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.
Tell your doctor about any unusual abdominal symptoms.
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 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 BENACTIV GOLA Spray and Mouthwash to children under 12 years of age.

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

• Aspirin andmedicines containing acetylsalicylic acid(a medicine against inflammation, pain, fever and heart disorders), as they can increase the side effects;
• antiplatelet agents(medicines that make the blood more fluid, such as low-dose aspirin daily), as it 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 it 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 drugs may increase renal toxicity;
• alcohol, as it can 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 can 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 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 can increase the risk of developing seizures;
• tacrolimus(an immunosuppressant medicine used after organ transplantation), as NSAIDs can 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 or are planning a pregnancy or if you are breastfeeding with breast milk
ask your doctor for advice before taking this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the unborn child. It is not known if
the same risk applies to Benactiv Gola.
Do not take Benactiv Gola in the last three months of pregnancy. Do not take Benactiv Gola 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 minimum dose for the shortest possible time.

Breastfeeding
The use of flurbiprofen during breastfeeding is not recommended unless strictly necessary and advised by
the 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 ability to become pregnant. However, ask your doctor if you have problems with
fertility before taking the medicine.

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

BENACTIV GOLA Mouthwash and BENACTIV GOLA Spray for oral mucosa contain hydrogenated castor oil-40-polyoxyethylene, parabens, mint essence (containing d-limonene)

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

Parabens: may cause allergic reactions (even delayed).

D-limonene:may cause allergic reactions

Sodium: this medicine contains less than 1 mmol (23mg) of sodium per 10 ml dose, i.e. essentially “sodium-free”.

3. How to take BENACTIV GOLA

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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).
Caution: do not exceed the indicated doses without the advice of your doctor.

Adults and adolescents over 12 years of age

Mouthwash
The recommended dose is 2-3 rinses or gargles per day (hold in mouth for up to 1 minute).
You can use/give 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, although it is advisable not to ingest the product.

Oral mucosal spray
The recommended dose is 2 sprays 3 times a day.
Spray the solution, directing it 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 have suffered from an ulcer (stomach lesion) in the past
If you are elderly or have suffered from a peptic ulcer (stomach lesion) in the past, it is recommended to use the lowest recommended dose, as there is a greater risk of serious consequences in the event of undesirable effects and the risk of developing an ulcer, bleeding or perforation of the stomach and intestines is greater (see paragraph 4 “Possible side effects”).

Use in children and adolescents
Donot give BENACTIV GOLA Spray and Mouthwash to children under 12 years of age.

Duration of treatment
Use BENACTIV GOLA only for short periods of treatment, not exceeding 7 days. If you do not notice appreciable results 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 BENACTIV GOLA than you should
If you accidentally ingest/take an excessive dose of BENACTIV GOLA, 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, irritation of the stomach or intestines, stomach pain or rarely diarrhea.
Ringing in the ears, headache and bleeding of the stomach or intestines can also occur. In such cases, the doctor will adopt appropriate treatments.

If you forget to take BENACTIV GOLA
Do not take a double dose to make up for a missed dose.

If you stop taking BENACTIV GOLA
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 BENACTIV GOLA, STOPtreatment
and consult 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
• sensations of heat or tingling in the mouth and throat(this effect may occur with the lozenges)
• 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 BENACTIV GOLA, consult 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. You may also experience the following side effects:

Common (may affect up to 1 in 10 people)

• dizziness;
• headache;
• paresthesia (numbness of the limbs or other parts of the body, including the mouth);
• sore throat;
• diarrhea;
• lesions inside the mouth;
• nausea;
• pain in the mouth and throat;
• feeling of warmth or burning, tingling in the mouth.

Uncommon (may affect up to 1 in 100 people)

• drowsiness;
• 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;
• abdominal distension;
• abdominal pain;
• constipation;
• dry mouth;
• difficulty digesting;
• flatulence (emission of gas from the intestine);
• inflammation of the tongue, including pain and burning of the tongue;
• altered taste;
• vomiting;
• skin rash;
• itching;
• fever;
• pain;
• insomnia.

Rare (may affect up to 1 in 1,000 people)

• anaphylactic reactions (severe allergic reaction).

Not known (frequency cannot be estimated based on available data)

• 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)
• 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
• angioedema (inflammatory reaction of the skin)
• hypersensitivity
• tinnitus (ringing in the ears)
• heart failure
• edema (swelling)
• hypertension (high blood pressure)
• 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 lining (gastritis)
• stomach lesion (peptic ulcer)
• gastric perforation
• bleeding due to stomach lesion
• urticaria (skin redness 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
• renal toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli that causes a loss of proteins with the urine)
• renal insufficiency (reduction of kidney function)
• discomfort
• fatigue
• hepatitis
• 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store BENACTIV GOLA

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 “Scad” or “Expiry”.
The expiry date refers to the last day of that month.

Mouthwash/Oral mucosal spray
No special storage conditions are required.
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 BENACTIV GOLA contains

Mouthwash

• the active ingredient is: flurbiprofen (1 ml of mouthwash contains 2.5 mg of flurbiprofen)
• the other ingredients are: glycerol, ethanol (96 percent), sorbitol 70, hydrogenated castor oil 40-polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate,sodium hydroxide, sodium saccharin, peppermint essence (containing d-limonene), Patent Blue V (E131), purified water (see paragraph “BENACTIV GOLA Mouthwash and BENACTIV GOLA Oral Mucosa Spray contain hydrogenated castor oil 40-polyoxyethylene, parabens, peppermint essence (containing d-limonene)”). Oral Mucosa Spray
• the active ingredient is: flurbiprofen (1 ml of solution contains 2.5 mg of flurbiprofen)
• the other ingredients are: glycerol, ethanol (96 percent), sorbitol 70, hydrogenated castor oil 40-polyoxyethylene, methyl parahydroxybenzoate, propyl parahydroxybenzoate,sodium hydroxide, sodium saccharin, peppermint essence (containing d-limonene), Patent Blue V (E131), purified water (see paragraph “BENACTIV GOLA Mouthwash and BENACTIV GOLA Oral Mucosa Spray contain hydrogenated castor oil 40-polyoxyethylene, parabens, peppermint essence (containing d-limonene)”).

Description of the appearance of BENACTIV GOLA and contents of the pack

Mouthwash
BENACTIV GOLA Mouthwash is presented in the form of a clear blue solution, contained in a yellow glass bottle
of 160 ml. The pack contains a 10 ml measuring cup.

Oral Mucosa Spray
BENACTIV GOLA Oral Mucosa Spray is presented in the form of a clear blue solution, contained in a
yellow glass bottle of 15 ml, equipped with a spray valve.
Not all pack sizes may be available.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano.

Manufacturer
Doppel Farmaceutici s.r.l., via Martiri delle Foibe 1, 29016 Cortemaggiore (PC).

BENACTIV GOLA 8.75 mg Lozenges Lemon and Honey flavour, Sugar-Free Orange flavour

flurbiprofene

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take 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 BENACTIV GOLA is and what it is used for
• 2. What you need to know before you take BENACTIV GOLA
• 3. How to take BENACTIV GOLA
• 4. Possible side effects
• 5. How to store BENACTIV GOLA
• 6. Contents of the pack and other information

1. What is BENACTIV GOLA and what is it used for

BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain relieving) medicine that acts against inflammation and pain of the throat, mouth and gums.
BENACTIV GOLA Lozenges Lemon and Honey flavour and BENACTIV GOLA Sugar-Free Lozenges Orange flavour
are used in adultsand adolescents over 12 years of agein the treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).
BENACTIV GOLA Sugar-Free Lozenges Orange flavour is indicated if you and/or the adolescent need to control
sugar and calorie intake.
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 taking BENACTIV GOLA

Do not take BENACTIV GOLA

• 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 disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and BENACTIV GOLA”);
• 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 nottake/give BENACTIV GOLA in the last 3 months of pregnancy (see section “Pregnancy, breastfeeding
and fertility”).

Do notgive BENACTIV GOLA lozenges to children under the age of 12 years.

Warnings and precautions
Consult your doctor or pharmacist before taking BENACTIV GOLA.
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);
• have previously suffered from allergies;
• 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);
• have been taking other painkillers for a long time or without respecting the dosage, as headache (pain in the head) may occur;
• 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”);
• if you are elderly (because you are more likely to experience side effects);
• have problems with the heart or blood vessels, as medicines like BENACTIV GOLA 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 BENACTIV GOLA 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);
• have an infection - refer to the section “Infections” below.

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 are taking this medicine during an infection and the symptoms of the infection persist or
worsen, contact your doctor or pharmacist immediately.
Tell your doctor about any unusual abdominal symptoms.
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 treatment and consult your doctor who, if
necessary, will carry out appropriate therapy.
If you experience irritation of the mouth, discontinue treatment.

Children and adolescents
Do notgive BENACTIV GOLA lozenges to children under the age of 12 years.

Other medicines and BENACTIV GOLA
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:

• Aspirin andmedicines containing acetylsalicylic acid(a 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 aspirin daily), as this increases the risk of bleeding from 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 from the stomach and intestine;
• 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 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 rejection after organ transplantation), as it increases the risk of renal toxicity;
• corticosteroids(medicines used against inflammation/allergies), as they increase 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 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 you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen can cause adverse effects in the unborn child. It is not known if
the same risk applies to Benactiv Gola.
Do not take Benactiv Gola in the last three months of pregnancy. Do not take Benactiv Gola 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
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 can affect female fertility. This effect
is reversible when taking the medicine is stopped. Occasional use of this
medicine is unlikely to affect the ability to become pregnant. However, ask your doctor if you have problems with
fertility before taking the medicine.

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

BENACTIV GOLA Lemon and Honey flavored lozenges contains liquid sucrose, liquid glucose (containing
sulfites and wheat starch), honey (inverted sugar), lemon aroma and levomenthol (containing
butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol and linalool)

Liquid sucrose, liquid glucose and honey (inverted sugar):If you have been diagnosed with an intolerance
to certain sugars, contact your doctor before taking this medicine. This medicine contains 1.07 g of glucose and
1.41 g of sucrose per lozenge. This should be taken into consideration in people with diabetes mellitus.

Sulfites:rarely can cause severe hypersensitivity reactions and bronchospasm.

Gluten:this medicine contains only a very small amount of gluten (from wheat starch). This
medicine is considered “gluten-free” and it is very unlikely to cause you problems if you are celiac. A
lozenge contains no more than 21.38 micrograms of gluten. If you are allergic to wheat (a condition different from
celiac disease) do not take this medicine.

Citral, citronellol, d-limonene, farnesol, geraniol and linalool:can cause allergic reactions.

Butylated hydroxyanisole:can cause skin reactions localized (e.g. contact dermatitis) or irritation to the
eyes and mucous membranes.

BENACTIV GOLA Sugar-Free Orange flavored lozenges contains liquid maltitol (E965), isomalt
(E953), orange aroma and levomenthol (containing citral, citronellol, d-limonene, geraniol, linalool)

Liquid maltitol (E965), isomalt (E953):if you have been diagnosed with an intolerance to certain sugars, contact
your doctor before taking this medicine. It may have a mild laxative effect. The caloric value of maltitol and
isomalt is 2.3 kcal/g.

Citral, citronellol, d-limonene, geraniol and linalool:can cause allergic reactions.

3. How to take BENACTIV GOLA

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. 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).
Caution: do not exceed the indicated doses without the advice of your doctor.

Adults and adolescents over 12 years of age
The recommended dose is 1 lozenge every 3-6 hours as needed. Do not exceed the dose of 8 lozenges in 24 hours.
Dissolve the lozenge slowly in your mouth.

If you are elderly or have a history of ulcer (stomach lesion)
If you are elderly or have a history of 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 side effects and the risk of developing ulcer, bleeding or perforation of the stomach and intestines is greater (see paragraph 4 “Possible side effects”).

Use in children and adolescents
Donot give BENACTIV GOLA lozenges to children under 12 years of age.

Duration of treatment
Use BENACTIV GOLA 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.

If you take more BENACTIV GOLA than you should
If you accidentally ingest/take an excessive dose of BENACTIV GOLA, inform your doctor immediately or go to the nearest hospital.
In the case of accidental ingestion 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 can also occur. In such cases, the doctor will adopt appropriate treatments.

If you forget to take BENACTIV GOLA
Do not take a double dose to make up for a missed dose.

If you stop taking BENACTIV GOLA
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 BENACTIV GOLA, STOPtreatment
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
• sensations of heat or tingling in the mouth and throat(this effect may occur with the lozenges)
• 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 BENACTIV GOLA, 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 suffered from stomach and intestinal diseases in the past.

In addition, you may experience the following side effects:

Common (may affect up to 1 in 10 people)

• dizziness;
• headache;
• paresthesia (numbness of the limbs or other parts of the body, including the mouth);
• sore throat;
• diarrhea;
• lesions inside the mouth;
• nausea;
• pain in the mouth and throat;
• feeling of warmth or burning, tingling in the mouth.

Uncommon (may affect up to 1 in 100 people)

• drowsiness;
• 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;
• abdominal distension;
• abdominal pain;
• constipation;
• dry mouth;
• difficulty digesting;
• flatulence (passage of gas from the intestines);
• inflammation of the tongue, including pain and burning of the tongue;
• altered taste;
• vomiting;
• skin rash;
• itching;
• fever;
• pain;
• insomnia.

Rare (may affect up to 1 in 1,000 people)

• anaphylactic reactions (severe allergic reaction).

Not known (frequency cannot be estimated from available data)

• 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)
• 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
• angioedema (inflammatory reaction of the skin)
• hypersensitivity
• tinnitus (ringing in the ears)
• heart failure
• edema (swelling)
• hypertension (high blood pressure)
• 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 lining (gastritis)
• stomach lesion (peptic ulcer)
• gastric perforation
• bleeding due to stomach lesion
• urticaria (skin redness 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
• renal toxicity
• tubulo-interstitial nephritis (inflammation of the kidneys)
• nephrotic syndrome (alteration of the renal glomeruli that causes a loss of protein in the urine)
• renal insufficiency (reduction in kidney function)
• discomfort
• fatigue
• hepatitis
• 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store BENACTIV GOLA

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 “Scad” or “Expiry”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
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 BENACTIV GOLA contains

Lemon and Honey flavored lozenges

• the active ingredient is: flurbiprofen 8.75 mg
• the other ingredients are: liquid sucrose, liquid glucose(containing sulfites and wheat starch), honey,macrogol 300, potassium hydroxide, lemon aroma and levomenthol (containing butylated hydroxyanisole,citral, citronellol, d-limonene, farnesol, geraniol and linalool)(see paragraph “BENACTIV GOLA Lemon and Honey flavored lozenges contains liquid sucrose, liquid glucose (containing sulfites and wheat starch), honey (inverted sugar), lemon aroma and levomenthol (containing butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol and linalool).

Sugar-Free Orange flavored lozenges

• the active ingredient is: flurbiprofen 8.75 mg
• the other ingredients are: macrogol 300, potassium hydroxide, orange aroma and levomenthol, (containing citral, citronellol, d-limonene, geraniol, linalool) acesulfame potassium (E950), liquid maltitol, isomalt(E953)(see paragraph “BENACTIV GOLA Sugar-Free Orange flavored lozenges contains liquid maltitol, isomalt (E953), orange aroma and levomenthol (containing citral, citronellol, d-limonene,

geraniol, linalool)”).

Description of the appearance of BENACTIV GOLA and contents of the pack
BENACTIV GOLA Lemon and Honey flavored lozenges is presented in the form of round lozenges colored from yellow to brown
contained in blisters of 16, 24 or 36 lozenges.
BENACTIV GOLA Sugar-Free Orange flavored lozenges is presented in the form of round lozenges colored from
white to pale yellow contained in blisters of 16 or 24 lozenges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano.

Manufacturer
RB NL Brands B.V., Schiphol Boulevard 207, Schiphol 1118BH, Netherlands