Benactiv for sore throat: detailed information

Package leaflet: Information for the user

BENACTIV GOLA 2.5 mg/ml Mouthwash, Spray for oral mucosa

flurbiprofen
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take 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 of treatment.

Contents of this leaflet:

What BENACTIV GOLA is and what it is used for
What you need to know before taking BENACTIV GOLA
How to take BENACTIV GOLA
Possible side effects
How to store BENACTIV GOLA
Contents of the pack and other information

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

BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth and gums.
BENACTIV GOLA is used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), including those occurring after conservative or surgical dental procedures (e.g. dental caries treatment or tooth extraction).
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).

2. What you should know before taking BENACTIV GOLA

Do not take BENACTIV GOLA

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 BENACTIV GOLA”);
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 separate 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 BENACTIV GOLA during the last 3 months of pregnancy (see section “Pregnancy, breastfeeding
and fertility”).
Do not give BENACTIV GOLA Spray and Mouthwash to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking BENACTIV GOLA.
In particular, inform your doctor if:

you have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of developing 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 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 analgesics for a long time or without following the recommended dosage, as this may cause headache;
you have previously suffered from peptic ulcer (stomach lesion) or other stomach and intestinal diseases, as this increases the risk of recurrence. 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”);
if you are elderly (as you are more likely to experience side effects);
if you have heart or blood vessel problems, as medicines like BENACTIV GOLA may be associated with a small increased 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 BENACTIV GOLA and do not take it for extended 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.

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 increase the risk of
complications. If you take this medicine during an infection and infection symptoms persist or
worsen, consult your doctor or pharmacist immediately.
Inform your doctor of 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, if
necessary, will initiate appropriate therapy.
If you experience mouth irritation, discontinue treatment.
Children and adolescents
Do not give BENACTIV GOLA Spray and Mouthwash to children under 12 years of age.
Other medicines and BENACTIV GOLA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Inform your doctor if you are taking any of the following medicines:

Aspirin and medicines containing acetylsalicylic acid (medicines used 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 they increase the risk of gastrointestinal bleeding;
anticoagulants (medicines that slow down or inhibit blood clotting, such as warfarin), because their effect may be enhanced by NSAIDs;
selective serotonin reuptake inhibitors (medicines used for depression), as they increase the risk of gastrointestinal bleeding;
antihypertensive medicines (ACE inhibitors, angiotensin II antagonists and diuretics), because 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), because NSAIDs may worsen heart failure and increase blood levels of cardiac glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of gastrointestinal lesions or bleeding;
lithium (a medicine used for behavioral disorders), because blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis and cancer), because blood levels of methotrexate 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), because NSAIDs may increase the risk of seizures;
tacrolimus (an immunosuppressive medicine used after organ transplantation), because NSAIDs may increase the risk of renal toxicity;
zidovudine (a medicine used for AIDS), because NSAIDs increase the risk of blood toxicity;
Cox-2 inhibitors and other NSAIDs (medicines used for inflammation and pain), because this may enhance their effects and increase the risk of side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether
the same risk applies to Benactiv Gola.
Do not take Benactiv Gola during the last three months of pregnancy. Do not take Benactiv Gola during the first 6 months of
pregnancy unless strictly necessary and under medical advice. If treatment is necessary during this period, you should take the lowest effective dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding 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 your chances of becoming pregnant. However, consult your doctor if you have fertility problems before taking this medicine.
Driving and using machines
This medicine does not impair the ability to drive or use machinery.
BENACTIV GOLA Mouthwash and BENACTIV GOLA Oral Spray contain hydrogenated castor oil-40-polyoxylated, parahydroxybenzoates, peppermint essence (containing d-limonene)
Hydrogenated castor oil-40-polyoxylated: may cause localized skin reactions.
Parahydroxybenzoates: may cause allergic reactions (including delayed reactions).
D-limonene: may cause allergic reactions.
Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose, i.e. essentially “sodium-free”.

3. How to take BENACTIV GOLA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
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).
Warning: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
Oral rinse
The recommended dose is 2–3 mouth rinses or gargles per day (hold in the mouth for up to 1 minute).
You may use the oral rinse:

undiluted (without diluting with water): use 10 ml (1 measuring cup) of oral rinse
diluted: pour 10 ml (1 measuring cup) of oral rinse into half a glass of water.

When used at the recommended doses, accidental ingestion is unlikely to cause harm, although ingestion of the product should be avoided.
Oromucosal spray
The recommended dose is 2 sprays, 3 times daily.
Spray the solution directly onto the affected area (mouth, throat). Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of flurbiprofen.
If you are elderly or have previously suffered from stomach ulcer
If you are elderly or have previously had peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher, and the risk of developing stomach or intestinal ulcers, bleeding or perforation is increased (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give BENACTIV GOLA Spray or Oral Rinse to children under 12 years of age.
Duration of treatment
Use BENACTIV GOLA only for short-term treatment, not exceeding 7 days. If no noticeable improvement occurs after 3 days of treatment, the cause may be a different medical condition; in this case, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
If you take more BENACTIV GOLA than you should
If you accidentally ingest/overdose on BENACTIV GOLA, contact your doctor immediately or go to the nearest hospital.
If a large amount of flurbiprofen is accidentally ingested, you may experience symptoms such as: nausea, vomiting, irritation of the stomach or intestine, stomach ache, or rarely diarrhea.
Other possible symptoms include tinnitus (ringing in the ears), headache, and gastrointestinal bleeding. In such cases, the doctor will initiate appropriate treatment.
If you forget to take BENACTIV GOLA
Do not take a double dose to make up for the forgotten dose.
If you stop using BENACTIV GOLA
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects while taking BENACTIV GOLA, STOP treatment
and contact your doctor immediately:

allergic reactions (sensitisation reactions): or allergic reaction, or anaphylactic reactions (severe allergic reactions), or angioedema (sudden swelling of the mouth/throat and mucous membranes)
local irritation
sensation of warmth or tingling in the mouth and throat (this effect may occur with the tablets)
respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

If you experience any of the following side effects at the beginning of treatment with BENACTIV GOLA, 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 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:

Common (may affect up to 1 in 10 people)

dizziness;
headache;
paraesthesia (numbness of limbs or other body parts, including the mouth);
throat irritation;
diarrhoea;
mouth sores;
nausea;
mouth and throat pain;
sensation of warmth or burning, tingling of the mouth.

Uncommon (may affect up to 1 in 100 people)

drowsiness;
asthma;
bronchospasm (narrowing of the airways causing severe breathing difficulty due to reduced airflow);
dyspnoea (shortness of breath);
blisters in the mouth or throat;
numbness of mouth or throat;
abdominal distension;
abdominal pain;
constipation;
dry mouth;
indigestion;
flatulence (passing gas from the intestine);
inflammation of the tongue, including pain and burning of the tongue;
taste disturbances;
vomiting;
skin rash;
itching;
fever;
pain;
insomnia.

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

anaphylactic reactions (severe allergic reaction).

Frequency not known (cannot be estimated from the available data)

anaemia (reduction in the number 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)
cerebrovascular events (diseases caused by impaired blood flow to an area of the brain)
visual disturbances
optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
migraine (chronic condition characterised by recurrent headaches)
confusion
dizziness
angioedema (inflammatory reaction of the skin)
hypersensitivity
tinnitus (ringing in the ears)
heart failure
oedema (swelling)
hypertension (high blood pressure)
blood in the stools
blood in the vomit
bleeding from the stomach and intestine
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
inflammation of the stomach lining (gastritis)
stomach lesion (peptic ulcer)
gastric perforation
bleeding due to stomach lesion
urticaria (red, itchy skin rashes)
purpura (appearance of purplish skin patches of varying sizes)
bullous dermatoses (severe skin lesions characterised by erythema, blistering and 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 kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function)
malaise
fatigue
hepatitis
depression
hallucination.

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 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 stated on the packaging after “Exp” or “Expiry”.
The expiry date refers to the last day of that month.
Oral rinse/Spray for oral mucosa
No special storage conditions are required.
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 BENACTIV GOLA contains
Throat rinse

The active substance is: flurbiprofen (1 ml of mouthwash contains 2.5 mg of flurbiprofen)
The other components are: glycerol, ethanol (96 percent), sorbitol 70, castor oil hydrogenated-40- polyoxyethylenated, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, sodium saccharin, peppermint essence (containing d-limonene), patent blue V (E131), purified water (see section “BENACTIV GOLA Throat rinse and BENACTIV GOLA Oral mucosa spray contain castor oil hydrogenated-40-polyoxyethylenated, parahydroxybenzoates, peppermint essence (containing d-limonene)”).

Oral mucosa spray

The active substance is: flurbiprofen (1 ml of solution contains 2.5 mg of flurbiprofen)
The other components are: glycerol, ethanol (96 percent), sorbitol 70, castor oil hydrogenated-40- polyoxyethylenated, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium hydroxide, sodium saccharin, peppermint essence (containing d-limonene), patent blue V (E131), purified water (see section “BENACTIV GOLA Throat rinse and BENACTIV GOLA Oral mucosa spray contain castor oil hydrogenated-40-polyoxyethylenated, parahydroxybenzoates, peppermint essence (containing d-limonene)”).

Description of the appearance of BENACTIV GOLA and package contents
Throat rinse
BENACTIV GOLA Throat rinse is a clear blue solution, contained in a 160 ml amber glass bottle. The package includes a 10 ml measuring cup.
Oral mucosa spray
BENACTIV GOLA Oral mucosa spray is a clear blue solution, contained in a 15 ml amber glass bottle equipped with a spray valve.
Not all pack sizes may be marketed.

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

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

Package leaflet: Information for the user

BENACTIV GOLA 8.75 mg Lozenge Lemon and Honey Flavour, Sugar-Free Orange Flavour

flurbiprofen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If you experience any side effect, 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 of treatment.

Contents of this leaflet:

What BENACTIV GOLA is and what it is used for
What you need to know before taking BENACTIV GOLA
How to take BENACTIV GOLA
Possible side effects
How to store BENACTIV GOLA
Contents of the pack and other information

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

BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine, which acts against inflammation and pain in the throat, mouth and gums.
BENACTIV GOLA Lemon and Honey Flavour Lozenges and BENACTIV GOLA Sugar-Free Orange Flavour Lozenges are used in adults and adolescents over 12 years of age for the treatment of symptoms of pain and irritation affecting the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).
BENACTIV GOLA Sugar-Free Orange Flavour Lozenges are indicated if you and/or the adolescent need to control sugar and calorie intake.
Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).

2. What you should know before taking BENACTIV GOLA

Do not take BENACTIV GOLA

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 BENACTIV GOLA”);
if you have previously experienced stomach or intestinal bleeding or perforation related to previous 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 separate 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 BENACTIV GOLA during the last 3 months of pregnancy (see section “Pregnancy, breastfeeding
and fertility”).
Do not give BENACTIV GOLA tablets to children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking BENACTIV GOLA.
In particular, inform your doctor if you:

have previously suffered from bronchial asthma (a respiratory disease), as this increases the risk of developing bronchospasm (narrowing of the airways causing severe breathing difficulties due to reduced airflow);
have previously suffered from allergies;
are currently 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 analgesics for a long time or without following the recommended dosage, as this may lead to headache;
have previously suffered from peptic ulcer (stomach lesion) or other stomach or 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”);
if you are elderly (as you are more likely to experience side effects);
if you have heart or blood vessel problems, as medicines such as 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 higher doses and prolonged treatment; do not exceed the recommended dose of BENACTIV GOLA and do not take it for extended 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);
have an infection – refer to the section “Infections” below.

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, thereby increasing the risk of complications. If you take this medicine during an infection and infection symptoms persist or worsen, contact your doctor or pharmacist immediately.
Inform your doctor of any unusual abdominal symptoms.
Prolonged use of this medicine, especially if prolonged, may cause allergic reactions or local irritation (see section 4 “Possible side effects”); in such cases, discontinue treatment and consult your doctor, who will, if necessary, initiate appropriate therapy.
If you experience mouth irritation, discontinue treatment.

Children and adolescents
Do not give BENACTIV GOLA tablets to children under 12 years of age.

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

Aspirin and 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 they increase 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 they increase 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 blood levels of cardiac glycosides;
cyclosporine (a medicine used to prevent organ transplant rejection), as it increases the risk of renal toxicity;
corticosteroids (medicines used for inflammation/allergies), as they increase the risk of stomach or intestinal lesions or bleeding;
lithium (a medicine used for behavioral disorders), as blood levels of lithium may increase;
methotrexate (a medicine used for psoriasis, arthritis and cancer), as blood levels of methotrexate 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 their effects and the risk of side effects may be increased.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Oral formulations (e.g. tablets) of flurbiprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies to Benactiv Gola.
Do not take Benactiv Gola during the last three months of pregnancy. Do not take Benactiv Gola during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period, take the lowest effective dose for the shortest possible time.
Breastfeeding
The use of flurbiprofen during breastfeeding 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 this medicine.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

BENACTIV GOLA Lemon and Honey Flavour Tablets contain liquid sucrose, liquid glucose (containing
sulphites and wheat starch), honey (invert sugar), lemon flavour and levomenthol (containing
butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol and linalool)
Liquid sucrose, liquid glucose and honey (invert sugar): If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. This medicine contains 1.07 g of glucose and 1.41 g of sucrose per tablet. This should be considered in patients with diabetes mellitus.
Sulphites: Rarely may 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 problems if you have coeliac disease. One tablet contains no more than 21.38 micrograms of gluten. If you are allergic to wheat (a condition different from coeliac disease), do not take this medicine.
Citral, citronellol, d-limonene, farnesol, geraniol and linalool: May cause allergic reactions.
Butylated hydroxyanisole: May cause localized skin reactions (e.g. contact dermatitis) or irritation to eyes and mucous membranes.

BENACTIV GOLA Sugar-Free Orange Flavour Tablets contain liquid maltitol (E965), isomalt (E953), orange flavour and levomenthol (containing citral, citronellol, d-limonene, geraniol, linalool)
Liquid maltitol (E965), isomalt (E953): If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. 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: May cause allergic reactions.

3. How to take BENACTIV GOLA

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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).
Warning: Do not exceed the recommended doses without medical advice.
Adults and adolescents over 12 years of age
The recommended dose is 1 tablet every 3–6 hours as needed. Do not exceed 8 tablets in 24 hours.
Allow the tablet to dissolve slowly in the mouth.
If you are elderly or have previously suffered from stomach ulcer
If you are elderly or have previously suffered from peptic ulcer (stomach lesion), it is advisable to use the lowest recommended dose, as the risk of serious consequences from adverse effects is higher, and the risk of developing stomach or intestinal ulcers, bleeding, or perforation is increased (see section 4 “Possible side effects”).
Use in children and adolescents
Do not give BENACTIV GOLA Tablets to children under 12 years of age.
Duration of treatment
Use BENACTIV GOLA only for short-term treatment, not exceeding 7 days. If no significant improvement is observed after 3 days of treatment, the cause may be a different medical condition; in this case, consult your doctor.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
If you take more BENACTIV GOLA than you should
If you accidentally ingest an excessive dose of BENACTIV GOLA, contact your doctor immediately or go to the nearest hospital.
In case of accidental ingestion of large amounts of flurbiprofen, you may experience symptoms such as: nausea, vomiting, irritation of the stomach or intestines, stomach pain, or rarely diarrhea.
Other possible symptoms include tinnitus, headache, and gastrointestinal bleeding. In such cases, the doctor will initiate appropriate treatment.
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 questions 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 any of the following side effects during treatment with BENACTIV GOLA, STOP the treatment
and contact your doctor immediately:

allergic phenomena (sensitization reactions), or allergic reaction, or anaphylactic reactions (severe allergic reactions), or angioedema (sudden swelling of the mouth/throat and mucous membranes)
local irritation
sensation of heat or tingling in the mouth and throat (this effect may occur with the tablets)
respiratory events: asthma, bronchospasm, breathlessness or shortness of breath
various skin disorders: skin rashes of different types, itching, redness, swelling, skin peeling, blisters, desquamation or ulceration of the skin and mucous membranes.

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

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

In addition, you may experience the following side effects:
Common (may affect up to 1 in 10 people)

dizziness;
headache;
paresthesia (numbness of limbs or other body parts, including the mouth);
throat irritation;
diarrhea;
mouth lesions;
nausea;
mouth and throat pain;
sensation of warmth or burning, mouth tingling.

Uncommon (may affect up to 1 in 100 people)

drowsiness;
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;
abdominal distension;
abdominal pain;
constipation;
dry mouth;
indigestion;
flatulence (passing intestinal gas);
inflammation of the tongue, including tongue pain and burning;
taste disturbances;
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 the available data)

anemia (reduced number of red blood cells in the blood)
thrombocytopenia (reduced number of platelets in the blood)
aplastic anemia (reduction in all types of blood cells: red blood cells, white blood cells, platelets)
agranulocytosis (reduced number of granulocytes, a type of white blood cell, in the blood)
cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
visual disturbances
optic neuritis (severe inflammation of the optic nerve, which may lead to vision loss up to blindness)
migraine (chronic disorder characterized by recurrent headaches)
confusion
vertigo
angioedema (inflammatory skin reaction)
hypersensitivity
tinnitus (ringing in the ears)
heart failure
edema (swelling)
hypertension (high blood pressure)
blood in stool
blood in vomit
bleeding from stomach and intestine
colitis
worsening of inflammatory bowel diseases (Crohn's disease)
inflammation of the stomach lining (gastritis)
stomach lesion (peptic ulcer)
gastric perforation
bleeding due to stomach lesion
urticaria (reddened, itchy skin patches)
purpura (appearance of purple-colored skin patches of varying sizes)
bullous dermatoses (severe skin lesions characterized by erythema, blistering and 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 kidney glomeruli leading to protein loss in urine)
renal failure (reduced kidney function)
malaise
fatigue
hepatitis
depression
hallucination.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You may also report side effects directly via 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 stated on the packaging after "Exp" or "Expiry".
The expiry date refers to the last day of that month.
Store below 25°C.
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 BENACTIV GOLA contains
Lozenge Lemon and Honey flavour

The active substance is: flurbiprofen 8.75 mg
The other components are: liquid sucrose, liquid glucose (containing sulphites and wheat starch), honey, macrogol 300, potassium hydroxide, lemon flavour and levomenthol (containing butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol and linalool) (see section “BENACTIV GOLA Lemon and Honey Flavour Lozenges contain liquid sucrose, liquid glucose (containing sulphites and wheat starch), honey (invert sugar), lemon flavour and levomenthol (containing butylated hydroxyanisole, citral, citronellol, d-limonene, farnesol, geraniol and linalool)”.

Sugar-free Orange flavour lozenges

The active substance is: flurbiprofen 8.75 mg
The other components are: macrogol 300, potassium hydroxide, orange flavour and levomenthol (containing citral, citronellol, d-limonene, geraniol, linalool), acesulfame potassium (E950), liquid maltitol, isomalt (E953) (see section “BENACTIV GOLA Sugar-free Orange Flavour Lozenges contain liquid maltitol, isomalt (E953), orange flavour 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 Flavour Lozenges are yellow to brown, round lozenges, supplied in blisters of 16, 24 or 36 lozenges.
BENACTIV GOLA Sugar-free Orange Flavour Lozenges are white to pale yellow, round lozenges, supplied 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, Italy.

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