BENACTIV THROAT "0.25% SPRAY FOR ORAL MUCOSA" 15 ML BOTTLE"

Name
BENACTIV THROAT 2.5 mg/ml Mouthwash
BENACTIV GOLA 2.5 mg/ml Spray for oral mucosa
flurbiprofen


What is it and what is it used for?
BENACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (painkiller) medicine, which acts against inflammation and pain in the throat, mouth and gums.

BENACTIV GOLA is used in adults and adolescents over 12 years of age to treat the symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), also following conservative or extractive dental therapy (e.g. caries treatment or tooth extraction).

Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 3).


What you need to know before taking the medicine
Do not take BENACTIV THROAT
- 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 used to treat inflammation, pain, fever and heart problems) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section "Other medicines and BENACTIV THROAT");
- if you have suffered in the past 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 bowel diseases (ulcerative colitis and Crohn's disease);
- if you suffer frequently from peptic ulcer (stomach ulcer) or bleeding from 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 renal 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 THROAT.

In particular, tell your doctor if you:
- have suffered from bronchial asthma (a breathing disease) in the past, as this increases the risk of developing bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- has suffered from allergies in the past;
- are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- suffers from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic failure);
- suffer from hypertension (high blood pressure);
- you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
- have suffered from peptic ulcers (stomach ulcers) and other stomach and intestinal diseases in the past, 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 your 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);
- if you have heart or blood vessel problems, as medicines like BENACTIV THROAT may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatment; do not exceed the dose of BENACTIV THROAT or take it for long periods. Tell your doctor if you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke);
- have an infection – see “Infections” below.

Infections
Nonsteroidal 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, may increase the risk of complications. If you take this medicine during an infection and the symptoms persist or worsen, contact your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.

Use of this medicine, especially if prolonged, may give rise to allergic reactions or local irritation (see section 4 "Possible side effects"); in such cases, discontinue treatment and consult your doctor who, if necessary, will perform 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.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following side effects while taking BENACTIV THROAT, STOP the treatment and contact your doctor immediately:
• allergic phenomena (sensitization phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- 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 tablets)
• respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
• various skin disorders: 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 start 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 especially likely if you are elderly or have a history of stomach or intestinal diseases.

Additionally, you may experience the following side effects:

Common (may affect up to 1 in 10 people)
- dizziness;
- headache (headache);
- paresthesia (numbness of the limbs or other parts of the body, including the mouth);
- throat irritation;
- diarrhea;
- lesions inside the mouth;
- nausea;
- sore mouth and throat;
- sensation of heat or burning, tingling in the mouth.

Uncommon (may affect up to 1 in 100 people)
- drowsiness;
- asthma;
- bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- dyspnea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat;
- abdominal distension;
- stomach pain;
- constipation;
- dry mouth;
- difficulty digesting;
- flatulence (emission of gas from the intestine);
- inflammation of the tongue, including pain and burning of the tongue;
- alteration of taste;
- vomit;
- 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 (reduction in the amount 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 cell, in the blood)
- cerebrovascular accidents (diseases caused by a lack of blood flow to an area of ​​the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to vision loss and even blindness)
- migraine (chronic disease 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 the stool
- blood in vomit
- loss of blood from the stomach and intestines
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- inflammation of the stomach lining (gastritis)
- stomach injury (peptic ulcer)
- gastric perforation
- bleeding due to stomach injury
- hives (redness of the skin accompanied by itching)
- purpura (appearance of purple skin patches of varying sizes)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme
- renal toxicity
- tubulointerstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli which causes a loss of proteins in the urine)
- renal failure (reduced kidney function)
- unease
- fatigue
- hepatitis
- depression
- hallucination.

Reporting of side effects
If you experience any side effects, including any 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/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.