BENACTIV GOLA*SPRAY 15ML 0.25%

BENACTIV GOLA 2.5 mg/ml Mouthwash
BENACTIV GOLA 2.5 mg/ml Oral Mucosal Spray
flurbiprofen

What it 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 is used in adults and adolescents over 12 years of age to treat symptoms of pain and irritation of the gums, mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), including as a result of conservative or extractive dental therapy (e.g., dental fillings or tooth extraction).

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

What you need to know before taking the medicine
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 (medicine for inflammation, pain, fever and heart disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section Other medicines and BENACTIV GOLA);
- if you have a history of 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 frequently suffer from peptic ulcers (stomach lesions) 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 take/give BENACTIV GOLA in 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
Consult your doctor or pharmacist before taking BENACTIV GOLA.

In particular, inform your doctor if you:
- have suffered from bronchial asthma (a respiratory disease) in the past, as this increases the risk of bronchospasm (narrowing of the bronchi causing severe respiratory distress due to reduced airflow);
- have suffered from allergies in the past;
- 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 analgesics for a long time or without respecting the dosage, as headaches may occur;
- have suffered from peptic ulcers (stomach lesions) and other stomach and intestinal diseases in the past, as this increases the risk of these diseases recurring.
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);
- if you have heart or blood vessel problems, as medicines like BENACTIV GOLA may be associated with a modest 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 GOLA and do not take 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);
- have an infection - refer to the Infections section 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 take this medicine during an infection and the infection symptoms persist or worsen, consult your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, can give rise to allergic phenomena or local irritation (see section 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will carry out appropriate therapy.

If you experience mouth irritation, stop 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 being treated with BENACTIV GOLA, STOP treatment and contact your doctor immediately:
• allergic phenomena (sensitisation phenomena):
     - allergic reaction
     - anaphylactic reactions (severe allergic reactions)
     - angioedema (sudden swelling of the mouth/throat and mucous membranes)
• local irritation
• sensations of warmth or tingling in the mouth and throat (this effect may occur with lozenges)
• respiratory phenomena: asthma, bronchospasm, shortness of breath or dyspnoea
• various skin disorders: skin rashes of different types, itching, redness, swelling, skin shedding, blisters, peeling 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 (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 a history of stomach and 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 the limbs or other parts of the body, including the mouth);
- throat irritation;
- diarrhoea;
- lesions inside the mouth;
- nausea;
- mouth and throat pain;
- sensation of warmth or burning, tingling of the mouth.

Uncommon (may affect up to 1 in 100 people)
- somnolence;
- asthma;
- bronchospasm (narrowing of the bronchi causing severe respiratory distress due to reduced airflow);
- dyspnoea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat;
- abdominal distension;
- abdominal pain;
- constipation;
- dry mouth;
- indigestion;
- flatulence (passing gas from the intestine);
- tongue inflammation, including tongue pain and burning;
- 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 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 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 lack of 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 characterised by recurrent headaches)
- confusion
- vertigo
- angioedema (inflammatory skin reaction)
- hypersensitivity
- tinnitus (ringing in the ears)
- heart failure
- oedema (swelling)
- hypertension (high blood pressure)
- blood in stools
- blood in vomit
- bleeding from the stomach and intestines
- 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 (skin redness accompanied by itching)
- purpura (appearance of purplish skin patches of various sizes)
- bullous dermatoses (severe skin lesions characterised by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme
- renal toxicity
- tubulointerstitial nephritis (kidney inflammation)
- nephrotic syndrome (alteration of renal glomeruli leading to protein loss in urine)
- kidney failure (reduced kidney function)
- discomfort
- fatigue
- hepatitis
- depression
- hallucination.

Reporting of side effects
If you get 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.