BENACTIVDOL THROAT*SPRAY15ML8.75

Benactivdol Gola 8.75 mg/dose Oral spray, solution
Flurbiprofen

What it is and what it is used for
Benactivdol Gola contains flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). These medicines work by changing the body's response to pain, swelling and fever.

Benactivdol Gola is indicated for the short-term relief of sore throat symptoms such as throat inflammation, pain, difficulty swallowing and swelling in adults aged 18 years and over.

What you need to know before taking the medicine
Do not use Benactivdol Gola if:
• You are allergic to flurbiprofen, or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs) such as acetylsalicylic acid or any of the excipients listed in paragraph 6.
• You have previously had allergic reactions after taking Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or acetylsalicylic acid; for example asthma, wheezing, itching, runny nose, skin rashes, swelling.
• You have or have had 2 or more episodes of gastric ulcers or bleeding or intestinal ulcers.
• You have ever had severe colitis (inflammation of the intestine).
• You have ever had blood clotting problems or bleeding problems after taking NSAIDs.
• You are in the last 3 months of pregnancy.
• You have severe heart, kidney or liver failure.
• Children and adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Benactivdol Gola, if:
• You are already taking other Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or acetylsalicylic acid.
• You suffer from tonsillitis (inflammation of the tonsils) or you think you have a bacterial throat infection (as antibiotics may be required).
• You have an infection - refer to the Infections paragraph below.
• You are elderly (as you are more likely to experience side effects).
• You have or have had episodes of asthma or suffer from allergies.
• You suffer from systemic lupus erythematosus or mixed connective tissue disease.
• You suffer from hypertension (high blood pressure).
• You have intestinal diseases (ulcerative colitis, Crohn's disease).
• You have heart, kidney or liver problems.
• You have had a stroke.
• You are in the first 6 months of pregnancy or if you are breastfeeding.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) may mask signs of infections such as fever and pain. This may delay appropriate treatment of the infection, which, in turn, may lead to an increased risk of complications. If you take this medicine during an infection and the infection symptoms persist or worsen, contact your doctor or pharmacist immediately.

During the use of Benactivdol Gola
• At the first symptom of any skin reaction (rash, peeling, blisters) or other evidence of an allergic reaction, immediately stop using the spray and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• Contact your doctor if you do not notice improvements or if you notice a worsening or if you develop new symptoms.
• Medicines like Flurbiprofen may be associated with a modest increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatments. Do not exceed the recommended dose or duration of treatment (see paragraph 3).

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

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

If you experience any of the following side effects, stop taking Benactivdol Gola and inform your doctor immediately:
• severe forms of skin reactions such as bullous reactions, including Steve-Johnson syndrome and toxic epidermal necrolysis (these are rare conditions due to severe adverse reactions to treatment or an infection in which there is a severe reaction of the skin or mucous membranes. Frequency: Not known (frequency cannot be estimated from the available data)
• signs of anaphylactic shock characterized by swelling of the face, tongue or throat causing difficulty breathing, rapid heartbeat, drop in blood pressure up to shock (side effects that can occur even with the first use of the medicine). Frequency: Rare (may affect up to 1 in 1,000 people).
• signs of hypersensitivity and skin reactions (rashes) such as redness, swelling, skin exfoliation, blisters, peeling or ulceration of the skin and mucous membranes. Frequency: Uncommon (may affect up to 1 in 100 people)
• signs of an allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rashes. Frequency: Uncommon (may affect up to 1 in 100 people)

If you experience any of the following side effects or any other side effect, tell your doctor or pharmacist:

Common (may affect up to 1 in 10 people)
• dizziness, headache
• throat irritation
• mouth ulcers, pain or numbness of the mouth
• sore throat
• oral discomfort (sensation of heat or burning, tingling)
• nausea and diarrhoea
• tingling and itching of the skin

Uncommon (may affect up to 1 in 100 people)
• drowsiness
• blisters in the mouth or throat, numbness of the mouth
• abdominal bloating, abdominal pain, flatulence, constipation, indigestion, malaise
• dry mouth
• burning sensation in the mouth, altered taste
• fever, pain
• feeling sleepy or difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• reduced sensitivity of the throat

Not known (frequency cannot be estimated from the available data)
• anaemia, thrombocytopenia (low platelet count in the blood that can cause bruising and bleeding)
• swelling (oedema), high blood pressure, heart failure or heart attack
• hepatitis (inflammation of the liver)

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