BENACTIVDOLMED*SPRAY 15ML

Benactivdolmed 8.75 mg/dose Oral spray, solution
Flurbiprofen

What it is and what it is used for
The active ingredient is flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs), which work by altering the body's response to pain, swelling, and fever.

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

What you need to know before taking the medicine
Do not use Benactivdolmed if:
• you are allergic to flurbiprofen, or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs), aspirin (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 aspirin (acetylsalicylic acid); e.g. asthma, wheezing, itching, runny nose, rashes, swelling.
• you currently have or have had two or more episodes of stomach 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.
• you are a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Benactivdolmed if:
• you are already taking other Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or aspirin.
• you suffer from tonsillitis (inflamed tonsils) or think you may have a bacterial throat infection (as you may need to take antibiotics).
• you have an infection - refer to the Infections section 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 a skin problem called systemic lupus erythematosus or mixed connective tissue disease.
• you suffer from hypertension (high blood pressure).
• you have had 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 are breastfeeding.

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, contact your doctor or pharmacist immediately.

While using Benactivdolmed
• At the first sign of any skin reaction (rash, peeling, blistering) or other signs of an allergic reaction, stop using the spray and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• Talk to your doctor if you do not notice any improvement or if you notice a worsening, or if you develop new symptoms.
• Medicines such as Flurbiprofen may be associated with a modest increased risk of heart attack or stroke. Any risk is more likely with higher doses or prolonged treatment.
Do not exceed the recommended dose or duration of treatment (see paragraph 3).

Children and adolescents
This medicine should not be used in children or 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 this medicine and contact your doctor immediately:
• severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (rare medical conditions due to severe adverse reactions to treatment or an infection in which there is a severe skin and mucous membrane reaction). 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 leading to shock (these effects can also occur with the first use of the medicine). Frequency: rare (may affect up to 1 in 1,000 people).
• signs of hypersensitivity and skin reactions such as redness, swelling, 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).

Tell your doctor or pharmacist if you notice any of the following effects or any other effect not listed:

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

Uncommon (may affect up to 1 in 100 people)
• drowsiness
• blisters in the mouth or throat, numbness of the throat
• bloated stomach, abdominal pain, flatulence, constipation, indigestion, malaise
• dry mouth
• burning sensation in the mouth, altered taste
• fever, pain
• feeling drowsy 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)
• anemia, thrombocytopenia (decrease in blood platelet count that can cause bruising and bleeding)
• swelling (edema), high blood pressure, heart failure or heart attack
• hepatitis (inflammation of the liver)

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.