ASPIGOLADOLACT*SPRAY 15ML

Aspigoladolact 8.75 mg/dose Oral spray, solution
Flurbiprofen
Equivalent medicinal product

What it is and what it is used for
Aspigoladolact contains the active ingredient 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.

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

What you need to know before taking the medicine
Do not use Aspigoladolact if:
• You are allergic to flurbiprofen, or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as 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); 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 three months of pregnancy (see section Pregnancy, breastfeeding and fertility).
• You have severe heart, kidney or liver failure.

Warnings and precautions
Talk to your doctor or pharmacist before using Aspigoladolact if:
• You are already taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin.
• You suffer from tonsillitis (inflammation of the tonsils) or think you have a bacterial throat infection (as antibiotics may be needed).
• 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 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 are breastfeeding.

While using Aspigoladolact
• At the first sign of any skin reaction (rash, peeling, blistering) or other evidence of an allergic reaction, immediately stop using the spray and consult a doctor.
• 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 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 treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

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.

Children and adolescents
This medicine cannot 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 Aspigoladolact and tell your doctor immediately:
• severe forms of skin reactions such as bullous reactions, including Steven-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 skin or mucous membrane reaction). Frequency: Not known (frequency cannot be estimated from the available data).
• signs of anaphylactic shock characterised by swelling of the face, tongue or throat causing difficulty breathing, rapid heartbeat, drop in blood pressure which may cause shock (these side effects 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, cracking of the skin, blisters, peeling or ulceration of the skin and mucous membranes. Frequency: Uncommon (may affect up to 1 in 100 people).
• signs of 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, mouth pain or numbness
- sore throat
- mouth discomfort (warm or burning sensation, 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 sensation
- fever, pain
- feeling sleepy or difficulty falling asleep
- worsening of asthma, wheezing, shortness of breath
- reduced sensation in the throat

Not known (frequency cannot be estimated from the available data)
- anaemia, thrombocytopenia (decreased platelet count in the blood which 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 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.