ASPIGOLADOLACT 8.75 MG/DOSE SPRAY FOR ORAL MUCOSA 1 HDPE BOTTLE OF 15 ML

Name
Aspigoladolact 8.75 mg/dose Oral spray, solution
Flurbiprofen
Equivalent medicine


What is it and what is it for?
Aspigoladolact contains the active ingredient flurbiprofen. Flurbiprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain, swelling, and fever.

Aspigoladolact is indicated for short-term treatment to relieve the symptoms of sore throat, 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 Aspigoladolact if:
• You are allergic to flurbiprofen, or to other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as aspirin (acetylsalicylic acid) or to any of the other ingredients listed in section 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 rash, swelling.
• You have or have had 2 or more episodes of stomach ulcers or bleeding or intestinal ulcers.
• Have you ever had severe colitis (inflammation of the bowel).
• Have you 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").
• 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 have tonsillitis (inflammation of the tonsils) or think you have bacterial inflammation of the throat (as you may need to take antibiotics).
• have an infection – see “Infections” below.
• You are elderly (as you are more likely to experience side effects).
• Have or have had episodes of asthma or suffer from allergies.
• You suffer from systemic lupus erythematosus or mixed connective tissue disease.
• Suffers from hypertension (high blood pressure).
• Has intestinal diseases (ulcerative colitis, Crohn's disease).
• Have heart, kidney or liver problems.
• He had a stroke.
• She is in the first 6 months of pregnancy or is breastfeeding.

While using Aspigoladolact
• At the first sign of any skin reaction (rash, peeling, blisters) or other evidence of an allergic reaction, stop using the spray immediately and consult a doctor immediately.
• Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• Talk to your doctor if you notice no improvement or if you notice worsening or if you develop new symptoms.
• Drugs such as flurbiprofen may be associated with a small 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
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.

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 any of the following side effects occur, STOP TAKING Aspigoladolact and tell your doctor immediately:
• severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (these are rare conditions due to serious adverse reactions to treatment or to 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 which may cause shock (these side effects can occur even when you first use 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, blistering, 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 rash. Frequency: Uncommon (may affect up to 1 in 100 people)

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

Common (may affect up to 1 in 10 people)
- dizziness, headache
- throat irritation
- mouth ulcers, pain or numbness in the mouth
- sore throat
- discomfort in the mouth (sensation of heat or burning, tingling)
- nausea and diarrhea
- 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 sense of taste
- fever, pain
- feeling drowsy or having difficulty falling asleep
- worsening of asthma, wheezing, shortness of breath
- reduced sensitivity in the throat

Not known (frequency cannot be estimated from the available data)
- anemia, thrombocytopenia (low blood platelet count which can cause bruising and bleeding)
- swelling (edema), high blood pressure, heart failure or heart attack
- hepatitis (liver inflammation)

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.