ASPIGOLADOLACT*SPRAY 15ML

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 to relieve sore throat symptoms such as throat inflammation, pain, difficulty swallowing, and swelling for short-term treatment for adults aged 18 years and older.

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 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, rash, swelling;
• You have or have had 2 or more episodes of gastric ulcers or bleeding or intestinal ulcers;
• Have you ever had severe colitis (inflammation of the intestine);
• Have you ever had blood clotting or bleeding problems after taking NSAIDs;
• You are in the last 3 months of pregnancy;
• 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 bacterial inflammation of the throat (as you may need to take antibiotics);
• You are elderly (since more likely to experience side effects);
• You have or have had episodes of asthma or suffer from allergies;
• Suffer from systemic lupus erythematosus or mixed connective tissue disease;
• You suffer from hypertension (high blood pressure);
• Has intestinal diseases (ulcerative colitis, Crohn's disease);
• You have heart, kidney or liver problems;
• Have had a stroke;
• And in the first 6 months of pregnancy or are breastfeeding;

While using Aspigoladolact
• At the first symptom of any skin reaction (rash, scaling, 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;
• Talk to your doctor if you don't feel better or if you feel worse or if you develop new symptoms;
• Drugs such as flurbiprofen may be associated with a modest increase in the 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).

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 (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 which causes difficulty in breathing, rapid heartbeat, drop in blood pressure which may cause shock (these side effects may occur even the first time you use the medicine) . Frequency: Rare (may affect up to 1 in 1000 people);
• signs of hypersensitivity and skin reactions (rashes) such as redness, swelling, cracking of the skin, blistering, scaling or ulceration of the skin and mucous membranes. Frequency: Uncommon (may affect Aspigoladolact f.ill 1 to 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 some 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;
- throat pain;
- 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 in the mouth;
- abdominal swelling, abdominal pain, flatulence, constipation, indigestion, malaise;
- dry mouth;
- burning sensation in the mouth, alteration of the sense of taste;
- fever, pain;
- feeling drowsy or difficulty falling asleep;
- worsening of asthma, wheezing, shortness of breath;
- reduced sensitivity of the throat;

Not known (frequency cannot be estimated from the available data)
- anemia, thrombocytopenia (lowering of platelet counts in the blood which 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, talk to your doctor or pharmacist, including any not listed in this leaflet. 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.