ASPIGOLADOL*16PASTL 8.75MG

What it is and what it is used for
Aspigoladol contains the active ingredient flurbiprofen. Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) which have analgesic and anti-inflammatory properties in the treatment of sore throat. These medicines work by changing the way the body responds to pain, swelling, and high temperatures.

Aspigoladol is used for the short-term treatment of symptoms of throat pain and inflammation, such as sore throat, pain and swelling, and difficulty swallowing, in adults and adolescents over 12 years of age.

Talk to your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
Do not take Aspigoladol
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in section 6);
- if you have had asthma, wheezing or difficulty breathing, runny nose, swelling of the face or itchy skin rash (hives) after taking acetylsalicylic acid or similar substances used to treat pain, inflammation or rheumatism, called non-anti-inflammatory medicines steroids (NSAIDs);
- if you have or have had two or more episodes of gastric or intestinal ulcer;
- if you have or have had gastric or intestinal bleeding or perforation, severe colitis (inflammation of the intestine) or blood disorders after using another NSAID;
- if you suffer from heart, liver or kidney failure;
- if you are in the last trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspigoladol if:
- are using other NSAIDs or corticosteroids (such as celecoxib, ibuprofen, diclofenac or prednisolone) to treat pain, inflammation or rheumatism, since this may increase the risk of adverse events, in particular adverse events affecting the stomach and intestines such as ulcers and hemorrhage;
- have or have had asthma or suffer from allergies;
- have heart, liver or kidney problems;
- have had a stroke;
- have a history of gastric or intestinal diseases (ulcerative colitis, Crohn's disease);
- suffer from hypertension;
- have tonsillitis (swelling of the tonsils) or think you have a bacterial throat infection (because you may need antibiotics);
- have a chronic autoimmune disease (including systemic lupus erythematosus or mixed connective tissue disease).

Elderly people
Older people are more likely to experience the side effects listed in this leaflet.

Children
Do not give this medicine to children under 12 years of age.

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

STOP TAKING this medicine, contact a doctor or go to the nearest hospital straight away if you develop:
- signs of allergic reactions such as asthma, unexpected wheezing or difficulty breathing, itching, runny nose, skin rashes;
- swelling of the face, tongue or throat causing difficulty in breathing, tachycardia and drop in blood pressure leading to shock (these events can also occur the first time the medicine is used);
- serious skin reactions such as redness, swelling, peeling, blistering, flaking of the skin or ulceration of the skin and mucous membranes.

Talk to your doctor or pharmacist if you experience any of the following or any other effects not described:

Municipalities ( may affect 1 in 10 people )
- dizziness, headache
- throat irritation
- mouth ulcers or mouth pain
- pain in the throat
- feeling uncomfortable or unusual sensation in the mouth (such as warmth, burning, tingling, stinging)
- nausea and diarrhea
- sensation of tingling and itching of the skin

Uncommon ( may affect up to 1 in 100 people )
- drowsiness
- feeling drowsy or difficulty falling asleep
- worsening of asthma, wheezing, difficulty breathing
- blistering in the mouth or throat, feeling of numbness in the throat - dry mouth
- burning sensation in the mouth, altered sense of taste
- abdominal pain, bloated stomach, flatulence, constipation, poor digestion, vomiting
- reduction of throat sensitivity
- fever, pain
- skin rashes, itching

Rare ( may affect 1 in 1000 people )
- anaphylactic reaction

Frequency not known ( cannot be estimated from the available data )
- anemia, thrombocytopenia (low number of platelets in the blood which can cause bruising and bleeding)
- swelling (edema), high blood pressure, heart failure or heart attack
- severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis
- 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.