ASPIGOLADOL*16LOZ 8.75MG

Aspigoladol 8.75 mg orange flavored lozenges
flurbiprofen

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 pain and inflammation symptoms of the throat such as sore throat, pain and swelling, and difficulty swallowing, in adults and adolescents over 12 years of age.

Consult 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 use Aspigoladol
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have had asthma, wheezing or difficulty breathing, runny nose, facial swelling or itchy rash (urticaria) after taking acetylsalicylic acid or similar substances used to treat pain, inflammation or rheumatism, called non-steroidal anti-inflammatory drugs (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 three months of pregnancy.

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

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

Children
Do not administer 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 immediately or go to the nearest hospital 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 breathing, tachycardia and a drop in blood pressure leading to shock (these events can also occur on the first use of the medicine);
- severe skin reactions such as redness, swelling, peeling, blistering, skin exfoliation or ulceration of the skin and mucous membranes.

Talk to your doctor or pharmacist if you experience any of the following effects or any other unlisted effects:
Common (may affect 1 in 10 people)
- dizziness, headache
- throat irritation
- mouth ulcers or mouth pain
- sore throat
- feeling of discomfort or unusual sensation in the mouth (such as heat, burning, tingling, stinging)
- nausea and diarrhea
- tingling and itching of the skin

Uncommon (may affect 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, indigestion, vomiting
- reduced 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 platelet count in the blood which can cause bruising and bleeding)
- swelling (edema), hypertension, 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, 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.