ASPI GOLA*ORAL SPRAY 15ML 0.25%

ASPI GOLA 0.25% oral mucosa spray
Flurbiprofen

What it is and what it is used for
ASPI GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (pain-relieving) medicine that acts against inflammation and pain in the throat, mouth, and gums.

ASPI GOLA oral mucosa spray is used in adults and adolescents over 12 years of age for the treatment of pain symptoms and irritations of the gums, mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), also following conservative or extractive dental therapy (e.g., cavity treatment or tooth extraction).

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment (see paragraph 3).

What you need to know before taking the medicine
Do not use ASPI GOLA
- if you are allergic to flurbiprofen or any of the other ingredients of this medicine (listed in paragraph 6);
- if you are allergic to acetylsalicylic acid (medicine for inflammation, pain, fever, and heart conditions) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see paragraph Other medicines and ASPI GOLA);
- if you have a history of stomach or intestinal bleeding or perforation related to previous treatments with non-steroidal anti-inflammatory drugs (NSAIDs);
- if you suffer from chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
- if you frequently suffer from peptic ulcers (stomach lesions) or stomach or intestinal bleeding (two or more distinct episodes of ulcer or bleeding);
- if you suffer from severe heart failure (reduced heart function), severe liver failure (reduced liver function), and severe kidney failure (reduced kidney function).
- if you are in the last three months of pregnancy (see paragraph Pregnancy, breastfeeding, and fertility).
Do not give ASPI GOLA Spray to children under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using ASPI GOLA.

Consult your doctor or pharmacist if:
- you have an infection - refer to the Infections paragraph below.

In particular, inform your doctor if:
- you have a history of bronchial asthma (a respiratory disease), as this increases the risk of bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced airflow);
- you have a history of allergies;
- you are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- you suffer from systemic lupus erythematosus or mixed connective tissue disease;
- you suffer from reduced kidney, heart, or liver function (renal, cardiac, or hepatic insufficiency);
- you suffer from hypertension (high blood pressure);
- you are taking other analgesics for a long time or not according to the dosage, as headache may occur;
- you have a history of peptic ulcer (stomach lesion) and other stomach and intestinal diseases as this increases the risk that these diseases may recur. This risk increases, especially with high doses of flurbiprofen, if you are elderly or if the peptic ulcer has been complicated by bleeding or perforation of the stomach and intestine (see paragraph 4 Possible side effects);
- if you are elderly (as you are more likely to experience side effects);
- if you have heart or blood vessel problems, as medicines like ASPI GOLA can be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatments; do not exceed the dose of ASPI GOLA and do not use it for long periods. Inform your doctor if you have heart problems, a history of stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, or high cholesterol or smoke).

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, can lead to allergic phenomena or local irritation (see paragraph 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will provide appropriate therapy.

If you experience mouth irritation, stop treatment.

Infections
Non-steroidal anti-inflammatory drugs (NSAIDs) can mask signs of infections such as fever and pain. This can delay the 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
Do not give ASPI GOLA Spray to children under 12 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects while taking ASPI GOLA, STOP treatment and contact your doctor immediately:

allergic phenomena (sensitization phenomena):
- allergic reaction
- anaphylactic reactions (severe allergic reactions)
- angioedema (sudden swelling of the mouth/throat and mucous membranes).

local irritation
respiratory phenomena: asthma, bronchospasm, wheezing or shortness of breath
various skin disorders:
skin rashes of various types, itching, redness, swelling, skin shedding, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the beginning of treatment with ASPI GOLA, contact your doctor immediately:
- abdominal pain
- peptic ulcer (stomach lesion)
- perforation and bleeding of the stomach or intestine. These side effects can be fatal and may occur with or without warning symptoms. These side effects occur especially if you are elderly or if you have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects on the blood
- anemia (reduction of the amount of red blood cells in the blood)
- thrombocytopenia (reduction of the number of platelets in the blood)
- aplastic anemia (reduction of the amount of all types of blood cells, red blood cells, white blood cells, platelets)
- agranulocytosis (reduction of the number of granulocytes, a type of white blood cell, in the blood).

Effects on the nervous system
- dizziness
- headache, migraine (chronic disease characterized by recurrent headaches)
- paresthesia (numbness of the limbs or other parts of the body)
- drowsiness
- cerebrovascular accidents (diseases caused by lack of blood flow to an area of the brain)
- visual disturbances
- optic neuritis (severe inflammation of the optic nerve, which can lead to reduced vision up to blindness)
- confusion
- vertigo.

Effects on the immune system
- anaphylactic reactions (severe allergic reaction)
- hypersensitivity
- angioedema (inflammatory skin reaction).

Effects on the eye:
- visual disturbances.

Effects on the ear and labyrinth
- tinnitus (ringing in the ears).

Effects on the cardiovascular system
- heart failure
- swelling
- hypertension (high blood pressure).

Effects on the bronchi and lungs
- throat irritation
- asthma
- bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced airflow)
- dyspnea (shortness of breath).

Effects on the mouth, stomach, and intestine
- diarrhea
- constipation
- nausea
- vomiting
- lesions inside the mouth, blisters in the mouth or throat
- mouth and throat pain, numbness of the mouth or throat
- dry mouth
- abdominal distension, abdominal pain
- indigestion
- flatulence (emission of gas from the intestine)
- inflammation of the tongue, altered taste
- blood in the stool
- blood in the vomit
- colitis
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease)
- gastritis (inflammation of the stomach)
- peptic ulcer, bleeding from the stomach and intestine, gastric perforation.

Effects on the skin and subcutaneous tissue
- skin rash
- itching
- urticaria (skin redness accompanied by itching)
- purpura (appearance of purple skin patches of various sizes)
- bullous dermatoses (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment), including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema multiforme.

Effects on the kidneys and urinary tract
- kidney toxicity
- tubulointerstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)
- renal failure (reduced kidney function).

General effects and effects at the administration site
- fever, pain, discomfort, fatigue.

Effects on the liver
- hepatitis (inflammation of the liver).

Effects on the psychiatric sphere
- insomnia
- depression, hallucination.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.