ASPI GOLA "0.25% SPRAY FOR ORAL MUCOSA" 15 ML BOTTLE"

Name
ASPI GOLA 0.25% spray for oral mucosa
Flurbiprofen


What is it and what is it for?
ASPI GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (painkiller) medicine, which 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 to treat the symptoms of pain and irritation of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis), also following conservative or extractive dental therapy (e.g. caries treatment or tooth extraction).

Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment (see section 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 section 6);
- if you are allergic to acetylsalicylic acid (a medicine for inflammation, pain, fever and heart problems) or to other non-steroidal anti-inflammatory drugs (NSAIDs) (see section "Other medicines and ASPI GOLA");
- if you have suffered in the past from bleeding or perforation of the stomach or intestine 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 suffer frequently from peptic ulcer (stomach ulcer) or bleeding from the stomach or intestine (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 renal failure (reduced kidney function).
- if you are in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility").
Do not give ASPI GOLA Spray to children under 12 years of age.


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

Talk to your doctor or pharmacist if:
- have an infection – see “Infections” below.

In particular, tell your doctor if:
- have suffered from bronchial asthma (a breathing disease) in the past, as this increases the risk that you may experience bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- has suffered from allergies in the past;
- are taking other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
- suffers from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart or liver function (renal, cardiac or hepatic failure);
- suffer from hypertension (high blood pressure);
- you are taking other painkillers for a long time or without respecting the dosage, as headache may occur;
- have had a peptic ulcer (stomach sore) or other stomach and intestinal diseases in the past, as this increases the risk of these diseases recurring. This risk is especially increased with high doses of flurbiprofen, if you are elderly, or if your peptic ulcer has been complicated by bleeding or perforation of the stomach and intestines (see section 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 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk of side effects increases with high doses and prolonged treatment; do not exceed the dose of ASPI GOLA or use it for long periods. Tell your doctor if you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke).

Report any unusual abdominal symptoms to your doctor.

Use of this medicine, especially if prolonged, may give rise to allergic reactions or local irritation (see section 4 "Possible side effects"); in such cases, discontinue treatment and consult your doctor who, if necessary, will perform appropriate therapy.

If you experience mouth irritation, discontinue treatment.

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
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: various types of rashes, itching, redness, swelling, skin loss, blisters, peeling or ulceration of the skin and mucous membranes.

If you experience the following side effects at the start 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 are especially likely if you are elderly or have a history of stomach or intestinal diseases.

Additionally, you may experience the following side effects:

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

Effects on the nervous system
- dizziness;
- headache (cephalea), migraine (chronic disease characterized by recurrent headaches);
- paresthesia (numbness of the limbs or other parts of the body);
- drowsiness;
- cerebrovascular accidents (diseases caused by a 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 and even blindness);
- confusion;
- dizziness.

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

Effects affecting 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 affecting the bronchi and lungs
- throat irritation;
- asthma;
- bronchospasm (narrowing of the bronchi which causes severe breathing difficulty due to reduced airflow);
- dyspnea (shortness of breath).

Effects affecting the mouth, stomach and intestines
- diarrhea;
- constipation;
- nausea;
- vomit;
- sores inside the mouth, blisters in the mouth or throat;
- pain in the mouth and throat, numbness in the mouth or throat;
- dry mouth;
- abdominal distension, abdominal pain;
- difficulty digesting;
- flatulence (emission of gas from the intestine);
- inflammation of the tongue, alteration of taste;
- blood in the stool;
- blood in vomit;
- colitis;
- worsening of inflammatory diseases of the colon and intestine (Crohn's disease);
- gastritis (inflammation of the stomach);
- peptic ulcer, loss of blood from the stomach and intestines, gastric perforation.

Effects affecting the skin and underlying tissue
- skin rash;
- itching;
- hives (redness of the skin accompanied by itching);
- purpura (appearance of purple skin patches of varying 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 which leads to a loss of proteins in the urine);
- renal failure (reduced kidney function).

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

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

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

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.