Name
ASPI GOLA 8.75 mg lemon and honey flavoured lozenges
Flurbiprofen


What it is and what it is used 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 Pastiglie 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).

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 take 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 against 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 sore) 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, breast-feeding and fertility").

Do not give ASPI GOLA Lozenges to children under 12 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking 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 develop bronchospasm (narrowing of the bronchi causing 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 suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases in the past as this increases the risk of these diseases recurring. 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 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 such as ASPI GOLA may be associated with a small increase in the 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 and do not take 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 or high cholesterol or if you smoke).

Report any unusual abdominal symptoms to your doctor.

The use of this medicine, especially if prolonged, may give rise to allergic or local irritation phenomena (see paragraph 4 "Possible side effects"); in such cases, stop the treatment and consult your doctor who, if necessary, will carry out an appropriate therapy.

If you experience mouth irritation, stop treatment.

Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may hide signs of infection such as fever and pain. This may delay appropriate treatment of the infection, which may increase the risk of complications. If you take this medicine during an infection and the symptoms of the infection persist or worsen, contact your doctor or pharmacist immediately.

Children and adolescents
Do not give this medicine to children under 12 years of age (see "Do not take ASPI GOLA").


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 the 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:
- sensations of heat or tingling in the mouth and throat;
- respiratory phenomena: asthma, bronchospasm, shortness of breath or wheezing;
- various skin disorders: various types of skin 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 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 you may experience them with or without warning symptoms. These side effects occur especially if you are elderly or if you have suffered from stomach and intestinal diseases in the past.

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 amount 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;
- sore mouth and throat, numbness of mouth or throat;
- sensation of heat or burning, tingling in the mouth;
- 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 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 which causes 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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.