KETODOL GOLA*MOUTHWASH FL 160ML

LISOMUCIL GOLA 2.5 mg/ml mouthwash
Flurbiprofen

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

LISOMUCIL GOLA is used in adults and adolescents over 12 years of age to treat symptoms of pain and irritation of the gums, mouth and throat (e.g., gingivitis, stomatitis, pharyngitis), including as a result of 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 LISOMUCIL 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 problems) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see paragraph Other medicines and LISOMUCIL GOLA);
- if you have a history of bleeding or perforation of the stomach or intestine related to previous treatment 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 ulcer (stomach lesion) or bleeding of 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 kidney failure (reduced kidney function);
- if you are in the last 3 months of pregnancy (see paragraph Pregnancy and breastfeeding).

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

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

In particular, inform your doctor if:
- you have a history of bronchial asthma (a breathing disease), as it increases the risk of bronchospasm (narrowing of the bronchi causing severe respiratory difficulty due to reduced air passage);
- 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 without respecting the dosage, as headache may occur;
- you have a history of peptic ulcer (stomach lesion) and other stomach and intestinal diseases, as it 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 paragraph 4 Possible side effects);
- you are elderly (as you are more likely to experience side effects);
- you have heart or blood vessel problems, as medicines like LISOMUCIL GOLA may 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 LISOMUCIL 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);
- you have an infection - refer to the Infections paragraph below.

Infections
Non-steroidal anti-inflammatory drugs (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 use this medicine during an infection and the symptoms of the infection persist or worsen, contact your doctor or pharmacist immediately.

Report any unusual abdominal symptoms to your doctor.
The use of this medicine, especially if prolonged, may cause allergic phenomena or local irritation (see paragraph 4 Possible side effects); in such cases, stop treatment and consult your doctor who, if necessary, will carry out appropriate therapy.

If you experience mouth irritation, stop treatment.

Children and adolescents
Do not give LISOMUCIL GOLA 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 being treated with LISOMUCIL GOLA, STOP treatment and contact your doctor immediately:

• allergic reactions (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 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 start of treatment with LISOMUCIL 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 have a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects concerning the blood
- anemia (reduction in the number 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 concerning the nervous system
- dizziness;
- headache;
- 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);
- migraine (chronic disease characterized by recurrent headaches);
- confusion;
- vertigo.

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

Effects concerning the eye
- visual disturbances.

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

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

Effects concerning the bronchi and lungs
- throat irritation;
- asthma;
- bronchospasm (narrowing of the bronchi causing severe respiratory difficulty due to reduced air passage);
- dyspnea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat.

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

Effects concerning the skin and subcutaneous tissue
- rash (skin eruption);
- itching;
- urticaria (skin redness accompanied by itching);
- purpura (appearance of skin patches of different sizes, purple in color);
- 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 concerning 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);
- kidney failure (reduced kidney function).

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

Effects concerning the liver
- hepatitis.

Effects concerning the psychiatric sphere
- insomnia;
- depression;
- hallucination.

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.