KETODOL GOLA*16PASTL 8.75MG LM

KETODOL GOLA 8.75 mg lozenges lemon and honey flavour
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 for the treatment of pain and irritation symptoms of the gums, mouth and throat (e.g. gingivitis, stomatitis, pharyngitis).

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 take 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 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 frequently suffer from peptic ulcers (stomach lesions) 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
Consult your doctor or pharmacist before taking LISOMUCIL GOLA.

In particular, inform your doctor if:
- you have suffered from bronchial asthma (a respiratory disease) in the past, as it increases the risk that you may experience bronchospasm (narrowing of the bronchi causing severe respiratory difficulty due to reduced air passage);
- you have suffered from allergies in the past;
- 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 (kidney, heart or liver failure);
- you suffer from hypertension (high blood pressure);
- you have been taking other analgesics for a long time or without following the dosage, as headache may occur;
- you have suffered from peptic ulcer (stomach lesion) and other stomach and intestinal diseases in the past, as this increases the risk that these diseases may recur. This risk especially increases 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 take it for long periods. Inform your doctor if you have heart problems, previous strokes 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 take this medicine during an infection and the infection symptoms 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, 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 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 everyone gets them.
If you experience the following side effects during treatment with LISOMUCIL GOLA, STOP treatment and contact your doctor immediately:
• allergic phenomena (sensitisation 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 dyspnoea;
• various skin disorders: skin rashes of different types, 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 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 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.

In addition, you may experience the following side effects:

Effects concerning the blood
- anaemia (reduction of the amount of red blood cells in the blood);
- thrombocytopenia (reduction of the number of platelets in the blood);
- aplastic anaemia (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 cells, in the blood).

Effects concerning the nervous system
- dizziness;
- headache;
- paraesthesia (numbness of the limbs or other body parts);
- 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 characterised 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);
- dyspnoea (shortness of breath);
- blisters in the mouth or throat;
- numbness of the mouth or throat.

Effects concerning the mouth, stomach and intestine:
- diarrhoea;
- lesions inside the mouth;
- nausea;
- pain in the mouth and throat;
- sensation of heat or burning, tingling of the mouth;
- abdominal distension;
- abdominal pain;
- constipation;
- dry mouth;
- difficulty digesting;
- flatulence (emission of gas from the intestine);
- inflammation of the tongue;
- altered taste;
- vomiting;
- blood in the faeces;
- blood in the vomit;
- bleeding from the stomach and intestines;
- 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 purple skin patches of different sizes);
- bullous dermatoses (severe skin lesions characterised 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:
- renal 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.