ZERINOMED SORE THROAT*ORAL SPRAY 15ML

ZERINOMED GOLA 2.5 mg/ml oral mucosal spray
Flurbiprofen

What it is and what it is used for
ZERINOMED 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.

ZERINOMED GOLA is used in adults and adolescents over 12 years of age for the treatment 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 section 3).

What you need to know before taking the medicine
Do not use ZERINOMED 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 disorders) or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section Other medicines and ZERINOMED GOLA);
- if you have had stomach or intestinal bleeding or perforation in the past 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 ulcers (stomach lesion) 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 3 months of pregnancy (see section Pregnancy and breastfeeding).

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

Warnings and precautions
Talk to your doctor or pharmacist before using ZERINOMED GOLA.
In particular, inform your doctor if:
- you have suffered from bronchial asthma (a respiratory disease) in the past, as it increases the risk of developing bronchospasm (narrowing of the bronchi that causes severe difficulty in breathing 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 (renal, cardiac, or hepatic insufficiency);
- 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 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 intestines (see section 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 ZERINOMED GOLA may be associated with a modest increase in the 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 ZERINOMED 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 if you smoke);
- you have an infection - refer to the Infections section 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 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 cause allergic reactions or local irritation (see section 4 Possible side effects); in such cases, discontinue treatment and consult your doctor who, if necessary, will carry out appropriate therapy.

If you experience mouth irritation, discontinue treatment.

Children and adolescents
Do not give ZERINOMED 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 ZERINOMED 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, shortness of breath or breathlessness
• various skin disorders: skin rashes of different 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 ZERINOMED GOLA, contact your doctor immediately:
- abdominal pain
- peptic ulcer (stomach lesion)
- perforation and bleeding of the stomach or intestines.
These side effects can be fatal and may occur with or without warning symptoms. These side effects are especially common 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 concerning the blood
- anaemia (reduction in the number of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anaemia (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
- paraesthesia (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 that causes severe difficulty in breathing 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 intestines
- diarrhoea
- lesions inside the mouth
- nausea
- pain in the mouth and throat
- abdominal distension
- abdominal pain
- constipation
- dry mouth
- indigestion
- flatulence (passing gas from the intestines)
- inflammation of the tongue
- altered taste
- vomiting
- blood in stools
- blood in vomit
- bleeding from the stomach and intestines
- colitis
- worsening of inflammatory diseases of the colon and intestines (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 various sizes, purple in colour)
- 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
- renal toxicity
- tubulointerstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli leading to protein loss in the urine)
- renal insufficiency (reduced kidney function).

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

Effects concerning the liver
- hepatitis.

Psychiatric effects
- 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.