ZERINOACTIV THROAT*16LOZ LEM M

ZERINOACTIV GOLA 8.75 mg lozenges lemon and honey flavour
Flurbiprofen

What it is and what it is used for
ZERINOACTIV GOLA contains flurbiprofen, a non-steroidal anti-inflammatory and analgesic (painkiller) medicine, which acts against inflammation and pain in the throat, mouth and gums.
ZERINOACTIV GOLA is used in adults and adolescents over 12 years of age for the treatment of pain symptoms and irritations 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 section 3).

What you need to know before taking the medicine
Do not take ZERINOACTIV 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 other non-steroidal anti-inflammatory drugs (NSAIDs) (see section Other medicines and ZERINOACTIV GOLA);
- if you have a history of stomach or intestinal bleeding or perforation 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 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 ZERINOACTIV GOLA to children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ZERINOACTIV GOLA.

In particular, tell your doctor if you:
- have a history of bronchial asthma (a respiratory disease), as it increases the risk of bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced airflow);
- have a history of allergies;
- are taking other Non-Steroidal Anti-inflammatory Drugs (NSAIDs);
- suffer from systemic lupus erythematosus or mixed connective tissue disease;
- suffer from reduced kidney, heart or liver function (kidney, heart or liver failure);
- suffer from hypertension (high blood pressure);
- are taking other analgesics for a long time or not respecting the dosage, as headache may occur;
- 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 section 4 Possible side effects);
- are elderly (as you are more likely to experience side effects);
- have heart or blood vessel problems, as medicines like ZERINOACTIV 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 treatment; do not exceed the dose of ZERINOACTIV 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 for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or smoke);
- 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 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 cause allergic reactions or local irritation (see section 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 this medicine to children under 12 years of age (see Do not take ZERINOACTIV 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 during treatment with ZERINOACTIV 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 warmth or tingling in the mouth and throat • respiratory phenomena: asthma, bronchospasm, shortness of breath or breathlessness
• various skin disorders: skin rashes of various 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 ZERINOACTIV 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 a history of stomach and intestinal diseases.

In addition, you may experience the following side effects:

Effects on the blood
- anaemia (reduction in the amount of red blood cells in the blood)
- thrombocytopenia (reduction in the number of platelets in the blood)
- aplastic anaemia (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
- paraesthesia (numbness of the limbs or other parts of the body)
- drowsiness
- cerebrovascular accidents (diseases caused by lack of blood supply 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 on the immune system
- anaphylactic reactions (severe allergic reaction)
- angioedema (inflammatory skin reaction)
- hypersensitivity.

Effects on 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 on the bronchi and lungs
- throat irritation
- asthma
- bronchospasm (narrowing of the bronchi that causes severe breathing difficulties due to reduced airflow)
- dyspnoea (shortness of breath)
- blisters in the mouth or throat
- numbness of the mouth or throat.

Effects on the mouth, stomach and intestine
- diarrhoea
- lesions inside the mouth
- nausea
- pain in the mouth and throat
- feeling of warmth or burning, tingling in the mouth
- abdominal distension
- abdominal pain
- constipation
- dry mouth
- indigestion
- flatulence (gas emission from the intestine)
- inflammation of the tongue
- altered taste
- vomiting
- blood in the stool
- 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 on the skin and subcutaneous tissue
- rash (skin eruption)
- itching
- urticaria (skin redness accompanied by itching)
- purpura (appearance of purple skin patches of various 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 on the kidneys and urinary tract
- renal toxicity
- tubulointerstitial nephritis (inflammation of the kidneys)
- nephrotic syndrome (alteration of the renal glomeruli that leads to protein loss in the urine)
- renal failure (reduced kidney function).

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

Effects on 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.