Zerinoactiv gola 8.75 mg - 16 honey and lemon flavored sore throat lozenges

Product Description

Zerinoactiv Gola is A flurbiprofen-based medicine, indicated for the symptomatic treatment of irritation-inflammatory conditions and oropharyngeal pain.

Indications

Symptomatic treatment of irritation-inflammatory conditions, including those associated with oropharyngeal pain (e.g., gingivitis, stomatitis, pharyngitis).

Composition

Active ingredients

One tablet contains: Active ingredient: flurbiprofen 8.75 mg

Excipients

Sucrose, glucose, macrogol, potassium hydroxide, lemon flavoring, levomenthol, honey.

Directions for use and Dosage

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Dosage

• Adults: 1 lozenge every 3-6 hours, as needed. Do not exceed 8 lozenges in 24 hours.

Paediatric population

• Children over 12 years of age: as for adults.
• Children under 12 years of age: do not administer to children under 12 years of age. Use in children under 12 years of age (see section 4.3).

Special populations

• Elderly: Currently available clinical data are limited, therefore no recommendation on a posology can be made. The elderly are at increased risk of serious consequences in case of adverse reactions (see section 4.4).
• Patients with hepatic impairment: No dosage reduction is necessary in patients with mild to moderate hepatic impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3).
• Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe hepatic impairment (see section 4.3).
• Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment. Contraindicated in patients with severe renal impairment (see section 4.3).

Method of administration

For oropharyngeal use. Dissolve slowly in the mouth. As with all lozenges, flurbiprofen lozenges should be moved around the mouth during administration to avoid local irritation. If oral irritation occurs, treatment should be discontinued.

Interactions

It is advisable not to combine the medicinal product with other NSAIDs (see section 4.5).

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5).

Warnings

At the recommended doses, when using the medicinal product in its various pharmaceutical forms, swallowing does not cause any harm to the patient, since the dose of flurbiprofen is much lower than that commonly used in systemic treatments.

Elderly

Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

Respiratory disorders

Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies. Flurbiprofen should be used with caution in these patients.

Systemic lupus erythematosus (SLE) and mixed connective tissue disease

Patients with Systemic lupus erythematosus and mixed connective tissue disease may be at increased risk of aseptic meningitis (see section 4.8), however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen.

Cardiac, hepatic and renal impairment

The medicinal product should be used with caution in patients with cardiac, renal or hepatic insufficiency. NSAIDs have been reported to cause various forms of nephrotoxicity, including interstitial nephritis, nephrotic syndrome, and renal failure. Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at highest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those receiving diuretic therapy, and the elderly; However, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen.

Cardiovascular and cerebrovascular effects

Caution is required before starting treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatment, may increase the risk of developing cardiovascular disease. be associated with a small increased risk of arterial thrombotic events, such as myocardial infarction or stroke. There are insufficient data to exclude such a risk for flurbiprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with flurbiprofen only after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Effects on the central nervous system

Analgesic-induced headache. Headache may occur with prolonged or inappropriate use of analgesics and should not be treated by increasing the dose of the medicinal product.

Gastrointestinal Effects

Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases since it may increase the risk of intestinal ulcer. These conditions may be exacerbated. The risk of gastrointestinal bleeding, ulcer, or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with hemorrhage and perforation, and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulcer, or perforation have been reported with all NSAIDs at any time during treatment. These adverse reactions can be fatal and may occur with or without warning symptoms or in case of a previous history of serious gastrointestinal reactions. Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in the course of treatment. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2). When gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, treatment should be discontinued.

Dermatological effects

Use of the medicinal product, especially if prolonged, may give rise to sensitization or local irritation. In such cases, treatment should be discontinued and a doctor should be consulted to institute appropriate therapy, if necessary. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Infections

Since flurbiprofen is a common cause of allergic reactions, it is important to consult a doctor before use. Isolated cases of exacerbation of infection-related inflammation (e.g. development of necrotizing fasciitis) have been described in temporal association with the systemic use of drugs belonging to the class of NSAIDs. Patients are advised to consult a doctor immediately if signs of a bacterial infection appear or worsen during flurbiprofen therapy. The possible indication for initiation of antibiotic therapy should be considered. If mouth irritation develops, treatment should be discontinued.

Important information about some of the ingredients

Zerinoactiv Gola contains:

• Glucose: Patients with rare problems of glucose-galactose malabsorption should not take this medicine.
• Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Do not use for prolonged treatments beyond 7 days. If no appreciable results are seen after 3 days of treatment, the cause may be a different pathological condition. In these cases, it is advisable to consult your doctor.

Contraindications

• Do not use the medicine in children under 12 years of age.
• Flurbiprofen is Flurbiprofen is contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1.
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) to ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Flurbiprofen is contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients listed in section 6.1.
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm. Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Flurbiprofen should not be taken by patients with active or history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer disease, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
• Flurbiprofen is Contraindicated in patients with severe cardiac failure, severe hepatic failure, and renal failure (see section 4.4).
• Third trimester of pregnancy.

Undesirable effects

Hypersensitivity reactions to NSAIDs have been reported and may consist of: (a) nonspecific allergic reactions and anaphylaxis; (b) respiratory tract reactivity, e.g., asthma, exacerbated asthma, bronchospasm, dyspnoea; (c) various skin disorders, including for example skin rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). The most commonly observed adverse reactions are of a gastrointestinal nature. Local use of the medicinal product, especially if prolonged, may give rise to sensitization or local irritation phenomena. Dissolution of the medicinal product in the form of tablets in the oral cavity may be accompanied by sensations of heat or tingling in the oropharynx. In such cases, treatment should be discontinued and appropriate therapy instituted, if necessary. The following adverse reactions have been reported, particularly after administration of systemic formulations. They refer to those observed with short-term use of flurbiprofen at doses consistent with the classification of over-the-counter medicines. Additional adverse reactions may occur when treating chronic conditions and over long periods of time. The adverse reactions associated with the use of flurbiprofen are classified below by system organ class and frequency. The frequency is: defined as: very common (≥ 1/10), common (≥1/100,<1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdose

Given the low content of the active ingredient and its local use, it is advisable to report any suspected adverse reactions. Overdose is unlikely to occur.

Symptoms

The majority of patients who ingest clinically important quantities of NSAIDs develop nausea, vomiting, gastrointestinal irritation, epigastric pain, or more rarely diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more severe cases of NSAID intoxication, toxicity is observed. central nervous system effects, manifested by drowsiness, occasionally excitability, blurred vision, and disorientation or coma. Occasionally, patients develop convulsions. In severe NSAID intoxication, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the action of circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma exacerbation is possible in asthmatics.

Treatment

Treatment should be symptomatic and supportive and should include maintaining a clear airway and monitoring cardiac function and vital signs until stable. Oral administration of activated charcoal and, if necessary, correction of serum electrolytes should be considered if the patient presents within one hour of ingesting a potentially toxic amount. Seizures should be treated with diazepam or lorazepam intravenously if they are frequent or prolonged. Administer bronchodilators for asthma. There is no specific antidote for flurbiprofen.

Pregnancy and breastfeeding

Pregnancy

Flurbiprofen should not be administered during the first and second trimesters of pregnancy unless clearly necessary. The use of flurbiprofen during the third trimester of pregnancy is contraindicated. contraindicated.

Breastfeeding

In a limited number of studies, flurbiprofen appears in breast milk at very low concentrations and is unlikely to have any adverse effects on the breast-fed infant. However, administration of flurbiprofen is not recommended in breast-feeding mothers.

Fertility

There is evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation. This is Reversible upon discontinuation of treatment.

Storage

This medicine does not require any special storage precautions.

Format

16 Tablets