Benactiv gola eucalyptus and manuka honey 16 tablets

Product Description

Benactiv Gola 8.75mg Eucalyptus and Manuka Honey lozenges are a targeted treatment to relieve sore throat and inflammatory conditions of the oral cavity.

Indications

Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).

Composition

Active ingredients

One lozenge contains the active ingredient: flurbiprofen 8.75 mg. Excipients with known effect: liquid maltitol (E965), isomalt (E953), eucalyptus and Manuka honey flavouring (containing anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, geraniol, d-limonene, linalool).

Excipients

Macrogol 300, potassium hydroxide, ammonium caramel (E150c), curcumin (E100), eucalyptus and Manuka honey flavouring (containing anisyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, geraniol, d-limonene, linalool), acesulfame potassium (E950), liquid maltitol (E965), isomalt (E953).

Directions for use and Dosage

• Adults: 1 lozenge every 3-6 hours, as needed. Do not exceed the dose of 8 lozenges in 24 hours.
• Paediatric population:
  • Children over 12 years: as for adults.
  • Children under 12 years: do not administer to children under 12 years.
• Special populations:
  • Elderly: Currently available clinical data are limited, therefore no recommendation on a dosage can be made. Elderly people are at increased risk of serious adverse reactions.
  • 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.
  • Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment. Flurbiprofen is contraindicated in patients with severe renal impairment.

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 mouth irritation occurs, treatment should be discontinued.

Warnings

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

Special warnings and precautions for use

• 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.
• Other NSAIDs: It is advisable not to combine the medicine with other NSAIDs.
• 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, however this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen.
• Cardiac, hepatic and renal impairment: The medicine 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 taking diuretics, 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 initiating treatment in patients with a history of hypertension and/or heart failure (discuss with your doctor or pharmacist), as fluid retention, hypertension, and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs, especially at high doses and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events such as myocardial infarction or stroke. There are insufficient data to exclude a similar 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 consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking).
• Central nervous system effects: Analgesic-induced headache. Headache may occur with prolonged or inappropriate use of analgesics and should not be treated by increasing the dose of the drug.
• Gastrointestinal effects: Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal diseases, as these conditions may be exacerbated. The risk of gastrointestinal bleeding, ulceration, or perforation is greater. Higher risk with increasing flurbiprofen dosage in patients with a history of ulcers, particularly if complicated by haemorrhage or perforation, and in the elderly. These patients should start treatment on the lowest available dose. Gastrointestinal bleeding, ulceration, 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 with 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 treatment. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. 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. If gastrointestinal bleeding or ulceration occurs in patients taking flurbiprofen, the 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 physician 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. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Infections: Since 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 NSAID class, patients are advised to consult a physician 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.
• Masking of symptoms of underlying infections: Epidemiological studies suggest that systemic nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, which may be associated with increased risk of developing bacterial infections. This may lead to a delay in the initiation of appropriate treatment and thus worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox.

Interactions

Caution should be exercised in patients treated with any of the following drugs, as interactions have been reported in some patients. However, inform your doctor if you are taking other medicines.

• Aspirin: Flurbiprofen should be avoided in combination with aspirin, unless low-dose aspirin (not exceeding 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by your doctor. As with other NSAID-containing medicinal products, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse effects (see section 4.4).
• Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects and an increased risk of adverse reactions (see section 4.4).
• Anticoagulants: Flurbiprofen should be used with caution in combination with anticoagulants, since they may increase the risk of adverse reactions. NSAIDs may potentiate the effects of anticoagulants such as warfarin (see section 4.4).
• Antiplatelet agents: Increased risk of gastrointestinal bleeding.
• Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.
• Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics. Other antihypertensive drugs may potentiate nephrotoxicity caused by inhibition of cyclooxygenase, especially in patients with impaired renal function (these patients must be adequately hydrated).
• Alcohol: May increase the risk of gastrointestinal bleeding. increase the risk of adverse reactions, especially bleeding in the gastrointestinal tract.
• Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels.
• Cyclosporin: Increased risk of nephrotoxicity.
• Corticosteroids: Increased risk of gastrointestinal ulceration or haemorrhage with NSAIDs (see section 4.4).
• Lithium: There is evidence of a possible increase in plasma lithium levels.
• Methotrexate: There may be an increased risk of nephrotoxicity. be an increase in plasma levels of methotrexate.
• Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
• Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
• Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered with tacrolimus.
• Zidovudine: Increased risk of haematological toxicity when NSAIDs are administered with zidovudine.

Undesirable effects

Hypersensitivity reactions to NSAIDs have been reported, which may consist of:

• Non-specific allergic reactions and anaphylaxis.
• Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea.
• Various skin disorders, including for example rashes of different types, pruritus, urticaria, purpura, angioedema and, more importantly, rashes of different types, pruritus, urticaria, purpura, angioedema and, more specifically ... rarely, exfoliative and bullous dermatosis (including epidermal necrolysis and erythema multiforme).

The most commonly observed adverse reactions are gastrointestinal in nature. Local use of the medicine, especially if prolonged, may give rise to sensitization or local irritation. Dissolution of the medicinal product in lozenge form 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 and at doses compatible with the classification of over-the-counter medicines. Additional side effects may occur when treating chronic conditions and over long periods of time.

The side effects associated with the use of flurbiprofen are classified below by system organ class and frequency. 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.

Blood and lymphatic system disorders

• Not known: anaemia, thrombocytopenia, aplastic anaemia and agranulocytosis.

Nervous system disorders

• Common: dizziness, headache, paraesthesia.
• Uncommon: somnolence.
• Not known: cerebrovascular accident, optic neuritis, migraine, confusional states, vertigo.

Immune system disorders

• Rare: anaphylactic reaction.
• Not known: angioedema, hypersensitivity.

Patient disorders Eye disorders

• Not known: visual impairment.

Ear and labyrinth disorders

• Not known: tinnitus.

Cardiac disorders

• Not known: cardiac failure, oedema.

Vascular disorders

• Not known: hypertension.

Respiratory, thoracic and mediastinal disorders

• Common: throat irritation.
• Uncommon: asthma, bronchospasm and dyspnoea, oropharyngeal vesicular rash, oropharyngeal hypoaesthesia.

Gastrointestinal disorders

• Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (hot or burning sensation, tingling of the mouth).
• Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting.
• Not known: melaena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage.

Skin and subcutaneous tissue disorders

• Uncommon: rash, pruritus.
• Not known: urticaria, purpura, bullous dermatitis (including Stevens-Johnson syndrome, skin necrolysis toxic epidermal necrolysis and erythema multiforme).

Renal and urinary disorders

• Not known: toxic nephropathy, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs).

General disorders and administration site conditions

• Uncommon: pyrexia, pain.
• Not known: discomfort, tiredness.

Hepatobiliary disorders

• Not known: hepatitis.

Psychiatric disorders

• Uncommon: insomnia.
• Not known: depression, hallucination.

Reporting of adverse reactions suspected

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.

Pregnancy and breastfeeding

Pregnancy

There are no clinical data on the use of Benactiv Gola during pregnancy. Although systemic exposure is lower than with oral administration, it is not known whether the systemic exposure of Benactiv Gola achieved after topical administration could be harmful to an embryo/fetus.

• First and second trimester of pregnancy: Benactiv Gola should not be administered unless strictly necessary. If administered, the dose should be as low as possible and the duration of treatment as long as possible. as short as possible.
• Third trimester of pregnancy: Systemic use of prostaglandin synthase inhibitors, including Benactiv Gola, can induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time may occur in both mother and child, and labor may take longer. Therefore, Benactiv Gola is contraindicated during the last trimester of pregnancy (see section 4.3).

Breastfeeding

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

Format

16 Tablets