Benactiv gola - treatment of oropharyngeal pain - 16 lemon and honey flavour tablets

Product Description

Symptomatic Treatment of Oropharyngeal Pain; Lemon and Honey Flavor; 16 Lozenges

Composition:

BENACTIV GOLA Lemon and Honey Flavor Lozenges One lozenge contains the active ingredient: flurbiprofen 8.75 mg. For the full list of excipients, see section 6.1.

Excipients

BENACTIV GOLA Lemon and Honey Flavor Lozenges Sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavor, menthol, honey.

Therapeutic indications

BENACTIV GOLA Lemon and Honey Flavor Lozenges Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis).

Contraindications

BENACTIV GOLA Lozenges: do not use in children under 12 years of age. Flurbiprofen is contraindicated in patients with known hypersensitivity (asthma, urticaria or allergic type) to flurbiprofen or to any of the excipients, and to aspirin or other NSAIDs. Flurbiprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment. Flurbiprofen should not be taken by patients with active or a history of ulcerative colitis, Crohn's disease, recurrent peptic ulcer, or gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding). Flurbiprofen is contraindicated in patients with severe heart failure. Third trimester of pregnancy.

Dosage

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section Special warnings and precautions for use). BENACTIV THROAT Lemon and Honey Flavored Lozenges Adults and children over 12 years: 1 lozenge to dissolve slowly in the mouth every 3-6 hours, as needed. Do not exceed the dose of 8 lozenges in 24 hours. Do not administer to children under 12 years of age. No dosage adjustments are necessary for elderly people.

Warnings and precautions

At the recommended doses, when using the product 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. Use of the 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. The product should be used with caution in patients with renal, cardiac, or hepatic insufficiency. It is advisable not to combine the product with other NSAIDs. Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma. Gastrointestinal Effects Flurbiprofen should be administered with caution to patients with a history of peptic ulcer and other gastrointestinal disease, as these conditions may be exacerbated. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should initiate treatment on the lowest available dose. Gastrointestinal bleeding, ulceration, or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and may occur with or without warning symptoms or with a previous history of serious gastrointestinal events. Patients with a history of gastrointestinal disease, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in the course of treatment. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2). BENACTIV THROAT Lemon and Honey Flavor Lozenges contain 1.069 g glucose and 1.407 g sucrose per lozenge. Not recommended in hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase insufficiency.

Do not use for long-term treatment. After short periods of treatment without appreciable results, consult your doctor. Keep this medicine out of the reach and sight of children.

Interactions

Caution should be exercised in patients treated with any of the following medicines, as interactions have been reported in some patients. In any case, inform your doctor if you are taking other medicines. Aspirin: As with other NSAID-containing medicines, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased side effects. Antiplatelet agents: increased risk of gastrointestinal bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs. Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects.

Undesirable effects

The following undesirable effects have been reported, particularly after administration of systemic formulations: Blood and lymphatic system disorders Thrombocytopenia, aplastic anemia and agranulocytosis Immune system disorders Anaphylaxis, angioedema, allergic reaction Nervous system disorders Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, discomfort, fatigue and somnolence Acoustic and labyrinth disorders Tinnitus Respiratory, thoracic and mediastinal disorders Respiratory tract reactivity (asthma, bronchospasm and dyspnea) Gastrointestinal Disorders: The most commonly observed adverse events are gastrointestinal in nature. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage, and exacerbation of colitis and Crohn's disease have been reported following administration of flurbiprofen. Less frequently, gastritis, peptic ulcer, perforation, and ulcer haemorrhage have been observed. Skin and Subcutaneous Tissue Disorders: Skin disorders including rash, pruritus, urticaria, purpura, and very rarely, bullous dermatoses (including Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Erythema multiforme). Renal and Urinary Tract Disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported. Topical use of the product, especially if prolonged, may give rise to sensitization or local irritation. Dissolving the product in tablet 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.

Pregnancy and breastfeeding

During the first and second trimesters of pregnancy, flurbiprofen should not be administered unless strictly necessary. Flurbiprofen administration is not recommended for breastfeeding mothers.