Flurbiprofen teva mouthwash - symptomatic treatment of inflammation and pain of oropharynx 160ml

Product Description

Drug useful for the treatment of the symptoms of inflammation and irritation of the oropharyngeal cavity, also associated with pain.

Indications

The anti-inflammatory mouthwash Flurbiprofene Teva is a drug based on the active ingredient Flurbiprofen, ideal in case of:

• gingivitis;
• stomatitis;
• pharyngitis;
• conservative or extractive dental therapy.

Dosage and Directions for Use

Two or three rinses or gargles a day with 10 ml of mouthwash, even diluted in water.

Active ingredient and excipients

Active ingredient: 100 ml of solution contain 0.25 g of Flurbiprofen.

Flurbiprofen Teva 0.25% Mouthwash contains the following excipients: Glycerol (98%), ethanol, non-crystallizing liquid sorbitol, hydrogenated castor oil - 40 polyoxyethylene, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavor, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.
History of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
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).
Patients with severe heart failure.
Pregnancy.

Warnings

At the recommended doses, swallowing Flurbiprofen Teva 0.25% Mouthwash does not cause any harm to the patient as these doses are much lower than those of the single dosage of the product for systemic administration.

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

Use of Flurbiprofen Teva 0.25% Mouthwash, especially if prolonged, may cause sensitization or local irritation. In such cases, discontinue use and consult your doctor to initiate appropriate therapy, if necessary. Do not use for prolonged periods. After short periods of treatment without appreciable results, the patient should be monitored.

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 diseases, 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 by haemorrhage and perforation, and in the elderly. These patients should start treatment with the lowest available dose. Gastrointestinal bleeding, ulceration, or perforation has 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, particularly when 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 may be fatal. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Important information about some of the excipients

The mouthwash contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed). The colorant patent blue V (E131) may cause allergic reactions. Hydrogenated castor oil - 40 polyoxyethylene may cause localized skin reactions. The mouthwash contains a small amount of ethyl alcohol, less than 100 mg per dose.

Interactions

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

Aspirin: As with other NSAID-containing medications, concomitant administration of flurbiprofen and aspirin is generally not recommended due to the potential for increased adverse 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.
Psychiatric disorders: Depression.
Nervous system disorders: Dizziness, cerebrovascular accident, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, vertigo, malaise, fatigue, and somnolence.
Ear and labyrinth disorders: Tinnitus
Cardiac disorders: Oedema, hypertension, and cardiac failure.

Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events (for example, myocardial infarction or stroke).

Respiratory, thoracic, and mediastinal disorders: Respiratory tract reactivity (asthma, bronchospasm, and dyspnoea).
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. Pancreatitis has been reported very rarely.
Skin and subcutaneous tissue disorders: Skin disorders including rash, pruritus, urticaria, purpura, angioedema, and very rarely, bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme). In clinical trials with flurbiprofen patches, the most commonly reported adverse reactions were local skin reactions (including redness, rash, pruritus, eruptions, numbness, and tingling); However, the incidence was low (4.6%).
Renal and urinary disorders: Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome. As with other NSAIDs, rare cases of renal failure have been reported.

Overdose

Symptoms Symptoms of overdose may include nausea, vomiting, and gastrointestinal irritation.

Treatment

Treatment should include gastric lavage and, if necessary, correction of serum electrolyte levels. There is no specific antidote for flurbiprofen.

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, the use of flurbiprofen is not recommended and should be administered only when strictly necessary. If flurbiprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
• Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• Renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.

The mother and newborn, at the end of pregnancy, may be exposed to:

• Possible prolongation of bleeding time, an antiaggregant effect that may occur even at very low doses;
• Inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.

Breastfeeding

Flurbiprofen is excreted in breast milk; however, the amount excreted is only a small fraction of the maternal dose. Administration of flurbiprofen is not recommended in mothers who are breastfeeding.

Format

160 ml bottle.