Froben gola mouthwash 0.25% - oropharyngeal irritation and inflammation 160 ml

Product Description

Drug based on flurbiprofen useful for treating irritative-inflammatory conditions of the oropharyngeal cavity, even those associated with pain.

Indications

Froben Gola Mouthwash is a drug belonging to the category of NSAIDs (non-steroidal anti-inflammatory drugs) and is useful for the treatment of symptoms related to:

• pharyngitis (sore throat);
• gingivitis;
• stomatitis;
• extractive or conservative dental therapy.

Dosage and Directions for Use

Adults can use 10 ml of Froben Gola mouthwash by rinsing or gargling two/three times a day, at any time. The recommended dose can be increased by 10 ml. It can also be diluted in water.
Avoid swallowing the medicine.
Do not use in children.

Composition

Active ingredient: flurbiprofen.
Excipients: purified water, alcohol, patent blue VE131 dye, glycerol, mint essence, 40-polyoxyethylened hydrogenated castor oil, potassium bicarbonate, sodium saccharinate, sorbitol.

Important information about some of the excipients

Froben Gola Mouthwash contains:

• Sorbitol (E420). Patients with hereditary fructose intolerance should not be given this medicine.
• Ethanol. This medicine contains 12 vol % ethanol (alcohol), e.g. up to 1 g per dose, equivalent to 24 ml of beer, 10 ml of wine per dose. May be harmful for alcoholics. To be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy. For those who participate in sports, the use of medicines containing ethyl alcohol may cause positive doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.
• Patent blue V (E131) dye which may cause allergic reactions.

Warnings

Undesirable effects can be minimized by using the lowest effective dose for the lowest effective dose. Use in elderly patients as short as possible to control symptoms.

Use in elderly patients

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

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. 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. The risk of gastrointestinal bleeding, ulceration or perforation is greater with NSAIDs. High risk of gastrointestinal events 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. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low-dose aspirin or other drugs that may increase the risk of gastrointestinal events. Patients with a history of gastrointestinal disease, especially if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) early in treatment. If gastrointestinal bleeding or ulceration occurs in patients taking Froben Gola, the treatment should be discontinued.

Respiratory Disorders

Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma.

Cardiac, Renal and Hepatic Impairment

Particular caution should be exercised when treating patients with severely impaired renal, cardiac or hepatic function, as the use of NSAIDs may result in deterioration of renal function. In such patients, the dosage should be kept as low as possible and renal function should be monitored. Administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation, accelerating renal failure. Patients at highest risk of developing this reaction are those with impaired renal function, heart failure and liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Flurbiprofen should be administered with caution in patients with a history of heart failure or hypertension, as cases of edema have been reported in association with flurbiprofen administration.

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are necessary in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported in association with flurbiprofen administration and NSAID treatment. Froben Gola should be administered with caution in these patients. Clinical trial and epidemiological data suggest that the use of some NSAIDs, particularly at high doses and for long-term treatment, may be associated with a small 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, hyperlipidaemia, diabetes mellitus, smoking).

Skin Reactions

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. Patients appear to be at highest risk early in the course of therapy, with the onset of the reaction occurring in the majority of cases within the first month of treatment. Flurbiprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Renal Effects

Caution should be exercised when initiating treatment with NSAIDs such as flurbiprofen in patients with considerable dehydration.

Hematological Effects

Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time.

Systemic Lupus Erythematosus (SLE) and Connective Tissue Diseases

Patients with Systemic Lupus Erythematosus (SLE) and connective tissue disorders may be at increased risk of aseptic meningitis. The above effects have been reported in particular after the administration of systemic formulations of Flurbiprofen. At the recommended doses, swallowing Froben Gola 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. The use of Froben Gola, 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 establish appropriate therapy, if necessary. Flurbiprofen should not be used for prolonged treatments. Patients should be advised to seek medical advice if, after short periods of treatment, no appreciable results are seen.

Impairment of fertility

The use of flurbiprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, discontinuation of treatment with flurbiprofen should be considered.

Contraindications

This medicine is contraindicated in case of:

• Allergy to the active substance or to any of the other ingredients of this medicine;
• asthma, hives or any other allergic reaction after taking acetylsalicylic acid known as aspirin or other NSAIDs; 
• peptic ulcer (stomach or duodenal ulcer) or Crohn's disease, ulcerative colitis, ulcer or bleeding in the stomach or intestine, bleeding or perforation of the stomach and/or intestine due to NSAIDs; 
• heart, kidney or liver problems; 

This medicine is not It should be used during the last three months of pregnancy.

Interactions

The drugs or active substances listed below may interact with the effect of Froben Gola 0.25% mouthwash:

Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity of NSAIDs. In some patients with compromised renal function (for example, dehydrated patients or elderly patients with compromised renal function).
Anticoagulants, such as warfarin: increased anticoagulant effect.
Antiplatelet agents: increased risk of gastrointestinal bleeding.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.
Aspirin: 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.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides.
Cyclosporines: increased risk of nephrotoxicity with NSAIDs.
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.
Mifepristone: NSAIDs should not be taken for 8-12 days after mifepristone administration as NSAIDs may reduce the effects of mifepristone.
Quinolone Antibiotics: Results from animal studies suggest that NSAIDs may increase the risk of convulsions associated with the use of quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Tacrolimus: Possible increased risk of nephrotoxicity when coadministered with NSAIDs.
Zidovudine: Increased risk of haematotoxicity when coadministered with NSAIDs. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-infected haemophiliac patients receiving concomitant treatment with Zidovudine and other NSAIDs.

The interactions reported above have been reported in particular after the administration of systemic formulations of Flurbiprofen. At the recommended doses of Froben Gola, no interactions with other medicinal products or other types of drugs have been reported. In any case, inform your doctor if you are taking other medicines.

Storage

This medicine must not be stored above 25°C.

Format

160 ml bottle.