Spray for fast and effective relief from sore throat.
Indications
Benactivdolmed Spray 8.75 mg/dose is a drug indicated for the short-term symptomatic treatment of acute pain in sore throat in adults.
- Analgesic.
- Anti-inflammatory.
- Acts up to 6 hours.
- Suitable for adults.
Lemon and Honey flavor.
Composition
Active ingredients
One spray contains 2.92 mg of flurbiprofen.
A dose equal to three sprays contains 8.75 mg of flurbiprofen, corresponding to 16.2 mg/ml of flurbiprofen.
Excipients
Betadex, disodium phosphate dodecahydrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, honey flavouring, lemon flavouring, N,2,3-Trimethyl-2-isopro pilbutanamide, sodium saccharin (E954), hydroxypropylbetadex, purified water.
Qualitative composition of honey flavouring: flavouring substance(s), flavouring preparation(s), propylene glycol (E1520).
Qualitative composition of lemon flavouring: flavouring substance(s), flavouring preparation(s), propylene glycol (E1520).
How to use and Dosage
Dosage: For short-term treatment only.
Adults aged 18 years and over: One dose (3 sprays) administered at the back of the throat every 3-6 hours as needed, up to a maximum of 5 doses in a 24-hour period.
Paediatric population: The safety and efficacy of this medicine in children or adolescents under 18 years of age have not been established.
Elderly patients: A general dosage recommendation cannot be made, as clinical experience is currently limited.
Elderly people are at increased risk of serious consequences in the event of adverse reactions.
The lowest effective dose for the lowest effective dose should be used. short duration of treatment necessary to control symptoms.
Method of administration: For oromucosal administration.
Do not inhale during actuation.
This medicine should be used for a maximum of 3 days.
Before first use, activate the pump by pointing the nozzle away from your body and spraying at least four times until a fine, uniform mist is released.
The pump is then activated and ready for use.
Between one use and the next, point the nozzle away from your body and spray a minimum amount of product to ensure that the mist is fine and uniform.
Always ensure that the mist is fine and uniform before using the product.
Warnings
Undesirable effects can be minimised by using the lowest effective dose for the most effective treatment. short duration of treatment necessary to control symptoms.
Infections: Since exacerbation of infectious inflammation (e.g. development of necrotizing fasciitis) has been described in isolated cases in temporal association with the systemic use of drugs belonging to the class of NSAIDs, the patient is advised to consult a doctor immediately in case of appearance or worsening of signs of a bacterial infection during therapy with flurbiprofen spray.
It should be taken into consideration whether the initiation of antibiotic therapy is indicated.
In case of purulent bacterial pharyngitis/tonsillitis, the patient is advised to consult a doctor for a reassessment of the treatment.
Treatment should be administered for a maximum of 3 days.
If symptoms worsen or new symptoms appear, treatment should be reassessed.
If mouth irritation occurs, treatment with flurbiprofen should be discontinued.
Elderly population: Elderly people experience an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Respiratory effects: bronchospasm may be precipitated in patients with or with a history of bronchial asthma or allergic disease.
Flurbiprofen spray should be used with caution in these patients.
Other NSAIDs: The use of flurbiprofen spray should be avoided in conjunction with other NSAIDs, including cyclooxygenase-2 selective inhibitors.
Systemic lupus erythematosus (SLE) and mixed connective tissue disease: Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at increased risk of aseptic meningitis, however this effect is not usually seen with products intended for limited and short-term use such as flurbiprofen spray.
Cardiovascular, renal and hepatic impairment: 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 greatest risk of developing this reaction are those with impaired renal function, cardiac impairment, hepatic dysfunction, those on diuretic therapy, and the elderly; however, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen spray.
Hepatic effects: Mild to moderate hepatic dysfunction.
Cardiovascular and cerebrovascular effects: Caution is required before initiating treatment in patients with a history of hypertension and/or heart failure (consult your doctor or pharmacist) as fluid retention, hypertension, and edema have been reported in association with NSAID therapy.
Clinical studies and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may increase the risk of developing this reaction. be associated with a small increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
There are insufficient data to exclude this risk with flurbiprofen when administered at a daily dose not exceeding 5 doses (3 actuations for each dose).
Effects on the nervous system.
Analgesic-induced headache: in case of prolonged or irregular use of analgesics, headache may occur. may experience headache, which should not be treated by increasing the dose of the drug.
Gastrointestinal effects: NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly; However, this effect is not usually seen with products intended for limited, short-term use such as flurbiprofen spray.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to their doctor.
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 receiving flurbiprofen, the treatment should be discontinued.
Hematological effects: Flurbiprofen, like other NSAIDs, may cause gastrointestinal bleeding. inhibit platelet aggregation and prolong bleeding time.
Flurbiprofen spray should be used with caution in patients with the potential for abnormal bleeding.
Dermatological effects: 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 spray should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
This product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (sometimes delayed).
This product contains less than 1 mmol (23 mg) sodium per dose, i.e. initially "sodium-free".
Flavors containing allergens: This product contains flavors containing anisyl alcohol, citral, citronellol, d-Limonene, geraniol and linalool.
Anisyl alcohol, citral, citronellol, d-Limonene, geraniol, linalool may cause allergic reactions.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other NSAIDs.
Current or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration) and intestinal ulceration.
History of gastrointestinal bleeding or perforation, severe colitis, bleeding or haematopoietic disorders related to previous NSAID therapy.
Last trimester of pregnancy.
/>Severe heart failure, severe renal failure or severe hepatic failure.
Children and adolescents under 18 years of age.
Interactions
Flurbiprofen should be avoided in combination with: other NSAIDs including cyclooxygenase-2 selective inhibitors: avoid the concomitant use of two or more NSAIDs, as this may increase the risk of adverse effects (especially gastrointestinal adverse events such as ulcers and bleeding).
Acetylsalicylic acid (low dose): unless low-dose aspirin (not exceeding 75 mg/day) has been recommended by your doctor, as this may increase the risk of adverse effects. the risk or adverse events may increase.
Flurbiprofen should be used with caution in combination with:
Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.
Antiplatelet agents: There is an increased risk of gastrointestinal ulceration or bleeding.
Antihypertensive drugs (diuretics, ACE inhibitors, angiotensin antagonists): NSAIDs may reduce the effect of diuretics, and other antihypertensive drugs may enhance nephrotoxicity caused by cyclooxygenase inhibition, especially in patients with impaired renal function.
Alcohol: May increase the risk of nephrotoxicity caused by cyclooxygenase inhibition. 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. Appropriate monitoring and, if necessary, dose adjustment are recommended.
Cyclosporin: There is an increased risk of nephrotoxicity.
Corticosteroids: There is an increased risk of gastrointestinal ulceration or bleeding.
Lithium: There may be an increase in serum lithium levels. Appropriate monitoring and, if necessary, dose adjustment are recommended.
Methotrexate: Administration of NSAIDs within 24 hours before or after methotrexate administration may increase the risk of renal failure. lead to elevated methotrexate concentrations and an increase in its toxic effects.
Mifepristone: NSAIDs should not be used for 8 - 12 days after mifepristone administration, as NSAIDs may reduce the effect of mifepristone.
Oral antidiabetics: alterations in blood glucose levels have been reported (an increased frequency of monitoring is recommended).
Phenytoin: serum phenytoin levels may increase; adequate monitoring and, if necessary, dose adjustment are recommended.
Potassium-sparing diuretics: concomitant use may increase the risk of circulating potassium in the blood. cause hyperkalemia.
Probenecid and sulfinpyrazone: Medicines containing probenecid and sulfinpyrazone may delay the excretion of flurbiprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of convulsions associated with quinolone antibiotics.
Patients taking NSAIDs and quinolones may be at increased risk of developing convulsions.
Selective serotonin reuptake inhibitors (SSRIs): There is an increased risk of gastrointestinal ulceration or bleeding.
Tacrolimus: There is a possible increased risk of nephrotoxicity when NSAIDs are administered concomitantly with tacrolimus.
Zidovudine: There is an increased risk of haematological toxicity when NSAIDs are administered concomitantly with zidovudine.
Paediatric population: No additional information is available.
Undesirable effects
Hypersensitivity reactions to NSAIDs have been reported and these may consist of: non-specific allergic reactions and anaphylaxis; respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea; various skin reactions, e.g. pruritus, urticaria, angioedema and, more generally, rash. rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Data are insufficient to exclude this risk with the use of flurbiprofen oromucosal spray, solution.
The list of adverse effects reported below refers to those recorded with flurbiprofen, used at doses compatible with the OTC classification and for a short period.
(very common (>=1/10), common (from >=1/100 to <1/10), uncommon (from >=1/1,000 to <1/100), rare (from >=1/10,000 to <1/1,000), very rare (<1/10,000), not known (frequency cannot be estimated from the available data). cannot be estimated from the available data).
Blood and lymphatic system disorders.
Not known: anemia, thrombocytopenia.
Cardiovascular and cerebrovascular disorders.
Not known: edema, hypertension, cardiac failure.
Nervous system disorders.
Common: dizziness, headache, paraesthesia; uncommon: somnolence.
Respiratory, thoracic and mediastinal disorders.
Common: throat irritation;
Uncommon: exacerbation of asthma and bronchospasm, dyspnoea, wheezing, oropharyngeal vesicular rash, hypoaesthesia of the pharynx.
Gastrointestinal disorders.
Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort (sensation of heat or burning, tingling of the mouth);
Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting.
Skin and subcutaneous tissue disorders.
Uncommon: rashes of various types, pruritus;
Not known: severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome and epidermal necrolysis toxic.
General disorders and administration site conditions.
Uncommon: pyrexia, pain.
Immune system disorders.
Rare: anaphylactic reaction.
Psychiatric disorders.
Uncommon: insomnia.
Hepatobiliary disorders.
Not known: hepatitis.
Pregnancy and breastfeeding
Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryonic/foetal development.
Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis following use of a prostaglandin synthesis inhibitor in early pregnancy.
The absolute risk of cardiovascular malformation was increased from less than 1%, up to approximately 50%. 1.5%.
The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered a prostaglandin synthesis inhibitor during the organogenetic period.
Flurbiprofen should not be administered during the first and second trimesters of pregnancy.
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 lead to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction which may lead to:
- renal insufficiency, ... progress to renal failure with oligo-hydramnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, an antiaggregant effect which may may occur even at very low doses.
- Inhibition of uterine contractions resulting in a delay or prolongation of labor.
Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.
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, due to the possible adverse effects of NSAIDs on breast-fed infants, the use of flurbiprofen spray by breast-feeding mothers is not recommended.
Fertility: There is some evidence to suggest that cyclooxygenase/prostaglandin synthase inhibitors may cause impairment of female fertility by an effect on ovulation.
This is reversible upon discontinuation of treatment.
Storage
Do not refrigerate or freeze.
Format
15 ml oral mucosal spray
Product Code:FRCM159798
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