Active ingredients: Flurbiprofen
BENACTIV THROAT 0.25% Mouthwash
BENACTIV THROAT 0.25% Oral mucosal spray
BENACTIV THROAT 8.75 mg Lemon and Honey flavored tablets
BENACTIV THROAT 8.75 mg Sugar-free Orange flavored tablets
Why is Benactiv throat used? What is it for?
WHAT IS IT
BENACTIV THROAT is a non-steroidal anti-inflammatory / antirheumatic, derivative of propionic acid.
WHY IT IS USED
BENACTIV THROAT Mouthwash / BENACTIV THROAT Spray is used in the symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a result of conservative or extractive dental therapy.
BENACTIV THROAT Lemon and Honey flavored tablets / BENACTIV THROAT Orange flavored sugar-free tablets are used in the symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis).
Contraindications When Benactiv throat should not be used
BENACTIV THROAT Lemon and Honey flavored tablets / BENACTIV THROAT Orange flavored sugar-free tablets: 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 anamnestic 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.
When it can be used only after consulting your doctor
It is also advisable to consult your doctor in cases where the aforementioned disorders have occurred in the past.
What to do during pregnancy and breastfeeding
During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases.
Administration of flurbiprofen is not recommended in nursing mothers
Precautions for use What you need to know before taking Benactiv throat
At the recommended doses, when using the product in its various pharmaceutical forms, any swallowing does not cause any harm to the patient, as the dose of flurbiprofen is much lower than that commonly used in systemic treatments.
The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy.
In patients with renal, cardiac or hepatic insufficiency the product should be used with caution. It is advisable not to associate 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, ulcer or perforation is higher with increasing dose of flurbiprofen in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment at the lowest dose. available.
Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events.
Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section "HOW TO USE THIS MEDICINAL PRODUCT").
Interactions What drugs or foods can change the effect of Benactiv throat
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients.
However, 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 gastrointestinal ulcer or haemorrhage with NSAIDs.
Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.
Warnings It is important to know that:
It does not affect the ability to drive and use machines.
BENACTIV THROAT Mouthwash and BENACTIV THROAT Spray contain para-hydroxy-benzoates which can cause delayed allergic reactions, such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm.
BENACTIV THROAT Lemon and Honey flavor tablets contain 1.069 g of glucose and 1.407 g of sucrose per tablet. Not recommended in hereditary fructose intolerances, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency.
BENACTIV THROAT Sugar-free Orange flavored tablets is instead indicated for those patients who need to control the intake of sugars and calories.
BENACTIV THROAT Sugar-free Orange flavor tablets contain the color E110 which can cause allergic reactions.
Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor.
Dosage and method of use How to use Benactiv throat: Dosage
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
BENACTIV THROAT Mouthwash
How much and How
2-3 rinses or gargles a day with 10 ml (1 scoop) of mouthwash diluted in half a glass of water or pure.
BENACTIV THROAT Spray
How much and How
2 sprays 3 times a day addressed directly to the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.
BENACTIV THROAT Lemon and Honey flavored tablets BENACTIV GOLA Orange flavored sugar-free tablets
How much and How
Adults and children over 12 years: 1 tablet every 3-6 hours as needed.
Do not exceed the dose of 8 tablets in 24 hours.
Dosage changes are not necessary for the elderly.
Do not administer to children under the age of 12.
The lozenge should be dissolved slowly in the mouth.
Warning: do not exceed the indicated doses without medical advice.
Use only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics
Overdose What to do if you have taken an overdose of Benactiv throat
Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur. In the event of this occurrence, appropriate symptomatic treatments should be adopted.
Symptoms
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
Treatment
Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture.
There is no specific antidote for flurbiprofen.
In case of accidental ingestion / intake of an excessive dose of the product, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT USING BENACTIV THROAT, CONTACT YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Benactiv throat
Like all medicines, BENACTIV THROAT can cause side effects, although not everybody gets them.
The following undesirable effects have been reported, particularly after administration of formulations for systemic use:
Disorders of the blood and lymphatic system
Thrombocytopenia, aplastic anemia and agranulocytosis
Disorders of the immune system
Anaphylaxis, angioedema, allergic reaction
Disorders of the nervous system
Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, discomfort, fatigue and somnolence
Acoustic and labyrinth disturbances
Tinnitus 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. Gastritis, peptic ulcer, perforation and ulcer haemorrhage have been observed less frequently
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)
Kidney and urinary system disorders
Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome
As with other NSAIDs, rare cases of renal insufficiency have been reported. Topical use of the product, especially if prolonged, may give rise to sensitization or local irritation.
The dissolution in the oral cavity of the product in the form of tablets may be accompanied by sensations of heat or tingling in the oropharynx.
In such cases, treatment must be interrupted and appropriate therapy instituted if necessary.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Request and fill in the undesirable effects report form available at the pharmacy.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
Warning: do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Benactiv Gola Sugar-Free Orange Flavor Tablets: store at a temperature not exceeding 25 ° C.
Keep this medicine out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
BENACTIV THROAT Mouthwash
100 ml of mouthwash contains:
Active ingredient: flurbiprofen 250 mg
Excipients: glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E 131), purified water.
BENACTIV THROAT Spray
100 ml of solution contain:
Active ingredient: flurbiprofen 250 mg
Excipients: glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E 131), purified water.
BENACTIV THROAT Lemon and Honey flavored tablets
One tablet contains:
Active ingredient: flurbiprofen 8.75 mg
Excipients: sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavor, menthol, honey.
BENACTIV THROAT Sugar-free Orange flavored tablets
One tablet contains:
Active ingredient: flurbiprofen 8.75 mg
Excipients: macrogol 300, potassium hydroxide, orange flavor, levomentol, acesulfame K, E110, maltitol syrup, isomaltose.
HOW IT LOOKS
BENACTIV THROAT Mouthwash comes in the form of a solution. The content of the bottle is 160 ml and contains a 10 ml measuring cup.
BENACTIV THROAT Spray comes in the form of a solution. The vial, which contains 15 ml, is equipped with a spray valve.
BENACTIV THROAT Lemon and Honey flavored tablets / BENACTIV THROAT Orange flavored sugar-free tablets comes in the form of tablets contained in blister packs. Packs of 16 or 24 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BENACTIV THROAT
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
BENACTIV THROAT Mouthwash
100 ml of mouthwash contain, active ingredient: flurbiprofen 250 mg.
BENACTIV THROAT Oral mucosal spray
100 ml of solution contain, active ingredient: flurbiprofen 250 mg.
BENACTIV THROAT Lemon and Honey flavored tablets
BENACTIV THROAT Sugar-free tablets
BENACTIV THROAT Orange flavored sugar-free tablets
One tablet contains, active ingredient: flurbiprofen 8.75 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Mouthwash.
Oral mucosal spray.
Pads.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
BENACTIV THROAT Mouthwash
BENACTIV THROAT Oral mucosal spray
Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.
BENACTIV THROAT Lemon and Honey flavored tablets
BENACTIV THROAT Sugar-free tablets
BENACTIV THROAT Orange flavored sugar-free tablets
Symptomatic treatment of irritative-inflammatory states also associated with oropharyngeal pain (eg gingivitis, stomatitis, pharyngitis).
04.2 Posology and method of administration
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section Special warnings and precautions for use).
BENACTIV THROAT Mouthwash
2-3 rinses or gargles a day with 10 ml (1 scoop) of mouthwash diluted in half a glass of water or pure.
BENACTIV THROAT Oral mucosal spray
2 sprays 3 times a day addressed directly to the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.
BENACTIV THROAT Lemon and Honey flavored tablets
BENACTIV THROAT Sugar-free tablets
BENACTIV THROAT Orange flavored sugar-free tablets
Adults and children over 12 years: 1 tablet to be dissolved slowly in the mouth every 3-6 hours, as needed. Do not exceed the dose of 8 tablets in 24 hours.
Do not administer to children under the age of 12. Dosage changes are not necessary for the elderly.
04.3 Contraindications
BENACTIV THROAT Tablets: 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 anamnestic 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.
04.4 Special warnings and appropriate precautions for use
At the recommended doses, when using the product in its various pharmaceutical forms, any swallowing does not cause any harm to the patient, as the dose of flurbiprofen is much lower than that commonly used in systemic treatments.
The use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation; in such cases it is necessary to interrupt the treatment and consult the doctor to establish, if necessary, a suitable therapy.
In patients with renal, cardiac or hepatic insufficiency the product should be used with caution. It is advisable not to associate 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, ulcer or perforation is higher with increasing flurbiprofen dosage in patients with a history of ulcer, particularly if complicated with haemorrhage and perforation and in the elderly. These patients should start treatment at the lowest dose. available.
Gastrointestinal bleeding, ulcer or perforation have been reported with all NSAIDs at any time during treatment. These adverse events can be fatal and can occur with or without warning symptoms or with a previous history of serious gastrointestinal events.
Patients with a history of gastrointestinal disease, particularly if elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) in the initial stages of treatment.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal haemorrhage and perforation, which can be fatal.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2).
BENACTIV THROAT Mouthwash and BENACTIV THROAT Spray contain para-hydroxy-benzoates which can cause delayed allergic reactions, such as contact dermatitis; more rarely they can cause immediate reactions, with hives and bronchospasm.
BENACTIV THROAT Lemon and Honey flavor tablets contain 1.069 g of glucose and 1.407 g of sucrose per tablet. Not recommended in hereditary fructose intolerances, glucose-galactose malabsorption syndrome or sucrase-isomaltase insufficiency.
BENACTIV THROAT Sugar-Free Tablets and BENACTIV GOLA Sugar-Free Tablets Orange flavor, on the other hand, are indicated for those patients who need to control the intake of sugars and calories.
BENACTIV THROAT Sugar-free Orange flavor tablets contain the color E110 which can cause allergic reactions.
Do not use for prolonged treatments. After short periods of treatment without appreciable results, consult your doctor.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Caution should be exercised in patients treated with any of the medicines listed below, as interactions have been reported in some patients.
However, inform your doctor if you are taking other medicines.
Aspirin: As with other NSAID-containing medicinal products, 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 ulcer or haemorrhage with NSAIDs.
Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to potential additive effects.
04.6 Pregnancy and lactation
During the first and second trimester of pregnancy, flurbiprofen should not be administered except in strictly necessary cases.
Administration of flurbiprofen is not recommended in nursing mothers.
04.7 Effects on ability to drive and use machines
It does not affect the ability to drive and use machines.
04.8 Undesirable effects
The following undesirable effects have been reported, particularly after administration of formulations for systemic use:
Disorders of the blood and lymphatic system
Thrombocytopenia, aplastic anemia and agranulocytosis
Disorders of the immune system
Anaphylaxis, angioedema, allergic reaction
Disorders of the nervous system
Dizziness, cerebrovascular accidents, visual disturbances, optic neuritis, migraine, paraesthesia, depression, confusion, hallucination, dizziness, discomfort, fatigue and somnolence
Acoustic and labyrinth disturbances
Tinnitus
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. Gastritis, peptic ulcer, perforation and ulcer haemorrhage were observed less frequently.
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).
Kidney and urinary system disorders
Nephrotoxicity in various forms, including interstitial nephritis and nephrotic syndrome.
As with other NSAIDs, rare cases of renal failure have been reported.
The topical use of the product, especially if prolonged, can give rise to sensitization phenomena or local irritation.
The dissolution in the oral cavity of the product in the form of tablets may be accompanied by sensations of heat or tingling in the oropharynx.
In such cases, treatment must be interrupted and appropriate therapy instituted if necessary.
04.9 Overdose
Considering the reduced content of active ingredient and its local use, it is unlikely that overdose situations will occur.
Symptoms
Symptoms of overdose may include nausea, vomiting and gastrointestinal irritation.
Treatment
Treatment should include gastric lavage and, if necessary, correction of the serum electrolyte picture. There is no specific antidote for flurbiprofen.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: stomatologicals, other substances for local oral treatment
ATC code: A01AD11
In pharmacological studies, flurbiprofen has been shown to have a marked anti-inflammatory, analgesic and antipyretic activity, typical of the pharmacological profile of non-steroidal anti-inflammatory drugs and due to the "inhibition of cyclooxygenase and lipoxygenase enzymes and, consequently, to the" inhibition of prostaglandin synthesis and of leukotrienes.
The research carried out in animals has highlighted the anti-inflammatory activity of flurbiprofen in various experimental models, such as ultraviolet ray erythema, carrageenan edema, capillary permeability and adjuvant arthritis.
The analgesic effect of flurbiprofen was confirmed in experimental models of pain induced by chemical, mechanical and thermal stimuli (acetylcholine contortions, pressure on the inflamed paw and hot plate test).
The high antiprostaglandin activity exerted by flurbiprofen amply justifies the use of the drug in all those morbid states in which the anti-inflammatory component is predominant.
05.2 Pharmacokinetic properties
The product, in its various formulations, gives rise to a poor systemic absorption, correlated to the reduced concentration of active principle.
Flubiprofen is also rapidly absorbed through the oropharyngeal mucosa. Maximum plasma concentrations are reached after 30-40 minutes, are dose proportional and are not influenced by either age or gender.
In the animal (rat and baboon) oral flurbiprofen is distributed mainly in the liver and kidney, moreover, in the dog and baboon it is present in the enterohepatic circulation.
Flurbiprofen is rapidly distributed, is mainly metabolised by hydroxylation in the liver and the two main metabolites are eliminated mainly by the kidney. Flurbiprofen is excreted in very small quantities via breast milk (less than 0.05 mg / ml).
Flurbiprofen binds extensively to plasma proteins and the half-life of the molecule in plasma is between 3 and 6 hours.
05.3 Preclinical safety data
The acute toxicity of oral flurbiprofen, expressed as LD50, is 750 mg / kg in the mouse and 600 mg / kg in the rat.
The study of sub-acute toxicity after oral treatment with 3 mg / kg / day in rats for 34 days and with 0.025 mg / kg / day in dogs for 30 days showed that the drug is well tolerated.
Chronic toxicity showed the good tolerability of flurbiprofen after oral treatment for 6 months in the rat with 2 mg / kg / day and in the dog with 0.05 mg / kg / day.
There were no differences in the haematological and haematochemical parameters considered, nor were there any histopathological changes compared to controls.
Teratogenic studies, performed on rats and rabbits, have shown that flurbiprofen does not affect fertility and the course of pregnancy, nor does it modify the number of fetuses, that of newborns and the development of the latter when administered orally at a dose of 4. mg / kg.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
BENACTIV THROAT Mouthwash
Glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E 131), purified water.
BENACTIV THROAT Oral mucosal spray
Glycerol, ethyl alcohol, sorbitol 70, hydrogenated castor oil-40-polyoxyethylenate, sodium hydroxide, sodium saccharinate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint essence, patent blue V (E 131), purified water.
BENACTIV THROAT Lemon and Honey flavored tablets
Sucrose, glucose, macrogol 300, potassium hydroxide, lemon flavor, menthol, honey.
BENACTIV THROAT Sugar-free tablets
Isomaltose, maltitol syrup, calcium carbonate, anhydrous colloidal silica, povidone, magnesium stearate, cherry essence.
BENACTIV THROAT Orange flavored sugar-free tablets
Macrogol 300, potassium hydroxide, orange flavor, levomenthol, acesulfame K, E110, maltitol syrup, isomaltose.
06.2 Incompatibility
In the studies conducted so far, there have been no cases of incompatibility of flurbiprofen with other substances.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Benactiv Gola Sugar-Free Orange Flavor Tablets: store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
BENACTIV THROAT Mouthwash
Type III yellow glass bottle, closed with an aluminum screw cap fitted with a polythene seal.
Polythene measuring cup, graduated at 10 ml.
BENACTIV THROAT Oral mucosal spray
Plasticized type III yellow glass vial, closed with spray valve fitted with polythene gasket and polypropylene body with polythene end portion, complete with dispenser made of polypropylene and polythene.
BENACTIV THROAT Lemon and Honey flavored tablets
BENACTIV THROAT Sugar-free tablets
BENACTIV THROAT Orange flavored sugar-free tablets
Packs containing 16 or 24 tablets of flurbiprofen 8.75 mg, packed in PVC / PVDC aluminum blisters.
06.6 Instructions for use and handling
None known.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare International Ltd - 103-105, Bath Road - Slough SL1 3UH - Great Britain
Representative for Italy
Reckitt Benckiser Healthcare (Italy) S.p.A. - via G. Spadolini, 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
BENACTIV THROAT 0.25% Mouthwash - 160 ml bottle - AIC n. 033262015
BENACTIV THROAT 0.25% Oral mucosal spray - 15 ml vial - AIC n. 033262041
BENACTIV THROAT 8.75 mg Lemon and Honey flavored tablets - pack of 16 tablets - AIC n. 033262027
BENACTIV THROAT 8.75 mg Lemon and Honey flavored tablets - pack of 24 tablets - AIC n. 033262039
BENACTIV THROAT 8.75 mg Sugar-free tablets - pack of 16 tablets - AIC n. 033262054
BENACTIV THROAT 8.75 mg Sugar-free tablets - pack of 24 tablets - AIC n. 033262066
BENACTIV THROAT 8.75 mg Orange flavored sugar-free tablets - pack of 16 tablets - AIC n. 033262078
BENACTIV THROAT 8.75 mg Orange flavored sugar-free tablets - pack of 24 tablets - AIC n. 033262080
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
BENACTIV THROAT 0.25% Mouthwash, 160 ml bottle: May 16, 1998
BENACTIV THROAT 0.25% Oral mucosal spray, 15 ml vial: April 20, 2001
BENACTIV THROAT 8.75 mg Lemon and Honey flavored tablets, pack of 16 tablets: May 8, 1999
BENACTIV THROAT 8.75 mg Lemon and Honey flavored tablets, pack of 24 tablets: May 8, 1999
BENACTIV THROAT 8.75 mg Sugar-free tablets, pack of 16 tablets: March 8, 2004
BENACTIV THROAT 8.75 mg Sugar-free tablets, pack of 24 tablets: March 8, 2004
BENACTIV THROAT 8.75 mg Orange flavored sugar-free tablets, pack of 16 tablets: March 8, 2004
BENACTIV THROAT 8.75 mg Orange flavored sugar-free tablets, pack of 24 tablets: March 8, 2004
10.0 DATE OF REVISION OF THE TEXT
April 2009
