Ketodol gola - spray against sore throat 15 ml

Product Description

Spray to combat inflammation and irritation of the throat.

Indications

Ketodol Throat Spray 12.5 mg/ml is a spray to always carry with you when needed for a rapid action against sore throat.
Thanks to the dispenser, it acts in a targeted manner on the oral mucosa and can be used as a spray. be used to treat irritative-inflammatory conditions, even associated with pain, of the oropharyngeal cavity.
It is a symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), even as a consequence of conservative or extractive dental therapy.

Ingredients

Active ingredients: 100 ml of solution contain 250 mg of Flurbiprofen.
Excipients: glycerol (98%), ethanol, non-crystallizing liquid sorbitol, polyoxyethylene-40 hydrogenated castor oil, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, mint flavoring, patent blue V (E131), anhydrous citric acid, sodium hydroxide, purified water.

Directions for use and Dosage

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Adults: Apply one dose (2 sprays) 3 times a day directly to the affected area.
Each spray delivers 0.2 ml of solution, equivalent to 0.5 mg of active ingredient.
Paediatric population.
Children over 12 years: As for adults.
Children under 12 years: Do not administer to children under 12 years of age.
Special populations.
Elderly: The clinical data currently available are limited, therefore the use of this product cannot be recommended. No dosage recommendations should be made.
Elderly people are at greater risk of serious consequences in the event of adverse reactions.
Patients with hepatic impairment: No dosage reduction is necessary in patients with mild to moderate hepatic impairment.
Flurbiprofen is contraindicated in patients with severe hepatic impairment.
Patients with renal impairment: No dosage reduction is necessary in patients with mild to moderate renal impairment.
Flurbiprofen is contraindicated in patients with severe renal impairment.
Method of administration:
For oropharyngeal use.
Point the dispenser towards the back of the throat and spray on the affected area.

Warnings

At the recommended doses, when using the medicine 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.
Elderly.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Respiratory disorders.
Cases of bronchospasm have been reported with flurbiprofen in patients with a history of bronchial asthma or allergies.
Flurbiprofen should be used with caution in these patients.
Other NSAIDs
It is advisable not to combine the medicinal product with other NSAIDs.
Systemic lupus erythematosus (SLE) and mixed connective tissue disease.
Patients with systemic lupus erythematosus 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.
Impairment cardiac, hepatic and renal impairment.
The medicine should be used with caution in patients with cardiac, renal or hepatic insufficiency.
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 renal insufficiency should be monitored carefully. Patients with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics, and the elderly are at increased risk of developing this reaction; however, this effect is not usually observed with products intended for limited and short-term use such as flurbiprofen.
For more information, see the package leaflet.

Contraindications

Do not use the medicine in children under 12 years of age.
Flurbiprofen is contraindicated in patients with known hypersensitivity to flurbiprofen or to any of the excipients.
Patients who have previously shown hypersensitivity reactions (e.g., asthma, urticaria, allergy, rhinitis, angioedema, bronchospasm) to ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
Flurbiprofen is also contraindicated in patients with a history of 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, severe hepatic insufficiency, and renal insufficiency.
Third trimester of pregnancy.

Interactions

Caution should be exercised in patients treated with any of the following drugs, as interactions have been reported in some patients.
Inform your doctor if you are taking other medicines.
Flurbiprofen should be avoided in combination with Acetylsalicylic acid:
Unless taking low dose acetylsalicylic acid (not exceeding 100 mg) is recommended, 100 mg/day or local prophylactic doses for cardiovascular protection) has been recommended by the doctor;
As with other medicinal products containing NSAIDs, concomitant administration of flurbiprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects;
Cox-2 inhibitors and other NSAIDs: Concomitant use of other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided due to potential additive effects and an increased risk of adverse reactions.
Flurbiprofen should be used with caution in combination with Anticoagulants:
NSAIDs may enhance the effects of anticoagulants such as warfarin;
Antiplatelet agents: increased risk of gastrointestinal bleeding.
Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Antihypertensives (diuretics, ACE inhibitors and angiotensin II antagonists): NSAIDs may reduce the effect of diuretics.
For more information, see the package leaflet.

Undesirable effects

Hypersensitivity reactions to NSAIDs have been reported and these may consist of:

1. Non-specific allergic reactions and anaphylaxis;
2. Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea;
3. Various skin disorders, including, for example, rashes of different types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).

The most commonly observed adverse reactions are of a gastrointestinal nature.
Local use of the medicine, especially if prolonged, may give rise to sensitization or local irritation phenomena.
In such cases, treatment should be discontinued and, if necessary, appropriate therapy instituted.
The following undesirable effects have been reported, particularly after the administration of systemic formulations.
They refer to those observed with the use of flurbiprofen used short-term and at doses compatible with the classification of over-the-counter medicines.
In the case of treatment of chronic conditions and for long periods of time, additional undesirable effects may occur.
The undesirable effects associated with the use of flurbiprofen are divided below according to system organ class and frequency.
The frequency is defined as: very common (>= 1/10), common (>= 1/100,<1/10), uncommon (>=1/1,000, <1/100), rare (>=1/10,000, <1/1,000), very rare (<1/10,000) and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders:
Not known: anaemia, thrombocytopenia, aplastic anaemia and agranulocytosis.
Nervous system disorders:
Common: dizziness, headache, paraesthesia; uncommon: somnolence; Not known: cerebrovascular accident, optic neuritis, migraine, confusional states, vertigo.
Immune system disorders:
Rare: anaphylactic reactions; Not known: angioedema, hypersensitivity. Eye disorders: Not known: visual disturbances.
Ear and labyrinth disorders:
Not known: tinnitus. Cardiac disorders: Not known: cardiac failure, oedema.
Vascular disorders:
Not known: hypertension.
Respiratory, thoracic and mediastinal disorders:
Common: throat irritation; Uncommon: asthma, bronchospasm and dyspnoea, oropharyngeal blistering, oropharyngeal hypoaesthesia.
Gastrointestinal disorders:
Common: diarrhoea, mouth ulceration, nausea, oral pain, oral paraesthesia, oropharyngeal pain, oral discomfort; Uncommon: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting; Not known: melaena, haematemesis, gastrointestinal haemorrhage, colitis, exacerbation of Crohn's disease, gastritis, peptic ulcer, gastric perforation, ulcer haemorrhage.
Skin and subcutaneous tissue disorders:
Uncommon: rash, pruritus; Not known: urticaria, purpura, bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).
Renal and urinary disorders:
Not known: nephrotoxicity, tubulointerstitial nephritis and nephrotic syndrome, renal failure (as with other NSAIDs).
General disorders and administration site conditions:
Uncommon: pyrexia, pain; not known: discomfort, fatigue. Hepatobiliary disorders: Not known: hepatitis.
Psychiatric disorders:
Uncommon: insomnia; Not known: depression, hallucination.

Pregnancy and Breastfeeding

• Pregnancy
  Flurbiprofen should not be administered during the first and second trimester of pregnancy unless clearly necessary.
  The use of flurbiprofen during the third trimester of pregnancy is contraindicated.
• 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, administration of flurbiprofen is not recommended in breast-feeding mothers.
• Fertility
  There is evidence to suggest that cyclooxygenase/prostaglandin synthesis inhibitors may cause impairment of female fertility by an effect on ovulation.
  This is reversible following administration. upon discontinuation of treatment.

Storage

This medicine does not require any special storage precautions.

Format

Throat Spray 15 ml