Strefen Spray 8.75 Mg

/ rb

For short-term use only.
Adults aged 18 years and over:
One dose (3 actuations) administered to the back of the throat every 3-6 hours as required, up to a maximum of 5 doses in a 24 hour period.

Symptomatic relief of acute sore throat in adults.

* 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.
* Active, 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, haemorrhagic 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 below 18 years.

Infections
Since in isolated cases an exacerbation of infective inflammations (e.g. development of necrotising fasciitis) has been described in temporal association with the use of systemic NSAIDs as a class, the patient is advised to consult a physician immediately if signs of a bacterial infection occur or worsen during the flurbiprofen spray therapy.
It should be considered whether initiation of an anti-infective antibiotic therapy is indicated.
Masking of symptoms of underlying infections:
Epidemiological studies suggest that systemic non-steroidal anti-inflammatory drugs (NSAIDs) can mask symptoms of infection.
Treatment should be administered for three days maximum. If the symptoms get worse or if new symptoms occur, the treatment should be reevaluated. If mouth irritation occurs, flurbiprofen treatment should be withdrawn.
Elderly population
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Respiratory
Bronchospasm may be precipitated in patients suffering from or with a previous
history of bronchial asthma or allergic disease. Flurbiprofen spray should be used with caution in these patients.
Other NSAIDs
The use of flurbiprofen spray with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided
Cardiovascular and cerebrovascular effects
Caution (talk with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs, (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for flurbiprofen when given at a daily dose of no more than 5 doses (3 sprays per dose).
Gastrointestinal
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated 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 anti-platelet agents such as acetylsalicylic acid. If GI bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.
Haematological effects
Flurbiprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time. Flurbiprofen spray should be used with caution in patients with a potential for abnormal bleeding.
Dermatological
Serious skin reactions, some of them fatal, including exfoliative dermatitis, StevensJohnson 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.
See prescribing information for full details.

Common: dizziness, headache, parasthesia, throat irritation, diarrhoea, mouth ulceration, nausea, oral pain, paraesthesia oral, oropharyngeal pain, oral discomfort (warm or burning feeling or tingling of the mouth).
See prescribing information for full details.

Flurbiprofen should be avoided in combination with:

Other NSAIDS (including cyclooxygenase-2 selective inhibitors): Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (esp. gastrointestinal adverse events such as ulcers and bleeding).
Acetylsalicylic acid: This may increase the risk of adverse reactions. Low-dose aspirin (up to 75 mg/day) should be taken only when necessary.
Flurbiprofen should be used with caution in combination with:
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin.
Anti-platelet Agents: Increased risk of gastrointestinal ulceration or bleeding.
Antihypertensive drugs (Diuretics, ACE inhibitors, angiotensin-II antagonists): NSAIDs may reduce the effect of diuretics and other antihypertensive drugs may enhance nephrotoxicity caused by inhibition of cyclooxygenase, especially in patients with compromised renal function.
Lithium: May increase serum levels of lithium – adequate control and, if necessary, dose adjustment is recommended.
Methotrexate: The administration of NSAIDs within 24 hours before or after administration of methotrexate may lead to elevated concentrations of methotrexate and an increase in its toxic effect.
Mifepristone: NSAIDs should not be used for 8 – 12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Oral antidiabetics: Alteration of blood glucose levels reported (increased check rate recommended).
Phenytoin: May increase serum levels of phenytoin – adequate control and, if necessary, dose adjustment is recommended.
See prescribing information for full details.

Pregnancy: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy.
Rarely, taking NSAIDs after the 20th week of pregnancy may cause impaired renal function of the fetus, which may cause low levels of amniotic fluid (oligohydramnios). The effects were observed after days to weeks of treatment. However, in rare cases, low levels of amniotic fluid were observed already after 48 hours of taking NSAIDs. In most cases, oligohydramnios passed with the treatment discontinuation.
Using NSAIDs after the 20th week of pregnancy should be limited. If it was decided that the benefit outweighs the risk for the fetus and the treatment with the medicine is essential after the 20th week of pregnancy, the lowest effective dose should be used for the shortest possible period. Referring the patient to ultrasound scan should be considered, in order to estimate the amount of amniotic fluid when the treatment with therapeutic dosage of these medicines exceeding 5 days and stopping the treatment if low levels of amniotic fluid is detected.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
* Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
* Renal dysfunction, which may progress to renal failure with oligohydroamniosis; the mother and the neonate, at the end of pregnancy, to:
* Possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
* Inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, flurbiprofen is contraindicated during the third trimester of pregnancy.
Lactation: Flurbiprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely. However, because of possible adverse effects of NSAIDs on breast-fed infants, flurbiprofen spray is not recommended for use in nursing mothers.

See prescribing information for full details.