Strepsils MaxPro Direct

The oromucosal spray, solution is a clear colourless to slightly yellow solution with a taste of cherry and mint.
The active substance is flurbiprofen.
One dose (3 sprays) contains 8.75 mg corresponding to 16.2 mg/mL.
Excipients/Inactive Ingredients: Other ingredients: Betadex, Disodium phosphate dodecahydrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sodium hydroxide, Mint flavour, Cherry flavour, N,2,3-Trimethyl-2-isopropylbutanamide, Saccharin sodium, Hydroxypropylbetadex and Purified water.

Flurbiprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which work by changing how the body responds to pain, swelling and high temperature.

Flurbiprofen (Strepsils MaxPro Direct) is used for the short-term relief of symptoms of sore throats such as throat soreness, pain, difficulty swallowing and swelling.

Always use this medicine exactly as described in this monograph or as the doctor or pharmacist has told. Check with the doctor or pharmacist if the patient is not sure.
Recommended dose: Adults: Apply 1 dose (3 sprays) to the affected area every 3-6 hours as required. Do not exceed 5 doses in any 24-hour period.
Paediatric population: Children aged 12 years and over: As above for adults.
Children under 12 years: Not indicated for children under 12 years (see Contraindications).
Elderly: A general dose recommendation cannot be given since, to date, clinical experience is limited.
The elderly are at increased risk of the serious consequences of adverse reactions (see Precautions).
Impaired hepatic: In patients with mild to moderate impairment of hepatic function, no dose reduction is required. In patients with severe hepatic insufficiency flurbiprofen is contraindicated (see Contraindications).
Impaired renal: In patients with mild to moderate impairment of renal function, no dose reduction is required. In patients with severe renal insufficiency flurbiprofen is contraindicated (see Contraindications).
For oromucosal only.
Spray at the back of the throat only.
Do not inhale while spraying.
Do not take more than 5 doses (15 sprays) in 24 hours.
Flurbiprofen (Strepsils MaxPro Direct) is for short-term use only. The patient should use as few doses as needed for the shortest time necessary to relieve the symptoms. If mouth irritation occurs, flurbiprofen treatment should be withdrawn.
Do not use this medicine for more than 3 days unless instructed to do so by the doctor. If the patient does not get better, the patient gets worse, or if new symptoms occur, talk to the doctor or pharmacist.
Priming the pump: When using the pump for the first time (or after storage for a long period of time) the patient must first prime the pump.
Point the nozzle away from the patient and spray a minimum of four times until a fine, consistent mist is produced. The pump is then primed and ready for use. If the product is not used for a period of time, point the nozzle away from the patient and spray a minimum of once ensuring a fine, consistent mist is produced. Always ensure a fine consistent mist is produced before dosing the product.
Using the spray: Aim the nozzle towards the back of the throat.
Using a smooth rapid motion, depress the pump three times, taking care to fully depress the pump for each spray, while removing the finger from the top of the pump between each spray.
Do not inhale while spraying.
If the patient uses more Flurbiprofen (Strepsils MaxPro Direct) than the patient should, talk to a doctor or pharmacist or go to the nearest hospital straight away.

Signs and Symptoms of Overdose: Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more serious poisoning with NSAIDs, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation, blurred vision and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning with NSAIDs metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
What to Do When the Patient Has Taken More Than the Recommended Dosage: Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal and if necessary, correction of serum electrolytes if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma. There is no specific antidote to flurbiprofen overdose.

When should the patient not take this medicine: If the patient is allergic to flurbiprofen or to any of the excipients listed in the product.
If the patient has previously shown hypersensitivity reactions (e.g., asthma, rhinitis, angioedema, bronchospasm or urticaria) in response to ibuprofen, acetylsalicylic acid (Aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
If the patient has active or history of recurrent peptic ulcer/haemorrhage (2 or more distinct episodes of proven ulceration or bleeding).
If the patient has a history of gastrointestinal bleeding or perforation, severe colitis, haemorrhagic or haematopoietic disorders related to previous NSAID therapy.
If the patient has severe heart failure, severe hepatic failure, or severe renal failure. (See Precautions.)
If the patient is in the last trimester of pregnancy.
If the patient is children under 12 years of age.

Talk to the doctor or pharmacist before using Flurbiprofen (Strepsils MaxPro Direct).
Respiratory: Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. Flurbiprofen should be used with caution in these patients.
Other NSAIDs: The use of flurbiprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see Interactions).
Systemic lupus erythematosus and mixed connective tissue disease: Patients with systemic lupus erythematosus and mixed connective tissue disease may have an increased risk of aseptic meningitis (see Adverse Reactions), however this effect is not usually seen with short term and limited use flurbiprofen products.
Cardiovascular and Cerebrovascular Effects: Caution (discussion with a 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.
Nervous System Effects: In the event of prolonged use of analgesics or use beyond the product posology, analgesic induced headache may occur, which must not be treated with increased doses of the medicinal product.
Impaired female fertility: There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
Gastrointestinal Effects: 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 (see Adverse Reactions).
Gastrointestinal bleeding, ulceration and perforation which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI 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 (see Contraindications) and in the elderly, however this effect is not usually seen with short term limited use flurbiprofen products. Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) to their healthcare professional.
Caution is 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 (see Interactions).
If gastrointestinal bleeding or ulceration occurs in patients receiving flurbiprofen, the treatment should be withdrawn.
Dermatological: 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 (see Adverse Reactions). Flurbiprofen use should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Infections: Since in isolated cases an exacerbation of infective inflammations (e.g., development of necrotizing 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 therapy. If the symptoms get worse or if new symptoms occur, the treatment should be re-evaluated by a healthcare professional. If mouth irritation occurs, treatment should be withdrawn.
Effects on ability to drive and use machines: The product has no or negligible influence on the ability to drive and use machines.
Renal and Hepatic Impairment: NSAIDs have been reported to cause nephrotoxicity in various forms including interstitial nephritis, nephrotic syndrome, and renal failure. The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly, however, this effect is not usually seen with short term, limited use flurbiprofen products.
Use in the Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Pregnancy: As a precautionary measure, it is preferable to avoid the use of flurbiprofen during the first and second trimesters of pregnancy. Flurbiprofen is contraindicated during the third trimester of pregnancy.
Breast-feeding: In limited studies, flurbiprofen appears in the breast milk in a very low concentration and is unlikely to affect the breast-fed infant adversely. Flurbiprofen can be used during breast-feeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING this medicine and contact a doctor immediately if the patient develops: Signs of an allergic reaction such as asthma, unexplained wheezing, or shortness of breath, itching, runny nose, or skin rashes.
Swelling of the face, tongue or throat causing difficulty in breathing, racing heart, drop in blood pressure leading to shock (these can happen even on the first use of the medicine).
Signs of hypersensitivity and skin reactions such as redness, swelling, peeling, blistering, flaking or ulceration of skin and mucous membrane.
Tell the doctor or pharmacist if the patient notices any of the following effects or any effects not listed: Common (may affect up to 1 in 10 people): dizziness, headache; throat irritation; mouth ulcers, pain, or numbness in the mouth; oropharyngeal pain; discomfort (warm or burning feeling or tingling) in the mouth; nausea and diarrhoea; itching sensation in skin.
Uncommon (may affect up to 1 in 100 people): drowsiness; blistering in the mouth or throat, numbness in the throat; abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, glossodynia, dysgeusia, oral dysaesthesia, vomiting; dry mouth; burning sensation in the mouth, altered sense of taste; skin rashes, itchy skin (pruritus); fever, pain; feeling sleepy (somnolence) and difficulty falling asleep (insomnia); worsening of asthma and bronchospasm; reduced sensation in the throat (pharyngeal hypoaesthesia).
Rare (may affect up to 1 in 1000 people): anaphylactic reaction.
Not known (frequency cannot be estimated from the available data): anaemia, thrombocytopenia (low platelet count in the blood that can give rise to bruising and bleeding); swelling (oedema), high blood pressure, heart failure or attack; severe forms of skin reaction such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis; hepatitis (inflammation of the liver); hypersensitivity.

Flurbiprofen should be avoided in combination with: Acetylsalicylic Acid: Unless low-dose acetylsalicylic acid (not above 100 mg daily or local prophylactic dose for cardiovascular protection) has been advised by a doctor, as this may increase the risk of adverse reactions (see Precautions).
Other NSAIDs (including Ibuprofen and Cyclooxygenase-2-Selective Inhibitors): Avoid concomitant use of 2 or more NSAIDs as this may increase the risk of adverse effects (see Precautions).
Flurbiprofen should be used with caution in combination with: Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see Precautions).
Anti-platelet agents and Selective Serotonin Reuptake Inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see Precautions).
Antihypertensives (ACE inhibitors and Angiotensin II Antagonists) and Diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. This may enhance nephrotoxicity caused by inhibition of cyclooxygenase, especially in patients with compromised renal function (Patients should be adequately hydrated).
Alcohol: May increase the risk of adverse reactions, especially of bleeding in the gastrointestinal tract.
Cardiac Glycosides: NSAIDs may exacerbate cardiac failure, reduce glomerular filtration rate (GFR), and increase plasma glycoside levels.
Ciclosporin: Increased risk of nephrotoxicity.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see Precautions).
Lithium: There is evidence for potential increases in plasma levels of lithium.
Methotrexate: There is a potential for an increase in plasma levels of methotrexate.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Quinolone Antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine.

Do not refrigerate or freeze. Do not use this medicine for more than 6 months after the first use. Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.

Preparations for Oral Ulceration & Inflammation

R02AX01 - flurbiprofen ; Belongs to the class of other throat preparations.

Non-Rx