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SUDAFED SINUS PRESSURE & PAIN is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Symptomatic treatment of nasal congestion associated with acute rhinosinusitis suspected to be of viral origin with headache and/or fever. This product is indicated in adults and adolescents aged 15 years and older.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and adolescents aged 15 years and older: 1 tablet (equivalent to 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride) every 6 hours if necessary. For more intense symptoms, 2 tablets (equivalent to 400 mg ibuprofen and 60 mg pseudoephedrine hydrochloride) every 6 hours if necessary, to a maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride).
The maximum total daily dose of 6 tablets (equivalent to 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride) must not be exceeded. For short-term use. 4). The patient should consult a doctor if symptoms worsen. The maximum duration of treatment is 4 days for adults and 3 days for adolescents aged 15 years and older.
In situations where the symptoms predominantly consist of either pain/fever or nasal congestion, administration of single entity products is to be preferred. 4). 3). Method of administration For oral use. The tablets should be swallowed whole without chewing with a large glass of water, preferably during meals.
The most commonly-observed adverse reactions related to ibuprofen are gastrointestinal in nature. 4). 4 Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.
In general, the risk of development of adverse reactions (in particular the risk of development of serious gastrointestinal complications) increases with increasing dose and with increasing duration of treatment administration. Hypersensitivity reactions have been reported following treatment with ibuprofen.
These may consist of: (a) Non-specific allergic reaction and anaphylaxis (b) Respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea (c) Assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. 4). The following list of adverse reactions relates to those experienced with ibuprofen and pseudoephedrine hydrochloride at OTC doses, for short-term use.
In the treatment of chronic conditions, under long-term treatment, additional adverse reactions may occur. Patients should be informed that they should stop taking this product immediately and consult a doctor if they experience a serious adverse drug reaction.
g. 4) Ibuprofen Very rare Oesophagitis, pancreatitis, intestinal diaphragm-like stricture Pseudoephedrine hydrochloride Common Dry mouth, nausea Pseudoephedrine hydrochloride Not known Thirst, vomiting, ischaemic colitis Hepatobiliary disorders Ibuprofen Very rare Hepatic dysfunction, hepatic damage, particularly in long- term therapy, hepatic failure, acute hepatitis Skin and subcutaneous tissue disorders Ibuprofen Uncommon Various skin rashes Ibuprofen Very rare Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), Erythema multiforme, exfoliative dermatitis, alopecia, severe skin infections and soft-tissue complications in a varicella infection Ibuprofen Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP) Ibuprofen Not known […]
Concomitant use of this product with other NSAIDs including cyclo-oxygenase (COX)-2 selective inhibitors should be avoided. Undesirable effects may be reduced by using the minimum effective dose for the shortest duration necessary to control symptoms (see "Gastro-intestinal effects" and "Cardiovascular and cerebrovascular effects" below).
If symptoms persist beyond the recommended maximum duration of treatment with this medicinal product (4 days for adults and 3 days for adolescents), measures to be taken should be re-evaluated, in particular the possible usefulness of an antibiotic treatment.
Acute rhinosinusitis, suspected to be of viral origin, is defined by moderate intensity, bilateral rhinological symptoms dominated by nasal congestion with serous or puriform rhinorrhea, occurring in an epidemic context. The puriform appearance of rhinorrhea is common and does not systematically correspond to bacterial superinfection.
Sinus pains, during the first days of the illness, are associated with congestion of the sinus mucosa (acute congestive rhinosinusitis) and most often are resolved spontaneously. In the event of acute bacterial sinusitis, antiobiotic therapy is justified.
8). • Patients should be informed that treatment must be discontinued if they develop hypertension, tachycardia, palpitations, cardiac arrhythmias, nausea or any neurological signs such as onset or worsening of headache. • Patients should not exceed the recommended dose and/or the recommended duration of treatment.
Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing. Depression may follow rapid withdrawal. • Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. • Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
g. g. 5) or use of monoamine oxidase inhibitors within the last two weeks.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. • Severe Skin reactions Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.
Patients should be carefully monitored. 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. • Before using this medicinal product, patients should consult their doctor in case of: • Hypertension, heart disease, hyperthyroidism, psychosis or diabetes.
• Concomitant administration of antimigraine agents, especially ergot alkaloid vasoconstrictors (because of the α-sympathomimetic activity of pseudoephedrine). 8). • Neurological symptoms such as seizures, hallucinations, behavioural disturbances, agitation and insomnia have been described after systemic administration of vasoconstrictors, especially during febrile episodes or on overdose.
These symptoms have been more commonly reported in paediatric population. As a result, it is advisable: • to avoid administration of this product either in combination with medicines which can lower the epileptogenic threshold, such as terpene derivatives, clobutinol, atropine-like substances and local anaesthetics, or where there is a history of seizures; • to adhere strictly to the recommended dosage in all cases and to inform the patients about the risks of overdose if this product is taken concomitantly with other medicines containing vasoconstrictors.
Patients with urethroprostatic disorders are more prone to develop symptoms like dysuria and urinary retention. Elderly patients may be more sensitive to the effects on the central nervous system (CNS). 5). • Athletes should be informed that treatment with pseudoephedrine hydrochloride can lead to positive results in doping tests.
3): Severe cardiovascular disorders, coronary heart disease (heart disease, hypertension, angina pectoris), tachycardia, hyperthyroidism, diabetes, pheochromocytoma, history of stroke or presence of risk factors for stroke, […]