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CONTAC NON DROWSY DUAL RELIEF is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contac Non Drowsy Dual Relief is a mild to moderate analgesic, antipyretic and decongestant. Contac Non Drowsy Dual Relief is recommended for the relief from the symptoms of colds and flu including: • Nasal congestion • Sore throat pain • Headache • Body aches and pains • Fever • Sinus symptoms e.g. sinus…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral use.
Adults, including the elderly and children 16 years and over:
Two tablets every four to six hours, to be taken orally. The dose should not be repeated more frequently than every four hours nor should more than three doses be given in any 24-hour period. Minimum dosing interval: 4 hours Do not exceed the stated dose.
Should not be used with other paracetamol-containing or decongestant products. Users should be advised to seek medical advice if symptoms persist for more than 7 days. If pain or fever persist for more than 3 days or get worse, or if any other symptoms occur, treatment should be discontinued, and a physician consulted.
Not to be used in children under 16 years of age. Elderly patients, especially those who are frail or immobile, may require a reduced dose or frequency of dosing.
Renal impairment:
Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication. It is recommended, when giving paracetamol to patients with renal failure, to reduce the dose and to increase the minimum interval between each administration to at least 6 hours.
The kidney impairment restrictions relate to the use of both paracetamol and pseudoephedrine. 4).
Hepatic impairment:
Patients who have been diagnosed with hepatic impairment must seek medical advice before taking this medication. 4).
The following convention has been utilized for the classification of undesirable effects; very common (>/=1/10), common (>=1/100, <1/10), common (<=1/1000, <1/100), rare (>=1/10000, <1/1000), very rare (<1/10000), not known (cannot beestimated from the available data).
Paracetamol Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post- marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.
Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Body System Undesirable effect Frequency Blood and lymphatic system disorders Thrombocytopenia, Agranulocytosis Not known Immune system disorders Anaphylaxis Not known Metabolism and nutrition disorders High anion gap metabolic acidosis Not known Respiratory, thoracic andmediastinal disorders Bronchospasm* Not known Hepatobiliary disorders Hepatic dysfunction Not known Cutaneous hypersensitivity reactions including skin rashes, pruritus, sweating, purpura, urticaria and angioedema.
Not known Skin and subcutaneous tissue disorders Very rare cases of serious skin reactions have been reported. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. *There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Pseudoephedrine The frequency of reactions identified during post-marketing use is not known. 4) Not known Eye disorders Ischaemic optic neuropathy Not known Cardiac Disorders Tachycardia, palpitations Not known Vascular Disorders Increased blood pressure* Not known Vomiting, dry mouth, nausea Not knownGastrointestinal Disorders Ischaemic colitis Not known Rash, allergic dermatitis** Not known Skin and subcutaneous tissue disorders Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP) Not known Renal and Urinary Disorders Dysuria, urinary retention*** Not known *Increases in systolic blood pressure have been observed.
Patients should be advised not to take other paracetamol-containing products concurrently. 9) Care is advised in the administration of this product in patients with liver impairment or mild to moderate kidney impairment. The hazard of overdose is greater in patients with non-cirrhotic alcoholic liver disease.
Caution should also be exercised in patients with arrhythmias. 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. e. patients who are underweight (adults or adolescents less than 50kg) or of low body mass index, malnourished, dehydrated, those with chronic alcoholism, co-existing renal or hepatic impairment, concomitantly taking hepatotoxic drugs and those with conditions that may predispose to glutathione deficiency or depletion.
2). Paracetamol should be administered only with particular caution to patients with Glucose-6-phosphate dehydrogenase deficiency who are at risk of haemolysis after exposure to paracetamol. Ischaemic optic neuropathy Cases of ischaemic optic neuropathy have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. Risks of abuse Pseudoephedrine carries the risk of abuse. Increased doses may ultimately produce toxicity. Continuous use can lead to tolerance resulting in an increased risk of overdosing.
2). g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended.
This product is contraindicated in patients. • With hypersensitivity to paracetamol, pseudoephedrine or excipients • With severe hypertension or uncontrolled hypertension • With severe acute or chronic kidney disease/renal failure • With cardiovascular disease including hypertension or severe coronary artery disease.
Who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) • With hyperthyroidism, prostatic enlargement, diabetes, glaucoma or phaeochromocytoma, • Who are receiving Monoamine Oxidase Inhibitors (MAOIs), or for two weeks after stopping a MAOI drug • Who are taking beta-blockers or other anti-hypertensives
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant. **A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine ***Urinary retention is most likely to occur in those with bladder outlet obstruction,such as prostatic hypertrophy.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors. Ischaemic colitis Some cases of ischaemic colitis have been reported with pseudoephedrine.
Pseudoephedrine should be discontinued immediately, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. Keep out of the reach and sight of children. Precaution should be observed in patients with asthma who are sensitive to acetylsalicylic acid since mild bronchospasms are reported in association with paracetamol (cross reaction).
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with 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. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of Contac Non-Drowsy Dual Relief should be discontinued and appropriate measures taken if needed.
The stated dose should not be exceeded. If symptoms persist, medical advice must be sought. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.