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BOOTS DECONGESTANT WITH PAIN 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: For the symptomatic relief of the symptoms of colds and influenza including feverishness, aches and pains, headache, nasal and sinus congestion (blocked nose and sinuses). For oral administration.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults and children over 12 years One tablet to be taken three or four times a day, up to a maximum daily dose of 4 tablets (240mg pseudoephedrine and 2g paracetamol). Elderly Although no specific studies have been carried out in this age group, there is no need for dosage reduction in the elderly.
Children 6 to 12 years Half a tablet to be taken four times a day, up to a maximum daily dose of 2 tablets (120mg pseudoephedrine and 1g paracetamol). 3). Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor.
Parents or carers should seek medical attention if the child's condition deteriorates during treatment. Administration in those with hepatic disorders Care should be taken in administering this product to patients with severe hepatic impairment.
Administration in those with renal disorders Care should be taken in administering this product to patients with moderate to severe renal impairment.
Warning:
Do not exceed the stated dose. Keep all medicines out of the sight and reach of children.
Pseudoephedrine Immune system disorders:
Hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.
Cardiac disorders:
Tachycardia, palpitations, other cardiac dysrhythmias.
Vascular disorders:
Hypertension.
Gastrointestinal disorders:
Nausea and/or vomiting. 4) Renal and urinary disorders: Psychiatric disorders: Anxiety, restlessness, irritability, excitability, hallucinations (particularly in children), insomnia, sleep disturbance, paranoid delusions Skin and subcutaneous tissue disorders: Skin reactions including rash.
Frequency unknown - Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).
Eye disorders:
Frequency unknown: Ischaemic optic neuropathy Paracetamol Hypersensitivity to paracetamol, including a skin rash, may occur. Very rare cases of serious skin reactions have been reported.
Blood and lymphatic system disorders:
There have rarely been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Metabolism and nutrition disorders:
Frequency “Not known” (cannot be estimated from the available data): High anion gap metabolic acidosis. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Caution in moderate to severe renal impairment. Should be taken with caution by patients with hepatic impairment, prostatic enlargement and those with alcohol dependence.
If any of the following occur, the product should be stopped:
Hallucinations Restlessness Sleep disturbances Severe Skin reactions 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 this medicine should be discontinued and appropriate measures taken if needed. 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.
Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. 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. g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
Hypersensitivity to the active substances or any of the excipients. Severe renal impairment Cardiovascular disease including hypertension, severe hypertension or uncontrolled hypertension and peripheral vascular disease. 5) Not to be used in children under the age of 6 years
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as the underlying cause of HAGMA in patients with multiple risk factors.
Glutathione deficiency can also increase the risk of hepatotoxicity with paracetamol use, even at therapeutic doses. 9). Hepatotoxicity at therapeutic dose Cases of paracetamol induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetamol at doses within the therapeutic range.
These cases were reported in patients with one or more risk factors for hepatotoxicity including low body weight (adults <50 kg), renal and hepatic impairment, chronic alcoholism, concomitant intake of hepatotoxic drugs and in acute and chronic malnutrition (low reserves of hepatic glutathione).
Paracetamol should be administered with caution to patients with these risk factors. 9). Dosage adjustment of paracetamol should be considered where there are risk factors for glutathione deficiency or hepatotoxicity and for those of low weight (for adults those weighing less than 50kg).
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). Not to be given to children under 6 years.
Do not give this medicine to children aged 6-12 for more than five days, unless your doctor agrees. If symptoms persist, consult your doctor. Do not take with any other decongestant-containing products. Do not take with any other paracetamol-containing products.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially ‘sodium free’. Label Immediate medical advice should be sought in the event of an overdose, even if you feel well. Leaflet or combination label/leaflet Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.