This information is intended for use by health professionals

1. Name of the medicinal product

Boots Decongestant with Pain Relief Tablets

2. Qualitative and quantitative composition

Active ingredient

mg/tab

Paracetamol Ph Eur

Pseudoephedrine hydrochloride BP

500.0

60.0

3. Pharmaceutical form

Tablets

4. Clinical particulars
4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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).

This medicine is contraindicated in children under 6 years of age (see section 4.3).

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.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma or where intraocular pressure is raised

Severe liver disease

Concomitant use of other sympathomimetic decongestants

Monoamine oxidase inhibitors (MAOIs, or within 14 days of stopping treatment, see section 4.5)

Beta-blockers – (see section 4.5)

Not to be used in children under the age of 6 years

4.4 Special warnings and precautions for use

Caution in moderate to severe renal impairment.

Should be taken with caution by patients with hepatic impairment, prostatic enlargement and 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.

Not to be given to children under 6 years.

Do not take for longer 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.

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.

4.5 Interaction with other medicinal products and other forms of interaction

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives (including adrenergic neurone blockers & beta-blockers): this product may block the hypotensive effects.

Cardiac glycosides: increased risk of dysrhythmias.

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Oxytocin – risk of hypertension.

Enhances effects of anticholinergic drugs (such as TCAs).

Concomitant use of this medicine with tricyclic antidepressants and sympathomimetic agents such as decongestants may cause a rise in blood pressure.

Paracetamol

Drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the rate at which paracetamol is metabolised, leading to a reduced plasma concentration of the drug.

Alcohol may reduce the capacity of the liver to metabolise paracetamol.

Chronic use of paracetamol enhances the effects of anticoagulants.

Concurrent use of paracetamol with NSAIDs may increase the risk of adverse renal effects. The prolonged combined use of these compounds may increase the risk of renal damage.

4.6 Fertility, pregnancy and lactation

Pregnancy

Paracetamol

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency

Pseudoephedrine

There are limited amount of data on the use of pseudoephedrine in pregnant women. The use of pseudoephedrine during the first trimester of pregnancy has been associated with an increased frequency of gastroschisis (a developmental defect in the abdominal wall with intestinal herniation) and of small intestinal atresia (congenital obstruction of small intestine). Due to the vasoconstrictive properties of pseudoephedrine, it may induce a reduction in uteroplacental circulation. Pseudoephedrine is not recommended in pregnancy

Breastfeeding

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding. Pseudoephedrine has been detected in human milk with a small percentage of the maternal dose potentially administered to the breastfed infant. Irritability and disturbed sleep have been reported in breastfed infants. Pseudoephedrine may suppress lactation.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Pseudoephedrine

Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.

Gastrointestinal disorders: Nausea and/or vomiting.

Frequency unknown: Ischaemic colitis

General disorders and administration site conditions: Irritability.

Immune system disorders: Hypersensitivity reactions, including cross-sensitivity that may occur with other sympathomimetics.

Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.

Psychiatric disorders: Sleep disturbance.

Renal and urinary disorders: Urinary retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash. Frequency unknown - Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP).

Vascular disorders: Hypertension.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Liver damage is possible in adults who have taken 10G or more of paracetamol.

Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes OR

b) Regularly consumes ethanol in excess of recommended amounts OR

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral odema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable) but results should not delay initiation of treatment beyond 8 hours after ingestion, as the effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside of hospital.

Symptomatic and supportive measures should be undertaken, particularly with regard to the cardiovascular and respiratory systems. Convulsions should be controlled with intravenous diazepam. Chlorpromazine may be used to control marked excitement and hallucinations. Severe hypertension may need to be treated with an alpha-adrenoreceptor blocking drug, such as phentolamine. A beta blocker may be required to control cardiac arrhythmias.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Paracetamol is a peripherally acting analgesic with antipyretic activity.

Pseudoephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It has alpha and beta adrenergic activity and some stimulant effect on the central nervous system. The sympathomimetic effect of pseudoephedrine produces vasoconstriction which in turn relieves nasal congestion.

5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, although this is dose-dependent.

The rate and extent of paracetamol absorption is normal in the elderly but plasma half life is longer and paracetamol clearance lower than in young adults.

In renal impairment though the mean plasma half-life of paracetamol is similar in normal and renally impaired subjects at 2-8 hours, from 8-24 hours paracetamol is eliminated less rapidly. An increase in the interval between doses of paracetamol has been recommended for adults with chronic renal failure.

With severe hepatic impairment the mean plasma half life of paracetamol is significantly prolonged (by approximately 75%). The clinical significance of this is however unclear, as no evidence exists of drug accumulation or hepatotoxicity in patients with liver disease.

Pseudoephedrine is readily and completely absorbed from the gastrointestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted in the urine unchanged. It has an elimination half-life of 5 to 8 hours but its urinary elimination and hence half-life is pH dependent. Pseudoephedrine is rapidly distributed throughout the body, its volume of distribution being 2 to 3L/Kg bodyweight.

5.3 Preclinical safety data

Pseudoephedrine

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Paracetamol

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6. Pharmaceutical particulars
6.1 List of excipients

Pregelatinised maize starch

Microcrystalline cellulose

Sodium lauryl sulphate

Magnesium stearate

Quinoline yellow (E104)

Croscarmellose sodium

6.2 Incompatibilities

None.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Do not store above 30°C.

Store in the original package.

6.5 Nature and contents of container

A child-resistant push through pack of opaque 250 micron PVC/40gsm PVdC blisters, heat sealed to 35gsm Glassine paper/9 micron soft temper aluminium foil.

Pack sizes: 6, 12.

6.6 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

or

The Boots Company PLC

trading as BCM

8. Marketing authorisation number(s)

PL 00014/0594

9. Date of first authorisation/renewal of the authorisation

First authorisation: 29 July 1999

10. Date of revision of the text

10th February 2020