- pseudoephedrine hydrochloride
This information is intended for use by health professionals
Lemsip Max Flu Lemon
*Equivalent to pseudoephedrine (base) 49.1 mg.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
For relief of the symptoms of heavy colds and influenza, including the relief of aches and pains, headache and sore throat, nasal congestion or a runny nose, pain and congestion of sinusitis, and lowering of temperature.
Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or worsen.
Adults, the elderly and children aged 16 years and over: Content of one sachet dissolved by stirring in hot water and sweetened to taste.
Dose may be repeated every 4-6 hours as required.
Do not take more than 4 sachets in 24 hours.
Do not give to children under 16 years of age.
Elderly Population: No dosage adjustment is considered necessary in the elderly.
Method of Administration
Oral administration after dissolution in water.
• Hypersensitivity to paracetamol, pseudoephedrine or any of the excipients listed in section 6.1
• Severe coronary heart disease and cardiovascular disorders
• Severe hypertension
• Patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors
Use with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, hyperexcitability, phaeochromocytoma, prostatic enlargement or close angle glaucoma. Each sachet contains approximately 2.1 g of carbohydrate. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently.
Label warnings: Warning - Do not exceed the stated dose (panel). Keep out of the reach of children. Contains paracetamol (panel). If symptoms persist, consult your doctor. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product. Total sugars 2.1 g. Contains aspartame. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.
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.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine
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.
Pseudoephedrine: Pseudoephedrine may adversely interact with antihypertensive agents or tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants, to cause a rise in blood pressure. Pseudoephedrine may partially reverse the hypotensive action of drugs which interfere with sympathetic activity, such as bethanidine or methyldopa.
Paracetamol: Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
Defective closure of the abdominal wall (gastroschisis) reported very rarely in newborns after first trimester exposure. The product should not be used in pregnancy unless considered essential by the physician. Pseudoephedrine is excreted in breast milk in small amounts, but the effect of this on breast-fed infants is not known. It has been estimated that 0.5–0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Acute pancreatitis after ingestion of above normal amounts.
Adverse reactions due to pseudoephedrine are uncommon, but dry mouth, anorexia, urinary retention in men, skin rashes and symptoms of CNS excitation such as tension, restlessness, sleep disturbance or hallucinations may rarely occur.
Adverse reactions of Ischaemic colitis may occur with frequency unknown.
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: http:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g of more of paracetamol may lead to liver damage if the patient has risk factors (see below).
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.
(b) Regularly consumes ethanol in excess of recommended amounts.
(c) Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
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 oedema 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.
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 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). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. 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 hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Caffeine: Symptoms - emesis and convulsions may occur. No specific antidote. However, treatment is usually fluid therapy. Fatal poisoning is rare. If symptoms become apparent or overdose is suspected, consult a doctor immediately.
Phenylephrine hydrochloride: Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent.
Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.
Pseudoephedrine: Pseudoephedrine is an adrenergic agonist acting at both alpha- and beta- adrenoreceptors. It is reported to have less tachycardia and pressor activity and central nervous system effects that ephedrine. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.
The active ingredients are not known to cause sedation.
Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T½ of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.
Pseudoephedrine: Pseudoephedrine is rapidly and completely absorbed after oral administration, up to about 90% of a dose is excreted unchanged in the urine within 24 hours of dosing. The half life is between 5 and 8 hours but may be increased when the urine is alkaline and reduced when it is acid. Onset of nasal decongestant action occurs approximately 30 minutes after an oral dose of 60 mg and continues for at least 4 hours.
No preclinical findings of relevance have been reported.
Caster sugar, pulverised sucrose, citric acid, lemon flavour, saccharin sodium, aspartame, sodium citrate, ascorbic acid granular and curcumin (curcumin (E100), Lactose, Polysorbate 80 (E433) and Silica (E551)).
Store below 25°C.
Heat-sealed laminate sachet of Paper, PE, Aluminium foil and Ionomer
Pack sizes: 5, 7, 9 and 10 sachets. Not all pack sizes may be marketed
Oral administration after dissolution in water.
Reckitt Benckiser Healthcare (UK) Limited
24/04/1995 / 13/03/2009
RB Consumer Relations, PO Box 4644, SLOUGH, SL1 0NS, UK
0333 2005 345
0333 2005 345
0333 2005 345