Lemsip Max All In One
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Max All In One Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20ml dose contains:
Paracetamol 1000mg Phenylephrine Hydrochloride 12.18mg Guaifenesin 200mg Cetylpyridinium Chloride 3.0mg
Each 20ml dose also contains potassium 23mg, sodium 19mg, propylene glycol 4300mg, sorbitol 3000mg, maltitol liquid 2000mg and ethanol 3000mg.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the short term symptomatic relief of the symptoms of colds and influenza, including aches and pains, headache, nasal congestion, tickly sore throat and chesty coughs.
4.2 Posology and method of administration
For short term use only. Duration of treatment should be limited to a maximum of 3 days. Patients should consult a doctor or pharmacist if symptoms persist for more than 3 days, or worsen.
Posology
Adults (16 years and over): Fill the measure cup with 10 - 20ml for each dose. Take one dose up to 4 times per day.
Leave at least 4 hours between doses, and do not take more than 4 doses in any 24 hours.
Wipe the neck of the bottle clean and replace the cap securely, without overtightening it. Rinse the measure cup after use.
Do not exceed the stated dose. Do not give to children under 16 years of age.
Elderly Population: No dosage adjustment is considered necessary in the elderly.
Method of administration
For oral administration. It is important to shake the bottle for at least 10 seconds before use.
4.3 Contraindications
• Hypersensitivity to any of the active substances or to any of the excipients listed in section 6.1
• Contraindicated during pregnancy.
• Severe coronary heart disease and cardiovascular disorders.
• Hypertension.
• Hyperthyroidism.
• Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
4.4 Special warnings and precautions for use
Use with caution in patients with Raynaud’s phenomenon or diabetes mellitus.
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.
Immediate medical advice should be sought in the event of an overdose, even if the patient feels well because of the risk of delayed serious liver damage (see section 4.9).
Phenylephrine should be used with care in patients with closed angle glaucoma and prostatic enlargement.
The product should not be used during pregnancy unless recommended by a healthcare professional (see section 4.6).
Use during breastfeeding should be avoided, unless recommended by a healthcare professional (see section 4.6).
The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes, i.e. orally and topically (nasal, aural and eye preparations).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Each 20ml dose contains 2g Liquid Maltitol and approximately 3g of Sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This product may have a mild laxative effect.
This product contains 19% (v/v) ethanol. Each 20ml dose contains up to 3g of ethanol (alcohol) equivalent to 32ml of wine or 76ml of beer. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast feeding women, children and high-risk groups such as patients with liver disease, epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines. The amount of alcohol in this medicinal product may impair the ability to drive or use machines.
This product contains propylene glycol, which may cause alcohol-like symptoms.
4.5 Interaction with other medicinal products and other forms of interaction Paracetamol
The rate 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.
Phenylephrine Hydrochloride
Monoamine oxidase inhibitors (including moclobemide): hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see section 4.3).
Sympathomimetic amines: concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa): phenylephrine may reduce the efficacy of beta-blockers and antihypertensives. The risk of hypertension and other cardiovascular side effects may be increased (see section 4.3).
Tricyclic antidepressants (e.g. amitriptyline): may increase the risk of cardiovascular side effects with phenylephrine (see section 4.3).
Digoxin and cardiac glycosides: concomitant use of phenylephrine may increase the risk of irregular heartbeat or heart attack.
Guaifenesin
Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid.
Laboratory tests: If urine is collected within 24 hours of a dose of the medicinal product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-H HIAA) and vanillylmandelic acid (VMA).
4.6 Fertility, pregnancy and lactation Pregnancy
The product should not be used during pregnancy unless recommended by a healthcare professional.
The safety of this medicine during pregnancy has not been established but in view of a possible association of foetal abnormalities with first trimester exposure to phenylephrine, the use of the product during pregnancy should be
avoided. In addition, because phenylephrine may reduce placental perfusion, the product should not be used in patients with a history of pre-eclampsia.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage.
Guaifenesin been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy.
Breast-feeding
The product should be avoided during lactation unless recommended by a healthcare professional.
In view of the lack of data on the use of phenylephrine during lactation, this medicine should not be used during breast feeding.
Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
There is no information on the use of guaifenesin in lactation.
Fertility
There are no available data regarding the effects of the active ingredients on fertility.
4.7 Effects on ability to drive and use machines
Lemsip Max All In One Liquid has no or negligible influence on ability to drive or use machinery.
4.8 Undesirable effects
Adverse events which have been associated rarely with paracetamol, phenylephrine, guaifenesin and cetylpyridinium chloride are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (>1/10); Common (>1/100 and <1/10); Uncommon (>1/1000 and <1/100); Rare (>1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Events |
|
Blood and Lymphatic System Disorders |
Not known |
Thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis1 |
|
Immune System Disorders |
Not known |
Hypersensitivity |
|
Gastrointestinal Disorders |
Not known |
Abdominal discomfort, nausea, vomiting |
|
Skin and Subcutaneous Tissue Disorders |
Very rare Not known |
Cases of serious skin reactions have been reported Skin rash |
|
Renal and Urinary |
Not known |
Urinary retention2 |
|
Disorders |
Description of Selected Adverse Reactions
1 There have been reports of blood dyscrasias including thrombocytopenia, leucopenia, pancytopenia, neutropenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
2 Especially in males
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.
4.9 Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g 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 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.
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 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.
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.
Phenylephrine overdose is likely to result in: nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, Mydriasis, acute angle closure glaucoma (most likely to occur in those with closed angle glaucoma), tachycardia, palpitations, allergic reactions (e.g. rash, urticaria, allergic dermatitis), dysuria, urinary retention (most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy).
Additional symptoms may include hypertension, and possibly reflex bradycardia. In severe cases confusion, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.
Guaifenesin: Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics, Anilides, paracetamol, combinations excl. psycholeptics.
ATC Code: N02BE51
Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis. It is effective against pain of mild to moderate severity, but is less successful against chronic pain.
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effect on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. It may be given orally to relieve nasal congestion.
Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.
Cetylpyridinium Chloride is a cationic disinfectant with properties and uses similar to other cationic surfactants. These surfactants have bactericidal activity against Gram-positive and, at higher concentration against some
Gram-negative organisms. Cetylpyridinium Chloride may be used in a variety of preparations for the local treatment of minor infections.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 4 hours.
Phenylephrine hydrochloride is irregularly absorbed after oral administration and undergoes first-pass metabolism by monoamine oxidase in the gut and liver, resulting in reduced bioavailability. Peak plasma concentrations are achieved in 1 to 2 hours. It is excreted in the urine mainly as the sulphate conjugate, with less than 20% as unchanged drug.
Guaifenesin is rapidly absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to P-(2 methoxy-phenoxy) lactic acid. Within 3 hours, approximately 40% of a single dose is excreted in the urine as this metabolite. The half-life in plasma is approximately 1 hour. Guaifenesin may increase the rate of absorption of paracetamol, however the clinical relevance of this is unknown.
Cetylpyridinium Chloride has only a local effect.
5.3 Preclinical safety data
There are no preclinical safety data on these active ingredients in the literature of relevance to the prescriber or to the recommended dosage and use of the product which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Liquid Maltitol (E965)
Sorbitol (E420)
Ethanol
Propylene Glycol (E1520)
Glycerol (E422)
Saccharin Sodium (E954)
Sodium Cyclamate (E952)
Acesulfame Potassium (E950)
Sodium Citrate (E331)
Anhydrous Citric Acid (E330)
Xanthan Gum (E415)
Levomenthol Eucalyptus Oil Quinoline Yellow (E104)
Patent Blue V (E131) Purified Water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 25°C.
Keep the container in the outer carton.
Keep the container tightly closed.
6.5 Nature and contents of container
Clear type III glass bottle and polypropylene child resistant closure with aluminium foil film liner containing 160ml.
Clear PET bottle and polypropylene child resistant closure with aluminium foil film liner containing 160ml.
Graduated polypropylene measuring cup.
6.6 Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0625
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/01/2010
10 DATE OF REVISION OF THE TEXT
18/10/2016