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Reckitt Benckiser Ireland Limited

7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299


Summary of Product Characteristics last updated on medicines.ie: 10/02/2014
SPC Lemsip Cough & Cold Capsules with Caffeine



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1. NAME OF THE MEDICINAL PRODUCT

Lemsip Cough & Cold Capsules with Caffeine

Paracetamol 500mg

Guaifenesin 100mg

Caffeine 25mg.


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Active Ingredients

mg/Capsule

Paracetamol

500.00

Caffeine anhydrous

25.00

Guaifenesin

100.00

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Size 00 Capsule, hard.

Red/green hard gelatin capsule with 'Lemsip C&C' printed in white.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of symptoms of cold and influenza, including the relief of aches and pains, sore throat, headache, lowering of temperature and chesty coughs and fatigue and drowsiness.


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4.2 Posology and method of administration

Adults (over 12 years): Two capsules every 4 hours to a maximum of four doses in any 24 hours.

Do not exceed eight capsules in any 24 hours.

Swallow whole with water. Do not chew.

Not recommended for children under 12 years of age.


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4.3 Contraindications

Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

Contraindicated in children under 12 years of age.


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4.4 Special warnings and precautions for use

Should be given with care to patients with a history of peptic ulcer.

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.

Label: 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.

Do not exceed the stated dose. Do not take with any other paracetamol-containing products. If symptoms persist, consult your doctor. Keep out of the reach and sight of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product. Contains paracetamol (panel).


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4.5 Interaction with other medicinal products and other forms of interaction

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.

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.

Guaifenesin may increase the rate of absorption of paracetamol.


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4.6 Pregnancy and lactation

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.

Caffeine: Taken during pregnancy it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum.

The safety of guaifenesin in pregnancy and lactation has not been fully established. Lemsip Cough & Cold Capsules with Caffeine should only be used in pregnancy when considered essential by the doctor.


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4.7 Effects on ability to drive and use machines

None known.


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4.8 Undesirable effects

Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses.


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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 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 imumo 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.

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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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.

Caffeine: Caffeine is a central nervous system stimulant. It inhibits the enzyme phosphodiesterase and has an antagonistic effect at central adenosine receptors. Its action on the central nervous system is mainly on the higher centres and it produces a condition of wakefulness and increased mental activity.

Guaifenesin: Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.


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5.2 Pharmacokinetic properties

Paracetamol: Paracetamol is absorbed rapidly and completely 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.

Caffeine: Caffeine is absorbed readily after oral, rectal or parental administration, but absorption from the gastrointestinal tract may be erratic. There is little evidence of accumulation in any particular tissue. Caffeine passes readily into the central nervous system and into saliva. Concentrations have also been detected in breast milk. It is metabolised almost completely and is excreted in the urine as 1-methyluric acid and other metabolites, with only about 1% unchanged.

Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.


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5.3 Preclinical safety data

None available specific to the product.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

 

Capsule contents:

Maize starch Ph Eur

 

Croscarmellose sodium Ph Eur

 

Sodium laurilsulfate Ph Eur

 

Magnesium stearate Ph Eur

 

Talc sterilised Ph Eur

Capsule body:

Gelatin Ph Eur

 

Patent blue V (E131)

 

Quinoline yellow ( E104)

 

Erythrosin - FD&C red 3 (E127)

 

Titanium dioxide (E171) Ph Eur

Capsule cap:

Gelatin Ph Eur

 

Erythrosin (E127)

 

Quinoline yellow (E104)

 

Patent blue V (E131)

 

Titanium dioxide (E171) Ph Eur

Printing ink:

Shellac

 

Titanium dioxide (E171)

 

Aluminium hydroxide


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

Three years


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

250 micron opaque uPVC blister with foil/paper laminate, 35 gsm paper/9 micron soft-temper foil and heat-seal coated, contained in an outer cardboard carton.

Pack sizes: 6, 8 and 12 capsules.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/29/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22nd June, 2007


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10. DATE OF REVISION OF THE TEXT

December 2013



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Active Ingredients

 
   Paracetamol
   Guaifenesin
   Caffeine, anhydrous