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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
E-mail: customer.relations@gsk.com
Medical Information Direct Line: 1800 441 442


Summary of Product Characteristics last updated on medicines.ie: 17/07/2017
SPC Day Nurse Capsules


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1. NAME OF THE MEDICINAL PRODUCT

Day Nurse Capsules

Paracetamol 500mg

Pseudoephedrine Hydrochloride 30mg

Pholcodine 5mg


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients

Paracetamol

Pseudoephedrine

Pholcodine

Quantity mg/cap

500

30

5

Also contains Allura Red (E129).

For a full list of excipients see section 6.1


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3. PHARMACEUTICAL FORM

Capsule, hard (Capsule)

The capsule has an orange cap and yellow body, printed with an identifier in black ink. It contains a white powder.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the relief of the major symptoms of colds and influenza.


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4.2 Posology and method of administration

For oral administration only. To be taken during the day.

Adults and children over 12 years: Two capsules every four hours, up to a maximum of 4 doses (8 capsules) in 24 hours if needed.

Children under 12 years: Not to be given to children under 12 years of age. Elderly: There is no specific requirement for dosage reduction in the elderly. Maximum duration of continued use without medical advice: 7 days. Minimum dosing interval: 4 hours.

Do not exceed the stated dose.

The lowest dose necessary to achieve efficacy should be used.

Should not be used with other paracetamol containing products, decongestants or cough and cold medicines. If symptoms persist consult a doctor.

Hepatic Impairment: Patients who have been diagnosed with hepatic impairment must seek medical advice before taking this medication.

Renal Impairment: Pseudoephedrine is primarily excreted renally. This product should not be used by those with severe renal impairment and should be used with caution in those with mild to moderate renal impairment.


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4.3 Contraindications

This product is contraindicated in people:

• With a hypersensitivity to paracetamol, pseudoephedrine, pholcodine or any of the excipients. With severe hypertension or severe coronary artery disease.

• With, or at risk of developing, respiratory failure (e.g. those with chronic obstructive airways disease or pneumonia)

• or those with bronchiolitis or bronchiectasis, due to sputum retention.

• Who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants).

• Who are receiving Monoamine Oxidase Inhibitors (MAOIs), or for two weeks after stopping a MAOI drug.

• With severe renal impairment.

• Children under 12 years of age.


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4.4 Special warnings and precautions for use

Contains paracetamol. Do not use with any other paracetamol-containing products, antihistamines or cold and flu medicines. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

Cases of hepatic dysfunction/failure has been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.

Caution in patients with glutathione depleted states such as sepsis; the use of paracetamol may increase the risk of metabolic acidosis.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined label/leaflet:

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of irreversible, serious liver damage.

Caution should be exercised in patients with mild to moderate kidney impairment and in those with hepatic impairment. Underlying liver disease increases the risk of paracetamol-related liver damage.

Caution should be exercised in patients with cardiovascular disease, arrhythmias, hypertension, hyperthyroidism, prostatic enlargement, diabetes, glaucoma, phaeochromocytoma, or in those with chronic or persistent cough, asthma, or where cough is accompanied by excessive secretions.

There have been rare cases of posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported included sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment. Pseudoephedrine should be discontinued and medical advice sought immediately, if signs/symptoms of PRES/RCVS develop.

There have been reports of ischaemic colitis with pseudoephedrine. Pseudoephedrine should be discontinued immediately and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Pholcodine may enhance the CNS effects of alcohol or other CNS depressants. Use with caution in patients taking beta-blockers or other anti-hypertensives.

If symptoms persist medical advice must be sought.

Do not exceed the stated dose.

Do not take with decongestants or cough medicines.

Keep out of the sight and reach of children.


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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-containing products with increased risk of bleeding; occasional doses have no significant effect.

Concomitant administration of pseudoephedrine hydrochloride-containing products and MAOIs (or within two weeks of stopping of MAOI) may lead to hypertensive crisis.

Concomitant use of this medication with sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

Pseudoephedrine-containing products may antagonise the effect of certain classes of antihypertensives (e.g. beta blockers, methyl-dopa, reserpine, debrisoquine guanethidine) and increase the possibility of arrhythmias in digitalised patients.

Pholcodine may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillizers (phenothiazines and tricyclic antidepressants).

Pholcodine may predispose patients to developing anaphylaxis with neuromuscular blocking agents.


4.6 Fertility, pregnancy and lactation

Pregnancy

This product should not be used in pregnancy without medical advice.

Human and animal studies with paracetamol have not identified any risk to pregnancy or embryo-foetal development. Safe use of pseudoephedrine and pholcodine in pregnancy has not been established despite widespread use over many years. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

Lactation

This product should not be used whilst breastfeeding without medical advice.

Although paracetamol is excreted in breast milk, human studies with paracetamol have not identified any risk to lactation or the breast-fed offspring.

Pseudoephedrine is excreted in breast m milk in small amounts but the effect of this on breast fed infants is unknown.

It is not known whether pholcodine is excreted into breast milk.


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4.7 Effects on ability to drive and use machines

Patients should be advised not to drive or operate machinery if affected by dizziness.


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4.8 Undesirable effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class and frequency.

The following convention has been utilised for the classification of undesirable effects: very common (2: 1110), common (2: 11100, <1110), uncommon (2:111000, <11100), rare (2: 1110000, <111000), very rare (<1110000).

Adverse event frequencies have been estimated from spontaneous reports received through post-marketing data.

Paracetamol

Body System

Undesirable Effect

Frequency

Blood and Lymphatic System Disorders

Thrombocytopaenia

Very rare

Immune System Disorders

Anaphylaxis

Cutaneous hypersensitivity reactions including skin rashes, angiodema, and Steven Johnson syndrome.

Very rare cases of serious skin reactions have been reported

Very rare

Respiratory, Thoracic and Mediastinal Disorders

Bronchospasm in patients sensitive to aspirin and other NSAIDs

Very rare

Hepatobiliary Disorders

Hepatic dysfunction

Very rare

Pseudoephedrine

Body System

Undesirable Effect

Frequency

Psychiatric Disorders

Nervousness, insomnia

Common

Agitation, restlessness

Uncommon

Hallucinations (particularly in children)

Rare

Nervous System Disorders

Dizziness

Common

Cardiac Disorders

Tachycardia, palpitations

Rare

Vascular Disorders

Increased blood pressure*

Rare

Gastrointestinal disorders

Vomiting, dry mouth, nausea

Common

Skin and Subcutaneous Tissue Disorders

Rash, allergic dermatitis**

Rare

Renal and Urinary Disorders

Dysuria, urinary retention***

Uncommon

*Increases in systolic blood pressure have been observed. At therapeutic doses, the effects of pseudoephedrine on blood pressure are not clinically significant.

**A variety of allergic skin reactions, with or without systemic features such as bronchospasm and angioedema have been reported following use of pseudoephedrine.

***Urinary retention is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

Pholcodine

Body System

Undesirable Effect

Frequency

Immune System Disorders

Hypersensitivity reactions including skin rashes, angiodema, anaphylaxis

Rare

Gastrointestinal disorders

Nausea, vomiting

Common

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.


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4.9 Overdose

Symptoms and Signs

Paracetamol

Paracetamol overdose may cause liver failure, which can lead to liver transplant and death.

There is a risk of poisoning with paracetamol particularly in elderly subjects, young children, patients with liver disease, cases of chronic alcoholism and in patients with chronic malnutrition. Overdosing may be fatal in these cases.

Symptoms generally appear within the first 24 hours and may comprise: nausea, vomiting, anorexia, pallor, and abdominal pain, or patients may be asymptomatic.

Overdose of paracetamol in a single administration in adults or in children can cause liver cell necrosis likely to induce complete and irreversible necrosis, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which may cause coma and death. Simultaneously, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed together with increased prothrombin levels that may appear 12 to 48 hours after administration. Liver damage is likely in adults who have taken more than the recommended amounts of paracetamol. It is considered that excess quantities of toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Some patients may be at increased risk of liver damage from paracetamol toxicity.

Risk Factors include: If the patient;

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

• Regularly consumes ethanol in excess of recommended amounts.

• Is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Emergency Procedure:

Immediate transfer to hospital.

Blood sampling to determine initial paracetamol plasma concentration. In the case of a single acute overdose, paracetamol plasma concentration should be measured 4 hours post ingestion.

Administration of activated charcoal should be considered if >150mg/kg paracetamol has been taken within 1 hour.

The antidote N-acetylcysteine, should be administered as soon as possible in accordance with National treatment guidelines

Symptomatic treatment should be implemented.

Pseudoephedrine

Pseudoephedrine overdose may result in symptoms due to central nervous system and cardiovascular stimulation e.g. excitement, restlessness, hallucinations, hypertension and arrhythmias. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to extracellular to intracellular shifts in potassium.

Treatment:

Treatment should consist of standard supportive measures. Beta blockers should reverse the cardiovascular complications and the hypokalemia.

Pholcodine

Symptoms of pholcodine overdose may include nausea, drowsiness, restlessness, excitement and ataxia. Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large.

Treatment:

Supportive and symptomatic care should be provided as required. If overdose is severe, naloxone may be helpful, particularly for patients with respiratory depression.


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5. PHARMACOLOGICAL PROPERTIES


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5.1 Pharmacodynamic properties

Paracetamol has analgesic and antipyretic actions.

Pseudoephedrine is a sympathomimetic agent with both direct and indirect effects on adrenergic receptors. Pholcodine is a cough suppressant with little analgesic activity.


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5.2 Pharmacokinetic properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after oral administration. Paracetarnol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. Paracetamol is metabolised predominantly 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 paracetarnol. The elimination half life varies from about 1 to 4 hours.

Pseudoephedrine is rapidly and completely absorbed from the gastrointestinal tract after oral administration, with no presystemic metabolism. Peak plasma levels are achieved after 1-2 hours. The plasma half-life varies from 4.3-7.0 hours in adults. No protein binding data are available.

There is little metabolism of pseudoephedrine in man with approximately 90% being excreted in the urine unchanged. Approximately 1% is eliminated by hepatic metabolism, by N-demethylation to norpseudoephedrine.

As a weak base, the extent of renal excretion is dependent on urinary pH. At low urinary pH, tubular reabsorption is minimal and urine flow rate will not influence clearance of the drug. At high pH (>7.0), pseudoephedrine is extensively reabsorbed in the renal tubule and renal clearance will depend on urine flow rate.

Pholcodine is rapidly absorbed after oral administration and maximum plasma concentrations are attained at about 4-8 hours. The elimination half life ranges from 32 to 50 hours. The drug has a large volume of distribution and is only 23.5% protein bound. Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and sulphate. Approximately 25-50% of the drug is recovered unchanged in the urine.


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5.3 Preclinical safety data

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


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Capsules contents

Sodium laurilsulfate

Sodium starch glycollate

Magnesium stearate

Hard gelatin capsule

(containing: Gelatin, Quinoline yellow (E104), Allura red (E129), Titanium dioxide (El71).)

Black print ink

(containing: Shellac, isopropyl alcohol, black iron oxide (E172), N-butyl alcohol, propylene glycol, ammonium hydroxide.)


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.


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6.5 Nature and contents of container

PVC/PVdC blister tray with aluminium foil lid. Pack sizes: 8, 10, 12, 16, 20 or 24 tablets.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

12 Riverwalk

CityWest Business Campus

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 678/100/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 November 2003

Date of last authorisation: 04 November 2008


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10. DATE OF REVISION OF THE TEXT

July 2017



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Active Ingredients

 
   Paracetamol
   Pholcodine
   Pseudoephedrine Hydrochloride