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DAY NURSE CAPSULES

Active substance(s): PARACETAMOL / PHOLCODINE / PSEUDOEPHEDRINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

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NAME OF THE MEDICINAL PRODUCT
Day Nurse Capsules

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QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Paracetamol Pseudoephedrine Hydrochloride Pholcodine For excipients, see 6.1. mg/cap 500 30 5

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PHARMACEUTICAL FORM
Capsule, hard The Capsule has an orange cap and yellow body printed axially in black ink Day Nurse on the cap and the body.

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4.1

CLINICAL PARTICULARS
Therapeutic indications For the relief of the symptoms of colds and influenza. For oral administration.

4.2.

Posology and Method of Administration Take during the day. Should not used with other paracetamol-containing products, decongestants or cough and cold medicines Adults and Children over 12 years Two capsules every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night-time paracetamol-containing product is taken before bedtime. Minimum dosing interval: 4 hours. Do not exceed the stated dose.

Children under 12 years

Not to be given to children under twelve years of age. Elderly: There is no specific requirement for dosage reduction in the elderly.

4.3

Contraindications This product is contraindicated in patients with: Hypersensitivity to any of the ingredients or excipients. Severe hypertension or severe coronary artery disease., Severe renal impairment. Hyperexcitability 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.



4.4.

Special Warnings and Precautions for Use
Should be given with caution to patients with mild to moderate kidney impairment and in those with impaired liver function. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. 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 immediately and medical advice sought if signs/symptoms of PRES/RCVS develop. Caution should also 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. Pholcodine may enhance the CNS effects of alcohol and other CNS depressants. Use with caution in patients taking beta-blockers and other antihypertensives Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this product Contains paracetamol. Warning: Do not exceed the stated dose. Asthmatics should consult their doctor before using this product. Do not use for longer than 7 days unless your doctor agrees. If symptoms persist, consult your doctor. Do not take with any other paracetamol-containing products. Do not take with any other flu, cold or decongestant products. Keep out of reach and sight of children. Label Immediate medical advice should be sought in the case 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 delayed, serious liver damage.

4.5

Interaction with other medicinal products and other forms of interaction Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment as this may lead to a hypertensive crisis. Pseuodephedrine may diminish the antihypertensive effects of hypotensive drugs and increase the possibility of arrhythmias in digitalised patients. Pholcodinemay enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Pholcodine may also predispose patients to developing anaphylaxis with neuromuscular blocking agents. Concomitant use of this medication with sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) which interfere with the catabolism of sympathomimietic amines, may occasionally cause a rise in blood pressure.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestryramine. 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.

4.6

Fertility, pregnancy and lactation 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. In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine this product should not be used in pregnancy without medical advice. Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast fed infants is unknown. The safety of the ingredients during lactation has not been established and therefore the product should not be used whilst breastfeeding without medical advice.

4.7

Effects on ability to drive and use machines Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8

Undesirable effects

The following convention has been utilised or the classification of undesirable effects: very common (>/=1/10), common (>=1/100. <1/10), uncommon (<=1/1000,<1/100), rare (<=1/10000, <1/1000), very rare (1
Paracetamol Adverse events of paracetamol 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 class. The frequency of these adverse is not known (cannot be estimated from available data).

Body System Blood and lymphatic system disorders Immune System Disorders

Undesirable effect Thrombocytopaenia

Frequency Very rare

Respiratory, thoracic and mediastinal disorders Hepatobiliary disorders Pseudoephedrine

Very rare Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema, and Stevens Johnson syndrome Bronchospasm in patients Very rare sensitive to aspirin and other NSAIDs Hepatic dysfunction Very rare

The frequency of reactions identified during post-marketing use is not known. Body System Psychiatric disorders Undesirable effect Nervousness, insomnia Blurred Vision Agitation, restlessness Hallucinations (particularly in children) Nightmares Dizziness Headache, tinnitus, irritability, tremor Tachycardia, palpitations Increased blood pressure* Vomiting, dry mouth, nausea Diarrhoea or constipation; epigastric pain, anorexia Rash, allergic Frequency Common Unknown Uncommon Rare Unknown Common Unknown Rare Rare Common Unknown

Nervous System Disorders

Cardiac Disorders Vascular Disorders Gastrointestinal Disorders

Skin and subcutaneous

Rare

tissue disorders Renal and Urinary Disorders

dermatitis** Sweating Dysuria, urinary retention*** Micturition difficulty

Unknown Uncommon Unknown

*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 The frequency of reactions identified during post-marketing use is not known. Body System Immune System disorders Undesirable effect Hypersensitivity reactions including skin rashes, angioedema, anaphylaxis Nausea vomiting Sputum retention Frequency Rare

Gastrointestinal Disorders Respiratory, thoracic and mediastinal disorders

Common Unknown

4.9

Overdose Paracetamol Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g 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 Johns 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 Nacetylcysteine, 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 24h from ingestion should be discussed with the NPIS or a liver unit. Pseudoephedrine Hydrochloride Symptoms: As with other sympathomimetics pseudoephedrine overdose will result in symptoms due to central nervous system and cardiovascular stimulation e.g. excitement, irritability, restlessness, tremor, hallucinations, hypertension, palpitations,arrhythmias and difficulty with micturition. 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. Management: Treatment should consist of standard supportive measures. Beta-blockers should reverse the cardiovascular complications and the hypokalaemia. Pholcodine The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Symptoms:

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been coingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely. Management: This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg. Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

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5.1

PHARMACOLOGICAL PROPERTIES
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.

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. Paracetamol 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 paracetamol. The elimination half life varies from about 1 to 4 hours. Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism and is excreted largely unchanged in the urine. It has a half life of several hours but elimination is enhanced and half life shortened in acid urine. 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 43 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.

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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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Sodium lauryl sulphate Sodium starch glycollate Magnesium stearate E572 Hard gelatin capsule (containing: Quinoline yellow E104, Allura red E 129, Titanium dioxide E171) Printing Ink: Opacode black (containing: shellac, black iron oxide (E172), propylene glycol)

6.2

Incompatibilities Not applicable

6.3

Shelf life 36 months

6.4

Special precautions for storage Do not store above 25C. Store in the original package.

6.5

Nature and contents of container
250m PVC/60gsm PVDC blister tray with 30m aluminium foil lid in a cardboard carton containing 8, 10, 12, 16, 20, 24 or 32 tablets. Not all pack sizes may be marketed.

6.6

Special precautions for disposal Not applicable

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MARKETING AUTHORISATION HOLDER
Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS

United Kingdom Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK

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MARKETING AUTHORISATION NUMBER
PL 00079/0379

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/09/2001 / 25/02/2009

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DATE OF REVISION OF THE TEXT
20/02/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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