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BEECHAMS ULTRA ALL IN ONE CAPSULES HARD.

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Beechams Ultra All In One Capsules, hard.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient Paracetamol Guaifenesin 500 100 mg/Capsule

Phenylephrine hydrochloride 6.1 For a full list of excipients, see section 6.1.

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PHARMACEUTICAL FORM
Capsule, hard. Dark blue/dark green hard gelatin capsules containing the drug product, an off-white powder.

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4.1

CLINICAL PARTICULARS
Therapeutic indications
For the relief of symptoms associated with colds and flu and the pain and congestion of sinusitis, including aches and pains, headache, blocked nose and sore throat, chills, lowering of temperature, and to loosen stubborn mucous and provide relief from chesty coughs.

4.2.

Posology and method of administration
For oral use. Swallow whole with water, do not chew. Adults, the elderly and children aged 12 years and over: Two capsules every four hours as required. Do not take more than 8 capsules (4 doses) in any 24 hour period. Not to be given to children under 12 years except on medical advice. Do not take continuously for more than 5 days without medical advice.

4.3.

Contraindications
Known hypersensitivity to any of the ingredients. Concomitant use of other sympathomimetic decongestants. Phaeochromocytoma. Closed angle glaucoma. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken within the last two weeks, monoamine oxidase inhibitors (see section 4.5).

4.4

Special warnings and precautions for use
Patients suffering from chronic cough or asthma should consult a physician before taking this product. Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache. Do not take with a cough suppressant. Medical advice should be sought before taking this product in patients with these conditions: An enlargement of the prostate gland Occlusive vascular disease (e.g. Raynauds Phenomenon) This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see section 4.5).

Concomitant use of other paracetamol-containing products should be avoided.

Special label warnings If you are taking medication or are under medical care, consult your doctor before using this medicine. Do not exceed the stated dose. If symptoms persist consult your doctor. Keep all medicines out of the reach and sight of children. Contains paracetamol. 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. Special leaflet warnings Contains paracetamol. 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, because of the risk of delayed, serious liver damage.

4.5.

Interaction with other medicinal products and other forms of interaction
Paracetamol The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding. The hepatotoxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed. Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported: Monoamine oxidase inhibitors (including moclobemide) Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications). Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects. Phenylephrine may reduce the efficacy of betablocking drugs and antihypertensive drugs. The risk of

Sympathomimetic amines

Beta-blockers and other antihypertensives (including

debrisoquine, guanethidine, reserpine, methyldopa) Tricyclic antidepressants (e.g. amitriptyline) Ergot alkaloids (ergotamine and methylsergide) Digoxin and cardiac glycosides

hypertension and other cardiovascular side effects may be increased. May increase the risk of cardiovascular side effects with phenylephrine. Increased risk of ergotism

Increase the risk of irregular heartbeat or heart attack

If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5HIAA) and vanillymandelic acid (VMA). No significant interactions with other drugs have been noted for guaifenesin.

4.6.

Pregnancy and lactation
This product should not be used during pregnancy without medical advice. Human and animal studies with paracetamol have not identified any risk to pregnancy or embryo-foetal development. No relevant data are available for products containing phenylephrine. The safety of guaifenesin during pregnancy has not been established. Lactation This product should not be used whilst breast feeding without medical advice. Human studies with paracetamol have not identified any risk to lactation or the breast-fed offspring. Paracetamol crosses the placental barrier and is excreted in breast milk. Phenylephrine may be excreted in breast milk. No relevant data available for guaifenesin.

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
Adverse events from historical clinical trial data are both infrequent and from small patient exposure.

Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare. Body System Blood and lymphatic system disorders Undesirable effect Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome Bronchospasm in patients sensitive to aspirin and other NSAIDs Hepatic dysfunction Acute pancreatitis

Immune system disorders

Respiratory, thoracic and mediastinal disorders Hepatobiliary disorders Gastrointestinal disorders

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Psychiatric disorders Nervous system disorders Cardiac disorders Gastrointestinal disorders Undesirable effect Nervousness, irritability, restlessness, and excitability Headache, dizziness, insomnia Increased blood pressure Nausea, Vomiting, diarrhoea

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown but likely to be rare. Eye disorders 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). Hypersensitivity reactions including that cross-sensitivity may occur with other sympathomimetics.

Cardiac disorders Skin and subcutaneous disorders

Renal and urinary disorders

Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

Guaifenesin The frequency of these events is unknown but considered likely to be rare. Body system Immune system disorders Undesirable effect Allergic reactions, angioedema, anaphylactic reactions Dyspnoea*

Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders Skin and subcutaneous disorders

Nausea, vomiting, abdominal discomfort, Rash, urticaria

*Dyspnoea has been reported in association with other symptoms of hypersensitivity

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 is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes. or Regularly consumes ethanol in excess of recommended amounts. or 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 British National Formulary (BNF) overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within one hour. Plasma paracetamol concentration should be measured at four 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 eight 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 National Poisons Information Service (NPIS) or a liver unit. Guaifenesin Symptoms Very large doses of guaifenesin can cause nausea and vomiting. Treatment Vomiting should be treated by fluid replacement and monitoring of electrolytes. Phenylephrine Symptoms Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include irritability, restlessness, hypertension and possibly reflux brachycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than required to cause paracetamol-related liver toxicity. Treatment Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

Pharmacotherapeutic Group:

Other analgesics and antipyretics & Other cold combination preparations N02BE51

ATC code:

Paracetamol
Analgesic: The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting a prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent through a peripheral action by blocking painimpulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation. Antipyretic: Paracetamol probably produces antipyresis by acting on the hypothalamic heatregulating centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. Guaifenesin Guaifenesin is a well known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by cilary action and coughing.

Phenylephrine Hydrochloride
Sympathomimetic amines, such as phenylephrine, act on alpha-adrenergic receptors of the respiratory tract to produce vasoconstriction, which temporarily reduces the swelling associated with inflammation of the mucous membranes lining the nasal and sinus passages. This allows the free drainage of the sinusoidal fluid from the sinuses. In addition to reducing mucosal lining swelling, decongestants also suppress the production of mucous, therefore preventing a build up of fluid within the cavities which could otherwise lead to pressure and pain.

5.2

Pharmacokinetic properties Paracetamol
Absorption and Fate Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring between 10 and 120 minutes after oral administration. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours.

Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed-function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdose and cause liver damage. Guaifenesin Guaifenesin is rapidly absorbed after oral administration. It is rapidly metabolised by oxidation to -(2 methoxy-phenoxy)lactic acid, which is excreted in the urine.

Phenylephrine Hydrochloride
Phenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber additional to that already covered in other sections of the SPC.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Maize starch Croscarmellose sodium Sodium laurilsulfate Magnesium stearate Talc Gelatin capsule: Gelatin Quinoline yellow E104 Indigo carmine E132 Erythrosine E127 Titanium dioxide E171

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Do not store above 25C.

6.5

Nature and contents of container
Child Resistant blister comprising 250 micron PVC lidded with 35 gsm paper/9 micron aluminium foil. A pack size of 24 capsules is available.

6.6

Special precautions for disposal None.

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MARKETING AUTHORISATION HOLDER
Beecham Group p.l.c. 980 Great West Road, Brentford Middlesex TW8 9GS United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 00079/0655

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/03/2011

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DATE OF REVISION OF THE TEXT
10/05/2012

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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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