Perrigo Paracetamol Guaifenesin Phenylephrine Hydrochloride 250 Mg/100 Mg/5 Mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Paracetamol, Guaifenesin, Phenylephrine Hydrochloride 250 mg/100 mg/5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient mg/Tablet
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White capsule shaped tablet, embossed with “PGP”, free from specks and blemishes.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of symptoms associated with colds and flu, including aches and pains, headache, blocked nose and sore throat, chills and chesty cough.
4.2 Posology and method of administration
For oral use. Take tablets with water. Swallow whole, do not chew.
Adults, the Elderly and children aged 12 years and over:
Two tablets. Repeat every four hours as required. Do not take more than 8 tablets (4 doses) in any 24 hour period.
Do not give to children under 12 years, except on medical advice.
Do not exceed the stated dose.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other ingredients.
Hypertension, hyperthyroidism, diabetes, serious heart disease or those patients receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
Use in patients with glaucoma or urinary retention.
Use in patients who are currently receiving other sympathomimetic drugs.
4.4 Special warnings and precautions for use
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).
Care is advised in the administration of paracetamol to patients with severe renal or hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Use with caution in patients with circulatory disorders such as Raynaud’s Phenomenon.
Patients with prostatic hypertrophy may have increased difficulty with micturition.
Sympathomimetic-containing products may act as cerebral stimulants giving rise to insomnia, nervousness, hyperpyrexia, tremor and epileptiform convulsions.
Long term use of the product is not recommended.
Do not exceed the recommended dose.
If symptoms persist consult your doctor.
Keep all medicines out of the reach and sight of children.
Special label 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.
Do not take with any other flu, cold or decongestant products.
Special leaflet warnings
Contains paracetamol. 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 speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular 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. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.
PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta blockers.
Sympathomimetic-containing products should be used with great care in patients suffering from angina and in patients receiving phenothiazines or tricyclic antidepressants.
Sympathomimetic-containing products should be used in caution in patients receiving digitalis, beta-adrenergic blockers, guanethidine, reserpine, methyldopa or anti-hypertensive agents
Concurrent use with halogentated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.
4.6 Pregnancy and lactation
PARACETAMOL
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.
GUAIFENESIN
The safety of guaifenesin in pregnancy and lactation has not been fully established but this constituent is not thought to be hazardous. However the product should only be used in pregnancy when considered essential by the doctor.
PHENYLEPHRINE HYDROCHLORIDE
Due to the vasconstrictive properties of Phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.
4.7
4.8
PARACETAMOL
Adverse effects of paracetamol are rare but hypersensitivity including skin rashes may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
The active ingredients are usually well tolerated in normal use.
GUAIFENESIN
Gastrointestinal discomfort has occasionally been reported with guaifenesin.
PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride may elevate blood pressure with headache, vomiting and rarely palpitations, tachycardia or reflex bradycardia, tingling and coolness of the skin. There have been rare reports of allergic reactions.
4.9
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, phenobarbital, 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 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
Gastrointestinal discomfort has occasionally been reported with Guaifenesin.
PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine Hydrochloride may elevate blood pressure with headache, vomiting and rarely palpitations, tachycardia or reflex bradycardia, tingling and coolness of the skin. There have been rare reports of allergic reactions.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Other analgesics and antipyretics &
Other cold combination preparations
N02B E51
ATC code:
Paracetamol is an analgesic and antipyretic.
Guaifenesin is an expectorant.
Phenylephrine Hydrochloride is a sympathomimetic decongestant.
The active ingredients are not known to cause sedation.
5.2 Pharmacokinetic properties
Paracetamol is rapidly absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as the glucuronide and sulphate conjugates.
Guaifenesin is rapidly absorbed after oral administration. It is rapidly metabolised by oxidation to P-(2 methyoxy-phenoxy) lactic acid, which is excreted in the urine.
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
Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use in the product and which have not already been mentioned elsewhere in this Summary.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core:
Microcrystalline cellulose Stearic acid Povidone
Film Coat:
Hypromellose
Polyethylene glycol
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Child Resistant PVC/Al blister.
Pack sizes: 8, 10, 12, 16, 20 and 24 tablets, although not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited (T/A Perrigo)
Braunton Devon EX33 2DL
8 MARKETING AUTHORISATION NUMBER(S)
PL 12063/0079
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/05/2010
10
DATE OF REVISION OF THE TEXT
20/08/2012