Paracetamol Hot Drink 500 Mg Powder For Oral Solution In Sachet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Hot Drink 500 mg, powder for oral solution in sachet.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituent
Paracetamol
Excipients:
Sucrose
Aspartame (E951)
Trisodium citrate [(anhydrous) (source of sodium)] Blackcurrant flavour (contains sulphites)
Red colorant (contains carmoisine (E122), sunset yellow (E110) and brilliant black (E151)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution in sachet.
Pale pink coloured, free flowing powder with characteristic blackcurrant menthol odour.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The short term relief of the symptoms of cold and flu including fever, sore throat, headache, aches and muscle pains.
Posology and method of administration
4.2
For oral use.
Adults (including the elderly and children aged 16 years and over):
One to two sachets to be taken every 4 to 6 hours as required. Dissolve the contents of sachets in a cup or mug of hot water, but not boiling water, and stir well. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 sachets in 24 hours.
Children aged 12-15 years:
One to two sachets to be taken every 4 to 6 hours as required. Dissolve the contents of sachets in a cup or mug of hot water, but not boiling water, and stir well. The dose should not be repeated more frequently than every 4 hours. Do not exceed 6 sachets in 24 hours.
Children:
Not recommended for children under 12 years, except on medical advice.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents.
4.4 Special warnings and precautions for use
Medical consultation is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with noncirrhotic alcoholic liver disease.
Each sachet contains 2 g of sucrose - patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Each sachet contains aspartame (E951) which contains a source of phenylalanine. May be harmful to patients with phenylketonuria.
Each sachet contains 118 g of sodium. To be taken into consideration by people on a controlled sodium diet.
Each sachet contains azo dyes, sunset yellow (E110), carmoisine (E122) and brilliant black (E151) which may cause allergic reactions.
Blackcurrant flavour contains sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Immediate medical advice should be sought in the event of an overdose, even if you feel well.
Do not take any other paracetamol-containing products.
Patient Information 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
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 daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
4.6 Pregnancy and lactation
Epidermiological 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.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Paracetamol
Adverse events reported from extensive post-marketing experience at therapeutic / labeled dose and considered attributable are tabulated below by MedDRA System Organ Class.
As these reactions have been reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but considered likely to be very rare (<1/10,000).
|
Body System |
Undesirable effect |
|
Blood and Lymphatic system disorders |
Thrombocytopenia |
|
Immune System disorders |
Anaphylaxis |
|
Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson Syndrome | |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm in patients sensitive to aspirin and other NSAIDs |
|
Hepatobiliary disorders |
Hepatic dysfunction |
4.9 Overdose
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 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 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 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 24h from ingestion should be discussed with the National Poisons Information Service (NPIS) or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anilides ATC code: N02B E01
Paracetamol is an antipyretic and analgesic. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system. The lack of peripheral prostaglandin inhibition confers important pharmacological properties such as the maintenance of the protective prostaglandins within the gastrointestinal tract. Paracetamol is, therefore, particularly suitable for patients with a history of disease or on concomitant medication where peripheral prostaglandin inhibition would be undesirable (such as, for example, those with a history of GI bleeding or the elderly).
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Paracetamol is metabolized in the liver and excretion is almost exclusively renal, in the form of conjugated metabolites.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Aspartame (E951)
Tartaric acid
Trisodium citrate (anhydrous)
Blackcurrant flavour
Menthol Flavour
Red colouring agent containing:
Carmoisine (E122)
Sunset yellow (E110)
Brilliant black (E151)
Blackcurrant flavor contains sulphites.
6.2 Incompatibilities
None.
6.3 Shelf life
30 months.
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original packaging.
6.5 Nature and contents of container
Flexible laminate composed of printed paper/polyethylene / aluminium foil / polyethylene. The sachets are supplied in conventional cardboard cartons containing either 5, 6 or 10 sachets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
The powder dissolves in hot water into a dark red solution. Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0090
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16/05/2012
10
DATE OF REVISION OF THE TEXT
02/09/2016