Flu Strength Hot Lemon Paracetamol Powders
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flu Strength Hot Lemon Paracetamol Powders
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 1000 mg For excipients see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution.
Unit dose sachets.
4.1 Therapeutic Indications
Paracetamol is used for the relief from cold and flu symptoms.
Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, backache, rheumatic and muscle pains, dysmenorrhoea, sore throat, and for relieving the fever and aches.
4.2 Posology and method of administration
Adults and children over 12 years:
The contents of one sachet dissolved in hot water every 4 hours.
The dose should not be repeated more than four times in any 24-hour period.
The dosage should not be continued for more than 3 days without consulting a doctor.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents.
4.4. Special Warning and Precautions for Use
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol-containing products concurrently. Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
Pack Label:
Contains Paracetamol.
Do not take anything else containing paracetamol while taking this medicine and talk to a doctor at once if you take too much of this medicine, even if you feel well. Do not take if you are sensitive to paracetamol or to any of the other ingredients.
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 decreased 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.
4.6 Pregnancy and lactation
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
4.7 Effects on ability to drive and use machines
There are unlikely to be any problems with normal use.
4.8. Undesirable Effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-
marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Post marketing data
|
Body System |
Undesirable effect |
|
Blood and lymphatic system disorders |
Thrombocytopenia |
|
Agranulocytosis | |
|
Immune system disorders |
Anaphylaxis |
|
Cutaneous hypersensitivity reactions including skin rashes and angiodema | |
|
Respiratory, thoracic and mediastinal disorders |
Bronchospasm* |
|
Hepatobiliary disorders |
Hepatic dysfunction |
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
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 the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard.
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 NPIS or a liver unit.
5.1. Pharmacodynamic Properties
ATC Code N02BE01 Other analgesics and antipyretics.
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be on a selective basis.
5.2. Pharmacokinetic Properties
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. The peak plasma concentrations occurring 30 minutes to 60 minutes and the plasma half-life 1-4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Plasma protein binding is variable; 20 to 30% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged and the bulk is excreted after hepatic conjugation.
5.3 Preclinical safety data
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ascorbic acid
Sucrose
sodium citrate
tartaric acid
citric acid
tapioca starch
sodium cyclamate
Flav-O-lok Lemon Juice 610399
Lemon Flavour 8476
Turmeric powder extract (Curcumin, E100).
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
5 or 10 sachets in a carton. Each sachet contains 7.7 grammes of powder. Sachet specifications: 44 gsm paper, 10 gsm high density polythene,
8 micron soft tempered aluminium foil and 25 gsm polythene.
6.6 Special precautions for disposal
No special instruction necessary
7 MARKETING AUTHORISATION HOLDER
Aspar Pharmaceuticals Ltd
29-30 Capitol Way
Colindale
London
NW9 0EQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 08977/0040
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/02/2006
10 DATE OF REVISION OF THE TEXT
19/01/2015