Flu Strength Hot Lemon Powders
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flu Strength Hot Lemon Powders
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 7.7g sachet contains:
Paracetamol 1000 mg
For excipients see 6.1.
3. PHARMACEUTICAL FORM
Powder for oral solution.
Unit doses of a creamy, white powder contained in individual laminate sachets.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the treatment of symptoms of cold and flu.
4.2. Posology and method of administration
Adults, the elderly and children over 12 years: One sachet every 4 hours, to a maximum of four in any 24 hour period.
Empty the contents of one sachet into a tumbler and fill with hot water.
Stir until dissolved.
4.3. Contra-indications
Hypersensitivity to paracetamol or any of the other ingredients.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with chronic non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol-containing products concurrently.
If symptoms persist, consult your doctor.
Keep out of the sight and reach of children.
On the label
“Do not take with other paracetamol-containing products.”
“Immediate medical advice should be sought in the event of overdose, even if you feel well.”
On the leaflet (or label if no leaflet exists).
“Immediate medical advice should be sought in the event of overdose, even if you feel well, because of risk of delayed serious liver damage.”
4.5. Interactions with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide, domperidone and absorption reduced by cholestyramine. 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 affect.
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 clinically significant amounts.
Based on the available published data there is no requirement to contraindicate breast-feeding.
4.7. Effects on ability to drive and use machines
None.
Undesirable effects
4.8
Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
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.yellowcard.mhra.gov.uk.
4.9. Overdose
Symptom of overdose 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. It is considered that excess quantities of a toxic metabolite (usually detoxified glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
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 and any patient who has ingested more than 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
The active ingredient paracetamol has analgesic and antipyretic properties and is useful in the treatment of mild to moderate pain. It has weak antiinflammatory effects.
5.2. Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol.
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber, other than that which are already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Ascorbic acid Sucrose Sodium citrate Tartaric acid Citric acid
Modified tapioca starch Lemon flavours containing:--Maltodextrin acacia -Modified starch -Sodium citrate -Diphosphates E450 -BHA(E320)
Sodium cyclamate Turmeric extract powder
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
A triple laminated foil sachet containing 7.7 g of product. Packs of 5, 8 or 10 sachets contained in a cardboard carton. The laminate consists of an inner polyethylene layer, followed by aluminium foil, a second polyethylene layer and an outer paper coating.
6.6. Instructions for use and handling
Not applicable.
ADMINISTRATION DETAILS
7. MARKETING AUTHORISATION HOLDER
Bell Sons & Co (Druggists) Ltd Gifford House Slaidburn Crescent Southport
Merseyside PR9 9AL United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 03105/0071
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/04/2004
10 DATE OF REVISION OF THE TEXT
19/04/2016