Flu Strength Hot Lemon Powder
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flu Strength Hot Lemon Powder.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 1000mg
For excipients see 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of cold and flu symptoms.
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
Allergic reactions and sensitivity to any of the constituents.
Special warnings and precautions for use
4.4
(i) Do not exceed the stated dose.
(ii) If symptoms persist consult your doctor. This medicinal product should be given with care to patients with impaired kidney or liver function and also with caution to alcoholics.
(iii) If you are receiving a course of medicinal treatment, consult your doctor or pharmacist.
(iv) Contains paracetamol.
(v) Do not take with any other paracetamol containing-products
(vi) 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.
(vii) Should be given with care to patients with impaired kidney or liver function.
(viii) Should be given with care to alcoholics.
4.5 Interaction with other medicinal products and other forms of interaction
Should be given with care to patients taking other drugs that affect the liver. Reduced absorption with cholestyrarnine.
4.6 Pregnancy and lactation
There are unlikely to be any problems with normal use.
4.7 Effects on ability to drive and use machines
There are unlikely to be any problems with normal use.
4.8 Undesirable effects
At the recommended dosage drowsiness, impaired mental functions and methaemoglobinaemia may occur. Allergic reactions and sensitivity are rare and may include skin rash, drug fever, mucosal lesions, neutropaenia, pancytopaenia and leukopaenia.
4.9 Overdose
If the recommended dose is exceeded, and in any case of accidental dosing in children, seek medical advice immediately. Assessment of paracetamol plasma concentrations can then be made where indicated, and appropriate antidotes such as acetylcysteine or methionine administered.
Symptoms in first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent within 12-24 hours.
In severe poisoning hepatic failure may progress to encephalopathy, coma and death
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol: useful anti- has analgesic and antipyretic actions similar to Aspirin. It has no inflammatory properties.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as a glucuronide and sulphate conjugates. Less than 5 % is excreted as unchanged paracetamol. The elimination half-life varies from about 1-4 hours. Plasma protein binding is negligible at usual therapeutic concentrations, but increases with increased concentration.
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 can cause liver damage.
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.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Ascorbic acid Sucrose Sodium citrate,
Tartaric acid,
Citric acid,
Tapioca starch,
Sodium cyclamate,
Flav-o-lock lemon juice 610399,
Lemon flavour 8476,
Turmeric powder extract (curcumin, E 100).
6.2 Incompatibilities
None Known
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
Paper/HDPE/aluminium/polyethylene sachets
5 or 10 sachets in a carton. Each sachet contains 7.7 grammes of powder.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Bristol Laboratories Limited
Unit 3, Canalside, Northbridge road
Berkhamsted
Herts
HP4 1EG
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 17907/0348
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th January 2005
10 DATE OF REVISION OF THE TEXT
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)