Olbas Powerflu Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Uniflu Tablets Olbas PowerFlu Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Ingredients |
mg/tablet |
|
Paracetamol |
500 |
|
Caffeine |
30 |
|
Diphenhydramine Hydrochloride |
15 |
|
Codeine Phosphate |
10 |
|
Phenylephrine Hydrochloride |
10 |
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong, film-coated tablet.
4. Clinical Particulars
4.1 Therapeutic indications
For the symptomatic relief from the discomforts associated with influenza and colds i.e. nasal and sinus congestion, headache, fever, aching limbs, coughing and runny nose; and for the symptomatic relief of nasal congestion in allergic conditions such as hay fever.
4.2 Posology and method of administration
For oral use.
Adults: Swallow 1 tablet whole with water, followed by
1 tablet every six hours until the symptoms disappear.
Do not take more than 4 tablets in 24 hours. Elderly: As adult dose.
Children aged 12 and over: Swallow 1 whole with water, followed by 1
tablet every eight hours until symptoms disappear.
Do not take more than 3 tablets in 24 hours.
Not recommended for children under 12 years old.
4.3 Contraindications
Hypersensitivity to paracetamol or any of the other constituents. The phenylephrine content contra-indicates their use in hyperthyroidism and hypertension, cardiovascular and coronary disease and should not be given to patients being treated with monoamine oxidase inhibitors or within fourteen days of stopping such treatment. The tablets are contra-indicated in chronic obstructive airways disease.
4.4 Special warnings and precautions for use
Regarding paracetamol, Uniflu should be administered with care to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Caution is required in patients with epilepsy, prostatic hypertrophy and glaucoma.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.
Do not exceed the stated dose. Keep out of the reach of children.
If symptoms persist consult your doctor. Patients receiving other regular medication should be warned to consult their physician before using this product. Patients should be advised not to take other paracetamol-containing products concurrently.
The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the ‘before taking’ section:
• Do not take for longer than directed by your prescriber
• Taking codeine/dihydrocodeine (DHC) regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse
The leaflet will state in the “Pregnancy and breast-feeding” subsection of section 2 “Before taking your medicine”:
Usually it is safe to take Uniflu Tablets/Olbas Powerflu while breast feeding as the level of codeine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels of codeine in their breast milk. If any of the following side effects develop in you or your baby stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.
The label will state (To be displayed prominently on outer pack -not boxed):
• Do not take for longer than directed by your prescriber as taking codeine/DHC regularly for a long time can lead to addiction
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol and other central nervous system depressants can potentiate the sedative effect of the tablets. Patients are warned to avoid alcoholic drink whilst using this product. Phenylephrine may antagonise the effects of concurrent antihypertensive therapy. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
Paracetamol may cause a marginal increase in blood levels of chloramphenicol.
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily used of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
4.6 Pregnancy and lactation
The safe use of these tablets in pregnancy has not been established. They should not, therefore, be used in pregnancy except under close medical supervision. 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.
At normal therapeutic doses codeine may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of codeine may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.
If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.
4.7 Effects on ability to drive and use machines
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called ‘statutory defence’) if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
o It was not affecting your ability to drive safely
4.8 Undesirable effects
Headache, dry mouth, blurred vision, gastro-intestinal disturbance, urinary retention and occasional rashes have been reported. Hypertension may occur due to phenylephrine. Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
Regular prolonged used of codeine/DHC is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
Overdosage may lead to tachycardia, hypertension, nausea, vomiting, delayed onset hepatic failure due to paracetamol and respiratory depression due to codeine.
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.
Treatment consists of supportive measures, gastric lavage, as well as correction of any fluid or electrolyte imbalance. Intravenous N-acetylcysteine and naloxone may be needed as antidotes in severe cases. In cases of severe hypertension, intravenous phentolamine may be required.
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, 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. Liver damage is possible in adults who have taken 10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by 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 around 7.5 g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which 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
Pharmacotherapeutic group: Other Cold Combination Preparations, ATC code: R05X
Caffeine
Caffeine, like other xanthines, stimulates the central nervous system, increases respiration, affects smooth muscle and exerts a diuretic effect. These effects are all thought to be mediated by the inhibition of phosphodiesterase resulting in a raised cyclic AMP concentration. Of the xanthines, caffeine is the most active in stimulating the central nervous system and is principally used for this purpose and has the least diuretic effect. Its action on the central nervous system is mainly on the higher centres producing a condition of wakefulness and increased mental activity. Caffeine may stimulate the respiratory centre and increase the rate and depth of respiration.
Codeine Phosphate
Codeine phosphate has analgesic, antidiarrhoeal and antitussive actions. Codeine is the antitussive agent against which all other antitussives are evaluated. It acts by depressing the central pathways of the cough reflex in the medulla. The dosage of codeine phosphate employed in Uniflu tablets is that which is necessary to produce antitussive action.
Diphenhydramine Hydrochloride
Diphenhydramine hydrochloride is an ethanolamine derivative with the properties and use of antihistamine. It is less potent than promethazine hydrochloride but has a shorter duration of action. It has sedative, anti-emetic, anticholinergic and local anaesthetic properties.
Diphenhydramine hydrochloride is a histamine H1-receptor antagonist. It has action on the contraction of smooth muscle and the dilation and increased permeability of the capillaries. It also has anticholinergic activity.
Paracetamol
Paracetamol has both antipyretic and analgesic activities but no useful antiinflammatory properties. Its mechanism of analgesic effect is not yet defined. Prostaglandin synthetase from the central nervous system is sensitive to paracetamol, explaining its antipyretic effect. It does not, however, have an anti-inflammatory effect as the peripheral tissue prostaglandin synthetase is not affected.
Phenylephrine Hydrochloride
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects of adrenergic receptors. It has predominantly a-adrenergic activity and is without stimulator effects on the central nervous system. It is used for its bronchodilator effects and to elicit sympathetic responses (vasoconstriction) where there is congestion and inflammation of the nasal mucosa.
5.2 Pharmacokinetic properties
Caffeine
Caffeine is absorbed erratically from the gastro-intestinal tract and does not appear to accumulate in any particular tissue. It passes readily into the central nervous system and saliva.
Caffeine is almost completely metabolised and is excreted in the urine as 1-methyluric acid, 1-methylxanthine and other metabolites. Only about 1% remains unchanged.
Codeine Phosphate
Codeine phosphate is absorbed from the gastro-intestinal tract with peak plasma codeine concentrations produced in about one hour. Codeine is metabolised by O and N-demethylation in the liver to morphine and norcodeine. About 10% of an oral dose is demethylated to morphine. The plasma half life of Codeine in healthy volunteers has been found to be about 3.5 hours. Codeine and its metabolites are excreted almost entirely by the kidneys, mainly as conjugates with glucuronic acid.
Diphenhydramine Hydrochloride
Diphenhydramine hydrochloride is absorbed from the gastro-intestinal tract, metabolised by the liver and excreted mainly as metabolites in the urine. Any unchanged diphenhydramine is eliminated more rapidly than its metabolites.
It has been reported to be 98% bound to plasma proteins with a normal halflife of 4 to 7 hours.
Paracetamol
Paracetamol is a weak acid which is readily absorbed from the gastrointestinal tract with peak plasma concentration occurring about 30 minutes to 2 hours after ingestion. Following absorption it is mainly biotransformed by conjugation to the sulphate and glucuronide. Plasma-protein binding is negligible at the usual therapeutic concentrations.
The elimination of paracetamol does not appear to follow saturation kinetics. The half-life of paracetamol ranges from 2-4 hours in healthy adults. In adults, the sulphate and glucuronide account for about 90% of the urinary recovery of paracetamol, each metabolite contributing to half this amount.
Less than 5% is excreted as unchanged paracetamol.
In the overdose situation (10g paracetamol or above), the defence mechanisms of the liver which lead to non-toxic glucuronide and sulphate formation are overwhelmed. Normally minor metabolic pathways therefore participate actively in the overall biotransformation of the drug and these produce hepatoxic metabolites.
Phenylephrine Hydrochloride
The bioavailability of phenylephrine is reduced due to first pass metabolism by monoamine oxidase in the gut and liver.
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
List of excipients
6.1
Core:
Acacia, Spray-Dried
Alginic Acid
Magnesium Stearate
Protein S (Byco C) (hydrolysed gelatin)
Sodium Starch Glycolate (Type A)
Stearic Acid
Coating:
Opadry II White (Polyvinyl Alcohol part hydrolysed, Titanium Dioxide, Polyehthylene Glycol 3350, Talc)
Purified Water
6.2 Incompatibilities
Not applicable.
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
The product is presented in press through blisters containing six Uniflu tablets with six Gregovite C tablets or six Olbas Powerflu tablets with six Vitamin C Chewable tablets. The blister pack has a lidding material of 30 micron embossed lacquered aluminium foil, with a heat seal lacquer for sealing to PVC/PVDC and a base material of 250 micron/35 micron (60g/m2) PVC/PVDC.
The product is available in two pack sizes:
(i) 12 tablet box containing 1 blister strip
(ii) 24 tablet box containing 2 blister strips
6.6
Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
G. R. Lane Health Products Limited
Sisson Road
Gloucester
GL2 0GR
United Kingdom
Tel: +44 (0)1452 524012
Fax: +44 (0)1452 507930
Email: info@laneshealth.com
8. MARKETING AUTHORISATION NUMBER(S)
PL 01074/0225
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 3 October 2005.
10 DATE OF REVISION OF THE TEXT
08/12/2014