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ASPIRIN AND CODEINE TABLETS BP

Active substance(s): ASPIRIN / CODEINE PHOSPHATE / ASPIRIN / CODEINE PHOSPHATE / ASPIRIN / CODEINE PHOSPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Aspirin and Codeine Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Codeine Phosphate EP
Aspirin

3

mg
8.00
400.00

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the short term treatment of acute moderate pain which is not considered to
be relieved by other analgesics (e.g. paracetamol, ibuprofen or aspirin) alone,
such as: headache, migraine, neuralgia, toothache, period pain and rheumatic
pains.

4.2

Posology and method of administration
For oral administration.
Adults over 18 years: 1 to 2 tablets.
This dose may be taken, up to 4 times a day at intervals of not less than 4
hours.
Children aged 16 years to 18 years: The recommended dose for children 16
years and older is 1 to 2 tablets every 6 hours when necessary up to a
maximum of 8 tablets in 24 hours.
Do not give to children aged under 16 years, unless specifically indicated (e.g.
for Kawasaki’s disease).
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years because of
the risk of opioid toxicity due to the variable and unpredictable metabolism of
codeine to morphine (see sections 4.3 and 4.4).
Elderly: The normal adult dose is still appropriate in the elderly.
Do not take for more than 3 days continuously without medical review.

4.3

Contraindications
Hypersensitivity to any of the ingredients. Active peptic ulceration or a history of
ulceration, haemophilia or other clotting disorders. Gout, asthma, urticaria,
angiodema, rhinitis or other evidence of hypersensitivity to aspirin.
Aspirin should be avoided in patients with severe renal or hepatic impairment.
Obstructive airways disease, respiratory depression, acute alcoholism, where there is
as risk of paralytic ileus, head injuries and conditions in which intracranial pressure is
raised.
In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or
adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of
developing serious and life threatening adverse reactions (see section 4.4).
In women during breastfeeding (see section 4.6) and during the third trimester of
pregnancy.
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.

4.4

Special warnings and precautions for use
If symptoms persist consult your doctor.
There is a possible association between aspirin and Reye's syndrome when
given to children. Reye’s syndrome is a very rare disease, which affects the
brain and liver, and can be fatal. For this reason aspirin should not be given to
children aged under 16 years unless specifically indicated (e.g. for Kawasaki’s
disease).
Codeine should be taken with caution or in reduced doses by patients with
hypotension, decreased respiratory reserve, convulsive disorders,
hypothyroidism, adrenocortical insufficiency, impaired kidney or liver
function, prostatic hypertrophy, shock, inflammatory or obstructive bowel
disorders and myasthenia gravis.
Aspirin and other NSAIDs may cause salt and water retention and renal failure
especially in patients with pre-existing renal impairment. Aspirin should be
used with caution by patients with asthma, allergic disease, dehydration,
glucose-6-phosphate dehydrogenase deficiency and the elderly.
Keep all medicines out of the reach of children.
The Label will state:
Front of pack
• Can cause addiction
• For three days use only
Back of pack
• List of indications as agreed in 4.1 of the SPC
• If you need to take this medicine continuously for more than 3 days you
should see your doctor or pharmacist

• This medicine contains codeine which can cause addiction if you take it
continuously for more than 3 days. If you take this medicine for headaches
for more than 3 days it can make them worse.
The leaflet (or combined label/leaflet) will state:
‘Headlines’ section (to be prominently displayed)
• This medicine can only be used for.....(indications)
• You should only take this product for a maximum of 3 days at a time. If
you need to take it for longer than 3 days you should see your doctor or
pharmacist for advice.
• This medicine contains codeine which can cause addiction if you take it
continuously for more than 3 days. This can give you withdrawal
symptoms from the medicine when you stop taking it.
• If you take this medicine for headaches for more than 3 days it can make
them worse.
“What this medicine is for” section
• Succinct description of the indications from 4.1 of the SPC
“Before you take this medicine” section
• This medicine contains codeine which can cause addiction if you take it
continuously for more than 3 days. This can give you withdrawal
symptoms from the medicine when you stop taking it.
• If you take a painkiller for headaches for more than 3 days it can make
them worse.
“How to take this medicine” section
• Do not take for more than 3 days. If you need to use this medicine for more
than 3 days you must speak to your doctor or pharmacist.
• This medicine contains codeine and can cause addiction if you take it
continuously for more than 3 days. When you stop taking it you may get
withdrawal symptoms. You should talk to your doctor or pharmacist if you
think you are suffering from withdrawal symptoms.
“Possible side effects” section
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side
effects
directly
via
the
Yellow
Card
Scheme
at:
www.mhra.go.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
“How do I know if I am addicted?” section
If you take the medicine according to the instructions on the pack it is unlikely
that you will become addicted to the medicine. However, if the following
apply to you it is important that you talk to you doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended amount
• When you stop taking the medicine you feel very unwell but you feel better
if you start taking the medicine again

CYP2D6 metabolism
Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active
metabolite. If a patient has a deficiency or is completely lacking this enzyme
an adequate analgesic effect will not be obtained. Estimates indicate that up to
7% of the Caucasian population may have this deficiency. However, if the
patient is an extensive or ultra-rapid metaboliser there is an increased risk of
developing side effects of opioid toxicity even at commonly prescribed doses.
These patients convert codeine into morphine rapidly resulting in higher than
expected serum morphine levels.
General symptoms of opioid toxicity include confusion, somnolence, shallow
breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In
severe cases this may include symptoms of circulatory and respiratory
depression, which may be life threatening and very rarely fatal. Estimates of
prevalence of ultra-rapid metabolisers in different populations are summarised
below:
Population
African/Ethiopian
African American
Asian
Caucasian
Greek
Hungarian
Northern European

Prevalence %
29%
3.4% to 6.5%
1.2% to 2%
3.6% to 6.5%
6.0%
1.9%
1% to 2%

Post-operative use in children
There have been reports in the published literature that codeine given postoperatively in children after tonsillectomy and/or adenoidectomy for
obstructive sleep apnoea, led to rare, but life threatening adverse events
including death (see also section 4.3). All children received doses of codeine
that were within the appropriate dose range; however there was evidence that
these children were either ultra-rapid or extensive metabolisers in their ability
to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function
might be compromised including neuromuscular disorders, severe cardiac or
respiratory conditions, upper respiratory or lung infections, multiple trauma or
extensive surgical procedures. These factors may worsen symptoms of
morphine toxicity.

4.5

Interaction with other medicinal products and other forms of interaction
Alcohol and corticosteroids may enhance the effects of aspirin on the
gastrointestinal tract. Aspirin may enhance the effects of coumarin
anticoagulants and oral hypoglycaemics of sulphonylurea type. The toxicity of
methotrexate may be enhanced by concomitant use of aspirin. Aspirin
diminishes the uricosuric action of probenecid and sulphinpyrazone.
Codeine may delay the absorption of mexiletine and thus reduce the
antiarrhythmic effect of the latter. The depressant effects of codeine are
enhanced by depressants of central nervous system such as hypnotics,

sedatives, tricyclic antidepressants and phenothiazines. Codeine may
antagonise the gastrointestinal effects of metoclopramide and domperidone.

4.6

Fertility, pregnancy and lactation
The safety of aspirin and codeine tablets during pregnancy has not been established
and use in this period should be avoided.
Doses of aspirin of 500 mg/day and above:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development. Data from epidemiological studies suggest an increased
risk of miscarriage and of cardiac malformation and gastroschisis after use of a
prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for
cardiovascular malformation was increased from less than 1%, up to approximately
1.5%. The risk is believed to increase with dose and duration of therapy. In animals,
administration of a prostaglandin synthesis inhibitor has been shown to result in
increased pre- and post-implantation loss and embryo-foetal lethality. In addition,
increased incidences of various malformations, including cardiovascular, have been
reported in animals given a prostaglandin synthesis inhibitor during the organogenetic
period. During the first and second trimester of pregnancy, acetylsalicylic acid
should not be given unless clearly necessary. If acetylsalicylic acid is used by a
woman attempting to conceive, or during the first and second trimester of pregnancy,
the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may
expose the foetus to:
-

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);

-

renal dysfunction, which may progress to renal failure with oligohydroamniosis;

the mother and the neonate, at the end of pregnancy, to:
-

possible prolongation of bleeding time, an anti-aggregating effect which may
occur even at very low doses.

-

Inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is
contraindicated during the third trimester of pregnancy.
As aspirin is secreted into breast milk in low concentrations, use of aspirin and
codeine tablets should be avoided during lactation because of the risk of Reye's
syndrome and the fact that high doses of aspirin could potentially impair platelet
function.
Codeine should not be used during breastfeeding (see section 4.3).
At normal therapeutic doses codeine and its active metabolite 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 the
active metabolite, morphine, may be present in breast milk and on very rare occasions
may result in symptoms of opioid toxicity in the infant, which may be fatal.

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 a ‘statutory
defence’) if:

The medicine has been prescribed to treat a medical or dental
problem and

You have taken it according to the instructions given by the
prescriber and in the information provided with the medicine and

It was not affecting your ability to drive safely

4.8

Undesirable effects
Dyspepsia, nausea, vomiting, constipation, increased bleeding time,
drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo,
bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia,
restlessness, changes of mood, miosis, respiratory depression, difficulty in
micturition and possibly ureteric or biliary spasm, headache, hallucinations,
dysphoria, decreased libido or potency, pruritis. Less commonly irritation of
the gastrointestinal mucosa may lead to erosion, ulceration, gastrointestinal
bleeding. Hepatotoxicity which occurs rarely.
Aspirin may precipitate bronchospasm and induce asthma attacks or other
hypersensitivity reactions including urticaria, rhinitis and angioneurotic
oedema in susceptible individuals.
Aspirin may also cause salt and water retention as well as deterioration in
renal function (see also section 4.4).
Regular prolonged use of codeine is known to lead to addiction and symptoms
of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
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
Salicylate poisoning is usually associated with plasma concentrations
>350mg/L (2.5mmol/L). Most adult deaths occur in patients whose

concentrations exceed 700mg/L (5.1mmol/L). Single doses less than
100mg/kg are unlikely to cause serious poisoning.
Common features of salicylate poisoning include vomiting, dehydration,
tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses,
increased respiratory rate and hyperventilation. Some degree of acid-base
disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high
arterial pH (normal or reduced hydrogen ion concentration) is usual in adults
and children over the age of 4 years. In children aged 4 years or less, a
dominant metabolic acidosis with low arterial pH (raised hydrogen ion
concentration) is common. Acidosis may increase salicylate transfer across the
blood brain barrier.
Uncommon features of salicylate poisoning include haematemesis,
hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased
INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary
oedema.
Central nervous system features including confusion, disorientation, coma and
convulsions are less common in adults than in children.
Give activated charcoal if an adult presents within one hour of ingestion of
more than 250mg/kg. The plasma salicylate concentration should be measured,
although the severity of poisoning cannot be determined from this alone and
the clinical and biochemical features must be taken into account. Elimination
is increased by urinary alkalinisation, which is achieved by the administration
of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct
metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check
serum potassium). Forced diuresis should not be used since it does not
enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be
considered in patients with plasma salicylate concentrations >700mg/L
(5.1mmol/L), or lower concentrations associated with severe clinical or
metabolic features. Patients under 10 years or over 70 have increased risk of
salicylate toxicity and may require dialysis at an earlier stage.
The effects of codeine in overdosage will be potentiated by simultaneous
ingestion of alcohol and psychotropic drugs.
Central nervous system depression, including respiratory depression, may
develop but is unlikely to be severe unless other sedative agents have been coingested, including alcohol, or the overdose is very large. The pupils may be
pin-point in size; nausea and vomiting are common. Hypotension and
tachycardia are possible but unlikely.
Management should include general symptomatic and supportive measures
including a clear airway and monitoring of vital signs until stable. Consider
activated charcoal if an adult presents within one hour of ingestion of more
than 350mg or a child more than 5mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a
competitive antagonist and has a short half-life so large and repeated doses

may be required in a seriously poisoned patient. Observe for at least 4 hours
after ingestion, or eight hours if a sustained release preparation has been taken.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Aspirin has analgesic, antipyretic and anti-inflammatory actions which are
considered to be due to inhibition of the synthesis of prostaglandins.
Codeine is a centrally acting weak analgesic. Codeine exerts its effect through
µ opioid receptors, although codeine has low affinity for these receptors, and
its analgesic effect is due to its conversion to morphine. Codeine, particularly
in combination with other analgesics, has been shown to be effective in acute
nociceptive pain.

5.2

Pharmacokinetic properties
Absorption of non-ionised aspirin occurs in the stomach and intestine. Some
aspirin is hydrolysed to salicylate in the gut wall. After absorption aspirin is
rapidly converted to salicylate but during the first 20 minutes following oral
administration, aspirin is the predominant form of the drug in the plasma.
Aspirin is bound to plasma proteins and is widely distributed. Plasma aspirin
concentrations decline rapidly (half-life 15-20 minutes) as plasma salicylate
concentrations increase.
Salicylate is mainly eliminated by hepatic metabolism the metabolites
including salicylic acid, salicyl phenolic glucuronide, salicylic acyl
glucuronide, gentisic acid and gentisuric acid. As a result of zero order
kinetics, plasma steady state salicylate concentrations increase
disproportionately with dose. Salicylate is also excreted unchanged in the
urine to an extent which depends on the dosage and urinary pH. Renal
excretion involves glomerular filtration, active renal tubular secretion and
passive tubular reabsorption.
Codeine phosphate is absorbed from the gastrointestinal tract and peak plasma
concentrations occur after about one hour. Codeine is metabolised by O- and
N-Demethylation in the liver to morphine and norcodeine. Codeine and its
metabolites are excreted almost entirely by the kidney, mainly as conjugates
with glucuronic acid. The plasma half-life has been reported to be between 3
and 4 hours.

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Specially Dried Maize Starch

Sodium Metabisulphite

6.2

Incompatibilities
None known

6.3

Shelf life
36 months: For glass bottle
24 months: For HDPE bottle

6.4

Special precautions for storage
HDPE bottle: Do not store above 25ºC. Store in the original package.
Glass bottle: None

6.5

Nature and contents of container
Amber glass bottle with a child-resistant polythene/polypropylene cap, fitted
with a lectraseal tamper-evident liner which is: surlyn/aluminium
foil/polythene/bleached kraft paper/dot adhered to melinex coated carton
board or a child-resistant polyethylene/polypropylene cap fitted with a waxed
aluminium faced pulpboard liner.
Pack sizes: 24, 25, 30, 32
or
A white HDPE bottle with a polypropylene cap fitted with an induction heat
seal membrane.
Pack sizes: 24, 25, 30, 32

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0155R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/04/1981

10

DATE OF REVISION OF THE TEXT
20/04/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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