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CO-CODAMOL TABLETS 8/500MG

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Co-Codamol Tablets BP 8/500mg.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Paracetamol BP 500mg,
Codeine Phosphate BP

3

8mg.

PHARMACEUTICAL FORM
Compressed tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Codeine is indicated in patients older than 12 years of age for the treatment of acute
moderate pain which is not considered to be relieved by other analgesics such as
paracetamol or ibuprofen (alone).
POM:
For the treatment of most febrile conditions such as headache, toothache, colds,
influenza, dysmenorrhoea, arthritic and rheumatic pain.
P:
For the short term treatment of acute moderate pain which is not relieved by
paracetamol, ibuprofen or aspirin alone. For headache, toothache, dysmenorrhoea,
arthritic and rheumatic pain.

4.2

Posology and method of administration

This preparation is intended for oral administration.

The duration of treatment should be limited to 3 days and if no effective pain relief is
achieved the patients/carers should be advised to seek the views of a physician.
Adults: One or two tablets to be taken four times a day.
Elderly patients: As the adult dose.
The dose should not be repeated more frequently than every four hours, and not more
than 4 doses should be taken in 24 hours.
Paediatric population:
Children aged 12 years to 18 years: one or two tablets every four hours when
necessary, and no more than 2 tablets at once and no more than 8 tablets in 24 hours.
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).

4.3

Contraindications

Known hypersensitivity to Paracetamol, Codeine or other opioid analgesics.
Moderate to severe renal failure.
Moderate to severe liver disease.
Respiratory depression and obstructive airways disease.
Bronchial asthma attack or heart failure secondary to chronic lung disease.
Raised intracranial pressure, head injuries and acute alcoholism.
Diarrhoea associated with pseudomembranous colitis. Diarrhoea caused by poisoning
until the toxic material has been eliminated from the gastrointestinal tract.
Not to be used in infants.
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)
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers

4.4

Special warnings and precautions for use

Caution is advised in the administration of both Paracetamol and Codeine to patients
with impaired kidney or liver function. The hazard of overdose with Paracetamol is
greater in those with non-cirrhotic liver disease.
Codeine should be given with caution or in reduced doses to patients with
hypotension, hypothyroidism, adrenal insufficiency, prostatic hypertrophy, shock,
obstructive bowel disorders, acute abdominal conditions, recent gastrointestinal
surgery, gallstones, myasthenia gravis, a history of cardiac arrhythmias or convulsions
and in patients with a history of drug abuse or emotional instability.
Prolonged use of Codeine may lead to dependence and should be avoided.
Abrupt withdrawal of opioids from persons physically dependent on them precipitates
a withdrawal syndrome, the severity of which depends on the individual, the drug
used, the size and frequency of the dose, and the duration of drug use.
Codeine may induce faecal impaction, producing incontinence, spurious diarrhoea,
abdominal pain, and rarely, colonic obstruction.
Elderly patients may metabolise or eliminate opioid analgesics more slowly than
younger adults.
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
summarized 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%-2%

Post-operative use in children
There have been reports in the published literature that codeine given post-operatively
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.

For product in packs of 32 tablets or fewer (P status), the label and leaflet will
state:
The label will state :
On front of pack (to be prominently displayed) –
o Can cause addiction.
o For three days use only.
On back of pack (to be prominently displayed not boxed) • For the short term treatment of acute, moderate pain when other
painkillers have not worked. Do not take less than four hours after
taking other painkillers. For headache, toothache, period pains,
arthritic and rheumatic pain.
• If you need to take this medicine for more than three days you must
see your doctor or pharmacist.
• This medicine contains codeine which can cause addiction if you take
it continuously for more than three days. If you take this medicine for
headaches for more than three days it can make them worse.
The leaflet will state :
Headlines section (to be prominently displayed)


This medicine can only be used for the short term treatment of acute,
moderate pain which is not relieved by paracetamol, ibuprofen or
aspirin alone.



You should only take this product for a maximum of three days at a
time. If you need to take it for longer than three 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 three 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 three days it
can make them worse.

Section 1 – What the medicine is for



For the short term treatment of acute, moderate pain which is not
relieved by paracetamol, ibuprofen or aspirin alone. For headache,
toothache, period pains, arthritic and rheumatic pain.

Section 2 – Before taking


This medicine contains codeine which can cause addiction if you take
it continuously for more than three 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 three days it can
make them worse.



Under ‘Pregnancy and Breastfeeding’:
Usually it is safe to take Co-codamol while breast feeding as the level
of the active ingredients of this medicine 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 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.

Section 3 – Dosage


Do not take for more than three days. If you need to use this
medicine for more than three 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 three 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.



Talk to your doctor at once if you take too much of this medicine
even if you feel well. This is because too much paracetamol can cause
delayed, serious liver damage.

Section 4 – Side effects


Some people may have side-effects when taking this medicine. If you
have any unwanted side-effects you should seek advice from your
doctor, pharmacist or other healthcare professional. Also you can
help to make sure medicines remain as safe as possible by reporting
any unwanted side-effects via the internet at www.yellowcard.gov.uk;
alternatively you can call Freephone 0808 100 3352 (available
between 10am-2pm Monday-Friday) or fill in a paper form available
from your local pharmacy.

How do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is
unlikely that you will become addicted to this medicine. However, if the
following apply to you it is important that you talk to your doctor:


You need to take the medicine for longer periods of time



You need to take more than the recommended dose



When you stop taking the medicine you feel very unwell but you feel
better if you start taking the medicine again.

For product in packs of more than 32 tablets (POM status):
The risk-benefit of continued use should be assessed regularly by the prescriber.
The label and leaflet will state:
Patient Information Leaflet (in ‘before taking’ section)
• Do not take for longer than directed by your prescriber
• Taking codeine 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.
• In Section 3 ‘How to take Co-codamol tablets’: Talk to your doctor at once if you
take too much of this medicine even if you feel well. This is because too much
paracetamol can cause delayed, serious liver damage.

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
regularly for a long time can lead to addiction
For product in any pack sizes:
Do not take more medicine than the label tells you to.
Talk to your doctor at once if you take too much of this medicine even if you feel
well.
Do not take anything else containing paracetamol while taking this medicine.
Keep out of the reach and sight of children.
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 reduced by colestyramine.

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 effect.
The risk of paracetamol toxicity may be increased in patients receiving other
potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes. The
plasma-paracetamol concentrations considered an indication for antidote treatment
should be halved in patients receiving enzyme-inducing drugs such as carbamazepine,
phenobarbital, phenytoin, primidone or rifampicin.
Excretion of paracetamol may be reduced and plasma concentrations increased when
given with probenecid.
Hepatotoxicity at therapeutic doses of paracetamol has been reported in patients
receiving isoniazid.
The depressant effects of Codeine are enhanced by depressants of the central nervous
system such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants
and phenothiazines. The hypotensive actions of diuretics and antihypertensive agents
may be potentiated when used concurrently with opioid analgesics. Concurrent use of
hydroxyzine with Codeine may result in increased analgesia as well as increased CNS
depressant and hypotensive effects.
Concurrent use of Codeine with antidiarrhoeal and antiperistaltic agents such as
loperamide and kaolin may increase the risk of severe constipation.
Concomitant use of antimuscarinics or medications with antimuscarinic action may
result in an increased risk of severe constipation which may lead to paralytic ileus
and/or urinary retention.
The respiratory depressant effects caused by neuromuscular blocking agents may be
additive to the central respiratory depressant effects of opioid analgesics.
CNS depression or excitation may occur if Codeine is given to patients receiving
monoamine oxidase inhibitors, or within two weeks of stopping treatment with them.
Quinidine can inhibit the analgesic effect of Codeine.
Codeine may delay the absorption of mexiletine and thus reduce the antiarrhythmic
effect of the latter. Codeine may antagonise the gastrointestinal effects of
metoclopramide, cisapride and domperidone.
Cimetidine inhibits the metabolism of opioid analgesics resulting in increased plasma
concentrations.
Naloxone antagonises the analgesic, CNS and respiratory depressant effects of opioid
analgesics. Naltrexone also blocks the therapeutic effect of opioids.
Interference with laboratory tests: Opioid analgesics interfere with a number of
laboratory tests including plasma amylase, lipase, bilirubin, alkaline phosphatase,
lactate dehydrogenase, alanine aminotransferase and aspartate aminotransferase.
Opioids may also interfere with gastric emptying studies as they delay gastric
emptying, and with hepatobiliary imaging using technetium Tc99m disofenin as

opioid treatment may cause constriction of the sphincter of Oddi and increases biliary
tract pressure.
4.6
Fertility, pregnancy and lactation
Codeine crosses the placenta. There is no adequate evidence of safety in human
pregnancy and a possible association with respiratory and cardiac malformations has
been reported. Regular use during pregnancy may cause physical dependence in the
foetus leading to withdrawal symptoms in the neonate. Use during pregnancy should
be avoided if possible.
Use of opioid analgesia during labour may cause respiratory depression in the
neonate, especially the premature neonate. These agents should not be given during
the delivery of a premature baby.
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.
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
Codeine may cause drowsiness, if affected patients should be advised not to
drive or operate machinery.
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:
- 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

Adverse effects of Paracetamol are rare but hypersensitivity including skin rash may occur.
Anaphylactic shock and angioedema may occur but frequency is unknown. There have been a
few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these
were not necessarily causally related to Paracetamol.
The most frequent undesirable effects of Codeine are constipation and drowsiness. Less
frequent effects are nausea, vomiting, sweating, facial flushing, dry mouth, blurred or double
vision, dizziness, orthostatic hypotension, malaise, tiredness, light-headedness, confusion,
headache, anorexia, vertigo, bradycardia, palpitations, respiratory depression, dyspnoea,
allergic reactions (itch, skin rash, facial oedema) and difficulties in micturition (dysuria,
increased frequency, decrease in amount). Side effects which occur rarely include
convulsions, hallucinations, nightmares, uncontrolled muscle movements, muscular rigidity,
mental depression and stomach cramps. There have been very rare occurrences of
pancreatitis.
The euphoric activity of Codeine may lead to its abuse and dependence.
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.

4.9

Overdose

Paracetamol
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, coma 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.
Liver damage is possible in adults who have taken 10G 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.
Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has any of the
following risk factors:
• is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone,
rifampicin, St. John's Wort or other drugs that induce liver enzymes, or
• regularly consumes ethanol in excess of recommended amounts, or
• is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection,
starvation, cachexia.
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 serious
hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver
unit.
Codeine
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and
psychotropic drugs.
Symptoms
Symptoms of Codeine overdosage include cold clammy skin, confusion, convulsions,
dizziness, drowsiness, nervousness or restlessness, miosis, bradycardia, dyspnoea,
unconsciousness, circulatory failure and deepening coma. Nausea and vomiting are common.
Hypotension and tachycardia are possible but unlikely. Central nervous system depression,
including respiratory depression, may develop but is unlikely to be severe unless other
sedative agents have been co-ingested, including alcohol, or the overdose is very large.
Death may occur from respiratory failure.
Management
This 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.
Intensive support therapy may be required to correct respiratory failure and shock due to the
effects of Codeine. In addition the specific narcotic antagonist, naloxone hydrochloride, may
be used to rapidly counteract the severe respiratory depression and coma. Naloxone has a
short half-life so large and repeated doses may be required in a seriously poisoned patient. A
dose of 0.4 - 2mg is given intravenously or intramuscularly to adults, this is repeated at
intervals of 2 - 3 minutes if necessary. Up to a total of 10mg of naloxone may be given. In
children doses of naloxone of 5 - 10mcg/Kg bodyweight may be given intravenously or
intramuscularly. Observe for at least four hours after ingestion, or eight hours if a sustained
release preparation has been taken.
Codeine is not dialysable.
General supportive measures must be available.

5

PHARMACOLOGICAL PROPERTIES

5.1
Pharmacodynamic properties
Paracetamol has analgesic and antipyretic actions.

Codeine Phosphate is an analgesic of the opioid class. Opioid analgesic bind with
stereospecific receptors at many sites within the CNS to alter processes affecting both
the perception of pain and the emotional response to it. It has been hypothesised that
alterations in release of various neurotransmitters from afferent nerves sensitive to
painful stimuli may be partially responsible for the analgesic effect.
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 such as paracetamol, has been shown to be
effective in acute nociceptive pain.
The drugs are additive and some workers suggest there may be synergy between the
constituents.

5.2

Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak
plasma levels occurring about 30 minutes to 2 hours after ingestion. It is
metabolised in the liver and excreted in the urine mainly as the glucuronide
and sulphate conjugates. Less than 5% is excreted unchanged.
The elimination half life of Paracetamol varies from about 1 to 4 hours.
Plasma protein binding is negligible at usual therapeutic doses.
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 and other
metabolites. Codeine and its metabolites are excreted almost entirely by the
kidney, mainly as conjugates with glucuronic acid.
Codeine is not extensively bound to plasma proteins. The plasma half life
varies from about 3 to 4 hours.

5.3

Preclinical safety data
Both actives have been in clinical use separately and in combination products
for many years. Preclinical data has therefore been superseded by clinical data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Each tablet contains:

Maize Starch BP
Povidone BP
Colloidal Silica BP

77.000mg
10.000mg
3.200mg

Magnesium Stearate BP
Potassium Sorbate BP

6.2

1.500mg
0.700mg

Incompatibilities
This product is designed for oral administration.
Admixture with other medicines prior to ingestion is not intended or desirable.

6.3

Shelf life
The shelf life of the product is 36 months when stored in the unopened
container and taking the precautions described below.
In the case of tubs, provided the pack is re-sealed after each use there should
be no reduction in shelf life.
Re-packing into any other pack may affect the shelf life and appropriate
pharmaceutical judgement should be exercised.

6.4

Special precautions for storage
Store in a well-closed container. Store in a dry place at a temperature not
exceeding 25°C, protected from light.

6.5

Nature and contents of container
A HDPE or polypropylene tub fitted with a plastic cap, child resistant and/or
tamper-evident as appropriate, containing 16, 25, 32, 50, 100, 500 or 1000
tablets.
Child Resistant Blister pack strips, 0.25mm PVC/35 gsm Glassine (Pergamin)
paper/ 0.009mm Aluminium enclosed in a cardboard carton, containing 10, 12,
16, 20, 24, 30, 32, 50, and 100 tablets.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
M & A Pharmachem Limited.
Allenby Laboratories,
Wigan Road,

Westhoughton,
Bolton BL5 2AL

8

MARKETING AUTHORISATION NUMBER(S)
PL 04077/0169

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/02/2009

10

DATE OF REVISION OF THE TEXT
24/04/2014

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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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