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CO-CODAMOL 8/500MG TABLETS

Active substance: PARACETAMOL

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Summary of Product Characteristics

1

Name of the medicinal product
Co-Codamol 8/500mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 500mg and Codeine Phosphate BP 8mg per tablet

3

PHARMACEUTICAL FORM
Co-Codamol tablets are presented as white, flat bevelled edge tablets with a
bar and A459 embossed on one face and company logo on the other.

4

Clinical particulars

4.1

Therapeutic indications
Co-Codamol Tablets are 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).

4.2

Posology and method of administration
Adults:
As this medicine contains codeine it should be used at the lowest effective dose for
the shortest period of time. One to two tablets may be taken, up to 4 times a day at
intervals of not less than 6 hours. Maximum 8 tablets daily.
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.
Paediatric population:
Children aged 12 years to 18 years:
The recommended dose for children 12 years and older should be one to two tablets
every 6 hours when necessary up to a maximum dose of 8 tablets daily.
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.
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).
Route of administration: Oral

4.3

Contraindications
Hypersensitivity to paracetamol, to codeine or to any of the other ingredients.
Conditions where morphine and opioids are contraindicated e.g:
Respiratory depression.
Acute asthma
Acute alcoholism
Head injuries
Raised intra-cranial pressure
Following biliary tract surgery
Monoamine oxidase inhibitor therapy, concurrent or within 14 days
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
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers

4.4

Special warnings and precautions for use
Caution should be exercised when administering to the elderly with hepatic and renal
impairment. Caution should also be exercised in administration of paracetamol to
patients with severe hepatic or severe renal dysfunction.
The hazards of paracetamol overdose are greater in those with non-cirrhotic alcoholic
liver disease.
Care should be observed in administering the product to any patient whose condition
may be exacerbated by opioids, particularly the elderly, who may be sensitive to their
central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those
with prostatic hypertrophy and those with inflammatory or obstructive bowel
disorders. Care should also be observed if prolonged therapy is contemplated.

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, shallow breathing, small
pupils, nausea, vomiting, constipation, lack of appetite and somnolence. 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% to 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.

The leaflet will state in the “Pregnancy and breast-feeding” subsection of
Section 2 “Before taking your medicine”:
Do not take codeine while you are breastfeeding. Codeine and morphine passes into
breast milk.
The leaflet will state :
Headlines section (to be prominently displayed)
• This medicine can only be used in patients older than 12 years of age for
short term treatment of acute, moderate pain which is not relieved by other
painkillers such as paracetamol or ibuprofen 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
• Co-Codamol Tablets can be used in adults and children older than 12 years
of age for the short term treatment of moderate pain that is not relieved by
other painkillers such as paracetamol or ibuprofen alone.
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.
Section 3 – Dosage
• This medicine should not be taken for more than 3 days. If the pain does
not improve after 3 days, talk to your doctor for advice.
• 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 a 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


Reporting of side effects
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.gov.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?
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.
The label will state :
On front of pack (To be prominently displayed) –
Can cause addiction.
For three days use only.

On back of pack • For use in adults and children older than 12 years for the short term
treatment of acute, moderate pain when other painkillers have not worked.
Do not take less than six hours after taking other painkillers
• 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.
• Contains paracetamol.
• Do not take anything else containing paracetamol while taking this
medicine. Talk to a doctor at once if you take too much of this medicine,
even if you feel well.
• Do not take more medicine than the label tells you to. If you do not

get better, talk to your doctor. (This must appear adjacent to either
the directions for use or the recommended dosage).

4.5.

Interaction with other medicinal products and other forms of interaction
Paracetamol may increase the elimination half-life of chloramphenicol. Oral
contraceptives may increase its rate of clearance. The speed of absorption of
paracetamol may be increased by metoclopramide or domperidone and absorption
reduced by colestyramine.
The anti-coagulant effect of warfarin and other coumarins may be enhanced by
prolonged regular use of paracetamol with increased risk of bleeding; occasional
doses have no significant effect.
The effects of CNS depressants (including alcohol) may be potentiated by codeine.
Codeine when administered concurrently with metoclopramide or domperidone
opposes the effect of metoclopramide or domperidone on gastro-intestinal motility

4.6

Fertility, pregnancy and lactation
There is inadequate evidence of the safety of codeine in human pregnancy, but there
is epidemiological evidence for the safety of paracetamol. Both substances have been
widely used for many years without apparent ill consequence and animal studies have
not shown any hazard. Nonetheless careful consideration should be given before
prescribing the products for pregnant patients.
Opioid analgesics may depress neonatal respiration and cause withdrawal effects in
neonates of dependent mothers.
Paracetamol is excreted in breast milk but not in a clinically significant amount.

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 occasionally cause drowsiness, dizziness or sedation and the patients
are advised not to drive or operate machinery if so affected.
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 with paracetamol are rare.
Immune system disorders:
Hypersensitivity, including skin rash, may occur.
Not known – Anaphylactic shock, angioedema.
There have been reports of blood dyscrasias including thrombocytopenia and
agranulocytosis, but these were not necessarily causally related to paracetamol.
Very rare occurrence of pancreatitis.
Codeine can produce typical opioid effects including constipation, nausea, vomiting,
dizziness, light-headedness, confusion, drowsiness and urinary retention. The

frequency and severity are determined by dosage, duration of treatment and
individual sensitivity. Tolerance and dependence can occur, especially with
prolonged high doses of codeine.
Regular prolonged use of codeine is known to lead to addiction and tolerance, and
symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.
Other side effects due to codeine are sedation.
Rare cases of sensorineural hearing loss have been reported with codeine and codeine
containing products.
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
Liver damage is possible in adults who have taken 10g or more of paracetamol.
Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has
risk factors (see below).

Risk factors
If the patient:
a) Is on long term treatment with carbamazepine, phenobarbital, phenytoin,
primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes
b) Regularly consumes ethanol in excess of recommended amounts.
c) Is likely to be glutathione deplete eg. eating disorders, cystic fibrosis, HIV
infection, starvation, cachexia.
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, 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.
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 with serious
hepatic dysfunction beyond 24 hours from ingestion should be discussed with the
NPIS or a liver unit.
The effects in codeine overdosage will be potentiated by simultaneous ingestion of
alcohol and psychotropic drugs.

Symptoms
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. The pupils may be pin-point in size; nausea
and vomiting are common. Hypotension and tachycardia are possible but unlikely.
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 350 mg, or a child more than
5 mg/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 four hours after
ingestion, or eight hours if a sustained release preparation has been taken.

5.1

Pharmacodynamic properties
Paracetamol is an analgesic with antipyretic properties, the mechanism of analgesic
action has not been fully determined. It acts by inhibiting prostaglandin synthesis in
the central nervous system (CNS) and through a peripheral action by blocking pain
impulse generation. The peripheral action may also be due to inhibition of the
synthesis of prostaglandin or to inhibition of the synthesis of actions of other
substances, which sensitise pain receptors to mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the hypothalamic
heat - regulating centre to produce peripheral vasodilation resulting in increased
blood flow through the skin, sweating and heat loss. The central action probably
involves inhibition of prostaglandin synthesis in the hypothalamus.
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.

5.2

Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract
following oral administration. Peak plasma concentrations are attained within 30-60
minutes and the half-life in plasma is about 2 hours following therapeutic doses. The
duration of action is 3-4 hours.
Protein binding of paracetamol is variable; 20-50% may be bound at concentrations
encountered during acute intoxication. It is relatively uniformly distributed
throughout the body fluids. Approximately 90-95% of the drug is metabolised in the
liver primarily by conjugation with glucuronic acid and sulphuric acid. When high
doses are ingested, paracetamol undergoes N-hydroxylation to form N-acetyl-benzoquinoneimine, a highly reactive intermediate. This metabolite reacts with sulphdryl
groups in proteins and glutathione. When hepatic glutathione is depleted (following
overdosage) reaction with hepatic proteins is increased and hepatic necrosis results.
Paracetamol is excreted by the kidneys primarily as conjugates, about 3% of the dose
is excreted unchanged.
Codeine phosphate is absorbed from the gastro-intestinal tract. Following oral
administration peak plasma concentrations are attained in about an hour. It is
metabolised in the liver by O- and N-demethylation to morphine and norcodeine.
Codeine and its metabolites are excreted by the kidney mainly as conjugates with
glucuronic acid.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are not already
covered in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maize starch
Povidone
Magnesium stearate
Pregelatinised starch

6.2

Incompatibilities
None

6.3

Shelf life
5 years in plastic containers.
2 years in blister packs.

6.4

Special precautions for storage
Protect from heat, light and moisture.

6.5

Nature and contents of container
1. Opaque plastic containers composed of polypropylene tubes and polyethylene
tamper evident closures (packs of 10, 12, 20, 24 and 30).
2. Opaque plastic containers composed of either, high density polypropylene or high
density polyethylene with a tamper evident or child resistant tamper evident closure
composed of high density polyethylene (packs of 10, 12, 20, 24 and 30).
3. Blister packs of 20 μm hard aluminium foil laminated to 15 μm rigid PVC film,
and 250 μm white opaque PVC film in printed boxboard cartons (packs of 10, 12, 20,
24 30 and 32.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special instructions for use/handling

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units
Polhampton Lane
Overton
Hants
RG25 3ED,
United Kingdom

8

MARKETING AUTHORISATION NUMBER
PL 20416/0178

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/05/2005 / 27/03/2009

10

DATE OF REVISION OF THE TEXT
12/06/2014

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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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