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PARACODOL TABLETS

Active substance(s): CODEINE PHOSPHATE / PARACETAMOL DC (PVP) / CODEINE PHOSPHATE / PARACETAMOL DC (PVP) / CODEINE PHOSPHATE / PARACETAMOL DC (PVP)

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paracodol tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soluble tablet contains:
Paracetamol DC

520.0 mg

(equivalent to paracetamol 500.0 mg)
Codeine Phosphate Hemihydrate

8.0 mg

For a full list of excipients see section 6.1

3

PHARMACEUTICAL FORM
Soluble Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Paracodol Tablets (which contain codeine) are indicated in patients older than 12
years of age for the short term treatment of acute moderate pain (such as
muscular and rheumatic pains, headache, migraine, neuralgia, toothache, period
pains, aches and pains) which is not considered to be relieved by other analgesics
such as paracetamol, ibuprofen or aspirin alone.

4.2

Posology and method of administration
Posology:
Tablets are to be dissolved in water before oral administration.
Adults:
1 - 2 tablets, which may be repeated every four to six hours with a maximum of 8
tablets in 24 hours.

Elderly:
No current evidence for the alteration of the adult dose except where there is
impaired hepatic function when dosage reduction may be necessary.
Children aged 12 - 18 years:
1 - 2 tablets, which may be repeated every four to six hours with a maximum of 8
tablets in 24 hours.
Children under 12 years:
Paracodol Tablets (which contains Codeine) should not be used in children under
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).
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.
4.3

Contraindications





4.4

Hypersensitivity to paracetamol and/or other constituents.
In women during breastfeeding (see section 4.6)
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
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)

Special warnings and precautions for use
The tablet has a sodium content of 383mg. Persons on a low sodium diet should
be aware of this if they wish to take Paracodol tablets.
In cases of renal insufficiency, the rate of excretion of codeine metabolites may
be reduced, and dosage schedules may need to be revised accordingly. Patients
with kidney problems should consult their doctor before taking Paracodol
Tablets. Care is advised in the administration of paracetamol with severe renal or
hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
If symptoms persist for more than 3 days a doctor should be consulted.

Contains paracetamol. Do not take with other paracetamol-containing products.
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.
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 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.

The label will state:








Front of Pack
Can cause addiction
For three days use only
Back of Pack
This medicine can only be used for the short term treatment of acute moderate
pain when other pain killers have not worked. If you have already taken
another pain killer wait at least four hours before taking this medicine. For
relief from muscular and rheumatic pains, headache, migraine, neuralgia,
toothache, period pains, aches and pains.
If you need to take this medicine continuously for more than three days you
should 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 are Paracodol Tablets for
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. This
includes and rheumatic pains, headache, migraine, neuralgia, toothache, period
pains, aches and pains.
Section 2: Before you take Paracodol Tablets
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
Pregnancy and Breast-feeding
Consult your doctor before taking the tablets if you are pregnant or think you
may be pregnant.
Do not take codeine while you are breast-feeding. Codeine and morphine passes
into breast milk.









4.5

Section 3: How should I take Paracodol Tablets?
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.
Section 4: Do Paracodol Tablets cause any side effects
Some people may have side-effects when taking this medicine.
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 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 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

Interaction with other medicinal products and other forms of interaction
Paracetamol should be given with care to patients taking other drugs, which
affect the liver.
The speed of absorption of paracetamol may be increased by metoclopramide
or domperidone and absorption reduced by cholestyramine.
The anticoagulant 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.

4.6

Fertility, pregnancy and lactation
Pregnancy

There is inadequate evidence of safety of the drug in human pregnancy, but it has
been in wide use for many years without apparent ill-consequence, although
there is evidence that exposure to codeine during pregnancy may give a higher
incidence of respiratory malformations. If drug therapy is needed in pregnancy,
this drug can be used if there is no safer alternative. At normal doses, low levels
of paracetamol and codeine are present in breast milk.
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.
Lactation
Paracetamol is excreted in the 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.
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 taking 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
o

You have taken it according to the information provided with the
medicine and

o

4.8

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

It was not affecting your ability to drive safely

Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash
may occur. Very rare cases of serious skin reactions have been reported.

There have been some reports of blood dyscrasias including thrombocytopenia
and agranulocytosis, but there were not necessarily causally related to
paracetamol.
Codeine may sometimes cause constipation.
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
Codeine
The effects in 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 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
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.
Paracetamol

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, phenobarbitone, phenytoin,
primidone, rifampicin, St John’s Wort or other drugs that induce liver
enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. 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 Nacetylcysteine, 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 24h from ingestion should be discussed with the NPIS or
a liver unit.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Other Analgesics and Antipyretics, ATC code:
N02B.
Paracodol has analgesic and antipyretic actions.
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
Not applicable.

5.3

Preclinical safety data
None.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Povidone
Sodium hydrogen carbonate
Anhydrous sodium carbonate
Anhydrous citric acid
Mannitol
Saccharin sodium
Sodium docusate
Sodium benzoate

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months

6.4

Special precautions for storage
Protect from moisture and heat. Do not store above 25°C.

6.5

Nature and contents of container
Aluminium foil/ polyethylene laminate strip pack.
Or, Paper/polyethylene/ Aluminium foil/ polyethylene laminate.
Pack sizes: 2,10, 12, 16, 24, 30, 32.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Bayer Plc T/A Bayer Plc, Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00010/0340

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/06/1994

10

DATE OF REVISION OF THE TEXT
12/06/2014

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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