CODEINE PHOSPHATE 30MG TABLETS BP

Active substance: CODEINE PHOSPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Codeine phosphate 30mg Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Codeine phosphate 30mg
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Tablet
White circular tablets marked C30 on one face and CP on the other.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Mild to moderate pain
Dry or painful cough
Diarrhoea

4.2

Posology and method of administration
Oral route
For Mild to Moderate Pain
Adults:
30-60mg every four hours when necessary, to a maximum of 240mg daily.
Children:
Not recommended.
Elderly:
Dosage should be reduced in elderly patients.
For dry or painful cough
Adults:
15-30mg 3-4 times daily.

Children:
5-12 years, 15mg 3-4 times daily.
Elderly:
Dosage should be reduced in elderly patients.
Diarrhoea
Adults:
30mg three to four times daily (range 15-60mg)
Children:
Not recommended.
Elderly:
Dosage should be reduced in elderly patients.

4.3

Contraindications
Acute respiratory depression, hypersensitivity to codeine or other opioid analgesics or
to any of the excipients obstructive airways disease, liver disease, severe hepatic
dysfunction, acute alcoholism..
Use should be avoided in patients with raised intracranial pressure or head injury (in
addition to the risk of respiratory depression and increased intracranial pressure, may
affect pupillary and other responses vital for neurological assessment).
Codeine should not be given to comatose patients.
Codeine is also contraindicated in conditions where inhibition of peristalsis is to be
avoided, where there is a risk of paralytic ileus, where abdominal distension develops,
or in acute diarrhoeal conditions such as acute ulcerative colitis or antibiotic
associated colitis (e.g. pseudomembranous colitis) or diarrhoea caused by poisoning.

4.4

Special warnings and precautions for use
Not recommended for use in patients with acute asthma. Use with caution or in
reduced doses in asthma and decreased respiratory reserve, avoid use during an acute
asthma attack (see 4.3 Contraindications). It should only be used with caution in those
with renal or hepatic impairment, and in those with a history of drug abuse or in
reduced dose in elderly patients or debilitated patients, or in patients with
hypotension, hypothyroidism, prostatic hypertrophy, adrenocortical insufficiency,
inflammatory or obstructive bowel disorders, urethral stricture, shock, convulsive
disorders, myasthenia gravis. It should be avoided or the dose reduced in patients
with renal or hepatic impairment (see 4.3 Contraindications, liver disease). Use with
caution in those
with a history of drug abuse. Discontinuation should be carried out gradually in
patients who may have developed physical dependence, to avoid precipitating
withdrawal symptoms.
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.
Opioid analgesics should be avoided in patients with biliary tract disorders or used in
conjunction with an antispasmodic.
Administration of pethidine and possibly other opioid analgesics to patients taking a
monoamine oxidase inhibitor (MAOI) has been associated with very severe and
sometimes fatal reactions. If the use of codeine is considered essential then great care
should be taken in patients taking MAOIs or within 14 days of stopping MAOIs (see
section 4.5).
Alcohol should be avoided whilst under treatment with codeine.
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 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 Codeine Phosphate Tablets while breast-feeding as the levels
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.
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 to lead to addiction.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine as it
contains lactose.

4.5

Interaction with other medicinal products and other forms of interaction
Alcohol: the hypotensive, sedative and respiratory depressive effects of alcohol may
be enhanced.

Anaesthetics: concomitant administration of codeine and anaesthetics may cause
increased CNS depression and/or respiratory depression and/or hypotension.
Anti-arrhythmics: codeine delays the absorption of mexiletine. The analgesic activity
of codeine is likely to be significantly impaired by quinidine which impairs codeine
metabolism.
Antidepressants: The depressant effects of opioid analgesics may be enhanced by
tricyclic antidepressants.
MAOIs taken with pethidine have been associated with severe CNS excitation or
depression (including hypertension or hypotension). Although this has not been
documented with codeine, it is possible that a similar interaction may occur and
therefore the use of codeine should be avoided while the patient is taking MAOIs and
for 2 weeks after MAOI discontinuation.
Antihistamines: concomitant administration of codeine and antihistamines with
sedative properties may cause increased CNS depression and/or respiratory
depression and/or hypotension.
Antipsychotics: enhanced sedative and hypotensive effect.
Anxiolytics and hypnotics: enhanced sedative effect.
Domperidone and metoclopramide: codeine antagonises the effect of cisapride,
metoclopramide and domperidone on gastrointestinal activity.
Sodium oxybate: concomitant administration of codeine and sodium oxybate may
cause increased CNS depression and/or respiratory depression and/or hypotension.
Ulcer-healing drugs: Cimetidine may inhibit the metabolism of codeine
resulting in increased plasma concentrations.
Interference with laboratory tests: Opioids may interfere with gastric emptying
studies as they delay gastric emptying and with hepatobiliary imaging using
technetium Tc 99m disofenin as opioid treatment may cause constriction of the
sphincter of Oddi and increase biliary tract pressure.

4.6

Pregnancy and lactation
Pregnancy:
As with all medications caution should be exercised during pregnancy, especially in
the first trimester. A possible association with respiratory and cardiac malformations
has been reported following first trimester exposure to codeine.
Regular use of codeine during pregnancy may cause physical dependence in the
foetus leading to withdrawal symptoms in the neonate. Administration of codeine
during labour may depress respiration in the neonate. Opioid analgesics may cause
gastric stasis during labour, increasing the risk of inhalation pneumonia in the mother.
Lactation:

At normal therapeutic doses, codeine and its active metabolites 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 metabolites 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
Codeine produces sedation and may also cause changes in vision, including blurred or
double vision therefore treatment may impair ability to drive and use machines. If
affected, patients should not drive or operate machinery.
The effects of alcohol are enhanced by opioid analgesics.

4.8

Undesirable effects
Regular prolonged use of codeine is known to lead to addiction and tolerance.
Symptoms of restlessness and irritability may result when treatment is then stopped.
In therapeutic doses, codeine is much less liable than morphine to produce adverse
effects.
Prolonged use of a painkiller for headaches can make them worse.
Tolerance and some of the most common side effects – drowsiness, nausea, and
vomiting, and confusion – generally develops with long term use.
Immune system disorders: maculopapular rash has been seen as part of a
hypersensitivity syndrome associated with oral codeine phosphate; fever,
splenomegaly and lymphadenopathy also occurred.
Endocrine disorders: hyperglycaemia.
Metabolism and nutrition disorders: anorexia.
Psychiatric disorders: mental depression, hallucinations and nightmares, restlessness,
confusion, mood changes, euphoria and dysphoria.
Nervous system disorders: convulsions (especially in infants and children), dizziness,
drowsiness, headache (prolonged use of a painkiller for headaches can make them
worse). Raised intracranial pressure may occur in some patients.
Eye disorders: blurred or double vision or other changes in vision. Meiosis.
Ear and labyrinth disorders: vertigo.
Cardiac disorders: tachycardia, palpitations and bradycardia.

Vascular disorders: postural hypotension, facial flushing. Large doses produce
hypotension.
Respiratory, thoracic and mediastinal disorders: Dyspnoea. Large doses produce
respiratory depression.
Gastrointestinal disorders: nausea, vomiting, constipation, dry mouth, stomach
cramps, pancreatitis.
Hepatobiliary disorders: Biliary spasm (may be associated with altered liver enzyme
values).
Skin and subcutaneous tissue disorders: allergic ractions such as skin rashes, urticaria,
pruritus, sweating and facial oedema.
Musculoskeletal and connective tissue disorders: Uncontrolled muscle movements.
Muscle rigidity may occur after high doses.
Renal and urinary disorders: difficulty with micturation, urinary retention,
ureteric spasm, dysuria. An antidiuretic effect may also occur with codeine.
Reproductive system and breast disorders: sexual dysfunction, erectile dysfunction,
decreased potency. Decreased libido.
General disorders and administration site conditions: malaise, tiredness, hypothermia.

4.9

Overdose
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 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. Dry mouth, sweating
and facial flushing are other symptoms of overdose. High doses of codeine
may produce sedation or excitement and, in children, convulsions may occur.
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 sustained release preparation has been taken.
Naloxone may be given according to the following dose regimens:
Intravenous Injection:
0.8-2mg repeated at intervals of 2-3 minutes to a maximum of 10mg.
Child: 10µg/kg and, if no response, subsequent doses of 100µg/kg.

Subcutaneous or Intramuscular Injection:
As for intravenous injection but only if the i.v. route is not feasible. The onset
of action is slower with s.c. or i.m. injection.
Continuous intravenous infusion:
2mg diluted in 500ml of intravenous infusion solution at a rate adjusted
according to the patient's response.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Codeine has similar uses to morphine but is much less potent as an analgesic
and has only mild sedative effects.

5.2

Pharmacokinetic properties
Codeine is well absorbed from the gastrointestinal tract following oral
administration. It is metabolised in the liver to morphine and norcodeine,
which are both excreted in the urine partly as conjugates with glucuronic acid.
Most of the excretion products appear in the urine within 6 hours and up to
86% of the dose is excreted in 24 hours. About 70% of the dose is excreted as
free codeine, 10% as free and conjugated morphine and a further 10% as free
or conjugated norcodeine. Only traces are found in the faeces. The plasma half
life is between approximately 3 and 4 hours.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are
additional to those included in other sections.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose monohydrate
Acacia
Maize starch
Magnesium stearate
Stearic Acid

6.2

Incompatibilities
None

6.3

Shelf life
36 months for polypropylene/polyethylene containers
24 months for blister packaging

6.4

Special precautions for storage
Do not store above 25°C
Store in the original container.

6.5

Nature and contents of container
100, 250 and 500 tablets in polypropylene/polyethylene containers with
polypropylene/polyethylene tamper evident closures.
28, 30, 56, 60, 84 and 90 tablets in polypropylene/polyethylene containers
with polypropylene/polyethylene tamper evident closures in cartons.
28, 30, 56, 60, 84 and 90 tablets in blister pack strips of 20 micron, hard
tempered aluminium foil, coated with PVC compatible heat seal lacquer on the
reverse side, and PVC film, in cartons.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
Aurobindo Pharma Limited
Ares Block,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom

8

MARKETING AUTHORISATION NUMBER
PL 20532/0089

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

12/03/2009

10

DATE OF REVISION OF THE TEXT
21/02/2012

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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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