MYPAID 60MG SR TABLETS
Active substance(s): DIHYDROCODEINE TARTRATE / DIHYDROCODEINE TARTRATE / DIHYDROCODEINE TARTRATE
NAME OF THE MEDICINAL PRODUCT
Mypaid 60mg SR Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60mg dihydrocodeine tartrate.
For excipients, see section 6.1
Round, flat, white to off-white tablets.
For the relief of severe pain in cancer and other chronic conditions.
Posology and method of administration
The tablets should not be chewed.
Adults and children older than 12 years: 60 mg - 120 mg every 12 hours.
Elderly: Dosage should be reduced.
Children up to 12 years: Not recommended.
Hypersensitivity to dihydrocodeine or any of the excipients.
Respiratory depression, obstructive airways disease.
As dihydrocodeine may cause the release of histamine, it should not be given during
an asthma attack.
Avoid in acute alcoholism and where there is a risk of paralytic ileus.
Opioid analgesics should not be administered to patients with increased intracranial
pressure and head injury.
Avoid concomitant use with and for 2 weeks after stopping MAOIs
Special warnings and precautions for use
Caution should be exercised in hypotension, hypothyroidism, asthma (see 4.3),
decreased respiratory reserve, prostatic hypertrophy and convulsive disorders. Severe
withdrawal symptoms may occur in dependent patients if treatment is withdrawn
The dose should be reduced in elderly and debilitated patients. Reduce dose or avoid
in hepatic or renal function impairment.
Interaction with other medicinal products and other forms of interaction
Opioid analgesics may interact wth the following:
Alcohol - enhanced hypotensive and sedative effects
Antidepressants, Tricyclic - sedative effects possibly increased
Antipsychotics - enhanced hypotensive and sedative effects
Anxiolytics and Hypnotics - increased sedative effect
Cimetidine- metabolism of opioid analgesics inhibited by cimetidine (increased
Ciprofloxacin - avoid premedication with opioid analgesics (reduced plasma
concentration of ciprofloxacin) when ciprofloxacin used for surgical prophylaxis.
Domperidone- opioid analgesics antagonise effects of domperidone on gastrointestinal activity
MAOIs- possible CNS excitation or depression (hypertension or hypotension) when
opioid analgesics given with MAOIs —avoid concomitant use and for 2 weeks after
Metoclopramide- opioid analgesics antagonise effects of metoclopramide on gastrointestinal activity.
Mexiletine- opioid analgesics delay absorption of mexiletine
Moclobemide- possible CNS excitation or depression (hypertension or hypotension)
Ritonavir- plasma concentration of opioid analgesics (except methadone) possibly
increased by ritonavir
There is an increased risk of toxicity with myelosuppressive drugs
Pregnancy and lactation
Dihydrocodeine has been taken in pregnancy, although there is very little published
about its safety.
Third trimester: Depression of neonatal respiration; withdrawal effects in neonates of
dependent mothers; gastric stasis and risk of inhalation pneumonia in mother during
Dihydrocodeine has not been reported to be excreted in breast milk. However, it is
advisable that dihydrocodeine only be administered to breast-feeding mothers if
Effects on ability to drive and use machines
Dihydrocodeine may cause drowsiness: If affected, patients should not drive or
Nausea and vomiting (particularly in initial stages), constipation, and drowsiness;
larger doses may produce respiratory depression and hypotension. Other side-effects
include abdominal pain, difficulty with micturition, urinary retention, ureteric or
biliary spasm, dry mouth, sweating, paraesthesia, headache, facial flushing, vertigo,
bradycardia, tachycardia, palpitations, postural hypotension, hypothermia, confusion,
hallucinations, dysphoria, mood changes, dependence, miosis, decreased libido or
potency, rashes, urticaria and pruritus.
Opioid analgesics cause varying degrees of coma, respiratory depression, and
pinpoint pupils. The specific antidote naloxone is indicated if there is coma or
Since naloxone has a shorter duration of action than many opioids, close monitoring
and repeated injections are necessary according to the respiratory rate and depth of
coma. Where repeated administration of naloxone is required, it may be given by
continuous intravenous infusion and the rate of infusion adjusted according to vital
ATC code: NO2A AO8
Dihydrocodeine is a semisynthetic narcotic analgesic with a potency between
morphine and codeine. It acts on opioid receptors in the brain to reduce the patient's
perception of pain and improve the psychological reaction to pain by reducing the
Dihydrocodeine is well absorbed from the gastrointestinal tract following
administration and plasma levels are maintained throughout the twelve hour dosing
Like other phenanthrene derivatives, dihydrocodeine is mainly metabolised in the
liver with the resultant metabolites being excreted mainly in the urine. Metabolism of
dihydrocodeine includes o-demethylation, n-demethylation and 6-keto reduction.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to
that already included in other sections of the SPC.
List of excipients
Calcium sulphate dihydrate
Copovidone VA 64
Sodium stearyl fumarate
Special precautions for storage
Store below 25oC
Nature and contents of container
PVC/PVDC/Aluminium foil blister
Packs containing 56 or 60 tablets. Not all pack sizes may be marketed.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Frimley Business Park,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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