MEPTID TABLETS 200MG
Active substance(s): MEPTAZINOL HYDROCHLORIDE / MEPTAZINOL HYDROCHLORIDE / MEPTAZINOL HYDROCHLORIDE
NAME OF THE MEDICINAL PRODUCT
Meptid 200mg Film-Coated Tablets
QUANTITATIVE AND QUALITATIVE COMPOSITION
Each tablet contains 200mg of meptazinol (as hydrochloride).
For a full list of excipients, see section 6.1.
Oval, biconvex, orange, film coated tablets. The tablets are engraved “MPL 023”
For the short term treatment of moderate pain.
Posology and method of administration
200mg 3-6 hourly as required. Usually one tablet 4 hourly.
The adult dosage schedule can be used in the elderly.
Meptid Tablets have not been evaluated for use in children.
Patients with the following conditions:
- known hypersensitivity to the active ingredient or to any of the excipients
- acute alcoholism and where there is a risk of paralytic ileus
- raised intracranial pressure or head injury (in addition to interfering with respiration,
affect pupillary responses vital for neurological assessment).
- acute respiratory depression
- during an asthma attack
- patients on monoamine-oxidase inhibitors (MAOIs) and for 14 days after discontinuing
an MAOI (see section 4.5)
Special warnings and special precautions for use
Clinical studies have indicated absence of clinically significant respiratory depression but
caution should be exercised in patients already severely compromised. A reduced dose
may therefore be appropriate.
Patients with moderate to severe renal impairment should be given a reduced dose as the
effect in these patients may be prolonged and increased. Cerebral sensitivity may also be
increased. Patients with hepatic impairment should be given a reduced dose as opioid
analgesics may precipitate coma in these patients.
Safety in long term use is not known, therefore it is recommended that this drug be used
in the treatment of moderate pain, for short periods of time. Repeated administration of
opioid analgesics may cause dependence and tolerance (severe withdrawal symptoms if
Safety for use in myocardial infarction has not been established.
Meptazinol should also be used with caution in patients with the following conditions:
hypotension, hypothyroidism, asthma (avoid during an attack), prostatic hypertrophy and
Sunset yellow FCF (E 110) can cause allergic-type reactions including asthma. Allergy is
more common in those people who are allergic to aspirin.
Interaction with other medicinal products and other forms of interaction
The following undesirable effects could occur as a result of possible interaction with
Antidepressants: CNS excitation or depression manifesting as hypertension or
hypotension may occur if meptazinol is administered to patients receiving MAOIs
(including moclobemide). Avoid concomitant use for 14 days after an MAOI is
discontinued (see section 4.3). Possible increased sedation if meptazinol is used with
Antipsychotics: enhanced sedative and hypotensive effect.
Antivirals: avoid concomitant use with ritonavir as plasma concentration of meptazinol
may be increased.
Alcohol: enhanced sedative and hypotensive effect.
Quinolones (ciprofloxacin): Avoid premedication with meptazinol as a reduced plasmaciprofloxacin concentration may be experienced.
Anxiolytics and hypnotics: enhanced sedative effect.
Drugs used in nausea and vomiting: Concomitant use of metoclopramide or domperidone
may result in antagonism of gastro-intestinal side effects.
Ulcer healing drugs: cimetidine may inhibit metabolism of meptazinol resulting in
increased plasma concentration.
Pregnancy and lactation
Reproduction studies in animals have shown no evidence of teratogenic effect. No
experience is available in human beings. Meptazinol should not be used during
pregnancy, unless considered essential by the physician.
Meptazinol should not be given to lactating women, unless considered essential by
Effects on ability to drive and use machines
Since dizziness and occasionally drowsiness have been reported, patients should be
cautioned against driving or operating machinery until it is established that they do
not become dizzy or drowsy whilst taking meptazinol.
System Organ Class
Very Common (≥ 1/10)
Nervous system disorders
dizziness, headache, vertigo,
Respiratory, thoracic and
Skin and subcutaneous
Uncommon (≥ 1/1,000 to
abdominal pain, constipation,
diarrhoea, dyspepsia, nausea,
Increased sweating, rash
For very rare reports of psychiatric disorders (hallucination, confusion, depression), causal
relationship with the use of meptazinol has not been established and therefore omitted from the
Reactions not already stated which are attributable to opioid analgesics include difficulty with
micturition, ureteric or biliary spasm, dry mouth, facial flushing, bradycardia, tachycardia,
palpitations, hypothermia, dysphoria, mood changes, miosis, decreased libido or potency,
urticaria and pruritus.
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,
Meptid Tablets are subject to hepatic first pass metabolism which prevents
systemic concentrations of the drug reaching levels achieved by parenteral
Recommended treatment includes supportive therapy and naloxone if required.
Gut decontamination may be considered within an hour of a substantial overdose
provided the airway can be protected and the benefit outweighs the risk.
In the unlikely event of overdose producing respiratory depression, naloxone is the
treatment of choice. Naloxone has a short duration of action in comparison with
meptazinol. Repeated administration or administration by continuous intravenous
infusion may be considered necessary. The effects are only partially reversed by
Pharmacotherapeutic group : Nervous System; Opioids; Other Opioids
Meptid (meptazinol) is a centrally acting analgesic belonging to the
hexahydroazepine series, which has demonstrated mixed agonist and antagonist
activity at opioid receptors.
Receptor binding studies have shown that although meptazinol displays only a low
affinity for δ and κ opioid receptor sites, it has a somewhat higher affinity for the
subpopulation of µ sites. These binding sites also display a high affinity for the
endogenous opioid peptides, and are thought to be responsible for, among other
things, analgesia, but not for the mediation of respiratory depression. A component
its analgesic action is also attributable, in mice at least, to an effect on central
cholinergic transmission. In this respect it differs from all conventional analgesic
drugs which have been examined.
After oral administration, meptazinol is rapidly absorbed and peak plasma levels
are reached within 90 minutes. The plasma elimination half-life is variable (1.4-4
The peak analgesic effect is seen within 30-60 minutes and lasts about 3-4
The drug is rapidly metabolised to the glucuronide, and mostly excreted in the
Preclinical safety data
Standard toxicity tests revealed no unexpected findings of clinical significance.
List of excipients
Opadry 06B230000 orange containing:
Sunset yellow (E110)
Titanium dioxide (E171)
Special precautions for storage
Do not store above 25ºC.
Nature and contents of container
Glass bottles containing 50 or 100 tablets, or
Cartons containing PVC blister packs of 6, 28, 56, 100 or 112 tablets.
Not all pack sizes may be marketed.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Ronda General Mitre 151
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
17 December 1992/11 October 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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