MEPTID TABLETS 200MG

Active substance: MEPTAZINOL HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Meptid 200mg Film-Coated Tablets

2.

QUANTITATIVE AND QUALITATIVE COMPOSITION
Each tablet contains 200mg of meptazinol (as hydrochloride).
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film-coated tablet.

on

Oval, biconvex, orange, film coated tablets. The tablets are engraved “MPL 023”
one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the short term treatment of moderate pain.

4.2

Posology and method of administration

Adults

200mg 3-6 hourly as required. Usually one tablet 4 hourly.

Elderly

The adult dosage schedule can be used in the elderly.
Children

Meptid Tablets have not been evaluated for use in children.

4.3

Contraindications
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)

4.4

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
withdrawn abruptly).
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
convulsive disorders.

Sunset yellow FCF (E 110) can cause allergic-type reactions including asthma. Allergy is
more common in those people who are allergic to aspirin.

4.5

Interaction with other medicinal products and other forms of interaction
The following undesirable effects could occur as a result of possible interaction with
meptazinol hydrochloride.
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
tricyclic antidepressants.
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.

4.6

the

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
physician.

Undesirable effects

System Organ Class

Very Common ( 1/10)

Nervous system disorders

dizziness, headache, vertigo,
somnolence, drowsiness

Skin and subcutaneous
tissue disorders



Vascular disorders
Respiratory, thoracic and
mediastinal disorders
Gastrointestinal disorders

Uncommon ( 1/1,000 to
1/100)



4.8

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.



4.7

hypotension
Respiratory depression
abdominal pain, constipation,
diarrhoea, dyspepsia, nausea,
vomiting
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 table above.
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.

4.9

Overdose

Meptid Tablets are subject to hepatic first pass metabolism which prevents
systemic concentrations of the drug reaching levels achieved by parenteral
administration.

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
naloxone.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group : Nervous System; Opioids; Other Opioids

ATC Code

: N02AX

Meptid (meptazinol) is a centrally acting analgesic belonging to the
hexahydroazepine series, which has demonstrated mixed agonist and antagonist
activity at opioid receptors.

of

5.2

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.

Pharmacokinetic properties
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
hours).
The peak analgesic effect is seen within 30-60 minutes and lasts about 3-4
hours.

The drug is rapidly metabolised to the glucuronide, and mostly excreted in the
urine.

5.3

Preclinical safety data
Standard toxicity tests revealed no unexpected findings of clinical significance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Tablet Core:
Microcrystalline cellulose,
Polacrillin potassium,
Magnesium Stearate
Tablet Coating:
Hypromellose 2910,
Macrogol 400
Opaspray pigment M-1-3476 B (orange colour containing sunset yellow (E110),
titanium dioxide (E171), hypromellose (E464), erythrosine (E127)).

6.2

Incompatibilities
Not applicable.

6.3

6.4

Shelf life
3 years

Special precautions for storage
Do not store above 25ºC.

6.5

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.

6.6

Special precautions for disposal
No special requirements.

7.

MARKETING AUTHORISATION HOLDER

Almirall, S.A.
Ronda General Mitre 151
08022 Barcelona
Spain

8

MARKETING AUTHORISATION NUMBER(S)
PL 16973/0017

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 December 1992/11 October 2005

10

DATE OF REVISION OF THE TEXT
23/03/2011

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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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