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PROMAZINE 25MG TABLETS

Active substance(s): PROMAZINE HYDROCHLORIDE / PROMAZINE HYDROCHLORIDE / PROMAZINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Promazine 25mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of promazine hydrochloride
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Sugar-coated tablets
Yellow, sugar coated tablets, coded 7Z1 on one side and plain on the reverse

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Agitation and restlessness in the elderly
Short-term adjunctive management of psychomotor agitation

4.2

Posology and method of administration
To be taken orally.
ADULTS: For psychomotor agitation, 100-200mg four times daily
ELDERLY: For agitation and restlessness, 25-50mg four times daily.
These tablets are not recommended for use in children.

4.3

Contraindications
• Known sensitivity to phenothiazines or to any of the excipients
• Comatose states
• CNS depression
• Phaeochromocytoma

4.4

Special warnings and precautions for use
Promazine should be used only with great caution in the following conditions;
history of jaundice, blood dyscrasias (perform blood counts if unexplained
infection or fever develops), renal and hepatic impairment, respiratory disease,
Parkinsonism, epilepsy, hypothyroidism, depression, myasthenia gravis,
prostatic hypertrophy, personal or a family history of angle-closure glaucoma.

As with other neuroleptics, caution is advised in patients with cardiovascular
diseases and patients with a family history of QT prolongation.
Cases of venous thromboembolism (VTE) have been reported with
antipsychotic drugs. Since patients treated with antipsychotics often present
with acquired risk factors for VTE, all possible risk factors for VTE should be
identified before and during treatment with Promazine and preventive
measures undertaken.
As photosensitisation may occur with higher dosages, patients should avoid
direct sunlight.
In patients with Parkinson’s disease the anticholinergic side effects of
promazine may be aggravated by anti-parkinsonian agents.
Concomitant use of promazine with other neuroleptics should be avoided.
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly people with
dementia who are treated with antipsychotics are at a small increased risk of
death compared with those who are not treated. There are insufficient data to
give a firm estimate of the precise magnitude of the risk and the cause of the
increased risk is not known.
Promazine is not licensed for the treatment of dementia-related behavioural
disturbances.
The elderly are particularly susceptible to the side effects of promazine
especially sedation, hypotensive and temperature regulation effects.
Withdrawal of antipsychotic drugs after long-term therapy should always be
gradual and closely monitored to avoid the risk of acute withdrawal syndromes
or rapid relapse.
An approximately 3-fold increased risk of cerebrovascular adverse events has
been seen in randomised placebo controlled clinical trials in the dementia
population with some atypical antipsychotics. The mechanism for this
increased risk is not known. An increased risk cannot be excluded for other
antipsychotics or other patient populations. Promazine should be used with
caution in patients with risk factors for stroke.

4.5

Interaction with other medicinal products and other forms of interaction
The hypoglycaemic effect of sulphonylureas is possibly antagonised by
phenothiazines.
The convulsive threshold of antiepileptics may be lowered if taken
concomitantly with antipsychotic drugs.
An enhanced hypotensive effect can occur when antihypertensives are taken
with antipsychotic drugs.
The antimuscarinic side effects of phenothiazines can be increased (but with
reduced plasma concentrations) when taken with antimuscarinic drugs.
An increase in plasma concentration of antipsychotic drugs may occur if taken
with ritonavir.
An enhanced sedative effect may occur if antipsychotics are taken with
anxiolytics and hypnotic drugs.

An enhanced hypotensive effect may occur if calcium channel blockers are
taken with antipsychotic drugs.
An increased risk of extrapyramidal effects and possibility of neurotoxicity
may occur if lithium and phenothiazines are taken concomitantly.
There is an increased risk of CNS toxicity if sibutramine is taken
concomitantly with antipsychotic drugs.
There is an increased risk of extrapyramidal effects if tetrabenazine and
antipsychotics are taken together.
Cimetidine may enhance the effects of antipsychotic drugs.
There is an increased risk of extrapyramidal effects when antipsychotics are
taken with metoclopramide.
The effects of antipsychotics may possibly be reduced by memantine.
Reduced absorption of phenothiazines with antacids and possibly with kaolin
can occur.
Anaesthetics can cause an enhanced hypotensive effect when taken with
antipsychotics.
Increased plasma concentrations and increased antimuscarinic effects can
occur when tricyclics and phenothiazines are taken together.
An enhanced sedative and hypotensive effect can occur if opioid analgesics
and antipsychotics are taken together.
There is an increased risk of convulsions if tramadol is taken with
antipsychotics.
Sympathomimetics antagonise pressor action when taken with antipsychotics.
An enhanced sedative effect can occur if alcohol and antipsychotics are taken
together.
The manufacturer of reboxetine advises caution with antipsychotics.
Concomitant use of promazine with drugs known to prolong the QT interval
may increase the risk of ventricular arrhythmias, including Torsade de Pointes.
Therefore concomitant use of these products is not recommended. Examples
include certain antiarrhythmics, such as those of Class 1A (such as quinidine,
disopyramide and procainamide) and Class III (such as amiodarone, sotalol
and dofetilide), certain antimicrobials (sparfloxacin, moxifloxacin,
erythromycin IV), tricyclic antidepressants (such as amitriptyline), certain
tetracyclic antidepressants (such as maprotiline), other neuroleptics (e.g.
phenothiazines, pimozide, sertindole and haloperidol), certain antihistamines
(such as terfenadine), cisapride, bretylium and certain antimalarials such as
quinine and mefloquine. This list is not comprehensive.
Concurrent use of drugs causing electrolyte imbalance is not recommended.
Diuretics, in particular those causing hypokalaemia, should be avoided but, if
necessary, potassium-sparing diuretics are preferred.

4.6

Fertility, pregnancy and lactation
Promazine should not be used in pregnancy, especially during the first trimester
unless considered essential by the physician.
Neonates exposed to antipsychotics (including Promazine) during the third trimester
of pregnancy are at risk of adverse reactions including extrapyramidal and/or

withdrawal symptoms that may vary in severity and duration following delivery.
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence,
respiratory distress, or feeding disorder. Consequently, newborns should be
monitored carefully.
Promazine should not be used during lactation.

4.7

Effects on ability to drive and use machines
Initial sedation may occur. Patients taking promazine should not drive or
operate machinery unless the drug has been shown not to interfere with
physical or mental ability. Patients should be advised not to drink alcohol due
to the enhanced effects when combined with antipsychotics (see section 4.4.).

4.8

Undesirable effects
Promazine exhibits side effects associated with phenothiazines in general
including; nasal congestion, drowsiness, apathy, agitation, excitement,
convulsions and insomnia, dizziness, headache, gastrointestinal disturbances,
hypothermia.
Promazine may induce extrapyramidal side effects including dystonia, tremor,
tardive dyskinesia and akathisia.
Antimuscarinic symptoms include: dry mouth, constipation, micturition
difficulties and blurred vision.
Cardiovascular symptoms include: hypotension. Cardiac effects such as QTinterval prolongation, Torsade de Pointes, ventricular arrhythmias, including
ventricular fibrillation and ventricular tachycardia, and cardiac arrest have
been reported rarely. Cases of sudden unexplained death have also occurred.
These are class effects of neuroleptics.
Cases of venous thromboembolism, including cases of pulmonary embolism
and cases of deep vein thrombosis have been reported with antipsychotic
drugs- frequency unknown.
Sensitivity reactions such as agranulocytosis, leucopenia, allergic skin
reactions, rashes. Photosensitisation and contact sensitisation.
Corneal and lens opacities and purplish pigmentation of the skin, cornea,
conjunctiva, and retina.
Confusional states and epileptic fits can occur. Haemolytic anaemia and
jaundice (including cholestatic jaundice).
Endocrine effects such as menstrual
gynaecomastia, impotence and weight gain.

disturbances,

galactorrhoea,

Hypotension and interference with temperature regulation are dose-related
side effects and are liable to cause dangerous falls and hypothermia or
hyperthermia in the elderly.
Neuroleptic malignant syndrome (hyperthermia, fluctuating levels of
consciousness, muscular rigidity, and autonomic dysfunction with pallor,
tachycardia, labile blood pressure, sweating and urinary incontinence) is a rare
but potentially fatal side effect of some drugs. If this occurs, antipsychotics
should be discontinued.
Pregnancy, puerperium and perinatal conditions
Drug withdrawal syndrome neonatal (see 4.6) - frequency is not known.
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
Symptoms:
Drowsiness, confusion, hypotension and hypothermia may occur. Convulsions
and coma are possible. Rarely there may be respiratory depression,
rhabdomyolysis, renal failure and cardiac effects, including sinus tachycardia,
QT and QRS prolongation, ventricular tachycardia and fibrillation, AV block,
bundle branch block and torsade de pointes. Extra-pyramidal effects, including
acute dystonic reactions, may occur but are not dose related. The adverse
features seen with long-term therapeutic doses are not usually encountered
after acute overdosage.
Neuroleptic malignant syndrome may develop irrespective of the duration of
therapy but is not usually a feature of poisoning.
Management:
The benefit of gastric decontamination is uncertain.
• Activated charcoal (50g for adults; 10-15g for children) should only be
used within 1 hour of ingestion of a potentially toxic amount.
• Alternatively gastric lavage in adults may be carried out within 1 hour of a
potentially life-threatening overdose.
• A clear airway and adequate ventilation should be maintained if indicated.
• Asymptomatic patients should be observed for at least 4 hours after
ingestion, and blood pressure and pulse monitored.
• In symptomatic patients a 12 lead ECG should be carried out and cardiac
rhythm monitored.
• Hypotension should be corrected. If severe hypotension persists, inotropes
such as dopamine (2-10 micrograms/kg bodyweight/minute) or dobutamine
(2.5-10 micrograms/kg body weight/minute) can be used.

• Convulsions may respond to intravenous diazepam (0.1-0.3mg/kg body
weight) or lorazepam (4mg in an adult and 0.05mg/kg in a child). Correct
acid base and metabolic disturbances. Phenytoin (loading dose 15mg/kg IV
infusion in adults and children) may be useful if fits are unresponsive to
above measures. If seizures persist this may require intubation, paralysis
and ventilation.
• Correct hypothermia.
• In patients with acute dystonic reactions Procyclidine (5 to 10mg in adults)
or benztropine (1 to 2mg in adults) can be given. Diazepam (0.1-0.3mg/kg
bodyweight) is an alternative.
• Other measures as indicated by the patient's clinical condition.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC Code: N05A A03 Phenothiazines with aliphatic side-chain.
Promazine is a phenothiazine tranquilliser. It has a selective depression of the
CNS centres responsible for the control of behaviour and wakefulness. Other
properties include: anti-emetic, antipruritic, serotonic blocking, weak
antihistaminic, alpha-adrenergic blocking, anticholinergic and dopamine
inhibitory actions.

5.2

Pharmacokinetic properties
a) General characteristics: Promazine is absorbed readily from the GI tract
and subjected to considerable first-pass metabolism in the gut wall.
b) Characteristics in patients: Promazine is extensively metabolised in the
liver and excreted in the urine and bile. There is some evidence of
enterohepatic recirculation.

5.3

Preclinical safety data
Preclinical information has not been included because the safety profile of
promazine has been established after many years of clinical use. Please refer to
section 4.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablets contain:
Lactose
Maize starch
Maize starch (partially pregelatinised)
Magnesium stearate (E572)

Tablet coating
Talc (E553)
Light kaolin (E559)
Sucrose
Shellac
Beeswax (E901)
Carnauba wax (E903)
Tartrazine (E102)
Titanium dioxide (E171)
Sodium benzoate (E211)
Povidone
Acetylated monoglyceride

Printing ink (Opacode Black S-1-17823)
Shellac
Black Iron Oxide (E172)
Propylene Glycol (E1520).
6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25°C. Keep the container tightly closed.

6.5

Nature and contents of container
Polypropylene ‘Securitainer’ containing a polythene ‘Jayfilla’ and fitted with a
polythene cap
Polypropylene ‘Securitainers’ with LDPE lids
Containers of 50, 100, 250 and 1,000 tablets
Not all pack sizes may be marketed

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
Teva UK Limited
Brampton Road
Hampden Park
Eastbourne

East Sussex
BN22 9AG

8

MARKETING AUTHORISATION NUMBER(S)
PL 00289/0798

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31/12/1981 / 13/09/2009

10

DATE OF REVISION OF THE TEXT
14/07/2015

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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