Promazine 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Promazine hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

N05AA03

INN (International Name):

Promazine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

PAGE 1: FRONT FACE (INSIDE OF REEL)
HOW TO TAKE PROMAZINE
Always take Promazine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
The tablets should be swallowed preferably with
a drink of water. The usual dose is:
ADULTS:
•
FOR PSYCHOMOTOR AGITATION
100-200 mg four times daily.
THE ELDERLY:
•
FOR AGITATION AND RESTLESSNESS
25-50 mg four times daily.
CHILDREN:
Promazine is not recommended for use in children.
IF YOU TAKE MORE PROMAZINE THAN YOU SHOULD
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause drowsiness,
confusion, low blood pressure, low body
temperature, fits and coma are possible. Rarely
breathing difficulties may occur.
Please take this leaflet, any remaining tablets, and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
IF YOU FORGET TO TAKE PROMAZINE
If you forget to take a tablet, take one as soon as
you remember unless it is more than 2 hours after
the missed dose; if so, ignore the missed dose and
wait until the time of the next dose. DO NOT take a
double dose to make up for a forgotten dose.
STOPPING TREATMENT WITH PROMAZINE
DO NOT stop taking your medicine without
talking to your doctor first even if you feel better.
Your medicine should only be withdrawn
gradually under close supervision by your doctor.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Promazine can cause side
effects, although not everybody gets them.
STOP TAKING THE TABLETS AND TELL YOUR DOCTOR
IMMEDIATELY or go to the casualty department at
your nearest hospital if the following happens:
•
an allergic reaction causing swelling of the lips,
face or neck leading to severe difficulty in
breathing or severe skin rash or hives.
This is a very serious but rar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Promazine 25 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of promazine hydrochloride.
Excipient(s) with known effect
Each tablet contains 60 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
Yellow, round, biconvex film-coated tablets, embossed with 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 an