PROMAZINE 25MG TABLETS

Active substance: PROMAZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.



suffer from certain of the side effects such as
drowsiness, low blood pressure, high or low
body temperature
or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots.

Avoid exposure to direct sunlight while you are
taking this medicine, as this medicine may cause
you to become sensitive to sunlight, particularly if
you are taking high doses.

(Main)

Pharma code 70334

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
DO NOT take Promazine with:
• medicines to correct problems with heart rhythm
IN THIS LEAFLET:
e.g. quinidine, disopyramide, procainamide,
amiodarone, dofetilide, sotalol, bretylium
1. What Promazine is and what it is used for
• antimalarials e.g. quinine and mefloquine
2. Before you take Promazine
• antibiotics such as sparfloxacin, moxifloxacin,
3. How to take Promazine
intravenous erythromycin
4. Possible side effects
• certain types of (tricyclic or tetracyclic)
5. How to store Promazine
antidepressants such as amitriptyline,
6. Further information
maprotiline
• other antipsychotics e.g. risperidone,
PROMAZINE IS AND WHAT IT IS
1 WHAT FOR
amisulpride, sertindole, haloperidol and pimozide
USED
• cisapride, a medicine used in the treatment of
Promazine is one of a group of medicines called
certain gastro-intestinal disorders
phenothiazines, which are used to treat a range of • certain antihistamines e.g. terfenadine.
disorders including anxiety, agitation and
Talk to your doctor if you are taking any of the
disturbed behaviour.
following:
Promazine is used to treat:
• medicines which can affect the chemicals in your
• agitation and restlessness in the elderly
bloodstream known as electrolytes, such as:
• short-term additional management of
• diuretics e.g. furosemide
psychomotor agitation (unintentional and
• antibiotics e.g. amphotericin B
purposeless motions brought on by mental
• corticosteroids e.g. hydrocortisone
tension; symptoms may take the form of
• chemotherapy drugs e.g. cisplatin
restlessness, pacing, tapping fingers or feet,
• sulphonylureas (used to treat diabetes) e.g.
abruptly starting and stopping tasks,
gliclazide or glibenclamide
meaninglessly moving objects around, and more). • antiepileptics e.g. phenytoin
• blood pressure tablets
2 BEFORE YOU TAKE PROMAZINE
• calcium channel blockers e.g. amlodipine
• sympathomimetics e.g. salbutamol
DO NOT take Promazine if you:
• are allergic (hypersensitive) to promazine, any • antimuscarinics e.g. inhalations used for
bronchitis such as ipratropium bromide
other phenothiazine, or any of the other
• anticholinergics used to treat Parkinson’s or
ingredients of this medicine
restlessness, such as procyclidine, benzhexol,
• have phaeochromocytoma (adrenal gland
orphenadrine
tumour resulting in high blood pressure,
• tetrabenazine, used to treat essential tremor,
flushing, diarrhoea).
chorea, tics, and related disorders
Promazine should not be given to patients in a
• ritonavir (an antiviral for HIV/AIDS)
coma or suffering from central nervous system
• anti-anxiety or sleeping drugs e.g. diazepam,
(CNS) depression, symptoms include decreased
temazepam, zopiclone
rate of breathing, decreased heart rate, and loss
• reboxetine (used to treat depression)
of consciousness.
• lithium, (used to treat certain types of
Take special care with Promazine
depression)
Talk to your doctor before you start to take this
• memantine, used to treat dementia
medicine if you:
• sibutramine, used to help weight loss
• have a history of jaundice (yellowing of the
• cimetidine, used to treat stomach ulcer, reflux
skin or whites of the eyes caused by liver or
oesophagitis, Zollinger–Ellison syndrome, or
blood problems)
other conditions where gastric acid reduction
• blood dyscrasias (blood disorders which may
is beneficial
be characterised by fever or chills, sore throat, • antacids, used to treat indigestion and heartburn
ulcers in your mouth or throat, unusual
• metoclopramide, used to treat feeling or being
tiredness or weakness, unusual bleeding or
sick
unexplained bruising)
• kaolin, used to treat diarrhoea
• have liver, kidney or heart disease
• antispasmodics to treat gut spasm e.g.
• have previously had a stroke, transient
mebeverine hydrochloride
ischaemic attack (TIA, stroke that lasts only a few • medicines used for pain relief called opioid
minutes) or heart attack, have a family history
analgesics e.g. tramadol, morphine, codeine
of strokes, or have other risk factors which
• adrenaline or noradrenaline
may increase the risk of stroke, such as high
• alcohol.
cholesterol, uncontrolled high blood pressure,
If you are to undergo a surgical procedure that
diabetes, you smoke or are a heavy drinker
• have personal or a family history of a certain type requires a general anaesthetic, make sure you tell
of heart disorder known as “QT-prolongation” your doctor that you are taking Promazine.
• have a history of unexplained fainting or blackouts Important information about some of the
• have any disease of the lungs, lower and
ingredients of Promazine
upper airways, or any condition which causes
• Patients who are intolerant to lactose should
difficulty in breathing
note that Promazine contain a small amount of
• have Parkinson’s disease (tremor, stiffness and
lactose. If your doctor has told you that you have
shuffling)
an intolerance to some sugars, contact your
• have epilepsy
doctor before taking this medicinal product.
• have hypothyroidism (underactive thyroid gland) • Promazine 25 mg and 50 mg tablets contain
• suffer from depression
E102 (tartrazine) and the 50 mg tablets also
• have myasthenia gravis (progressive muscular
contain E110 (sunset yellow) which may cause
weakness)
allergic reactions.
• have an enlarged prostate (causing difficulty in
Taking Promazine with food and drink
passing water)
• have personal or a family history of glaucoma DO NOT drink alcohol whilst taking Promazine.
(increased pressure in the eye)
Pregnancy and breast-feeding
• are taking any other neuroleptic medicines
DO NOT take Promazine if you are pregnant,
• are elderly, as it is more likely that you may
planning to become pregnant or breast-feeding.

Ask your doctor for advice before taking any
medicine.
Driving and using machines
Promazine may cause drowsiness, dizziness, and
cloudy or blurred vision. If you are affected by any
of these, DO NOT drive or operate machinery.

3






drowsiness, confusion, difficulty sleeping
epileptic fits
low blood pressure
eye problems including blurred vision, clouding
or opacity of the front part of the eye (cornea)
or lens of the eye, purplish pigmentation of the
cornea, the membrane that covers the white
part of the eye and lines the inside of the
eyelids (conjunctiva), the retina or the skin
round the eyes
high body temperature or low body temperature
(especially in the elderly)
skin rash or itchiness
sensitivity to light
contact sensitisation (inflammation of the skin
or red, itchy skin rash, due to an immune
reaction in response to a substance which has
come into contact with the skin)
suffering from infections more frequently,
which may be due to a severe reduction in the
number of white blood cells
lethargy, weakness, dizzy spells and feeling
faint, pale skin, which may be due to a reduction
in the number of red blood cells (anaemia)
weight gain
in women, production of breast milk or
menstrual disturbance
in men, impotence (inability to achieve or
maintain an erection), or breast enlargement
in rare cases, sudden unexplained death has
occurred.

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.






The following have been reported at an unknown
frequency:
• blood clots in the vein especially in the legs
(symptoms include swelling, pain and redness
in the leg), which may travel through blood
If you forget to take Promazine
vessels to the lungs causing chest pain and
If you forget to take a tablet, take one as soon as
difficulty in breathing. If you notice any of
you remember unless it is more than 2 hours after
these symptoms seek medical advice
the missed dose; if so, ignore the missed dose
immediately.
and wait until the time of the next dose. DO NOT
• In elderly people with dementia, a small
take a double dose to make up for a forgotten dose.
increase in the number of deaths has been
reported for patients taking antipsychotics
Stopping treatment with Promazine
compared with those not receiving
DO NOT stop taking your medicine without
antipsychotics.
talking to your doctor first even if you feel better.
Your medicine should only be withdrawn
If any of the side effects get serious, or if you
gradually under close supervision by your doctor. notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

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 rare side effect. You may
need urgent medical attention or hospitalisation.
Tell your doctor immediately if any of the
following serious but rare effects happen:
• high body temperature, muscle rigidity,
increased involuntary movement or tremor
and altered consciousness (neuroleptic
malignant syndrome)
• involuntary restless or repetitive limb movements,
shaking, inability to sit or stand still
• jaundice (yellowing of the skin or whites of the
eyes caused by liver or blood problems)
• Torsades de pointes, a life threatening irregular
heart beat (symptoms may include recurrent
episodes of palpitations, dizziness, fainting,
feeling sick, paleness of the skin, cold sweats,
shortness of breath and chest pain)
• cardiac arrest (symptoms include loss of
consciousness, breathing stops and no
heartbeat or pulse can be felt. Some people may
first notice that they have a racing heartbeat or
feel dizzy or light-headed just before they faint.)

5

HOW TO STORE PROMAZINE

Keep out of the reach and sight of children. Store
the tablets below 25ºC. Keep the container tightly
closed.
Do not use Promazine after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Promazine Tablets contain:
• The active ingredient is promazine
hydrochloride 25 mg or 50 mg.
• The other ingredients are lactose, maize starch,
magnesium stearate (E572), talc (E553), light
kaolin (E559), sucrose, shellac (E904), beeswax
(E901), carnauba wax (E903), tartrazine (E102),
titanium dioxide (E171), sodium benzoate (E211),
povidone, acetylated monoglyceride, black
iron oxide (E172) and propylene glycol (E1520)
• The 50 mg tablets also contain sunset yellow
(E110) and erythrosine (E127).

What Promazine Tablets look like and contents of
the pack:
• Promazine 25 mg Tablets are round biconvex
yellow sugar-coated tablets coded 7Z1 on one
side and plain on the reverse.
• Promazine 50 mg Tablets are round biconvex
orange sugar-coated tablets coded 7Z2 on one
side and plain on the reverse.
The following side effects have also been reported: • The pack sizes are 50, 100, 250 and 1,000.
• nasal congestion
Not all pack sizes may be marketed.
• dry mouth
Marketing Authorisation Holder and Manufacturer
• agitation, excitement
Marketing Authorisation holder and company
• apathy (lack of feeling or emotion)
responsible for manufacture:
• dizziness, headache
TEVA UK Limited, Eastbourne, BN22 9AG.
• fast heart rate
• abdominal pain, diarrhoea, constipation
This leaflet was last revised: January 2010
• difficulty in passing water (especially with an
PL 00289/0798-9
enlarged prostate)
PM/20/316
87643-U

(Backup)

PROMAZINE 25 mg AND
50 mg TABLETS

Pharma code 70334

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Expand view ⇕

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.

Hide
(web5)