PROMAZINE 25MG TABLETS
Active substance(s): PROMAZINE HYDROCHLORIDE
231-30-87643-X LEA PROMAZINE A/S TAB TUK
12 June 2015
PAGE 1: FRONT FACE (INSIDE OF REEL)
PROMAZINE 25 mg AND
50 mg TABLETS
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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Promazine is and what it is used for
2. Before you take Promazine
3. How to take Promazine
4. Possible side effects
5. How to store Promazine
6. Further information
WHAT PROMAZINE IS AND WHAT IT IS
Promazine is one of a group of medicines called
phenothiazines, which are used to treat a range of
disorders including anxiety, agitation and
Promazine is used to treat:
• agitation and restlessness in the elderly
• short-term additional management of
psychomotor agitation (unintentional and
purposeless motions brought on by mental
tension; symptoms may take the form of
restlessness, pacing, tapping fingers or feet,
abruptly starting and stopping tasks,
meaninglessly moving objects around, and more).
BEFORE YOU TAKE PROMAZINE
DO NOT take Promazine if you:
• are allergic (hypersensitive) to promazine, any
other phenothiazine, or any of the other
ingredients of this medicine
• have phaeochromocytoma (adrenal gland
tumour resulting in high blood pressure,
Promazine should not be given to patients in a
coma or suffering from central nervous system
(CNS) depression, symptoms include decreased
rate of breathing, decreased heart rate, and loss
Take special care with Promazine
Talk to your doctor before you start to take this
medicine if you:
• have a history of jaundice (yellowing of the skin
or whites of the eyes caused by liver or blood
• blood dyscrasias (blood disorders which may
be characterised by fever or chills, sore throat,
ulcers in your mouth or throat, unusual
tiredness or weakness, unusual bleeding or
• have liver, kidney or heart disease
• have previously had a stroke, transient ischaemic
attack (TIA, stroke that lasts only a few minutes)
or heart attack, have a family history of strokes,
or have other risk factors which may increase
the risk of stroke, such as high cholesterol,
uncontrolled high blood pressure, diabetes, you
smoke or are a heavy drinker
• have personal or a family history of a certain
type of heart disorder known as
• have a history of unexplained fainting or
• have any disease of the lungs, lower and upper
airways, or any condition which causes
difficulty in breathing
• have Parkinson’s disease (tremor, stiffness and
• have epilepsy
• have hypothyroidism (underactive thyroid gland)
• suffer from depression
• have myasthenia gravis (progressive muscular
• have an enlarged prostate (causing difficulty in
• have personal or a family history of glaucoma
(increased pressure in the eye)
• are taking any other neuroleptic medicines
• are elderly, as it is more likely that you may
suffer from certain of the side effects such as
drowsiness, low blood pressure, high or low
• 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.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
DO NOT take Promazine with:
• medicines to correct problems with heart rhythm
e.g. quinidine, disopyramide, procainamide,
amiodarone, dofetilide, sotalol, bretylium
• antimalarials e.g. quinine and mefloquine
• antibiotics such as sparfloxacin, moxifloxacin,
• certain types of (tricyclic or tetracyclic)
antidepressants such as amitriptyline, maprotiline
• other antipsychotics e.g. risperidone,
amisulpride, sertindole, haloperidol and pimozide
• cisapride, a medicine used in the treatment of
certain gastro-intestinal disorders
• certain antihistamines e.g. terfenadine.
Talk to your doctor if you are taking any of the
• medicines which can affect the chemicals in your
bloodstream known as electrolytes, such as:
• diuretics e.g. furosemide
• antibiotics e.g. amphotericin B
• corticosteroids e.g. hydrocortisone
• chemotherapy drugs e.g. cisplatin
• sulphonylureas (used to treat diabetes) e.g.
gliclazide or glibenclamide
• antiepileptics e.g. phenytoin
• blood pressure tablets
• calcium channel blockers e.g. amlodipine
• sympathomimetics e.g. salbutamol
• antimuscarinics e.g. inhalations used for
bronchitis such as ipratropium bromide
• anticholinergics used to treat Parkinson’s or
restlessness, such as procyclidine, benzhexol,
• tetrabenazine, used to treat essential tremor,
chorea, tics, and related disorders
• ritonavir (an antiviral for HIV/AIDS)
• anti-anxiety or sleeping drugs e.g. diazepam,
• reboxetine (used to treat depression)
• lithium, (used to treat certain types of depression)
• memantine, used to treat dementia
• sibutramine, used to help weight loss
• cimetidine, used to treat stomach ulcer, reflux
oesophagitis, Zollinger–Ellison syndrome, or
other conditions where gastric acid reduction is
• antacids, used to treat indigestion and heartburn
• metoclopramide, used to treat feeling or being
• kaolin, used to treat diarrhoea
• antispasmodics to treat gut spasm e.g.
• medicines used for pain relief called opioid
analgesics e.g. tramadol, morphine, codeine
• adrenaline or noradrenaline
If you are to undergo a surgical procedure that
requires a general anaesthetic, make sure you tell
your doctor that you are taking Promazine.
Important information about some of the
ingredients of Promazine
• Patients who are intolerant to lactose should
note that Promazine contain a small amount of
lactose. If your doctor has told you that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.
• Promazine 25 mg and 50 mg tablets contain
E102 (tartrazine) and the 50 mg tablets also
contain E110 (sunset yellow) which may cause
Taking Promazine with food and drink
DO NOT drink alcohol whilst taking Promazine.
Pregnancy and breast-feeding
DO NOT take Promazine if you are pregnant,
planning to become pregnant or breast-feeding.
Page 1 of 3
TEVA UK Ref:
231-30-87643-X LEA PROMAZINE A/S TAB TUK
12 June 2015
Ask your doctor for advice before taking any
• low blood pressure
• eye problems including blurred vision, clouding
or opacity of the front part of the eye (cornea) or
Driving and using machines
lens of the eye, purplish pigmentation of the
Promazine may cause drowsiness, dizziness, and
cornea, the membrane that covers the white part
cloudy or blurred vision. If you are affected by any
of the eye and lines the inside of the eyelids
of these, DO NOT drive or operate machinery.
(conjunctiva), the retina or the skin round the eyes
HOW TO TAKE PROMAZINE
• high body temperature or low body
temperature (especially in the elderly)
Always take Promazine exactly as your doctor has • skin rash or itchiness
told you. You should check with your doctor or
• sensitivity to light
pharmacist if you are not sure.
• contact sensitisation (inflammation of the skin
or red, itchy skin rash, due to an immune
The tablets should be swallowed preferably with
reaction in response to a substance which has
a drink of water. The usual dose is:
come into contact with the skin)
• suffering from infections more frequently,
• For psychomotor agitation
which may be due to a severe reduction in the
100-200 mg four times daily.
number of white blood cells
• lethargy, weakness, dizzy spells and feeling
• For agitation and restlessness
faint, pale skin, which may be due to a reduction
25-50 mg four times daily.
in the number of red blood cells (anaemia)
• weight gain
Promazine is not recommended for use in children.
• in women, production of breast milk or
If you take more Promazine than you should
If you (or someone else) swallow a lot of the tablets • in men, impotence (inability to achieve or
all together, or if you think a child has swallowed
maintain an erection), or breast enlargement
any of the tablets, contact your nearest hospital
• in rare cases, sudden unexplained death has
casualty department or your doctor immediately.
An overdose is likely to cause drowsiness,
The following have been reported at an unknown
confusion, low blood pressure, low body
temperature, fits and coma are possible. Rarely
• blood clots in the vein especially in the legs
breathing difficulties may occur.
(symptoms include swelling, pain and redness
Please take this leaflet, any remaining tablets, and
in the leg), which may travel through blood
the container with you to the hospital or doctor so
vessels to the lungs causing chest pain and
that they know which tablets were consumed.
difficulty in breathing. If you notice any of these
symptoms seek medical advice immediately.
If you forget to take Promazine
elderly people with dementia, a small increase
If you forget to take a tablet, take one as soon as
in the number of deaths has been reported for
you remember unless it is more than 2 hours after
patients taking antipsychotics compared with
the missed dose; if so, ignore the missed dose and
those not receiving antipsychotics.
wait until the time of the next dose. DO NOT take
Reporting of side effects
a double dose to make up for a forgotten dose.
get any side effects, talk to your doctor or
Stopping treatment with Promazine
pharmacist. This includes any possible side effects
DO NOT stop taking your medicine without
talking to your doctor first even if you feel better. not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
Your medicine should only be withdrawn
gradually under close supervision by your doctor. www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
If you have any further questions on the use of
more information on the safety of this medicine.
this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
HOW TO STORE PROMAZINE
Keep out of the reach and sight of children. Store
Like all medicines, Promazine can cause side
the tablets below 25ºC. Keep the container tightly
effects, although not everybody gets them.
Stop taking the tablets and tell your doctor
Do not use Promazine after the expiry date that is
immediately or go to the casualty department at
stated on the outer packaging. The expiry date
your nearest hospital if the following happens:
refers to the last day of that month.
• an allergic reaction causing swelling of the lips, Medicines should not be disposed of via wastewater
face or neck leading to severe difficulty in
or household waste. Ask your pharmacist how to
breathing or severe skin rash or hives.
dispose of medicines no longer required. These
This is a very serious but rare side effect. You may measures will help to protect the environment.
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
• The active ingredient is promazine
involuntary movement or tremor and altered
hydrochloride 25 mg or 50 mg.
consciousness (neuroleptic malignant syndrome)
• The other ingredients are lactose, maize starch,
• involuntary restless or repetitive limb
maize starch (partially pregelatinised),
movements, shaking, inability to sit or stand still
magnesium stearate (E572), talc (E553), light
• jaundice (yellowing of the skin or whites of the
kaolin (E559), sucrose, shellac (E904), beeswax
eyes caused by liver or blood problems)
(E901), carnauba wax (E903), tartrazine (E102),
• Torsades de pointes, a life threatening irregular
titanium dioxide (E171), sodium benzoate
heart beat (symptoms may include recurrent
(E211), povidone, acetylated monoglyceride,
episodes of palpitations, dizziness, fainting,
black iron oxide (E172) and propylene glycol
feeling sick, paleness of the skin, cold sweats,
shortness of breath and chest pain)
50 mg tablets also contain sunset yellow
• cardiac arrest (symptoms include loss of
(E110) and erythrosine (E127).
consciousness, breathing stops and no
What Promazine Tablets look like and contents of
heartbeat or pulse can be felt. Some people
may first notice that they have a racing
• Promazine 25 mg Tablets are round biconvex
heartbeat or feel dizzy or light-headed just
before they faint.)
yellow sugar-coated tablets coded 7Z1 on one
side and plain on the reverse.
The following side effects have also been reported:
• Promazine 50 mg Tablets are round biconvex
• nasal congestion
orange sugar-coated tablets coded 7Z2 on one
• dry mouth
side and plain on the reverse.
• agitation, excitement
• The pack sizes are 50, 100, 250 and 1,000.
• apathy (lack of feeling or emotion)
all pack sizes may be marketed.
• dizziness, headache
• fast heart rate
Marketing Authorisation Holder and Manufacturer
• abdominal pain, diarrhoea, constipation
Marketing Authorisation holder and company
• difficulty in passing water (especially with an
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
• drowsiness, confusion, difficulty sleeping
This leaflet was last revised: June 2015
• epileptic fits
Page 2 of 3
Pharma code 386
PAGE 2: REAR FACE (OUTSIDE OF REEL)
THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V
Meaning of Signature
Regulatory Affairs Approval
16-Jun-2015 09:26:48 AM
Page 3 of 3
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