Skip to Content

PROMETHAZINE HYDROCHLORIDE 50 MG FILM-COATED TABLETS

Active substance(s): PROMETHAZINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
• A combination of symptoms (known
as ‘neuroleptic malignant syndrome’)
including high temperature, pale
complexion, muscle stiffness or tremor,
and changes in your mental state (such
as confusion, irritability and extreme
agitation). See also section 2 ‘Warnings
and precautions’.
Tell your doctor or pharmacist if
any of the following side effects get
serious or lasts longer than a few
days. Also tell them if you notice any
side effects not listed in this leaflet.
•D
 ry mouth, blurred vision or you
cannot pass water (urine)
• F eeling drowsy or sleepy, tiredness,
disorientation, having nightmares,
headaches, feeling restless
• L oss of appetite (anorexia), indigestion
• F eeling dizzy, lightheaded, faint
(hypotension)
• F eeling confused, especially in elderly
people
•B
 eing more sensitive to the sun than
usual. If this happens keep out of direct
sunlight and do not use sun lamps.

Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.
6

Reporting of side effects

If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
side effects directly via the Yellow Card
Scheme Website:
www.mhra.gov.uk/yellowcard

Continued top of next column
50889101 AAAJ0175

JDE No.:

What Promethazine Tablets look like
and contents of the pack
Promethazine 50mg Film‑coated Tablets
are white oval shaped, 12.3 x 7.8mm
biconvex with “C50” on one side and
plain on the other side.

Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

Keep this medicine out of the sight and
reach of children.
This medicine does not require any
special storage conditions.
Do not use this medicine after the expiry
date which is stated on the carton and
blister after EXP.
The expiry date refers to the last day of
that month.

Promethazine Tablets 50mg x 56’s
(UK)

• T he active substance is promethazine
hydrochloride
• The other ingredient(s) are:
Tablet core: microcrystalline cellulose,
calcium hydrogen phosphate dihydrate,
sodium starch glycolate (Type A), stearic
acid, magnesium stearate.
Tablet coating: hypromellose (E464),
macrogol 8000 (E1521), titanium dioxide
(E171), talc.

Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th floor, 94 Wigmore Street
London
W1U 3RF
UK

 ow to store Promethazine
H
Tablets

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

What Promethazine Tablets
contain

Pack sizes:
Blisters: 56 film-coated tablets.

By reporting side effects you can help
provide more information on the safety
of this medicine.
5

 ontents of the pack and other
C
information

This leaflet was last revised in May
2016

Package leaflet: Information for the patient

Promethazine
Hydrochloride 50mg
Film‑coated Tablets
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
•  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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness 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.
•  The full name of this medicine is
Promethazine Hydrochloride 50mg
Film‑coated Tablets but within
the leaflet it will be referred to as
Promethazine Tablets.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Promethazine Tablets may be used in
the following situations:
• To treat adults with difficulty sleeping
(insomnia).
• As a sedative for children over 10 years.
This is a medicine given to reduce
awareness or make you feel relaxed
and at ease.
2

 hat you need to know before
W
you take Promethazine Tablets
Do not take this medicine and tell
your doctor if:
• You are allergic to promethazine
hydrochloride or any of the other
ingredients of this medicine (listed
in section 6). The signs of an allergic
reaction include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
• You are taking a medicine for
depression called a monoamine
oxidase inhibitor (MAOI). Also, do not
take Promethazine Tablets if you have
stopped taking one of these MAOI
medicines within the last 14 days. If
you are not sure, ask your doctor or
pharmacist (see “Other medicines and
Promethazine Tablets” section below)
• The person is unconscious (in a coma)
or suffers from severe dizziness,
drowsiness or headache
Do not give Promethazine Tablets to
children younger than 10 years.

Continued top of next column

Continued over page

page 4

page 1

colours/plates:

Promethazine 50mg 56 Tablets PIL - UK

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
16/02/16
Technologist: R.Wrey

 hat Promethazine Tablets are
W
and what they are used for
Promethazine Tablets contain a
medicine called promethazine
hydrochloride. This belongs to a group
of medicines called phenothiazines. It
works directly on the brain to help you
feel more relaxed.

What is in this leaflet
1 What Promethazine Tablets are
and what they are used for
2 What you need to know before
you take Promethazine Tablets
3 How to take Promethazine
Tablets
4 Possible side effects
5 How to store Promethazine
Tablets
6 Contents of the pack and other
information

50889101

Pharmacode: 5783

1

1. Black

item no: AAAJ0175

dimensions: 296 x 210

print proof no: 3

pharmacode:

origination date: 11.05.16

min pt size: 9

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 12.05.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1. Profile
2.
3.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Promethazine Tablets if
• you have difficulty breathing,
wheezing, tightness in the chest
(asthma) or an infection in your lungs
(bronchitis)
• you have epilepsy
• you have any serious heart problems
• you have liver or kidney problems
• you have a stomach blockage or
difficulty passing water
• you have hearing problems
• you have increased pressure in the eye
(narrow angle glaucoma)
• you have had something called Reye’s
Syndrome or possible Reye’s Syndrome
– signs include being sick and confused
following a viral illness.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Promethazine
Tablets.
Promethazine Tablets may occasionally
cause a condition called neuroleptic
malignant syndrome which is potentially
life-threatening. If you notice symptoms
such as high temperature, pale
complexion, muscle stiffness or tremor,
and changes in your mental state (such
as confusion, irritability and extreme
agitation), you should stop taking these
tablets and immediately inform your
doctor. See also section 4 ‘Possible side
effects’.

Other medicines and
Promethazine Tablets

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Do not take this medicine, and tell
your doctor, if you are taking or
have taken the following in the last 2
weeks:
• Some medicines for depression called
monoamine oxidase inhibitors (MAOIs).
If you are not sure, ask your doctor or
pharmacist.

Continued top of next column

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Promethazine Tablets 50mg x 56’s
(UK)
JDE No.:

Tell your doctor or pharmacist
if you are taking any of the
following:

• Anticholinergic medicines – includes
some medicines used for irritable
bowel syndrome, asthma or weak
bladder. These can increase the risk
of dizziness, dry mouth and blurred
eyesight
• Medicines for depression (such as
amitriptyline)
• Medicines to help you to sleep or feel
more relaxed (such as diazepam or
zolpidem)
• Medicines such as aspirin (for arthritis
and pain in your joints). Promethazine
Tablets may hide the side effects of
these medicines.

Promethazine Tablets with alcohol
Do not drink alcohol while you are
taking Promethazine Tablets. This
is because it can affect the way the
medicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
for advice before taking this medicine.
Promethazine Tablets should not be
taken 2 weeks before birth.
You should not take Promethazine
Tablets if you are breast-feeding. This is
because small amounts may pass into
mothers’ milk. This can be harmful to
your baby. If you are breast-feeding or
planning to breast-feed, talk to your
doctor or pharmacist before taking any
medicine.

Driving and using machines

You may feel drowsy or sleepy after
taking this medicine. If this happens, do
not drive or use any tools or machines.

Continued over page

3

Taking this medicine

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Tests
Taking Promethazine Tablets may affect
the results of certain tests. These include
some pregnancy tests and skin tests.
Promethazine Tablets should not be
taken for at least 3 days before the start
of a skin test.

Take this medicine by mouth.
If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor.
The recommended dose is:
For treatment of adults with difficulty
sleeping (insomnia)
Adults (including the elderly):
- 25mg or 50mg taken at night.
As a sedative for children
Children over 10 years:
- 25mg or 50mg taken at night.

If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.
4

Possible side effects
Like all medicines, this medicine
can cause side effects, although not
everybody gets them.

Exposure to sunlight

Promethazine Tablets can make your
skin more sensitive to sunlight. Keep
out of direct sunlight while taking this
medicine.

If you take more Promethazine
Tablets than you should

If you or your child takes more
Promethazine Tablets than you should,
tell a doctor or go to a hospital casualty
department straight away. Take the
medicine pack with you. This is so the
doctor knows what you or your child
has taken. The following effects may
happen:
In children: Excitation, moving
unsteadily or stumbling, uncontrolled
writhing movements especially of the
hands or feet, hallucinations, fits
(seizures), loss of consciousness, uneven
heartbeat and breathing difficulties.
In adults: Feeling sleepy or drowsy, fits,
loss of consciousness, uneven heartbeat
and breathing difficulties.

Stop taking Promethazine Tablets
and see a doctor or go to a hospital
straight away if you notice any of the
following side effects:
• An allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
• Liver problems that may cause the eyes
or skin to go yellow (jaundice)
• Muscle stiffness or shaking
• Being unable to control some muscles
in your head or face
• You notice unusual movements of the
tongue, facial muscle spasms, rolling
eyes and trembling
• Very fast, uneven or forceful heartbeat
(palpitations)
• Tiredness which lasts for a long time.
This may be due to a blood problem
called anaemia
• Over-active behaviour in children

Continued top of next column

Continued over page

page 2

page 3

colours/plates:

Promethazine 50mg 56 Tablets PIL - UK

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
16/02/16
Technologist: R.Wrey

Do not take a double dose to make up
for a forgotten dose
• If you are taking Promethazine Tablets
for sedation or sleeping problems
- miss that dose and take the next
evening’s dose as usual.

Always take this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.

50889101

Pharmacode: 5783

If you forget to take Promethazine
Tablets

 ow to take Promethazine
H
Tablets

1. Black

item no: AAAJ0175

dimensions: 296 x 210

print proof no: 3

pharmacode:

origination date: 11.05.16

min pt size: 9

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 12.05.16

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1. Profile
2.
3.

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