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ZIZ EXTRA STRENGTH

Active substance(s): PROMETHAZINE HYDROCHLORIDE

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Product:

Ziz Extra Strength
(Promethazine)
25 mg Tablets

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Chelonia

PL No.:

33414/0147

Pack Size:

All Packs

Dimensions:

148 x 297 mm

Livery:

Chelonia

Created By:

DTawde

Manufacturer:

-

Artwork Code:

CL0147/P/PIL-Br/CL2

Bar Code:

-

Font Type:
Font Size:

Arial Narrow
8.6 pt

Chelonia

HEALTHCARE

Final Preparation Date For Submission: 19/05/2016

Packing Site Technical Approval:

Market:

UK

Component:

Leaflet

00/00/0000
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZIZ EXTRA STRENGTH
25 mg TABLETS
PROMETHAZINE HYDROCHLORIDE

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- 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.
- You must talk to a doctor if you do not feel better
or if you feel worse.

What is in this leaflet
1. What Ziz Extra Strength is and what it is
used for
2. What you need to know before you take Ziz
Extra Strength
3. How to take Ziz Extra Strength
4. Possible side effects
5. How to store Ziz Extra Strength
6. Contents of the pack and other information

1. WHAT ZIZ EXTRA STRENGTH IS
AND WHAT IT IS USED FOR
Ziz Extra Strength 25 mg Tablets contain a medicine
called promethazine hydrochloride. It belongs to a group
of medicines called phenothiazines, and works by
blocking a substance called histamine that your body
makes during an allergic reaction. It works directly on the
brain to help you feel more relaxed.
Ziz Extra Strength is used to treat the following
conditions:
 to treat allergic conditions, such as hay fever or
rashes (like nettle rash or hives)
 to treat and prevent you feeling sick (nausea) or being
sick (vomiting), such as travel sickness.
 to treat adults with difficulty sleeping (insomnia)
 for short term use: as a sedative for children

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ZIZ EXTRA STRENGTH
Do not take Ziz Extra Strength if:
 you are allergic to promethazine hydrochloride or any
of the other ingredients in the tablets (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.
 the person taking this medicine is under 2 years old
 you are taking a medicine for depression called a
monoamine oxidase inhibitor (MAOI) or you have
stopped taking one of these MAOI medicines within
the last 14 days
 the person taking this medicine is unconscious (in a
coma) or suffers from severe dizziness, drowsiness or
headache.
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Ziz Extra Strength.
Warnings and precautions
Tell your doctor or pharmacist before you take this
medicine if you:
 have difficulty in breathing, wheezing, tightness in the
chest (asthma) or an infection in your lungs (bronchitis)
 have epilepsy
 have any serious heart problems
 have liver or kidney problems
 have an enlarged prostate gland
 have a stomach blockage or difficulty passing water
(urine)
 have hearing problems
 have increased pressure in the eye (narrow angle
glaucoma)
 have had something called Reye’s Syndrome or you
have signs of Reye’s Syndrome, such as being sick
and confused after a viral illness.

If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Ziz Extra
Strength.
You may get high fever, muscle cramps or stiffness,
dizziness, very bad headache, fast heartbeat, confusion,
agitation, hallucinations, or are sweating a lot. This may
be signs of a very serious and sometimes deadly health
problem called neuroleptic malignant syndrome. Stop
taking your medicine and tell your doctor immediately.
There have been some cases of abuse with this medicine.
This risk of abuse is greater in those with a history of drug
abuse.
Other medicines and Ziz Extra Strength Tablets
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, even medicines
bought without a prescription, including herbal medicines.
This is because Ziz Extra Strength can affect the way
some medicines work. Also some medicines can affect
the way Ziz Extra Strength works.
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.
In particular, tell your doctor or pharmacist if you are
taking any of the following:
 other medicines for depression called tricyclic
antidepressants, such as amitriptyline or dosulepin
 medicines to help you to sleep or feel more relaxed,
such as diazepam or zolpidem
 medicines to relieve pain (for arthritis and pain in your
joints), such as aspirin. Promethazine may hide the
side effects of these medicines
 anticholinergic medicines. This includes some
medicines used for irritable bowel syndrome or weak
bladder, such as atropine or oxybutynin. These can
increase the risk of dizziness, dry mouth and blurred
vision.
Tests
Taking Ziz Extra Strength may affect the results of certain
tests. These include some pregnancy tests based
on urine samples and skin tests. Ziz Extra Strength
should not be taken at least 3 days before the start of a
skin test.
Ziz Extra Strength tablets with food and drink
Do not drink alcohol whilst taking Ziz. Alcohol may
increase the sedative effects of Ziz Extra Strength and
make you feel very sleepy.
Pregnancy and breast-feeding
Talk to your doctor before taking Ziz Extra Strength if you
are pregnant or planning to become pregnant or think you
may be pregnant. Ziz Extra Strength should not be taken
2 weeks before birth.
You should not take Ziz Extra Strength if you are
breast-feeding. This is because small amounts may pass
into the mothers’ milk. This could 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
or the day after you have taken this medicine. If this
happens, do not drive or operate machinery.
Ziz Extra Strength Tablet contains lactose and
sucrose
This medicine contains lactose and sucrose (types of
sugars). If you know you have an intolerance to some
sugars contact your doctor or pharmacist before taking
Ziz Extra Strength.

3. HOW TO TAKE ZIZ EXTRA STRENGTH
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The amount you need to take depends on the reason you
are taking Promethazine. The following information will
help you to decide how much you need to take.
Taking this medicine
 Swallow the tablets whole with a glass of water.
 This medicine may not work as well if you take it for
more than 7 days. If your symptoms worsen or do
not improve after 7 days talk to your doctor or
pharmacist.

How much to take
The usual doses are:
As a short-term paediatric sedative for short term
treatment of insomnia in adults
Adults (including the elderly) and children over 10
years: 1 or 2 tablets (25 mg to 50 mg) taken at night.
Children 5-10 years: A single tablet (25 mg) given at
night.
Children 2-5 years: A liquid form of this medicine should
be used.
For allergies (such as hay fever, rashes and hives)
Adults (including the elderly) and children over 10
years: Start with 1 tablet (25 mg) taken at night. This may
be increased to a maximum of 1 tablet (25 mg) twice a day
if necessary.
Children 5-10 years: A single tablet (25 mg) given at
night.
DO NOT give more than 25 mg per day.
Children 2-5 years: A liquid form of this medicine should
be used.
For treatment and prevention of feeling sick or being
sick (such as travel sickness)
Adults (including the elderly) and children over 10
years: A single tablet (25 mg) taken the night before the
journey. This may be repeated after 6 to 8 hours if
necessary.
Children 5-10 years: A liquid form of this medicine or
Promethazine 10 mg tablets should be used.
Children 2-5 years: A liquid form of this medicine should
be used.
Children under 2 years
DO NOT give this medicine to children under 2 years old.
Use this medicine only as recommended. Do not exceed
the recommended dose.
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 Ziz Extra Strength than you should
If you or your child accidentally takes too many tablets, 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 occur:
 In children: Excitation, moving unsteadily or
stumbling, uncontrolled writhing movements
especially of the hands or feet, hearing or seeing
things that are not there (hallucinations), fits
(seizures), loss of consciousness, uneven heart beat
and breathing difficulties
 In adults: Feeling drowsy or sleepy, fits, loss of
consciousness, uneven heart beat and breathing
difficulties.
If you forget to take Ziz Extra Strength
Do not take a double dose to make up for a forgotten
dose.
 If you are taking Ziz Extra Strength for an allergic
condition - take your medicine as soon as you
remember, then carry on as before
 If you are taking Ziz Extra Strength for sedation or
sleeping problems - miss that dose and take the next
evening’s dose as usual.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ziz Extra Strength can cause side
effects, although not everybody gets them.
STOP TAKING this medicine 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,
swelling of the face, lips, tongue or throat, difficulty in
breathing or swallowing, sudden wheezing or collapse
 liver problems which may cause yellowing of the skin
or whites of the eyes (jaundice)
 muscle stiffness or shaking
 being unable to control some muscles in the head or
face
 unusual movements of the tongue, facial muscle
spasms, rolling eyes and trembling
 over-active behaviour in children
 very fast, uneven or forceful heart beat (palpitations)

 irregular heartbeat
 changes in the numbers and types of your blood cells.
If you notice increased bruising, nosebleeds, sore
throats, infections, excessive tiredness,
breathlessness or abnormal paleness of the skin, you
should tell your doctor who may want you to have a
blood test.

Not Known: frequency cannot be estimated from the
available data
 You have high fever, muscle cramps or stiffness,
dizziness, very bad headache, fast heartbeat,
confusion, agitation, hallucinations, or are sweating a
lot. This may be signs of a very serious and
sometimes deadly health problem called neuroleptic
malignant syndrome.
Tell your doctor or pharmacist if any of the following
side effects become serious or last longer than a few
days. Also tell them if you notice any side effects not
listed in this leaflet:
 dry mouth, blurred vision, constipation and difficulty
shedding tears or passing urine, especially in the
elderly and children
 feeling drowsy, sleepy, dizzy or tired, headaches, fits
 feeling confused, especially in the elderly
 feeling depressed, restless or disorientated (not
knowing where you are), having nightmares or
problems sleeping
 loss of appetite (anorexia), feeling or being sick,
diarrhoea, indigestion, stomach upsets
 feeling dizzy, lightheaded or faint (hypotension)
 skin rash, itching, red and raised lumps (hives)
 being more sensitive to the sun than usual. If this
happens keep out of direct sunlight and do not use
sunbeds.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE ZIZ EXTRA STRENGTH
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package or
container and keep the container tightly closed.
Do not use the tablets after the expiry date, which is
stated on the package or container. The expiry date refers
to the last day of that month.
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 to
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION

What Ziz Extra Strength tablets contain
The active substance is promethazine hydrochloride.
Each tablet contains 25 mg of the active substance.
The other ingredients in the tablets are lactose, maize
starch, pregelatinised maize starch, magnesium stearate,
talc, bleached shellac, titanium dioxide (E171), povidone,
sucrose, beeswax, carnauba wax and opalux blue which
contains patent blue (E131), indigo carmine (E132),
titanium dioxide (E171) and sodium benzoate (E211).
What Ziz Extra Strength tablets look like and contents
of the pack
Ziz Extra Strength tablets are blue, sugar-coated tablets
which come in blister packs of 10 and 30 tablets and in
containers of 100, 500 and 1000 tablets.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia,
P.C. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London, SW5 9JQ
For more information about this product, please contact
the Marketing Authorisation Holder.
This leaflet was last revised in 05/2016

CL0146/P/PIL-Br/CL2

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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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