Phenergan® (fen-er-gan)

Active ingredient: Promethazine hydrochloride (PRO-meth-ar-zine HIGH-dro (h)-CLOR-ride)

other phenothiazines, or any of the ingredients listed

Consumer Medicine Information (CMI) at the end of this leaflet.
This leaflet provides important information about using Always check the ingredients to make sure you can
Phenergan. You should also speak to your doctor or use this medicine.
pharmacist if you would like further information or if you
Some of the symptoms of an allergic reaction may
have any concerns or questions about using Phenergan.
include:
Where to find information in this leaflet:
• shortness of breath
1. Why am I using Phenergan? • wheezing or difficulty breathing
2. What should I know before I use Phenergan? • swelling of the face, lips, tongue or other parts of the
3. What if I am taking other medicines? body
4. How do I use Phenergan? • rash, itching or hives on the skin
5. What should I know while using Phenergan? If you take this medicine after the expiry date has
6. Are there any side effects? passed, it may not work as well.
7. Product details
• the packaging is torn or shows signs of tampering.

1. Why am I using Phenergan? Any person who is unconscious or in a coma must not be
treated with Phenergan.
Phenergan contains the active ingredient promethazine
hydrochloride. Do not give Phenergan to newborn or premature babies.

Phenergan is an antihistamine used to treat a number of Check with your doctor or pharmacist if you:
conditions:
• have allergies to:
• allergies - allergic contact dermatitis, hives, hayfever,
bites and stings o any other medicines
o any other substances, such as foods,
• respiratory symptoms due to allergies - runny nose
preservatives or dyes
• nausea and vomiting - motion sickness
• for short-term use for sedation on the advice of a • have or have had any medical conditions, especially
pharmacist or doctor - do not use for more than 7-10 the following:
days
o kidney or liver disease
Antihistamines help reduce allergic symptoms by o Parkinson's disease
preventing the effects of a substance called histamine. o underactive thyroid gland (hypothyroidism)
Histamine is produced by the body in response to foreign o tumour growing in adrenal glands
substances that the body is allergic to. (pheochromocytoma)
Your pharmacist or doctor may have recommended o autoimmune disorder (myasthenia gravis)
Phenergan for another reason. o epilepsy
o cardiovascular disease/cardiac failure
Ask your pharmacist or doctor if you have any questions o blood pressure problems
about this medicine. o low blood cell count (agranulocytosis)
o bladder problems
2. What should I know before I use o breathing problems
Phenergan? o glaucoma - an eye condition
o prostate problems
Warnings o stomach ulcer or blockage
Phenergan must not be used in children under 6 years of • develop a fever or an infection to confirm if laboratory
age, due to the potential for fatal respiratory depression, tests are required to check your blood count.
psychiatric and CNS events. • plan to have surgery
Do not use Phenergan if: • take sedatives
• take any medicines for any other condition
• you are allergic to promethazine hydrochloride, • have any personal or family history of heart disease
medicines of similar properties or belonging to the • have an irregular heartbeat
specific family of chemicals called phenothiazines,

PHENERGAN® 1
If you experience an allergic reaction, seek medical help • medicines used to treat depression, especially
right away. monoamine oxidase inhibitors and tricyclic
Caution must be exercised when using Phenergan due to antidepressants
the risk of sedation. • medicines used to help you sleep or relax (sedatives
and hypnotics)
If you experience fever, sore throat or any other infection,
• opioid analgesics, medicines used to treat pain
you should inform your doctor or pharmacist immediately
• other antihistamines
and undergo a complete blood count. Treatment should
• alcohol and alcohol containing medicines
be discontinued if any marked changes are observed in the
blood count. • medicines for the treatment of irregular heartbeats
(antiarrhythmics)
During treatment, you may be at risk of developing certain • medicines that help with your mood (antidepressants)
side effects. It is important you understand these risks and • medicines used to help with mental illness
how to monitor for them. See additional information (antipsychotics)
under Section 6. Are there any side effects? • medicines to treat infections (antimicrobials)
Pregnancy and breastfeeding • medicines used to treat nausea and vomiting like
metoclopramide
Check with your doctor or pharmacist if you are a woman • medicines used to relieve muscle spasm like
of childbearing age and not using effective contraception. carisoprodol and cyclobenzaprine
Check with your doctor or pharmacist if you are • medicines for the treatment of epilepsy or seizures
pregnant, might become pregnant or you think you may
• medicines used to treat acid indigestion such as
be pregnant.
magnesium, aluminium and calcium salts, oxides and
Do not take Phenergan if you are pregnant or plan to hydroxides
become pregnant. • medicines used to smooth muscle contractions in the
It may affect your developing baby if you take it during gastrointestinal tract (antispasmodics)
pregnancy. If there is a need to consider Phenergan during These medicines may be affected by Phenergan or may
your pregnancy, your pharmacist or doctor will discuss the affect how well it works. You may need different amounts
benefits and possible risks of taking the medicine during of your medicines, or you may need to take different
pregnancy. medicines.
Talk to your doctor or pharmacist if you are breastfeeding Check with your doctor or pharmacist if you are not sure
or intend to breastfeed. about what medicines, vitamins or supplements you are
Do not take Phenergan if you are breastfeeding or plan to taking and if these affect Phenergan.
breastfeed.
It passes into the breast milk and there is a possibility that 4. How do I use Phenergan?
the baby may be affected.
How much to take
Use in Children
• Follow the instructions provided with the medicine.
• Do not give Phenergan to newborn or premature
If you do not understand the instructions on the
babies.
carton or the label, ask your pharmacist or doctor for
• Phenergan must not be used in children under 6 help.
years of age, due to the potential for fatal respiratory
depression, psychiatric and CNS events. • Follow all directions given to you by your pharmacist
• Because of the risk of chocking, the tablets should be or doctor carefully.
avoided in children who have difficulty swallowing They may differ from the information contained in
tablets. this leaflet.
• Use this drug only as recommended.
3. What if I am taking other medicines? • Do not exceed the recommended dosage. There have
Tell your doctor or pharmacist if you are taking any other been case reports of promethazine abuse.
medicines, including any medicines, vitamins or • Phenergan tablets and elixir are recommended for
supplements that you buy without a prescription from adults and children over 6 years of age.
your pharmacy, supermarket or health food shop. • It is recommended that the lowest effective dose of
Phenergan be used in children 6 years of age or
Some medicines may interfere with Phenergan and affect
older.
how it works
Phenergan may increase the sedative effect of some
medicines. These include:
Allergic Disorder

PHENERGAN® 2
• Adults: One to three 25mg tablets as a single dose at If you are not sure what to do, ask your pharmacist or
night, or one to two 10mg tablets, two to three times doctor.
daily. If you have trouble remembering to take your medicine,
• Children 6-12 years: One to two 10mg tablets, or 10 to ask your pharmacist for some hints.
25mL of the elixir as a single dose at night, or one
10mg tablet, or 10mL of the elixir, two to three times If you use too much Phenergan (overdose)
daily.
If you think that you have used too much Phenergan, you
Sedation may need urgent medical attention.
• For short term use on the advice of a pharmacist or You should immediately:
doctor. • phone the Poisons Information Centre
• Adults: One to three 25mg tablets as a single dose at (by calling 13 11 26 in Australia or 0800 764 766 in
night. New Zealand), or
Travel Sickness • contact your doctor, or
• go to the Emergency Department at your nearest
• Adults: One 25mg tablet.
hospital.
• Children 6-12 years: One 10mg tablet or 10mL of the
elixir. You should do this even if there are no signs of
• To be taken the night before travel and repeated after discomfort or poisoning.
6 to 8 hours on the following day if required. If you take too much Phenergan, you may experience:
Nausea and Vomiting Adults
• Adults: One 25mg tablet every 4 to 6 hours to a • drowsiness
maximum daily dose of four 25mg tablets. • convulsions and/or tremors
• Children 6-12 years: One 10mg tablet or 10mL of the • difficulty breathing
elixir, every 4 to 6 hours to a maximum daily dose of • unconsciousness
two 10mg tablets or 25mL of the elixir. • acute anxiety
Use in the Elderly • hallucinations
• heart palpitations, chest pain and/or rapid pulse
• If you are over 65 years of age, talk to your pharmacist • dizziness
or doctor about how much to take.
• nausea
• Elderly patients are more likely to have side effects
• cold sweats
from taking these medicines.
Children
How to take Phenergan
• over - excitement
Tablets • shaky and unsteady movements
• Swallow Phenergan tablets whole with a full glass of • convulsions and/or tremors
water. • hallucinations
• difficulty breathing
Elixir
• unconsciousness
• Measure out the amount of elixir to be taken. • high fever
How long to take it • heart palpitations, chest pain and/or rapid pulse
• dizziness
Phenergan should not usually be taken for more than 10 • nausea
days in a row. If your symptoms persist, see your • cold sweats
pharmacist or doctor for advice. • memory and thinking problems; difficulty with
If you forget to take it learning new things, concentrating, or making
decisions
If you are taking Phenergan for an allergic disorder and
you forget to take your bedtime dose, you may need to 5. What should I know while using
take your dose in two or three smaller doses during the
following day. Check with your pharmacist or doctor.
Phenergan?
If you are taking Phenergan for travel sickness or nausea Things you should do
and vomiting, take your dose as soon as you remember.
Remind any doctor, dentist or pharmacist you visit that
If you are taking Phenergan for sedation, take your dose as you are using Phenergan.
soon as you remember. Be careful because you may still
Phenergan may cause your skin to be more sensitive to the
be affected in the morning.
sun. You should protect your skin from exposure to bright
Do not take a double dose to make up for the dose that sunlight.
you missed. This may be harmful.

PHENERGAN® 3
If you are about to be started on any new medicine, tell Looking after your medicine
your pharmacist or doctor that you are taking Phenergan.
• Keep your medicine in the pack until it is time to take
If you plan to have surgery that needs a general it.
anaesthetic, tell your doctor or dentist that you are taking
• If you take your medicine out of the pack it will not
this medicine.
keep as well.
If you become pregnant while you are taking this • Store Phenergan tablets below 30°C.
medicine, stop taking it and tell your doctor immediately. • Store Phenergan elixir below 25°C.
Talk to your pharmacist or doctor if your symptoms do not Follow the instructions in the carton on how to take care
improve. of your medicine properly.
Your pharmacist or doctor will assess your condition and Store it in a cool dry place away from moisture, heat or
decide if you should continue to take the medicine. sunlight; for example, do not store it:
Things you should not do • in the bathroom or near a sink, or
• in the car or on window sills.
• Do not give Phenergan to anyone else, even if they
have the same condition as you. Keep it where young children cannot reach it, in a locked
• Do not take Phenergan to treat any other complaints cupboard at least one-and-a-half metres above the
unless your pharmacist or doctor tells you to. ground is a good place to store medicines
• Do not take more than the recommended dose unless
Getting rid of any unwanted medicine
your pharmacist or doctor tells you to.
If you no longer need to use this medicine or it is out of
Things to be careful of
date, take it to any pharmacy for safe disposal.
• Phenergan is a known sedative and may cause Do not use this medicine after the expiry date.
drowsiness in some people.
• If you have a single dose at bedtime, you may still be
6. Are there any side effects?
affected in the morning.
• Children and the elderly are especially sensitive to the All medicines can have side effects. If you do experience
effects of antihistamines. any side effects, most of them are minor and temporary.
However, some side effects may need medical attention.
Neuroleptic malignant syndrome
See the information below and, if you need to, ask your
A very serious and sometimes deadly health problem doctor or pharmacist if you have any further questions.
called neuroleptic malignant syndrome (NMS) may
happen. Stop treatment and call your doctor right away if Less serious side effects
you have high fever, muscle cramps or stiffness, Less serious side effects What to do
dizziness, very bad headache, fast heartbeat, confusion,
agitation, hallucinations, or are sweating a lot. General Speak to your
• dry mouth, nose & throat doctor or
Driving or using machines pharmacist if
Nervous system-related you have any
Phenergan can cause drowsiness, dizziness and blurred
vision. Make sure you know how you react to Phenergan • tiredness or sleepiness of these less
before you drive a car, operate machinery, or do anything • headache serious side
else that could be dangerous if you experience • involuntary muscle movements effects and
drowsiness, dizziness and blurred vision. If this occurs do (dystonia) they worry
not drive or operate machinery. you.
Mental
Be careful before you drive or use any machines or tools
• nightmares in children
until you know how Phenergan affects you.
• restlessness
Phenergan may affect your ability to drive a car or • confusion
operate machinery or do anything else that could be • anxiety
dangerous if you are drowsy, dizzy or experience blurred • aggression
vision. If this occurs do not drive or operate machinery.
• hallucination
Drinking alcohol Gastrointestinal
Tell your doctor or pharmacist if you drink alcohol. • stomach upset
Do not drink alcohol while taking Phenergan. • loss of appetite
• nausea or vomiting
The sedation effects of alcohol may be increased.
• diarrhoea or constipation
Eye disorders

PHENERGAN® 4
 • blurred vision • confusion
• twitching or jerking muscles
Respiratory
• dizziness, lightheadedness
• congested nose • severe headache
• muscle cramps or stiffness
Skin-related • psychomotor hyperactivity
• increased sensitivity of the skin Central nervous system-related
to sun • anxiety
These are mild side effects of the medicine and are short- • seizures (fits)
lived. • hallucinations
• agitation
• nervousness and irritability
Serious/rare side effects
The above list includes serious side effects that may
Serious side effects What to do require medical attention. Serious side effects are rare.
General Call your Very serious side effects What to do
• fever doctor straight Allergy related Call your
away if you
• excessive sweating • wheezing or difficulty breathing doctor straight
notice any of
• dizziness • swelling of the face, lips, tongue
away, or go
these serious
• nausea or other parts of the
straight to the
side effects.
• cold sweats body/severe allergic reaction
Emergency
• low blood pressure Department at
where adrenalin is required for
• shortness of breath your nearest
treatment (anaphylaxis)
hospital if you
Urinary • skin rashes
notice any of
• difficulty passing urine these serious
side effects.
Heart
The above list includes very serious side effects. You may
• irregular heart beat
need urgent medical attention or hospitalisation. These
• very fast or forceful heartbeats
side effects are very rare.
(palpitations)
• chest pain Tell your doctor or pharmacist if you notice anything else
• rapid pulse that may be making you feel unwell.
Other side effects not listed here may occur in some
Blood and Lymphatic System
people.
Disorders
• eosinophilia which is an increase Reporting side effects
in the number of eosinophils (a After you have received medical advice for any side effects
type of white blood cells) found you experience, you can report side effects to the
in the blood test. Therapeutic Goods Administration online at
• Thrombocytopenia which is a www.tga.gov.au/reporting-problems or Medsafe in New
decrease in the number of Zealand https://www.medsafe.govt.nz/safety/report-a-
platelets (cells in the blood that problem.asp#Medicine. By reporting side effects, you can
help with clotting) found in a help provide more information on the safety of this
blood test, which can lead to medicine.
bleeding and bruising
Allergy related 7. Product details
• difficulty breathing This medicine is available over-the-counter without a
Liver-related doctor's prescription.

• jaundice - yellow tinge to skin or What Phenergan Tablets contain

eyes
Active ingredient • 10mg tablets - 10mg of
Nervous system-related promethazine
(main ingredient)
• tremors or convulsions hydrochloride per tablet
• tinnitus - buzzing, hissing,
ringing or other persistent noise
in the ears

PHENERGAN® 5
 • 25mg tablets - 25mg of
promethazine
hydrochloride per tablet Who distributes Phenergan

Other ingredients • lactose monohydrate Phenergan Tablets and Elixir are supplied in Australia by:

(inactive • maize starch sanofi-aventis australia pty ltd

ingredients) • povidone 12-24 Talavera Road
• magnesium stearate
Macquarie Park NSW 2113
• hypromellose
• macrogol 200 Australia
• Opaspray Blue M-1-4210A Toll-free: 1800 818 806
Potential allergens Contains sugars as lactose Email: [email protected]

Do not take this medicine if you are allergic to any of

these ingredients.
What Phenergan Elixir contains Phenergan Tablets and Elixir are supplied in New Zealand
by:
Active ingredient • 1mg/mL of promethazine Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
(main ingredient) hydrochloride
58 Richard Pearse Drive
Other ingredients • maltitol solution Airport Oaks
(inactive • acesulfame potassium
Auckland
ingredients) • sodium benzoate
• sodium citrate dihydrate New Zealand
• citric acid monohydrate Freecall: 0800 283 684
• sodium sulfite Email: [email protected]
• sodium metabisulfite
• ascorbic acid This leaflet was prepared in April 2024.
• caramel phenergan-ccdsv6-cmi15-22apr24
• orange juice flavour
510844E
Do not take this medicine if you are allergic to any of
these ingredients.
What Phenergan looks like
Phenergan Tablets are available in two strengths:
• 10mg – circular, film-coated biconvex tablets with
bevelled edges, pale blue in colour, one face
impressed 'PN’ above ‘10', the reverse face plain.
• 25mg - circular, film-coated biconvex tablets with
bevelled edges, pale blue in colour, one face
impressed 'PN' above '25', the reverse face plain.
Both tablet strengths are available in blister packs of 50
tablets and 25 tablets (New Zealand only).
Phenergan Elixir is a clear, bright, golden, syrupy liquid.
Phenergan elixir is available in a 100mL bottle.

Australian Registration Numbers

Phenergan 10mg tablets
AUST R 80159
Phenergan 25mg tablets
AUST R 80160
Phenergan Elixir 1mg/mL
AUST R 61576

PHENERGAN® 6