PHENERGAN 25MG TABLETS

Active substance: PROMETHAZINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Phenergan™ Nightime
promethazine hydrochloride
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take
Phenergan Nightime carefully to get the best results from it.
• Keep this leaflet. You may need to read it again
• Ask your pharmacist if you need more information or advice
• You must contact a doctor if your symptoms worsen or do not improve after 7 days
• 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
In this leaflet:
1.
What Phenergan Nightime is and what it is used for
2.
Before you take Phenergan Nightime
3.
How to take Phenergan Nightime
4.
Possible side effects
5.
How to store Phenergan Nightime
6.
Further Information

1.

What Phenergan Nightime is and what it is used for

Phenergan Nightime contains a medicine called promethazine hydrochloride. This
belongs to a group of medicines called phenothiazines. It works by blocking a natural
substance (histamine) that your body makes during an allergic reaction. It also works
directly on the brain to help you feel more relaxed.
What Phenergan Nightime is used for
Phenergan Nightime can be given to you either by a doctor or directly by a pharmacist.
Phenergan Nightime may be provided directly by a pharmacist for use in the following
situations:
• To treat adults with difficulty sleeping (insomnia)
Phenergan Nightime Tablets may also be given to you by a doctor. This can be for use in
the above situation or for use in the following additional situations:


If you are having difficulty sleeping



2.

As a sedative for adults. This is a medicine given to reduce awareness or make you
feel relaxed and at ease

Before you take Phenergan Nightime

Do not take this medicine and tell your doctor if:
 The person taking the medicine is under 2 years of age
 You are allergic (hypersensitive) to promethazine hydrochloride or any of the other
ingredients of Phenergan Nightime (listed in Section 6 below)
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 Phenergan Nightime 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 “Taking other medicines” section below)
 The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or
headache
Do not take this medicine if any of the above applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Phenergan Nightime.
Take special care with Phenergan Nightime
Check with your doctor or pharmacist before taking your medicine 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 Phenergan Nightime.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you can buy without prescription, including herbal
medicines. This is because Phenergan Nightime can affect the way some medicines work.
Also some medicines can affect the way Phenergan Nightime 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
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). Phenergan
Nightime may hide the side effects of these medicines

Taking Phenergan Nightime with food and drink
Do not drink alcohol while you are taking Phenergan Nightime. This is because it can
affect the way the medicine works.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become
pregnant, or think you may be pregnant. Phenergan Nightime should not be taken 2
weeks before birth.
You should not take Phenergan Nightime 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.
Important information about some of the ingredients of Phenergan Nightime
This medicine contains:
• Lactose. This is a type of sugar. If you have been told by your doctor that you cannot
tolerate or digest some sugars (have an intolerance to some sugars), talk to your
doctor before taking this medicine.

3.

How to take Phenergan Nightime

Taking this medicine
• Take this medicine by mouth
• Do not take for longer than 7 days. If your symptoms worsen or do not improve after
7 days talk to your doctor or pharmacist
• If you feel the effect of your medicine is too weak or too strong, do not change the
dose yourself, but ask your doctor
How much to take
The usual dose is:
As a sedative
Adults (including the elderly):



One or two tablets (25mg-50mg) taken at night

If you take more Phenergan Tablets than you should
If you or your child takes more Phenergan 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 have 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 heart beat and
breathing difficulties
If you forget to take Phenergan Nightime
Do not take a double dose to make up for a forgotten dose
• miss that dose and take the next evening’s dose as usual
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
Tests
Taking Phenergan Nightime may affect the results of certain tests. These include some
pregnancy tests and skin tests. Phenergan Nightime should not be taken at least 3 days
before the start of a skin test.

4.

Possible side effects

Like all medicines, Phenergan Nightime can cause side effects, although not everybody
gets them.
Stop taking Phenergan Nightime 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
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.








Dry mouth, blurred vision or you cannot pass water (urine)
Feeling drowsy or sleepy, tiredness, disorientation, having nightmares, headaches,
feeling restless
Loss of appetite (anorexia), indigestion
Feeling dizzy, lightheaded, faint (hypotension)
Feeling confused, especially in elderly people
Being more sensitive to the sun than usual. If this happens keep out of direct sunlight
and do not use sun lamps

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 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 Phenergan Nightime
Keep out of the reach and sight of children
Do not take Phenergan Tablets after the expiry date which is stated on the carton and
blister pack after EXP. The expiry date refers to the last day of that month
Store below 30°C
Store in the original carton in order to protect from light

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 Phenergan Nightime contains.
• Each tablet contains 25mg of the active substance, promethazine hydrochloride The
other ingredients are lactose, maize starch, povidone, magnesium stearate,
polyethylene glycol, Opaspray (contains titanium dioxide-E171, hypromellose-E464
and indigo carmine aluminium lake blue-E132) and hypromellose
What Phenergan Nightime looks like and contents of the pack
A pale blue film coated tablet marked PN 25 on one side. The tablets are available in
blister packs of 14.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS

UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTHCARE SERVICES MADRID, S.A.U.
Avda. Leganes, 62,
Alcorcon 28923 (Madrid) Spain
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in: 11/2013
 Sanofi, 2003 – 2013

SIX HELPFUL STEPS FOR A GOOD NIGHT’S SLEEP
• Go to bed when you feel tired and avoid sleep during the day.
• Get up at the same time every morning.
• Make time for some gentle exercise during the day, preferably in the
afternoon or early evening but not just before going to bed.
• Sleep in a dark, well ventilated room on a comfortable bed.
• Every night, before bedtime, do something to help you relax and take
your mind off the stresses of the day.
• A small warm milky drink may help you sleep, but avoid alcohol, tea,
coffee and cocoa since these may keep you awake, as can late night
eating.

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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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