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NYTOL ONE-A-NIGHT

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE

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2. What you need to know before
you take Galpharm One a Night
Sleep Aid 50mg Tablets

Package leaflet: Information for the user

Galpharm One a Night
Sleep Aid 50mg Tablets

Pregnancy, breast feeding
and fertility

Talk to your doctor before taking
this medicine if you are pregnant,
trying to become pregnant, or
breast feeding.

Do not take this medicine:

Diphenhydramine Hydrochloride

• if you have ever had an allergic
reaction to diphenhydramine
hydrochloride or any of the other
ingredients (listed in Section 6)
• if you have an obstruction in your
stomach or gut (for example, because
of an ulcer).

Read all of this leaflet 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.

Driving and using machines

Do not drive or operate machinery.
This medicine is intended to
produce sleepiness or drowsiness
soon after the dose is taken.

Galpharm One a Night Sleep Aid
50mg Tablets contains lactose

If you have been told by your doctor that
you have an intolerance to some sugars,
ask your doctor before taking this
medicine.

Warnings and precautions
Talk to your doctor or pharmacist before
taking this medicine:
• if you have asthma, bronchitis or
Chronic Obstructive Pulmonary Disease
(COPD)
• if you have narrow-angle glaucoma (a
form of raised pressure in the eye)
• if you have an enlarged prostate or
urinary retention
• if you have moderate to severe liver or
kidney disease
• if you have myasthenia gravis,
epilepsy or seizure disorders
• If your sleeping difficulties persist, talk
to your doctor or pharmacist
• This medicine may get less effective if
you use it continuously.

In this leaflet:

1. What Galpharm One a Night Sleep Aid
50mg Tablets are and what they are
used for
2. What you need to know before you
take Galpharm One a Night Sleep Aid
50mg Tablets
3. How to take Galpharm One a Night
Sleep Aid 50mg Tablets
4. Possible side effects
5. How to store Galpharm One a Night
Sleep Aid 50mg Tablets
6. Contents of the pack and other
information

3. How to take Galpharm One a
Night Sleep Aid 50mg Tablets
Always take 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 recommended dose for adults
and children aged 16 years and
over: Swallow 1 tablet with water
20 minutes before you go to bed.
Not to be used by children under
16 years. Not to be used by the
elderly with confusion.
• Do not take more than the
recommended dose.
• Do not take extra tablets if you
wake up in the night.
• Do not take for more than 2
weeks without consulting a
doctor.

Other medicines and
Galpharm One a Night
Sleep Aid 50mg Tablets
Talk to your doctor or pharmacist before
taking these tablets if you are taking any
prescribed medicines; particularly tricyclic
antidepressants, monoamine
oxidase inhibitors (MAOIs prescribed for
depression) within the last two weeks,
atropine (used to dilate pupils of the
eyes) or medicines which make you
drowsy. Avoid the use of other
antihistamines including those used on
your skin and in cold and cough
medicines, while taking this medicine.

1. What Galpharm One a Night
Sleep Aid 50mg Tablets are
and what they are used for
Galpharm One a Night Sleep Aid 50mg
Tablets is used to relieve temporary
sleeping difficulties.
The active ingredient is diphenhydramine
hydrochloride, an antihistamine that
causes sleepiness or drowsiness. Temporary
difficulties in getting a good night’s sleep
can be caused by various problems such as
stress, jet lag or personal problems such as
bereavement. In sleep problems of this
type, this medicine has been shown to
help sufferers to fall asleep faster, have a
longer and deeper sleep, and to wake up
feeling rested in the morning.

If you take more Galpharm One a
Night Sleep Aid 50mg Tablets than
you should

Contact your doctor or casualty department.

If you forget to take Galpharm One
a Night Sleep Aid 50mg Tablets

Do not take a double dose to make up for
a forgotten dose. Take the next dose at
the usual time as described in this leaflet.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

Galpharm One a Night Sleep Aid
50mg Tablets with food, drink and
alcohol
Do not drink alcohol while using this
medicine.

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

Do not take this medicine for more than
2 weeks without consulting your doctor.

Common (may affect up to 1 in 10 people)
• The most common side effects are:
tiredness, drowsiness, reduced attention,
unsteadiness, dizziness or a dry mouth.

0

10

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3

This leaflet was last revised in
December 2017.

139.7 x 228.6mm

Supplier:

Wrafton Laboratories

Printer:

Essentra - Newmarket

Pharmacode:

4015

Print Process: Litho

N/A

Substrate:

EAN Code:

MAIN BODY TEXT

Component:

Leaflet

Customer Code:

N/A

-

Pack Size:

20

Supplier Code:

N/A

Licence No.:

PL 02855/0070

Export Code:

N/A

COLOURS

-

Manufacturer
Wrafton Laboratories Ltd, Wrafton,
Braunton, North Devon, EX33 2DL, U.K.

L164

H3L60H9JB1

Operator:

Marketing authorisation holder is Omega
Pharma Ltd., 32 Vauxhall Bridge Road,
London, SW1V 2SA, United Kingdom and
all enquiries should be sent to this address.

Profile No.:

11170

DH

What Galpharm One a Night Sleep Aid
50mg Tablets look like and contents of
the pack
Packs of Galpharm One a Night Sleep Aid
50mg Tablets contain 4, 8, 10, 16 or 20
tablets. Not all pack sizes may be marketed.

Project Heron

Component No.:

Operator:

What Galpharm One a Night Sleep Aid
50mg Tablets contain
- The active substance: Each tablet
contains Diphenhydramine
Hydrochloride 50 mg.
- The other ingredients are: Anhydrous
lactose, microcrystalline cellulose, maize
starch, stearic acid and silicon dioxide.

Galpharm One a Night Sleep Aid 50mg Tablets
HUB No.:

-

6. Contents of the pack and
other information

JOB SPECIFICATION

UK

Date:

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date (EXP) stated on the pack.
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.
Store in a dry place.

Dimensions:

Galpharm

Date:

5. How to store Galpharm One a
Night Sleep Aid 50mg Tablets

Project Name:

Market:

13/12/17

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.

Product Name:

Customer:
PREFLIGHT
VERSION:

Reporting of side effects:

100

JOB INFORMATION

ARTWORK
VERSION:

Not known (frequency cannot be
estimated from the available data)
• Allergic reactions (such as rash,
shortness of breath and swelling),
blurred vision, palpitations (feeling
your heart beat) or irregular heartbeat.
• Muscle twitching, convulsions,
headache or pins and needles.
• Also nausea (feeling sick), vomiting
(being sick), thicker bronchial mucus
and difficulty passing urine.

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KEYLINE

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SUBSTRATE

H3L60H9JB1

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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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