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NYTOL ONE-A-NIGHT

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / DIPHENHYDRAMINE HYDROCHLORIDE

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Package leaflet: Information for the user

2. What you need to know before you take
Nytol One-A-Night

Pregnancy, breast feeding and fertility
Talk to your doctor before taking Nytol
One-A-Night if you are pregnant, trying to
become pregnant, or breast feeding.

Do not take Nytol One-A-Night:

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.

PharmaCode 578 -->

In this leaflet:

1.What Nytol One-A-Night is and what it is used for
2.What you need to know before you take
Nytol One-A-Night
3.How to take Nytol One-A-Night
4.Possible side effects
5.How to store Nytol One-A-Night
6.Contents of the pack and other information

1. What Nytol One-A-Night is and what it is
used for
Nytol One-A-Night 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, Nytol
One-A-Night 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.
Do not take Nytol One-A-Night for more than 2 weeks
without consulting your doctor.

• 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).

Nytol One-A-Night 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

3. How to take Nytol One-A-Night

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.

Talk to your doctor or pharmacist before taking
Nytol One-A-Night:
• 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.
• Nytol One-A-Night may get less effective if you use it
continuously.

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.

If you take more Nytol One-A-Night than
you should

Other medicines and Nytol One-A-Night

PharmaCode 578 -->

mg Tablets

Diphenhydramine Hydrochloride

Driving and using machines

Do not drive or operate machinery.
Nytol One-A-Night is intended to produce
sleepiness or drowsiness soon after the dose is
taken.

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.

Contact your doctor or casualty department.

If you forget to take Nytol One-A-Night

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.

4. Possible side effects
Like all medicines, Nytol One-A-Night can have side
effects, although not everybody gets them.
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.

Nytol One-A-Night with food, drink and alcohol
Do not drink alcohol while using Nytol One-A-Night.

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.

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 Nytol One-A-Night
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.

6. Contents of the pack and other
information
What Nytol One-A-Night contains
- 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.
What Nytol One-A-Night looks like and contents of
the pack
Packs of Nytol One-A-Night contain 4, 8, 10, 16 or 20
tablets. Not all pack sizes may be marketed.
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.
Manufacturer
Wrafton Laboratories Ltd, Wrafton, Braunton, North
Devon, EX33 2DL, U.K.
This leaflet was last revised in February 2017.

LF03489C
H3L60FCJB1

File title:

9914_ LF03489C_H3L60FCJB1_Nytol OAN 50mg 20s PIL_UK_v7

Item No.:

H3L60FCJB1

OPI No.:

LF03489C

Last edit:

22nd May 2017

Brand:

Nytol

Variant:

One-A-Night 50mg

Component: Leaflet 20s
Market/s:

Regulatory Approval:

UK

Dimensions: 140 x 150mm (F166v2)
Printer:

Nampack Liverpool

Substrate:

Paper

EAN Code:

N/A

Sign:...............................................................................

Date:...............................

Name (please print):....................................................................................................

PharmaCode: 578
Replacement number:
Manufacturing Site: Perrigo Wrafton

Contact email:................................................................................................................

No. of colours:1 (one)
Process Black

Marketing Approval:
Sign:...............................................................................
81 Rivington Street
Shoreditch
London EC2A 3AY
UK
awk contact:
Phil Hinckley
phil@oneagency.co
+44 (0)7710 521027
+44 (0)203 008 6041

Name (please print):....................................................................................................

Contact email:................................................................................................................

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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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