NYTOL ORIGINAL 25MG TABLETS

Active substance: DIPHENHYDRAMINE HYDROCHLORIDE

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Nytol Original 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 Original 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.

1. What Nytol Original does

1.What Nytol Original does
2.Check before you take Nytol Original
3.How to take Nytol Original
.Possible side effects
5.How to store Nytol Original
6.Further information

In this leaflet:

Please read right through this leaflet before you
tart using this medicine. This medicine is available
ithout prescription, but you still need to use Nytol
Original carefully to get the best results from it.
• Keep this leaflet you may need to read it again.
• If you have any questions, or if there is anything
you do not understand, ask your pharmacist.
• If your sleep difficulties carry on for more than
two weeks, see your doctor.

Diphenhydramine Hydrochloride

5. How to store Nytol Original

Talk to your doctor or pharmacist before taking these
tablets if you are taking any prescribed medicines;
particularly monoamine oxidase inhibitors
(MAOIs prescribed for depression), medicines for
myasthenia gravis, seizure disorders (e.g. epilepsy) or
medicines which make you drowsy.

If you are taking other medicines

• Do not drive or operate machinery. Nytol Original
is intended to produce sleepiness or drowsiness
soon after the dose is taken.
• Do not drink alcohol while using Nytol Original.
• If you have been told by your doctor that you
have an intolerance to some sugars, ask your
doctor before taking this medicine.
• If you have myasthenia gravis or seizure
disorders (e.g. epilepsy).
• If you have temporary sleeping difficulties for
more than two weeks, talk to your doctor or
pharmacist.
• Nytol Original may get less effective if you use it
continuously.

Take special care with Nytol Original

• if you have ever had an allergic reaction to
diphenhydramine hydrochloride or any of the
other ingredients (listed in Section 6)
• if you have asthma
• if you have narrow angle glaucoma
(a form of raised pressure in the eye)
• if you have an obstruction in your stomach or gut
(for example, because of an ulcer)
• if you have an enlarged prostate, or bladder neck
obstruction
• if you are under 16 years.

Do not take Nytol Original:

2. Check before you take Nytol Original

Keep out of the reach and sight of children.
Do not use this medicine after the ‘Use by’ date
shown on the pack.
Store in a dry place.

Pregnancy and breast feeding

Do not take Nytol Original if you are pregnant,
rying to become pregnant or breast feeding.

6. Further information

Active ingredient Each tablet contains
Diphenhydramine Hydrochloride 25 mg.
Other ingredients Anhydrous lactose,
microcrystalline cellulose, maize starch, stearic acid
and silicon dioxide.

Packs of Nytol Original contain 4 or 16 caplets
(capsule shaped tablets). Not all pack sizes may be
marketed.

The marketing authorisation holder is
GlaxoSmithKline Consumer Healthcare, Brentford,
TW8 9GS, U.K. and all enquiries should be sent to
this address.

The manufacturer is Wrafton Laboratories Ltd,
Wrafton, Braunton, North Devon, EX33 2DL, U.K.

This leaflet was last revised in March 2009.

Nytol is a registered trade mark of the
GlaxoSmithKline group of companies.

X000000/00

3. How to take Nytol Original

Swallow 2 tablets with water 20 minutes
before you go to bed.

• Do not take more than the recommended
dose.
• Do not take extra tablets if you wake up in
the night.

If you take too many tablets

Contact your doctor or casualty department.

Do not take Nytol Original for more than two weeks
If your sleeping difficulties carry on for more than
wo weeks, see your doctor.

. Possible side effects

Like all medicines, Nytol Original can have side effects,
but not everybody gets them:

Common side effects
fter taking Nytol Original you may experience
dizziness, drowsiness, grogginess. These effects will
ear off within about 8 hours of taking Nytol Original.

Other side effects
Nervousness, nausea (feeling sick) or a dry mouth
have been reported with diphenhydramine
hydrochloride.

Rare side effects
ntihistamines have been reported rarely to cause
abnormal bleeding or bruising (due to a decrease in
he number of platelets in the blood).

If you do get any side effects, even those not
mentioned in this leaflet tell our doctor or harmacist.

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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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