NUMARK NIGHT TIME SLEEP AID TABLETS

Active substance: DIPHENHYDRAMINE HYDROCHLORIDE

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Patient Information Leaflet

NightAid Tablets

Ambe Limited

Diphenhydramine Hydrochloride

Please read this leaflet carefully before using this medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
This leaflet contains the following information.
1. What are NightAid Tablets and what do they do?
2. What should I know before using NightAid Tablets?
3. How do I use NightAid Tablets?
4. Do NightAid Tablets have any side effects?
5. How do I store NightAid Tablets?
6. Further information.

1. What are NightAid Tablets and what do they do?
NightAid Tablets contain the following active ingredient: Diphenhydramine
hydrochloride. Diphenhydramine hydrochloride is an antihistamine which
works by blocking the body’s response to histamine, which is an agent
responsible for causing allergic responses such as hay fever, stings and rashes.
Histamine is also involved in the brain’s waking system so Diphenhydarmine
hydrochloride can help alleviate temporary sleeplessness.
2. What should I know before using NightAid Tablets?
When shouldn’t I use NightAid Tablets?
Do not take NightAid Tablets if you are allergic to any of the ingredients listed
in section 6 of this leaflet.
Do not take NightAid Tablets if you suffer from porphyria.
What else should I be aware of before using NightAid Tablets?
You should inform your doctor or pharmacist before taking this medicine if any
of the following apply:
£ You are an asthmatic.
£ You suffer from prostate problems, epilepsy, glaucoma or liver disease.
£ You suffer from urinary retention.
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Can I use NightAid Tablets if I am pregnant or breastfeeding?
Do not take NightAid Tablets if you are pregnant or breast feeding.
Is it safe to drive or operate machinery after using NightAid Tablets?
NightAid Tablets may cause drowsiness. Do not drive or operate machinery.
Are there any foods or medicines that interact with NightAid Tablets?
While taking NightAid Tablets:
£ Avoid alcoholic drink.
Consult your doctor or pharmacist before taking NightAid Tablets if you are
taking any of the following:
£ Any other antihistamines (e.g. allergy treatments and cold remedies).
£ Any other products to help you sleep.
£ Medicines for anxiety.
£ Betahistine (used to treat balance disorders such as Ménière’s disease).
3. How do I use NightAid Tablets?
For the treament of hay fever, stings, rashes and other minor allergies:
Adults and children over 12 years: 1 or 2 tablets three or four times a day or as
prescribed by a doctor.
Not recommended for children under 12 years of age.
DO NOT EXCEED THE STATED DOSE.
For use as a temporary sleep aid:
Adults: 1 or 2 tablets to be taken at bedtime or after retiring when sleep is not
readily achieved.
Do not take a repeat dose in the same night.
Not recommended as a sleep aid in children under 16 years of age.
DO NOT EXCEED THE STATED DOSE.
What should I do if I accidentally swallow too many NightAid Tablets?
Seek medical attention as soon as possible. When seeking medical advice
you should, if possible, take the medicine and this leaflet with you provided it
doesn’t cause a delay.
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4. Do NightAid Tablets have any side effects?
All medicines can cause side effects.
Very rarely diphenydramine hydrochloride may cause bruising and/or
bleeding. If you suffer from spontaneous bruising or bleeding discontinue
treatment and seek immediate advice from your doctor.
The following side effects have also been reported to the ingredients of
NightAid Tablets:
£ Dizziness, drowsiness, poor co-ordination.
£ Confusion, depression, numbness, tremors.
£ Excitability (usually restricted to children).
£ Dryness of the mouth, headache, blurred vision, difficulty in urinating.
£ Nausea, vomiting, diarrhoea.
£ Heart palpitations.
£ Allergic reactions such as skin rashes.
£ Photosensitivity (sun allergy).
£ Convulsions, sweating, muscle pains.
£ Low blood pressure.
£ Hair loss.
£ Jaundice.
If you experience any severe side effect, or have a side effect which isn’t listed,
then discontinue use and seek the advice of your doctor or pharmacist.
5. How do I store NightAid Tablets?
Do not use after the expiry date marked on the pack. Keep all medicines out of
the reach and sight of children, preferably in a locked cupboard. Store below
25°C.

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6. Further information.
What is in NightAid Tablets?
Each tablet contains 25mg of the active ingredient diphenhydramine
hydrochloride. In addition NightAid Tablets also contain the following nonactive ingredients: lactose, corn starch, polyvinylpyrolidone, magnesium
stearate, polyvinylcetate phthalate, ethyl acetate, stearic acid, sucrose, calcium
carbonate, talc, acacia, carnauba wax, beeswax, silicone fluid and colourings
E171 (titanium dioxide) and E127 (erythrosine).
How are NightAid Tablets supplied?
NightAid Tablets are supplied in packs of 20 tablets.
Who is responsible for NightAid Tablets?
The marketing authorisation holder is:
Norma Chemicals Ltd.,51-53 Stert Street, Abingdon, Oxfordshire, England
OX14 3JF
The manufacturer is:
Custom Pharmaceuticals Ltd., Conway Street, Hove, East Sussex BN3 3LW
This Leaflet was revised February 2011

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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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