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Patient Information Leaflet Ambe Limited
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.
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.
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.
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 Meniere's disease).
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.
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.
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.
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.
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.
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.
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