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Night Time Sleep Aid Tablets
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 Night Time Sleep Aid Tablets and what do they do?
2. What should I know before using Night Time Sleep Aid Tablets?
3. How do I use Night Time Sleep Aid Tablets?
4. Do Night Time Sleep Aid Tablets have any side effects?
5. How do I store Night Time Sleep Aid Tablets?
6. Further information.
1. What are Night Time Sleep Aid Tablets and what do they do?
Night Time Sleep Aid 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 diphenhydramine hydrochloride can help alleviate temporary sleeplessness.
2. What should I know before using Night Time Sleep Aid Tablets?
When shouldn't I use Night Time Sleep Aid Tablets?
Do not take Night Time Sleep Aid Tablets if you are allergic to any of the ingredients listed in section 6 of this leaflet.
Do not take Night Time Sleep Aid Tablets if you suffer from porphyria.
What else should I be aware of before using Night Time Sleep Aid 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.
Can I use Night Time Sleep Aid Tablets if I am pregnant or breastfeeding?
Do not take Night Time Sleep Aid Tablets if you are pregnant or breast feeding. Is it safe to drive or operate machinery after using Night Time Sleep Aid Tablets?
Night Time Sleep Aid Tablets may cause drowsiness. Do not drive or operate machinery.
Are there any foods or medicines that interact with Night Time Sleep Aid Tablets?
While taking Night Time Sleep Aid Tablets:
® Avoid alcoholic drink.
Consult your doctor or pharmacist before taking Night Time Sleep Aid 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). Important Information about some of the ingredients of Night Time Sleep Aid Tablets
In addition to the active ingredient, some of the other ingredients in the tablets may affect some individuals:
® Lactose & Sucrose; If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
If you experience an allergic reaction then discontinue use of the medicine and consult your doctor.
3. How do I use Night Time Sleep Aid Tablets?
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 Night Time Sleep Aid 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.
4. Do Night Time Sleep Aid 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 Night Time Sleep Aid 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.
You can help make sure medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday - Friday) or fill in a paper form available from your local pharmacy.
5. How do I store Night Time Sleep Aid Tablets?
Do not use after the expiry date marked on the pack. Keep all medicines out of the sight and reach of children, preferably in a locked cupboard. Store below 25°C.
6. Further information.
What is in Night Time Sleep Aid Tablets?
Each tablet contains 25mg of the active ingredient diphenhydramine hydrochloride. In addition Night Time Sleep Aid Tablets also contain the following non-active 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 Night Time Sleep Aid Tablets supplied?
Night Time Sleep Aid Tablets are supplied in packs of 20 tablets.
Who is responsible for Night Time Sleep Aid 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 August 2013 H0123-2
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