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Patient Information Leaflet    /*    N

Aspar Sleep Aid 25mg Diphenhydramine Hydrochloride

Aspar Pharmaceuticals

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 Aspar Sleep Aid 25mg Tablets and what do they do?

2.    What should I know before using Aspar Sleep Aid 25mg Tablets?

3.    How do I use Aspar Sleep Aid 25mg Tablets?

4.    Do Aspar Sleep Aid 25mg Tablets have any side effects?

5.    How do I store Aspar Sleep Aid 25mg Tablets?

6.    Further information.

1.    What are Aspar Sleep Aid 25mg Tablets and what do they do?

Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg Tablets?

When shouldn't I use Aspar Sleep Aid 25mg Tablets?

Do not take Aspar Sleep Aid 25mg Tablets if you are allergic to any of the ingredients listed in section 6 of this leaflet.

Do not take Aspar Sleep Aid 25mg Tablets if you suffer from porphyria.

What else should I be aware of before using Aspar Sleep Aid 25mg 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.

Is it safe to drive or operate machinery after using Aspar Sleep Aid 25mg Tablets?

Aspar Sleep Aid 25mg Tablets may cause drowsiness. Do not drive or operate machinery.

Are there any foods or medicines that interact with Aspar Sleep Aid 25mg Tablets?

While taking Aspar Sleep Aid 25mg Tablets:

® Avoid alcoholic drink.

Consult your doctor or pharmacist before taking Aspar Sleep Aid 25mg 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).

3. How do I use Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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.

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 the package leaflet. You can 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 do I store Aspar Sleep Aid 25mg 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.

6.    Further information.

What is in Aspar Sleep Aid 25mg Tablets?

Each tablet contains 25mg of the active ingredient diphenhydramine hydrochloride. In addition Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg Tablets supplied?

Aspar Sleep Aid 25mg Tablets are supplied in packs of 20 tablets.

Who is responsible for Aspar Sleep Aid 25mg 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 November 2014 H0044-3C

Patient Information Leaflet    /*    N

Aspar Sleep Aid 25mg Diphenhydramine Hydrochloride

Aspar Pharmaceuticals

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 Aspar Sleep Aid 25mg Tablets and what do they do?

2.    What should I know before using Aspar Sleep Aid 25mg Tablets?

3.    How do I use Aspar Sleep Aid 25mg Tablets?

4.    Do Aspar Sleep Aid 25mg Tablets have any side effects?

5.    How do I store Aspar Sleep Aid 25mg Tablets?

6.    Further information.

1.    What are Aspar Sleep Aid 25mg Tablets and what do they do?

Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg Tablets?

When shouldn't I use Aspar Sleep Aid 25mg Tablets?

Do not take Aspar Sleep Aid 25mg Tablets if you are allergic to any of the ingredients listed in section 6 of this leaflet.

Do not take Aspar Sleep Aid 25mg Tablets if you suffer from porphyria.

What else should I be aware of before using Aspar Sleep Aid 25mg 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.

Is it safe to drive or operate machinery after using Aspar Sleep Aid 25mg Tablets?

Aspar Sleep Aid 25mg Tablets may cause drowsiness. Do not drive or operate machinery.

Are there any foods or medicines that interact with Aspar Sleep Aid 25mg Tablets?

While taking Aspar Sleep Aid 25mg Tablets:

® Avoid alcoholic drink.

Consult your doctor or pharmacist before taking Aspar Sleep Aid 25mg 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).

3. How do I use Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg 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.

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 the package leaflet. You can 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 do I store Aspar Sleep Aid 25mg 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.

6.    Further information.

What is in Aspar Sleep Aid 25mg Tablets?

Each tablet contains 25mg of the active ingredient diphenhydramine hydrochloride. In addition Aspar Sleep Aid 25mg 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 Aspar Sleep Aid 25mg Tablets supplied?

Aspar Sleep Aid 25mg Tablets are supplied in packs of 20 tablets.

Who is responsible for Aspar Sleep Aid 25mg Tablets?

The marketing authorisation holder is:

Norma Chemicals Ltd.,51-53 Stert Street, Abingdon,

Oxfordshire, England OX14 3JF The manufacturer is:

Surepharm Services Limited, Bretby Business Park, Ashby Road East Burton upon Trent, Staffordshire, England DE15 0YZ

This Leaflet was revised November 2014

H0044-3S

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