2. Check before you take Nytol Simply Sleep

□ Do not take Nytol Simply Sleep:

Simply Sleep

Hot Chocolate

50mg Powder for Oral Solution Diphenhydramine

Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Nytol Simply Sleep 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.

In this leaflet:

1.    What Nytol Simply Sleep does

2.    Check before you take Nytol Simply Sleep

3.    How to take Nytol Simply Sleep

4.    Possible side effects

5.    How to store Nytol Simply Sleep

6.    Further information

1. What Nytol Simply Sleep does

Nytol Simply Sleep Hot Chocolate Powder 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, diphenhydramine 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.

•    if you have ever had an allergic reaction to diphenhydramine or any of the other ingredients (listed in Section 6)

•    if you have an obstruction in your stomach or gut (for example, because of an ulcer)

H Take special care with Nytol Simply Sleep

Talk to your doctor:

•    if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD).

•    if you have narrow angle glaucoma (a form of raised pressure in the eye)

•    if you have an enlarged prostate or urinary retention

•    if you have moderate to severe liver or kidney disease

•    if you have myasthenia gravis, epilepsy or seizure disorders

•    Do not drive or operate machinery. Nytol Simply Sleep is intended to produce sleepiness or drowsiness soon after the dose is taken.

•    Do not drink alcohol while using Nytol Simply Sleep.

•    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 temporary sleeping difficulties for more than two weeks, talk to your doctor or pharmacist.

•    Nytol Simply Sleep may get less effective if you use it continuously.

[I If you are taking other medicines

Tell your doctor or pharmacist before taking Nytol Simply Sleep if you are taking or have recently taken:

•    Monoamine Oxidase Inhibitors (medicines used to treat depression) within the last two weeks

•    Tricyclic antidepressants

•    Atropine (used to dilate pupils of the eyes)

•    Any medicines which make you drowsy.

Avoid the use of other antihistamines, including those used on your skin and in cough and cold medicines, while taking this medicine.

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□ Pregnancy and breast feeding

Talk to your doctor before taking Nytol Simply Sleep if you are pregnant, trying to become pregnant or breast feeding.

3.    How to take Nytol Simply Sleep

Adults and children aged 16 years and over:

Take one sachet 20 minutes before bedtime. Empty the contents of one sachet into a mug. Half fill with very hot water and stir well. Add cold water as necessary.

Not to be used by children under 16 years.

Not to be used in the elderly with confusion.

•    Do not take more than one sachet per night.

•    Do not take Nytol Simply Sleep for more than two weeks

If your sleeping difficulties carry on for more than two weeks, see your doctor.

If you take too many sachets

Contact your doctor or casualty department.

4.    Possible side effects

Like all medicines, Nytol Simply Sleep can have side effects, but not everybody gets them.

The elderly are more likely to experience side effects with this medicine.

Stop taking the sachets and tell your doctor IMMEDIATELY if you experience any of the following rare side effects:

•    Difficulty swallowing or breathing

•    Swelling of the face, lips, tongue or throat

•    Skin rash

The above symptoms may mean you are having a severe allergic reaction to this medicine.

Other side effects may include:

Common:

•    Tiredness, drowsiness, reduced attention, unsteadiness, dizziness

•    Dry mouth

Frequency unknown:

•    Headache

•    Blurred vision

•    Palpitations (feeling your heart beat); fast or irregular heart beat

•    Confusion, nervousness

•    Stomach problems and discomfort, nausea (feeling sick), vomiting (being sick)

•    Muscle twitching, pins and needles

•    Difficulty passing urine

•    Thicker bronchial mucus

Rarely, the following side effects can happen:

You may become more prone to bleeding, bruising, fever and infections due to a decrease in the number of platelets in the blood.

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

5.    How to store Nytol Simply Sleep

Keep out of the sight and reach of children.

Do not use this medicine after the 'EXP' date shown on the pack.

Store in the original packaging below 30°C.

6.    Further information

Active ingredient Each sachet contains Diphenhydramine Hydrochloride 50 mg.

Other ingredients Fat reduced cocoa powder, skimmed milk powder, milk chocolate powder (sucrose, cocoa mass, whole milk powder, cocoa butter, skimmed milk powder), maltodextrin, chocolate flavour, colloidal anhydrous silica, golden syrup flavour, sucralose, carrageenan (E 407).

Packs of Nytol Simply Sleep contain 1, 2, 5, 6, 7, 10 or 14 sachets. Not all pack sizes may be marketed.

The marketing authorisation holder is Omega Pharma Ltd., 32 Vauxhall Bridge Road, London, SW1V 2SA, United Kingdom and all enquiries should be sent to this address.

The manufacturer is Famar Orleans, 5 avenue de Concyr, 45071 ORLEANS CEDEX 2, France.

This leaflet was last revised in August 2013.    49069/GB