Nytol Simply Sleep Hot Chocolate 50mg Powder For Oral Solution
Pharma code 103
Simply Sleep
Hot Chocolate
50mg Powder for Oral Solution Diphenhydramine
Read all of this leaflet before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. » 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.
i» If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects listed on this leaflet. See section 4.
i» You must talk to a doctor if you do not feel better or if you feel worse.
In this leaflet:
1. What Nytol Simply Sleep is and what it is used for
|2. What you need to know 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. Contents of the pack and other 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)
Q Warnings and precautions
Talk to your doctor or pharmacist before taking Nytol Simply Sleep:
• 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.
• Do not take Nytol simply sleep for more than 2 weeks without consulting a doctor.
• 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.
Nytol Simply Sleep contains Sucrose
• If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor before taking this medicine.
Other medicines and Nytol Simply Sleep
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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Pharma code 103
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□ Pregnancy, breast feeding and fertility
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
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
H* 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:
Allergic reactions such as;
- Skin rash
- Difficulty swallowing or breathing
- Swelling of the face, lips, tongue or throat
mean you are having a severe allergic reaction to this medicine.
Common (may affect up to 1 in 10 people):
• Tiredness, drowsiness, reduced attention, unsteadiness, dizziness
• Dry mouth
Rare (may affect up to 1 in 1,000 people): Antihistamines have been reported rarely to cause abnormal bleeding or bruising (due to a decrease in the number of platelets in the blood).
Not known (frequency cannot be estimated from the available data):
• Nervousness, confusion
• Blurred vision
• Palpitations (feeling your heart beat) fast or irregular heartbeat.
• Muscle twitching, convulsions, involuntary movements, headache or pins and needles.
• Stomach problems, nausea (feeling sick), vomiting (being sick)
• Thicker bronchial mucus
• Difficulty passing urine.
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 this leaflet. You can also 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 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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 November 2015. 49069/GB
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