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Nytol Original 25mg Tablets

View Patient Information Leaflet

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine.

This PIL is in PDF format and so you must have a PDF reader installed on your device to read it.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link above. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL 00036/0050.



Nytol Original 25mg Tablets

Package leaflet: Information for the user

Nytol®

Original 25mg Tablets

Diphenhydramine Hydrochloride

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.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse.

In this leaflet:

1.What Nytol is and what it is used for
2.What you need to know before you take Nytol
3.How to take Nytol
4.Possible side effects
5.How to store Nytol
6.Contents of the pack and other information

1. What Nytol is and what it is used for

Nytol 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, Nytol 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. Do not take Nytol for more than 2 weeks without consulting your doctor.

2. What you need to know before you take Nytol

Do not take Nytol:

  • if you have ever had an allergic reaction to diphenhydramine hydrochloride 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nytol:

  • 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.
  • If your sleeping difficulties persist, talk to your doctor or pharmacist.
  • Nytol may get less effective if you use it continuously.

Other medicines and Nytol

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs prescribed for depression) within the last two weeks, atropine (used to dilate pupils of the eyes) or medicines which make you drowsy. Avoid the use of other antihistamines including those used on your skin and in cold and cough medicines, while taking this medicine.

Nytol with food, drink and alcohol

Do not drink alcohol while using Nytol.

Pregnancy, breast feeding and fertility

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

Driving and using machines

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

Nytol contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor before taking this medicine.

3. How to take Nytol

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.

The recommended dose for adults and children aged 16 years and over: Swallow 2 tablets with water 20 minutes before you go to bed.

Not to be used by children under 16 years.

Not to be used by the elderly with confusion.

  • Do not take more than the recommended dose.
  • Do not take extra tablets if you wake up in the night.
  • Do not take for more than 2 weeks without consulting a doctor.

If you take more Nytol than you should Contact your doctor or casualty department.

If you forgot to take Nytol

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time as described in this leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nytol can have side effects, although not everybody gets them. Common (may affect up to 1 in 10 people)

  • The most common side effects are: tiredness, drowsiness, reduced attention, unsteadiness, dizziness or a dry mouth.

Not known (frequency cannot be estimated from the available data)

  • Allergic reactions (such as rash, shortness of breath and swelling), blurred vision, palpitations (feeling your heart beat) or irregular heartbeat.
  • Muscle twitching, convulsions, headache or pins and needles.
  • Also nausea (feeling sick), vomiting (being sick), thicker bronchial mucus and 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date (EXP) stated on the pack.

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.

Store in a dry place.

6. Contents of the pack and other information

What Nytol contains

  • The active substance: Each tablet contains Diphenhydramine Hydrochloride 25 mg.
  • The other ingredients are: Anhydrous lactose, microcrystalline cellulose, maize starch, stearic acid and silicon dioxide.

What Nytol looks like and contents of the pack

Packs of Nytol contain 4, 8, 16, 20 or 24 tablets. Not all pack sizes may be marketed.

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.

Manufacturer

Wrafton Laboratories Ltd
Wrafton
Braunton
North Devon
EX33 2DL
U.K.

This leaflet was last revised in July 2016.

LF03490B

G3U60FCJ1

Company Information

Omega Pharma Ltd

http://www.omegapharma.co.uk

Address : Omega Pharma Ltd, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK

Telephone : +44 (0)203 598 9603

Medical Information e-mail :

Customer Care direct line : +44 (0)1748 828 860

More information about this medicine

Legal categories

  • P

Active ingredients/generics

  • diphenhydramine hydrochloride

Summaries of Product Characteristics (SPCs):

© 2017 Datapharm Communications Ltd