What is a Patient Information Leaflet and why is it useful?

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. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: THR 01074/0002.


Nytol Herbal Simply Sleep One-A-Night Tablets

PATIENT INFORMATION LEAFLET

Nytol®

Herbal Simply Sleep One-A-Night TABLETS Valerian Root Extract 385mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However you still need to take Nytol Herbal Simply Sleep One-A-Night Tablets carefully to get the best results from it.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve after 4 weeks.
  • If any of the side effects become serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Nytol Herbal Simply Sleep One-A-Night Tablets are and what are they used for
2. Before you take Nytol Herbal Simply Sleep One-A-Night Tablets
3. How to take Nytol Herbal Simply Sleep One-A-Night Tablets
4. Possible side effects
5. How to store Nytol Herbal Simply Sleep One-A-Night Tablets
6. Further information

1. What Nytol Herbal Simply Sleep One-A-Night Tablets are and what are they used for

Nytol Herbal Simply Sleep One-A-Night Tablets are a traditional herbal medicinal product containing valerian root, used for the temporary relief of sleep disturbances, based on traditional use only.

2. Before you take Nytol Herbal Simply Sleep One-A-Night Tablets

Do not take this medicine if you:

  • are allergic to any of the ingredients (see Section 6 for a complete list of ingredients)
  • are already taking a medicine for sleep.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including:

  • medicines obtained without a prescription.

Taking Nytol Herbal Simply Sleep One-A-Night Tablets with food and drink

Alcohol may increase the sedative effect of Nytol Herbal Simply Sleep One-A-Night Tablets. Therefore, excessive alcohol consumption should be avoided whilst you are taking this medicine.

Pregnancy and breast-feeding

This medicine is not recommended for use during pregnancy or when breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine is used traditionally to help you sleep.

If you feel sleepy:

  • do not drive
  • do not operate any tools or machinery.

3. How to take Nytol Herbal Simply Sleep One-A-Night Tablets

The recommended dose is one tablet 30 to 60 minutes before bedtime. If necessary, one additional tablet may be taken earlier in the evening.

Not recommended for anyone under 18 years old.

As the effects of this product may not occur immediately, the tablets should be taken continuously for 2-4 weeks.

If you take more Nytol Herbal Simply Sleep One-A-Night Tablets than you should

Seek medical advice in the event of an overdose.

If you forget to take Nytol Herbal Simply Sleep One-A-Night Tablets

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice any of the following mild side effects:

  • nausea
  • abdominal cramps.

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 Yellow Card Scheme Website: 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 Herbal Simply Sleep One-A-Night Tablets

Keep out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the packaging.

Do not store above 25°C.

Do not use if foil strip is damaged.

Store in the original package.

6. Further Information

What Nytol Herbal Simply Sleep One-A-Night Tablets contain

The active substance per tablet is:

Dry extract from Valerian root 385mg (Valeriana officinalis L.) (equivalent to 1.54-1.93g of Valerian root) Extraction solvent: Ethanol 60% v/v Excipients: Maltodextrin, Colloidal Anhydrous Silica.

The other ingredients are:

Core: Croscarmellose Sodium, Magnesium Stearate, Silicified Microcrystalline Cellulose, Talc and Silicon Dioxide.

Coating: Hypromellose, Talc, Titanium Dioxide, Macrogol, Saccharine Sodium.

What Nytol Herbal Simply Sleep One-A-Night Tablets looks like and contents of the pack

Nytol Herbal Simply Sleep One-A-Night Tablets are white ovaloid film coated tablets. They are available in blister packs containing 21 tablets.

THR holder and Manufacturer is:

G.R. Lane Health Products Ltd.
Sisson Road
Gloucester
GL2 0GR
United Kingdom

This leaflet was revised: August 2016

THR: 01074/0002

P13112 603001

L636004/06 LF13844A