Sleepeezy Valerian tablets – patient leaflet, side effects, dosage

1. WHAT THE PRODUCT IS AND WHAT IT IS USED FOR

This product is a traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety based on traditional use only.

Each film-coated tablet contains 150mg of extract (as dry extract) from Valerian (Valeriana officinalis L.) root, equivalent to 750 – 900mg of Valerian root.

Extraction solvent: ethanol 70% v/v.

2. BEFORE YOU TAKE THIS PRODUCT

This product is not suitable for patients under 18 years of age.

Do not take this product if:

• you are allergic to Valerian or any of the other ingredients (see section 6 for more information). Take special care with this product:
• Do not exceed the recommended dose.

• The effect of this product may be increased by alcohol. Excessive use of alcohol should be avoided.

• This product contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

Taking other medicines.

Do not take this product if you are already taking a medicine that makes you sleepy or for anxiety. Pregnancy and breast-feeding.

Do not take this product if you are pregnant or breastfeeding, because there is no evidence that it is safe to do so.

Driving and using machines.

This product may make you feel sleepy or dizzy. If you are affected, do not drive or operate machines.

PATIENT INFORMATION LEAFLET

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

This medicine is available without prescription. However, you still need to use this product carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your doctor, pharmacist, or qualified healthcare practitioner if you need more information or advice.

You must contact a doctor if your symptoms worsen, or do not improve after four weeks.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Valerian root extract

Valerian Tablets SleepEezy_^®

In this leaflet:

3. HOW TO TAKE THIS PRODUCT

Adults and the elderly: swallow one to two tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening.

The effects of this product may not occur immediately. The tablets should therefore be taken continuously for 2-4 weeks.

Do not take if you are under 18 years of age.

Do not exceed stated dose.

If you take too much of this product (overdose).

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner. Take this leaflet with you.

If you forget to take this product.

Do not take a double dose to make up for a forgotten dose. Take the next dose when it becomes due. If you stop taking this product.

There are no reported adverse effects associated with stopping this product, but if you feel unwell talk to your doctor or qualified healthcare practitioner.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this product can have side-effects, although not everybody gets them. The following side effects have been reported:

• Nausea (feeling sick) • Dizziness
• Vomiting • Headache
• Abdominal Cramps • Nightmares or vivid dreams
• Abdominal Pain
• Diarrhoea

If these persist for more than a few days or become troublesome, stop taking this product. Speak to your doctor or pharmacist if you are at all concerned, if a side effect becomes serious, or you notice an effect not mentioned in this leaflet.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE THIS PRODUCT

Keep out of the reach and sight of children.

Do not store the tablets in a place where the temperature goes above 25°C. Store in the original packaging. Do not use this product after the expiry date which is stated on the base of the carton and the side of the bottle label after EXP. The expiry date refers to the last day of that month.

Do not use this product if you notice any discolouring or softening of the tablets, as this means they may have deteriorated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. FURTHER INFORMATION

Each tablet contains 150mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.). Equivalent to 750 – 900mg of Valerian root. Extraction solvent: Ethanol 70% v/v. It also contains other, non-active, ingredients. These ingredients are: calcium hydrogen phosphate; microcrystalline cellulose; colloidal silicon dioxide; croscarmellose sodium; magnesium stearate; lecithin; dextrose monohydrate; sodium citrate; dextrin. The product is available in packs of 30, 60 and 90 tablets (not all sizes may be marketed). Registration number: THR 33336/0006

Traditional Herbal Registration Holder and Manufacturer:

Natures Aid Ltd, St Georges Park, Preston, Lancs PR4 2DQ

Tel: 01772 686231

Email: sales@naturesaid.co.uk

This leaflet was last revised on 08/2023. Certification

Mark

For a large print, braille or audio version of this leaflet please call 01772 686231