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6: Further information

Each coated tablet of this product contains 150mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 450-900mg of Valerian root). Extraction solvent: ethanol 70%vlv.

This product also contains the following ingredients:

Liquid glucose, silica colloidal anhydrous, cellulose powdered, croscarmellose sodium, stearic acid, talc, sucrose, calcium carbonate (E170), acacia, tragacanth, white beeswax, carnauba wax, shellac.

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

Each tablet contains 35mg of glucose and 136mg of sucrose.

Each pack contains 30 or 60 coated tablets.

Registration holder for this product

Certification

Mark


Schwabe Pharma (UK) Ltd Alexander House, Mere Park, Dedmere Road Marlow, Bucks SL7 1FX

Manufacturer of this product

Wiewelhove GmbH,

Gildestrasse 39, 49477 Ibbenburen, Germany

Traditional herbal registration number: THR 23056/0006

If you would like further information about this product, please contact:

Schwabe Pharma (UK) Ltd Alexander House, Mere Park, Dedmere Road Marlow, Bucks SL7 1 FX

Telephone: 01628 401980 Email: info@schwabepharma.co.uk

This leaflet was revised in 02/2015

For a large print, Braille or audio version of this leaflet, call 01628 401980

o

Patient Information Leaflet

NiteHerb® Valerian Tablets

Valerian root extract 150mg

Please read this leaflet carefully before you start taking these tablets.

It contains some important information about NiteHerb Valerian Tablets.

Keep this leaflet with the tablets.

You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.


1: What this product is and what it is used for........................................page 1

2: Before you take this product................................................................page 2

3: How to take this product........................................................................page s

4: Possible Side-effects..............................................................................page 3

5: How to store this product......................................................................page 3

6: Further information................................................................................page 4

1: What this product is and what it is used for

This product is a traditional herbal medicinal product containing Valerian root.

Each coated tablet of this product contains 150mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 450-900mg of Valerian root). Extraction solvent: ethanol 70%vlv.

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

Adults and the elderly

Take 1 to 2 tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

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

Do not exceed the stated dose.


Side-effects


•    abdominal cramps    If these persist for more than a few days,

•    nausea    or become troublesome, stop taking this

product.


Other side-effects

Tell your doctor or pharmacist if you notice any other side-effect.

This product may cause drowsiness. If you are affected do not drive or operate machines.

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.


DO NOT TAKE this product if you are:

•    pregnant or breastfeeding

•    allergic to any of the ingredients (see section 6)

•    under 18 years of age

•    already taking a medicine which makes you drowsy

Tell your doctor before taking this product if you have an intolerance to some sugars (see section 6).

The effects of this product may be increased by alcohol. Excessive use of alcohol should therefore be avoided.

3: How to take this product

Like all medicines, this product can have side-effects. These are listed below.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if side-effects not mentioned in this leaflet occur.

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 and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time; it does not matter if you have missed a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

5: How to store this product

Do not use your tablets after the expiry date.

Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the tablets in a cool dry place below 25oC.

Keep the tablets out of the reach and sight of children.

Keep your tablets in the blister pack until it is time to take them.