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Simply Supplements Valerian Sleep Aid Tablets

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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 60 coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd,

Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL71FX

#


Manufacturer for 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:

Simply Supplements,

Le Bourg, Forest, Guernsey, GY8 0AN.

UK Customer Care Line: +44 (0)845 863 0622 Email: enquiries@simplysupplements.co.uk

THR 23056/0006

Certification

Mark


This leaflet was prepared in August 2014.


B943 Valerian Sleep Aid Leaflet r5.indd 1

Filename:

B943 Valerian Sleep Aid Leaflet r5

Product Code:

B943

Width:

210mm

Height:

148mm

Printing Colours:

Black

Patient Information Leaflet

Simply Supplements™ Valerian Sleep Aid Tablets

Valerian root extract 150mg

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

It contains some important information about Simply Supplements™ Valerian Sleep Aid.

Keep this leaflet with the tablets.

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


What is in this leaflet

..page 1 ..page 2 ..page 2 ..page 3 ..page 3 ..page 4


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

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

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

4: Possible side-effects.....................................

5: After taking this product...............................

6: Further information.......................................

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.

Simply Supplements™ Valerian Sleep Aid 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.

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

DO NOT TAKE this product if you:

•    are pregnant or breastfeeding

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

•    are under 18 years of age

•    are 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).

Tell your doctor before taking this product if you are currently suffering from active liver disease.

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


•    abdominal cramps

•    nausea

If these persist for more than a few days, or become troublesome, stop taking this product.

Stop taking this product immediately if you experience any allergic skin reaction. 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.

3: How to take this product


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.


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. After taking this product


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.

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.

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 capsules in a cool dry place below 25° C.

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

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

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B943 Valerian Sleep Aid Leaflet r5.indd 2


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