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For relief of sleep disturbances

image descriptionNiteHerb Valerian Tablets

Valerian root extract 150mg

30 tablets

Traditionally used for:

  • Sleep
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A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of mild anxiety exclusively based on long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
Valerian (Valeriana officinalis L.)
Strength
150mg of dried root extract (equivalent to 450-900mg of Valerian root)
Dose
One tablet daily

A licensed herbal medicine means a safe, high quality product

NiteHerb Tablets have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • NiteHerb is a regulated herbal product and meets specific standards of safety and quality
  • NiteHerb is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. NiteHerb’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that NiteHerb has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade coated tablet is foil blister packed to retain its freshness and maintain its potency.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe to see why we’re the leaders in traditional herbal medicine, worldwide.

NiteHerb is one of the few herbal sleep remedies that contains Valerian. It has been used as a medicinal herb since at least the time of ancient Greece and Rome, and was used as a perfume in the sixteenth century. Valerian is a hardy perennial flowering plant, with heads of sweetly scented pink or white flowers.

Also available from…

Holland & Barrett, Ocado and other leading pharmacy and health food stores.

About Valerian

Valerian has been used as a medicinal herb since at least the time of ancient Greece and Rome.

Visit Herbfacts.co.uk

About Sleeping Difficulties

Most of us experience sleep problems from time to time. It may be just for a few days e.g. jet lag, or a few weeks e.g. exam stress. However, often it is linked to anxiety and lack of sleep makes the situation worse.

Sleep Guide

Download your FREE guide to ‘Overcoming sleep problems naturally’.

Take a health check

Check your sleeping pattern using this simple questionnaire and get some useful tips on what might help.

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%v|v.

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

Before you take this product

DO NOT TAKE this product if you are:

  • pregnant or breastfeeding
  • allergic to any of the ingredients (see product description below)
  • 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 product description below)

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

Driving and using machines

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

Tell your doctor or pharmacist about any other medicines you are taking, including any bought without a prescription.

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 TAKE MORE THAN THE LEAFLET TELLS YOU TO.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or 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 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.

Possible side-effects

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

Side-effects

  • abdominal cramps
  • nausea

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

Other side-effects

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

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.

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 25°C. Store in the original packaging.

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.

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%v|v.

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. Not all pack sizes may be marketed.

Registration holder for this product

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

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional herbal registration number: THR 23056/0006

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

SchwabePharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road Marlow, Bucks SL7 1PD
Telephone: 01628 401 980,br />Email:info@schwabepharma.co.uk

This leaflet was revised in 01/2017

1 Name of the medicinal product

  • Niteherb® Tablets
  • Boots Sleep Well Valerian Tablets
  • Lloydspharmacy Sleep Well Tablets
  • Higher Nature Valerian Sleep Aid Tablets
  • Simply Supplements Valerian Sleep Aid Tablets

2 Qualitative and quantitative composition

Each coated tablet contains: 150 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(equivalent to 450-900 mg of Valerian root). Also contains 35 mg of glucose and 136 mg of sucrose. (See Section 4.4 Special warnings and precautions for use.’) For full list of excipients, see section 6.1

3 Pharmaceutical form

Coated tablet. White, glossy, round, biconvex.

4 Clinical particulars

4.1 Therapeutic indications

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

4.2 Posology and method of administration

For oral short term use only. For 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. The tablets should not be chewed. As treatment effects may not be apparent immediately, NiteHerb should be taken for 2-4 weeks continuously. If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted. The use in children or adolescents under 18 years of age is not recommended (see Section 4.4 ‘Special warnings and precautions for use.’)

4.3 Contraindications

Hypersensitivity to the active ingredient or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose This product contains glucose. 1 coated tablet contains max. 35mg of glucose. This product contains sucrose. 1 coated tablet contains max. 136mg of sucrose or 0,21 carbohydrate units. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine The use in children or adolescents under 18 years of age is not recommended and medical advice should be sought. If symptoms worsen, or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolized by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution. The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6 Fertility, pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy and lactation is not recommended. Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 10 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive. After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

5 Pharmacological properties

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. Adequate tests on reproductive toxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

  • Liquid glucose, spray dried
  • Silica, colloidal anhydrous
  • Cellulose, powdered
  • Croscarmellose sodium
  • Stearic acid
  • Talc
  • Sucrose
  • Calcium carbonate E170
  • Acacia
  • Tragacanth
  • Titanium dioxide E 171
  • Capol 600 T.S. containing:
    • Beeswax, white
    • Carnauba wax
    • Shellac

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Original packages containing 30 or 60 Niteherb coated tablets. Original packages containing 30 coated tablets (Boots Sleep Well Valerian tablets, Lloydspharmacy Sleep Well tablets, Higher Nature Valerian Sleep Aid tablets) or 60 (ZipVit Valerian Sleep Aid tablets, Simply Supplements Valerian Sleep Aid tablets). The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet. Not all package sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 Registration holder

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1PD

8 Registration number

THR 23056/0006

9 Date of first authorisation/renewal of the authorisation

02/06/2017

Date of revision of the text

02/06/2017

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