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For relief of sleep disturbances due to symptoms of mild anxiety

image descriptionBonuit Sleep Aid

Valerian root extract 125mg and Passion Flower herb extract 250mg

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 upon 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 root (Valeriana officinalis L.) and Passion Flower herb (Passiflora incarnata L.)
Strength
125mg of dried Valerian root extract (equivalent to 375-750mg of Valerian root) and 250mg of dried Passion Flower herb extract (equivalent to 1250-1750 Passion Flower herb)
Dose
One to two tablets daily – 30 minutes before bedtime

Bonuit is a unique herbal remedy containing both Valerian and Passion Flower.

Valerian 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.

Passion Flower has natural calming properties. It is a climbing shrub native to South America, which can grow as high as 9m and is widely cultivated throughout Europe. It produces wonderful showy flowers with white petals surrounded by a crown of pink or violet filaments and large stamens with orange coloured sacs.

A licensed herbal medicine means a safe, high quality product

Bonuit Sleep Aid has 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:

  • Bonuit is a regulated herbal product and meets specific standards of safety and quality
  • Bonuit  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. Bonuit’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 Bonuit 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 foiled blister packed to retain its freshness and maintain its potency.

Taking one to two tablets daily, half an hour before bedtime, can help promote a good night’s sleep. For maximum benefit Bonuit should be taken for two weeks continuously. If symptoms worsen or do not improve after 4 weeks you should consult a qualified healthcare practitioner.

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 for more information about our company.

Also available from…

Holland & Barrett and other leading independent pharmacies and health food stores nationwide.

About Valerian

Valerian has been used as a medicinal herb since at least the time of ancient Greece and Rome. Passionflower is widely used in remedies for anxiety and nervous tension.

Visit Herbfacts.co.uk

About Passion Flower

Passionflower was valued by Native Americans mainly for its ability to heal bruises and wounds. Later herbal practitioners valued the plant for its calming, sedative and pain- relieving actions.

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 a Good Night’s Sleep co-written by GP and health writer Dr Sarah Brewer

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 and Passion Flower herb. Each coated tablet of this product contains 125mg of extract(as dry extract) from Valerian root (Valeriana officinalis L.) (3-6:1) (equivalent to 375-750mg of Valerian root). Extraction solvent: Ethanol 70%v|v; and 250mg of extract (as dry extract) from Passion Flower herb (Passiflora incarnata L) (5-7:1)(equivalent to 1250-1750mg of Passion Flower herb). Extraction solvent Ethanol 50%v|v.

Bonuit 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.

Before you take this product

DO NOT TAKE this product if you are:

  • under 18 years of age
  • pregnant or breast-feeding
  • allergic to any of the ingredients (see further information below)
  • already taking medicines for sleep or anxiety

Tell your doctor before taking this product if you have an intolerance to some sugars (see further information below)

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

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.

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.

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

There has been one report of tachycardia (increased heart beat) and one report of hypersensitivity (vasculitis) in patients using Passion Flower herb. Tell your doctor or pharmacist if you notice any other side-effect not mentioned in this leaflet.

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

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am–2pm Monday – Friday).

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 occur.

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. Do not store the tablets in a place where the temperatures go above 30°C.

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 125mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3-6:1) (equivalent to  375-750mg of Valerian root). Extraction solvent: Ethanol 70%v|v; and 250mg of extract (as dry extract) from Passion Flower herb (Passiflora incarnata L) (5-7:1) (equivalent to 1250-1750mg of Passion Flower herb). Extraction solvent Ethanol 50%v|v.

This product also contains the following ingredients:

Tablet core: Maltodextrin, silica colloidal anhydrous, cellulose powdered, croscarmellose sodium, magnesium stearate, stearic acid, talc, liquid glucose.

Coating: Sucrose, talc, calcium carbonate (E170), acacia, tragacanth, titanium dioxide (E171), liquid glucose, iron oxide hydrate (E172), hypromellose, 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 32mg of glucose and 187mg of sucrose.

Each pack contains 14, 15, 28 or 30 coated tablets.

Not all sizes may be marketed.

Registration holder for this product

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

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional herbal registration number: THR 23056/0009

If you would like further information about this product, please contact:
Schwabe Pharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks SL7 1FX
Telephone: 01628 401980  Email: info@schwabepharma.co.uk

This information was revised 01/2013

1 Name of the medicinal product

Bonuit® Sleep Aid tablets

2 Qualitative and quantitative composition

Each coated tablet contains:

125 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3-6:1) (equivalent to 375 – 750 mg of Valerian root).

Extraction solvent: Ethanol 70% v/v,

and

250mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5-7:1) (equivalent to 1250 – 1750 mg of Passion flower herb).

Extraction solvent: Ethanol 50% v/v

Excipients: each coated tablet contains 187 mg of sucrose and 32 mg of glucose.

For full list of excipients, see section 6.1

3 Pharmaceutical form

Coated tablet. Light-yellow, round, biconvex, smooth glossy surface.

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 one to two tablets half an hour before bedtime. Tablets should be swallowed whole with some water or other liquid. The tablets should not be chewed.

As treatment effects may not be apparent immediately, Bonuit 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.

Not for children or adolescents under 18 years.

4.3 Contraindications

Hypersensitivity to Valerian, Passion Flower or any of the excipients in the product.

The product should not be used in children or adolescents under 18 years of age.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product contains sucrose and glucose.

1 sugar-coated tablet contains max. 187 mg of sucrose and a max. 32 mg glucose.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products are available. 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 Bonuit 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. Therefore it should be avoided during pregnancy or lactation.

Studies 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, do not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known. One case of hypersensitivity (vasculitis) and one case of tachycardia have been reported with Passion Flower. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

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.

No cases of overdose have been reported for Passion Flower.

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

The preclinical toxicology data available are limited. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Tablet Core

  • Maltodextrin
  • Silica, colloidal anhydrous
  • Cellulose, powdered
  • Croscarmellose sodium
  • Magnesium stearate
  • Stearic acid
  • Talc
  • Liquid glucose, spray dried

Coating

  • Sucrose
  • Talc
  • Calcium carbonate E170
  • Acacia
  • Tragacanth
  • Titanium dioxide E 171
  • Liquid glucose, spray dried
  • Iron oxide hydrate E 172 (=yellow iron oxide)
  • Hypromellose
  • Capol 600 T.S. containing:
    • Beeswax, white
    • Carnauba wax
    • Shellac

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf life is 4 years

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Original packages contain 14, 15, 28 and 30 coated tablets

Bonuit® Sleep Aid tablets are packed in PVC/VDC- aluminium blisters and inserted into a carton.

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 1FX

8 Registration number

THR 23056/0006

9 Date of first registration authorisation

3rd March 2008

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