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Chefaro UK Ltd

4th Floor, Hamilton House, Mabledon Place, Bloomsbury, London, WC1H 9BB, UK

Telephone: +44 (0)207 554 8791
Medical Information e-mail: enquiries@chefaro.co.uk
Customer Care direct line: +44 (0)1748 828 860

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 24/02/2011

SPC	Natrasleep

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
Administrative Data
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Natrasleep

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredient	mg/tablet
* Hops Powder Extract 5:1	33.40
** Valerian Powder Extract 4:1	62.50

* Contains 35% glucose syrup

** Contains maltodextrin and silicon dioxide

For excipients, see 6.1.

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3. PHARMACEUTICAL FORM

Tablet

Light brown speckled oval biconvex film coated tablet.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

A herbal remedy traditionally used to encourage natural sleep.

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4.2 Posology and method of administration

Method of administration:

Oral

Adults: One to three tablets as required half an hour before retiring.

Children: Not recommended.

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

Inadvisable in depression or when taking anti-depressant medication.

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4.4 Special warnings and precautions for use

Keep out of the sight and reach of children.

Do not drink alcohol while taking Natrasleep.

Do not exceed three tablets in 24 hours.

If you continue to have sleeping problems consult your doctor.

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4.5 Interaction with other medicinal products and other forms of interaction

There is a potential increase in sedative effects for persons using Natrasleep and taking sedatives and/or alcohol.

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4.6 Pregnancy and lactation

As with other medicines its use is not recommended.

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4.7 Effects on ability to drive and use machines

As Natrasleep is intended to be used prior to sleep, do not drive or operate machinery while affected.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Provide supportive treatment.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC Code: NO5C M Other hypnotics and sedatives

Hops is a soporific.

Valerian acts as a sedative and relaxant.

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5.2 Pharmacokinetic properties

Both hops and valerian contain numerous compounds which are believed to be responsible for their sedative and soporific properties.

No published data can be found about their mode of therapeutic actions or their fate in the body.

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5.3 Preclinical safety data

Not known.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Core:

Calcium Phosphate Dibasic DC

Croscarmellose Sodium

Microcrystalline Cellulose (E460)

Magnesium Stearate Vegetable

Silicon Dioxide

Film coat (typical):

Hypromellose (E464)

Purified Talc

Green Dispersion*

Water

* contains Purified Water, Industrial Methylated Spirits, Hypromellose (E464), Copper Chlorophyllin (E141), Vegetable Carbon Black (E153) and Titanium Dioxide BP (E171).

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6.2 Incompatibilities

None known.

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6.3 Shelf life

24 months

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6.4 Special precautions for storage

None.

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6.5 Nature and contents of container

30 tablets in a securitainer.