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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

Natracalm

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
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

Passiflora Tablets / Natracalm

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredient	mg/tablet
Passiflora Incarnata Dry Extract (7:1)	71.4mg

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3. PHARMACEUTICAL FORM

Film Coated Tablet.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

A traditional herbal remedy for the symptomatic relief of nervous tension and the stress and strain of everyday life.

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4.2 Posology and method of administration

Method of Administration

Oral

Adults

One tablet to be taken three times a day with meals. If required a further tablet may be taken at bedtime.

Elderly Patients

Normal Adult Dose.

Children

Not recommended for children under 12 years of age.

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4.3 Contraindications

When taking anti-depressant medication.

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4.4 Special warnings and precautions for use

Keep out of reach of children.

Do not drink alcohol while taking Natracalm.

Do not exceed four tablets in 24 hours.

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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 Natracalm and taking Sedatives.

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4.6 Pregnancy and lactation

Usual precautions concerning the administration of any medicine during pregnancy and lactation should be observed.

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4.7 Effects on ability to drive and use machines

To be used as a sedative, do not drive or operate machinery while affected.

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4.8 Undesirable effects

None known or reported.

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4.9 Overdose

Symptomatic and supportive measures as appropriate.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacodynamic Effects

Sedative.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

During the last five years there has been one report of an Adverse Drug Reaction for Passiflora Incarnata, categorised under 'Hepato-biliary disorders, hepatitis (all forms), Hepatitis NOS'. We have no further details, however, to establish the cause of this reaction.

There have been no fatalities associated with Passiflora Incarnata.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Other Core Ingredients

Lactose

Microcrystalline Cellulose

Magnesium Stearate

Stearic Acid

Coating Ingredients

Purified Talc