SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Omega Passiflora Tablets

Natracalm

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains 71.4 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (7:1) Extraction solvent: Ethanol 60 % v/v

Each film coated tablet also contains 192 mg of lactose.

For full list of excipients (see Section 6.1)

3    PHARMACEUTICAL FORM

Film coated tablet.

White, circular biconvex, film coated tablet with “N” logo on one side.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

Adults and elderly:

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

Not recommended for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use).

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

Not recommended for use in children or adolescents under 18 years because data are not sufficient and medical advice should be sought.

Each tablet contains 192 mg of lactose. 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

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.

The effects of this product may be increased with alcohol. Therefore execssive alcohol use should be avoided.

4.6 Fertility, pregnancy and lactation

Safety during human pregnancy and lactation has not been established.

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

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. Patients who are affected should not drive or use machines.

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. The frequency is not known

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

4.9    Overdose

Symptomatic and supportive measures as appropriate.

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipient

Maltodextrin

Tablet core

Lactose

Microcrystalline Cellulose Magnesium Stearate Stearic Acid Tablet coat Talc

Colour Dispersion (containing Lactose, Hypromellose, Titanium Dioxide, Polyethylene Glycol 4000)

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4    Special precautions for storage

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

6.5    Nature and contents of container

Blister pack containing 12 tablets.

Blister pack containing 48 tablets.

Polypropylene container and cap containing 96 tablets.

Blister pack containing 100 tablets

The tablets are packaged into PVC/PVDC laminate with aluminium foil and inserted into a carton.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 02855/0036

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/03/2013

10 DATE OF REVISION OF THE TEXT

28/03/2013